Page last updated: 2024-12-06

tenofovir

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Description

tenofovir (anhydrous) : A member of the class of phosphonic acids that is methylphosphonic acid in which one of the methyl hydrogens is replaced by a [(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy group. An inhibitor of HIV-1 reverse transcriptase, the bis(isopropyloxycarbonyloxymethyl) ester (disoproxil ester) prodrug is used as the fumaric acid salt in combination therapy for the treatment of HIV infection. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID464205
CHEMBL ID483
CHEBI ID63625
SCHEMBL ID39724
MeSH IDM0254881

Synonyms (107)

Synonym
AC-760
AB01274787-01
gs-1278
pmpa-(r)
phosphonic acid, [[(1r)-2-(6-amino-9h-purin-9-yl)-1-methylethoxy]methyl]- & hippeastrum hybrid agglutinin( hha)
gna & tenofovir
phosphonic acid, [[(1r)-2-(6-amino-9h-purin-9-yl)-1-methylethoxy]methyl]- & galanthus nivalis agglutinin (gna)
hha & tenofovir
truvada
tenofovir gel (gs-1278)
pmpa gel
(r)-pmpa
[(1r)-2-(6-aminopurin-9-yl)-1-methyl-ethoxy]methylphosphonic acid
phosphonic acid, [[(1r)-2-(6-amino-9h-purin-9-yl)-1-methylethoxy]methyl]-
9-pmpa
tenofovir ,
147127-20-6
(((r)-2-(6-amino-9h-purin-9-yl)-1-methylethoxy)methyl)phosphonic acid, monohydrate
phosphonic acid, ((2-(6-amino-9h-purin-9-yl)-1-methylethoxy)methyl)-, (r)-
(r)-9-(phosphonomethoxypropyl)adenine
viread (prodrug for tenofovir)
phosphonic acid, (((1r)-2-(6-amino-9h-purin-9-yl)-1-methylethoxy)methyl)-
(((1r)-2-(6-amino-9h-purin-9-yl)-1-methylethoxy)methyl)phosphonic acid
(r)-9-(2-phosphonomethoxypropyl)adenine
gs 1275
9-(2-phosphonylmethoxypropyl)adenine
{[(1r)-2-(6-amino-9h-purin-9-yl)-1-methylethoxy]methyl}phosphonic acid
[(2r)-1-(6-aminopurin-9-yl)propan-2-yl]oxymethylphosphonic acid
pmp-a
chebi:63625 ,
gs-1275 ,
CHEMBL483
9-pmpa (tenofovir)
A808613
[(2r)-3-(6-aminopurin-9-yl)-2-methyl-propyl] dihydrogen phosphate
HMS3264H05
d,l-tenofovir
tenofovir gel
ec 604-571-2
tfv gel
unii-w4hfe001u5
(r)-(1-(6-amino-9h-purin-9-yl)propan-2-yloxy)methylphosphonic acid
tenofovir [usan:inn:ban]
w4hfe001u5 ,
[[(1r)-2(6-amino-9h-purin-9-yl)-1-methylethoxy]methyl]phosphonic acid
BCPP000049
anhydrous tenofovir
({[(2r)-1-(6-amino-9h-purin-9-yl)propan-2-yl]oxy}methyl)phosphonic acid
anh. tenofovir
tenofovir (anhydrous)
tenofovir (anh.)
tenofovir [mi]
tenofovir anhydrous
tenofovir [who-dd]
tenofovir [inn]
phosphonic acid, p-(((1r)-2-(6-amino-9h-purin-9-yl)-1-methylethoxy)methyl)-
AKOS015856701
AKOS015894941
BRD-K15891719-001-02-8
(r)-(((1-(6-amino-9h-purin-9-yl)propan-2-yl)oxy)methyl)phosphonic acid
CS-1609
HY-13910
phosphonic acid, p-[[(1r)-2-(6-amino-9h-purin-9-yl)-1-methylethoxy]methyl]-
AM20090678
SCHEMBL39724
KS-5021 ,
9-[(r)-2-(phosphonomethoxy)propyl]adenine
SGOIRFVFHAKUTI-ZCFIWIBFSA-N
(r)-9-[2-(phosphonomethoxy) propyl] adenine
T3006
Q-201787
(r)-[[2-(6-amino-9h-purin-9-yl)-1-methylethoxy]methyl]phosphonic acid
(r)-9-(2-phosphonoylmethoxypropyl)adenine
AB01274787_03
AB01274787_02
DTXSID9040132 ,
mfcd00943794
C17407
gs 1278
SR-01000883934-1
sr-01000883934
tenofovir, >=98% (hplc)
[2-(6-amino-9h-purin-9-yl)-1-methylethoxy]methylphosphonic acid
TFO ,
bdbm50450813
147127-20-6 (tenofovir)
tenofovir (viread)
DB14126
rac tenofovir
Q155954
CCG-267345
gtpl10948
[[(1r)-2(6-amino-9h-purin-9-yl)-1-methylethoxy]methyl]phosphonic acid;
NCGC00167535-16
tenofovir- bio-x
BT164455
EN300-123033
tenofovirum
(r)-9-(phosphonomethoxypropyl)adenine hydrate
(((1r)-2-(6-amino-9h-purin-9-yl)-1-methylethoxy)methyl)phosphonic acid, monohydrate
(r)-9-(2-phosphonomethoxypropyl)adenine hydrate
((((2r)-1-(6-amino-9h-purin-9-yl)propan-2-yl)oxy)methyl)phosphonic acid
tenofovir (usp-rs)
dtxcid7020132
tenofovir (mart.)
j05af07
Z1546616194

Research Excerpts

Toxicity

Tenofovir is safe and tolerable for both the mother and foetus. The dolutegravir, emtricitabine, and ten ofovir alafenamide fumarate regimen had the lowest frequency of composite adverse pregnancy outcomes and of neonatal deaths.

ExcerptReferenceRelevance
" All subjects tolerated dosing without significant adverse events."( Safety, pharmacokinetics, and antiretroviral activity of intravenous 9-[2-(R)-(Phosphonomethoxy)propyl]adenine, a novel anti-human immunodeficiency virus (HIV) therapy, in HIV-infected adults.
Barditch-Crovo, P; Cundy, KC; Deeks, SG; Hellmann, NS; Hwang, F; Kahn, JO; Lietman, PS; Rooney, JF; Safrin, S, 1998
)
0.3
" Grade III or IV adverse events were limited to laboratory abnormalities, including elevated creatine phosphokinase and liver function tests, which resolved with or without drug discontinuation and without sequelae."( Phase i/ii trial of the pharmacokinetics, safety, and antiretroviral activity of tenofovir disoproxil fumarate in human immunodeficiency virus-infected adults.
Barditch-Crovo, P; Coakley, DF; Coleman, RL; Collier, A; Deeks, SG; Kahn, JO; Kearney, BP; Lamy, PD; Lietman, PS; McGowan, I; Miller, M; Safrin, S, 2001
)
0.31
"Drug-associated dysfunction of mitochondria is believed to play a role in the etiology of the various adverse symptoms that occur in human immunodeficiency virus (HIV)-infected patients treated with the nucleoside reverse transcriptase inhibitors (NRTIs)."( Assessment of mitochondrial toxicity in human cells treated with tenofovir: comparison with other nucleoside reverse transcriptase inhibitors.
Birkus, G; Cihlar, T; Hitchcock, MJ, 2002
)
0.31
"The rise in didanosine concentrations in plasma when given with tenofovir raises concern for a high risk of toxic effects."( Pancreatic toxic effects associated with co-administration of didanosine and tenofovir in HIV-infected adults.
Blanco, JL; de Lazzari, E; García, F; Gatell, JM; Larrousse, M; Mallolas, J; Martínez, E; Milinkovic, A; Miró, JM; Ravasi, G,
)
0.13
" Twelve subjects in the QD Group (14%) discontinued treatment due to adverse events, mainly nevirapine-related hepatitis (6%)."( Safety and efficacy of once-daily didanosine, tenofovir and nevirapine as a simplification antiretroviral approach.
Burger, D; Clotet, B; Galindos, MJ; Gel, S; Miralles, C; Moltó, J; Muñoz-Moreno, JA; Negredo, E; Pedrol, E; Puig, J; Ribera, E; Rodriguez Fumaz, C; Rodríguez, E; Ruiz, L; Viciana, P; Videla, S, 2004
)
0.32
" These data have now provided a clear and clinically relevant understanding of the individual profiles of drugs within the nucleoside analogue reverse transcriptase inhibitor , HIV protease inhibitor and non-nucleoside analogue reverse transcriptase inhibitor drug classes, and have provided a rational basis for assessing and monitoring these adverse effects in clinical practice."( Adverse effects of antiretroviral therapy for HIV infection: a review of selected topics.
Mallal, S; Nolan, D; Reiss, P, 2005
)
0.33
"Despite the recent publication of case reports describing various manifestations of tenofovir-related nephrotoxicity, data regarding the incidence of and risk factors for this adverse effect are currently lacking."( Incidence of and risk factors for tenofovir-induced nephrotoxicity: a retrospective cohort study.
Antoniou, T; Chirhin, S; Gough, K; Govan, V; Loutfy, M; Raboud, J; Rachlis, A; Yoong, D, 2005
)
0.33
" Although 92% of the women reported at least one adverse event, the majority were mild (87%) and involved the genitourinary tract (70%)."( Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women.
El-Sadr, WM; Eshleman, SH; Gai, F; Hendrix, C; Justman, J; Kwiecien, A; Maslankowski, LA; Mâsse, B; Mayer, KH; Morrow, K; Rooney, JF; Soto-Torres, L, 2006
)
0.33
" Together, these in vitro results indicate that combination with other antiretrovirals does not significantly increase the toxic potential of TFV in RPTECs."( In vitro cytotoxicity and mitochondrial toxicity of tenofovir alone and in combination with other antiretrovirals in human renal proximal tubule cells.
Alvarez, ML; Cihlar, T; Cordobilla, B; Domingo, JC; Domingo, P; Giralt, M; Guallar, J; López-Dupla, M; Sánchez de la Rosa, R; Saumoy, M; Torres, F; Vidal, F; Villarroya, F, 2006
)
0.33
" The US Food and Drug Administration's Adverse Event Reporting System was searched for reports of nephrolithiasis in HIV-infected patients taking an atazanavir-based regimen."( Atazanavir-associated nephrolithiasis: cases from the US Food and Drug Administration's Adverse Event Reporting System.
Birnkrant, DB; Chan-Tack, KM; Struble, KA; Truffa, MM, 2007
)
0.34
"To assess adverse events associated with antiretroviral regimens for human immunodeficiency virus (HIV) postexposure prophylaxis (PEP), with a particular focus on the treatment combination of zidovudine, lamivudine, and tenofovir (ZDV-3TC-TDF)."( Assessment of adverse events associated with antiretroviral regimens for postexposure prophylaxis for occupational and nonoccupational exposures to prevent transmission of human immunodeficiency virus.
Antenozzi, S; Hulse, S; Luque, A; Shahzad, U; Smith, B; Tanzman, E; Wang, D, 2007
)
0.34
"Retrospective chart review for individuals who received HIV PEP for occupational and nonoccupational exposure, and multivariate analyses to identify risk factors for noncompletion of PEP and adverse events associated with PEP."( Assessment of adverse events associated with antiretroviral regimens for postexposure prophylaxis for occupational and nonoccupational exposures to prevent transmission of human immunodeficiency virus.
Antenozzi, S; Hulse, S; Luque, A; Shahzad, U; Smith, B; Tanzman, E; Wang, D, 2007
)
0.34
"Preventive treatment of adverse events may be necessary to ensure completion of HIV PEP."( Assessment of adverse events associated with antiretroviral regimens for postexposure prophylaxis for occupational and nonoccupational exposures to prevent transmission of human immunodeficiency virus.
Antenozzi, S; Hulse, S; Luque, A; Shahzad, U; Smith, B; Tanzman, E; Wang, D, 2007
)
0.34
"A tenofovir DF expanded access program (EAP) was initiated in 2001; safety data were examined from this program and from the manufacturer's database, which contained reports of all postmarketing adverse drug reactions received up to 30 April 2005."( The safety of tenofovir disoproxil fumarate for the treatment of HIV infection in adults: the first 4 years.
Bischofberger, N; Chen, SS; Clotet, B; Cooper, DA; Curtis, S; Gazzard, B; Katlama, C; Lange, J; Lazzarin, A; Montaner, JS; Nelson, MR; Rooney, JF; Schewe, K; Smith, S; Wyatt, C, 2007
)
0.34
"The EAP enrolled 10 343 patients; serious adverse events (SAEs) were reported in 631 (6%)."( The safety of tenofovir disoproxil fumarate for the treatment of HIV infection in adults: the first 4 years.
Bischofberger, N; Chen, SS; Clotet, B; Cooper, DA; Curtis, S; Gazzard, B; Katlama, C; Lange, J; Lazzarin, A; Montaner, JS; Nelson, MR; Rooney, JF; Schewe, K; Smith, S; Wyatt, C, 2007
)
0.34
"The SCOLTA Project is a prospective, observational, multicenter study involving 25 infectious disease departments in Italy created to assess the incidence of severe adverse events in patients receiving new antiretroviral drugs."( Tenofovir renal safety in HIV-infected patients: results from the SCOLTA Project.
Bonfanti, P; Carradori, S; De Socio, GV; Grosso, C; Landonio, S; Madeddu, G; Marconi, P; Melzi, S; Miccolis, S; Mura, MS; Penco, G; Quirino, T; Ricci, E; Rosella, E, 2008
)
0.35
" No patient discontinued due to renal adverse events."( The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naïve HIV-1-infected patients.
Cassetti, I; Cheng, AK; Enejosa, J; Etzel, A; Madruga, JV; Suleiman, JM; Zhong, L,
)
0.13
" TDF treatment was not associated with renal adverse events or limb fat loss in antiretroviral-naïve patients."( The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naïve HIV-1-infected patients.
Cassetti, I; Cheng, AK; Enejosa, J; Etzel, A; Madruga, JV; Suleiman, JM; Zhong, L,
)
0.13
"Simplification to a once-daily regimen containing TDF, 3TC, and EFV is virologically and immunologically effective, well-tolerated, and safe with benefits in the lipid profile in the majority of patients."( Effectiveness and safety of simplification therapy with once-daily tenofovir, lamivudine, and efavirenz in HIV-1-infected patients with undetectable plasma viral load on HAART.
Aguirrebengoa, K; Alvarez, ML; Arazo, P; Arrizabalaga, J; Chocarro, A; Echevarría, S; Fariñas, MC; Ferrer, P; García-Palomo, D; Iribarren, JA; Labarga, P; Letona, S; Muñoz-Sánchez, MJ; Oteo, JA; Peralta, G; Pinilla, J; Uriz, J,
)
0.13
" All other combinations exhibited more pronounced adverse effects on mitochondrial endpoints."( Mitochondrial toxicity of tenofovir, emtricitabine and abacavir alone and in combination with additional nucleoside reverse transcriptase inhibitors.
Melkaoui, K; Setzer, B; Venhoff, N; Walker, UA, 2007
)
0.34
"Changing from drugs that have significant mitochondrial toxicity to less toxic compounds may be of benefit in human immunodeficiency virus (HIV)-positive patients who receive highly active antiretroviral therapy."( Effects of the change from Stavudine to tenofovir in human immunodeficiency virus-infected children treated with highly active antiretroviral therapy: studies on mitochondrial toxicity and thymic function.
Cossarizza, A; Dentone, C; Di Biagio, A; Esposito, R; Ferraresi, R; Mussini, C; Nasi, M; Nemes, E; Pinti, M; Repetto, E; Rosso, R; Viscoli, C, 2008
)
0.35
" A relatively uncommon adverse effect of this drug is Fanconi syndrome."( Tenofovir-associated Fanconi syndrome: review of the FDA adverse event reporting system.
Gupta, SK, 2008
)
0.35
" Symptoms disappeared after discontinuation of antiretroviral therapy and we suggest that syncope may be a side effect to one of the three antiretroviral drugs that has not been described previously."( Syncope as a probable side effect to combination antiretroviral therapy initiated during primary HIV-1 infection.
Larsen, CS; Lybaek, D, 2008
)
0.35
"100 patients were evaluated; 17 patients discontinued early including 6 for adverse events."( Evaluation of efficacy, safety, pharmacokinetics, and adherence in HIV-1-infected, antiretroviral-naïve patients treated with ritonavir-boosted atazanavir plus fixed-dose tenofovir DF/emtricitabine given once daily.
Cohen, C; Ebrahimi, R; Elion, R; Fisher, A; Flaherty, J; Kearney, B; McColl, D; Ortiz, R; Reddy, YS; Ruane, P; Ward, D,
)
0.13
"In two randomized, controlled trials, small differences in glomerular filtration rate over time were noted but no clinically relevant renal disease or adverse events were demonstrated in antiretroviral-naive patients treated with TDF through 144 weeks."( The 3-year renal safety of a tenofovir disoproxil fumarate vs. a thymidine analogue-containing regimen in antiretroviral-naive patients.
Chen, SS; Cheng, AK; DeJesus, E; Enejosa, JV; Gallant, JE; Pozniak, AL; Winston, JA, 2008
)
0.35
" Although frequency of severe renal toxicity was higher than has been reported in the literature, it was safe in patients with no comorbid renal conditions."( Effectiveness and safety of generic fixed-dose combination of tenofovir/emtricitabine/efavirenz in HIV-1-infected patients in Western India.
Bele, V; Dravid, A; Gupte, N; Joshi, K; Pujari, S, 2008
)
0.35
"To identify adverse effects of tenofovir use during pregnancy in HIV-infected women and their infants."( Adverse effects of tenofovir use in HIV-infected pregnant women and their infants.
Hayes, E; Mondy, K; Nurutdinova, D; Onen, NF; Overton, ET, 2008
)
0.35
" Each woman's chart was reviewed for clinical data and adverse events during the pregnancy; each infant's chart was reviewed for growth parameters from birth to 12 months."( Adverse effects of tenofovir use in HIV-infected pregnant women and their infants.
Hayes, E; Mondy, K; Nurutdinova, D; Onen, NF; Overton, ET, 2008
)
0.35
"The use of nucleoside analogues, especially that of thymidine analogues, depletes mitochondrial DNA, which is the cause of many of the adverse effects of this family of antiretroviral drugs, among them lipodystrophy."( [Tenofovir as a strategy to avoid or limit adverse effects].
Portilla, J, 2008
)
0.35
"Lipoatrophy is the most stigmatizing side effect of stavudine therapy."( Improvements in subcutaneous fat, lipid profile, and parameters of mitochondrial toxicity in patients with peripheral lipoatrophy when stavudine is switched to tenofovir (LIPOTEST study).
Castella, E; Crespo, M; Curran, A; Del Saz, SV; Diaz, M; Falcó, V; Feijoo, M; García-Arumí, E; Ocaña, I; Pahissa, A; Paradiñeiro, JC; Planas, M; Puiggròs, C; Ribera, E; Sauleda, S; Sureda, D,
)
0.13
" Significantly fewer drug-related clinical adverse events occurred in patients on raltegravir (n=124 [44."( Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial.
Barnard, RJ; Berger, DS; DeJesus, E; DiNubile, MJ; Lazzarin, A; Leavitt, R; Lennox, JL; Madruga, JV; Miller, MD; Nguyen, BY; Pollard, RB; Rodgers, AJ; Sklar, P; Williams-Diaz, A; Xu, X; Zhao, J, 2009
)
0.35
" Data on CD4 cell count, HIV viral load, metabolic parameters and adverse events of grade 3-4 are collected through an on-line system every six months."( Efficacy and safety of boosted and unboosted atazanavir-containing antiretroviral regimens in real life: results from a multicentre cohort study.
Abeli, C; Bonfanti, P; Gianelli, E; Giuntini, R; Grosso, C; Madeddu, G; Marconi, P; Martinelli, C; Palvarini, L; Pellicano, G; Penco, G; Quirino, T; Ricci, E; Vichi, F, 2010
)
0.36
"Our results suggest that, in unselected clinical settings, ATV-containing antiretroviral therapy is durable and safe in both its formulations."( Efficacy and safety of boosted and unboosted atazanavir-containing antiretroviral regimens in real life: results from a multicentre cohort study.
Abeli, C; Bonfanti, P; Gianelli, E; Giuntini, R; Grosso, C; Madeddu, G; Marconi, P; Martinelli, C; Palvarini, L; Pellicano, G; Penco, G; Quirino, T; Ricci, E; Vichi, F, 2010
)
0.36
" Treatment-related gastrointestinal adverse events were greater in patients taking lopinavir/ritonavir."( Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study.
Absalon, J; Andrade-Villanueva, J; Chetchotisakd, P; Corral, J; David, N; Echevarria, J; Lataillade, M; Mancini, M; McGrath, D; Molina, JM; Moyle, G; Percival, L; Wirtz, V; Yang, R, 2010
)
0.36
" Atazanavir/ritonavir had a better lipid profile and fewer gastrointestinal adverse events than lopinavir/ritonavir."( Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study.
Absalon, J; Andrade-Villanueva, J; Chetchotisakd, P; Corral, J; David, N; Echevarria, J; Lataillade, M; Mancini, M; McGrath, D; Molina, JM; Moyle, G; Percival, L; Wirtz, V; Yang, R, 2010
)
0.36
" The adverse event rate was similar between arms (except drug hypersensitivity, reported more in the abacavir/lamivudine arm)."( Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study.
Branco, T; Cavassini, M; Domingo, P; Fisher, M; Givens, N; Khuong-Josses, MA; Lim, ML; Moyle, GJ; Norden, AG; Pearce, HC; Podzamczer, D; Post, FA; Rieger, A; Stellbrink, HJ; Vavro, C, 2010
)
0.36
" No increase in the overall adverse event rates was observed."( Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women.
Abdool Karim, Q; Abdool Karim, SS; Arulappan, N; Baxter, C; Frohlich, JA; Gengiah, TN; Grobler, AC; Kharsany, AB; Maarschalk, S; Mansoor, LE; Mlisana, KP; Mlotshwa, M; Morris, L; Omar, Z; Sibeko, S; Taylor, D, 2010
)
0.36
" Through 96 weeks, 77 subjects from each group discontinued prematurely; adverse or HIV-related events contributed to discontinuation of 36 subjects overall, with no significant differences between treatment groups."( Short communication: Comparable safety and efficacy with once-daily versus twice-daily dosing of lopinavir/ritonavir tablets with emtricitabine + tenofovir DF in antiretroviral-naïve, HIV type 1-infected subjects: 96 week final results of the randomized t
Bernstein, B; Cohen, D; da Silva, B; Fredrick, L; González-García, J; Johnson, M; Naylor, C; Sloan, L, 2010
)
0.36
" Renal biopsy revealed toxic acute tubular necrosis, with distinctive proximal tubular eosinophilic inclusions representing giant mitochondria visible by light microscopy."( Tenofovir nephrotoxicity: acute tubular necrosis with distinctive clinical, pathological, and mitochondrial abnormalities.
D'Agati, VD; Herlitz, LC; Markowitz, GS; Mohan, S; Radhakrishnan, J; Stokes, MB, 2010
)
0.36
" There were no significant adverse effects from these drugs and no alteration of renal function during the follow-up period."( Efficacy and safety of entecavir and/or tenofovir for prophylaxis and treatment of hepatitis B recurrence post-liver transplant.
de la Cruz-Lombardo, J; Jiménez-Pérez, M; Lozano-Rey, JM; Mongil Poce, L; Rodrigo-López, JM; Sáez-Gómez, AB, 2010
)
0.36
"Therapy with ETV and/or TDF seems to be efficient and safe when used in the prophylaxis and treatment of HBV recurrence after liver transplantation."( Efficacy and safety of entecavir and/or tenofovir for prophylaxis and treatment of hepatitis B recurrence post-liver transplant.
de la Cruz-Lombardo, J; Jiménez-Pérez, M; Lozano-Rey, JM; Mongil Poce, L; Rodrigo-López, JM; Sáez-Gómez, AB, 2010
)
0.36
" Ten percent (13/123) of the subjects discontinued the treatment due to adverse events."( Evaluation of the safety and effectiveness of nevirapine plus coformulated tenofovir/emtricitabine as first-line therapy in routine clinical practice.
Blanch, J; Cervantes, M; Domingo, P; Ferrer, E; Knobel, H; Llibre, JM; Mallolas, J; Pedrol, E; Vallecillo, G, 2012
)
0.38
" All regimens were safe and well tolerated."( Pharmacokinetics and safety of single-dose tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their infants.
Bardeguez, A; Cotter, A; Fiscus, SA; Flynn, PM; Heckman, B; Huang, S; Jean-Philippe, P; Kearney, B; Mirochnick, M; Mofenson, LM; Purswani, M; Robbins, B; Rodman, J; Rooney, JF; Shapiro, DE; Thorpe, E; Van Rompay, KK; Watts, DH, 2011
)
0.37
" The occurrence of treatment-related, moderate/severe adverse events was similar between treatment groups through 48 weeks of treatment."( Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naïve subjects: the progress study, 48-week results.
Fredrick, LM; Gathe, J; Lawal, A; Nilius, AM; Podsadecki, TJ; Pulido, F; Reynes, J; Soto-Malave, R; Tian, M,
)
0.13
"US-based prospective cohort study of HEU children to examine potential adverse effects of prenatal TDF exposure."( Safety of tenofovir use during pregnancy: early growth outcomes in HIV-exposed uninfected infants.
DiMeglio, LA; Griner, R; Hazra, R; Jacobson, DL; Kacanek, D; Mendez, H; Miller, T; Mofenson, LM; Rich, KC; Seage, GR; Siberry, GK; Tassiopoulos, K; Watts, DH; Williams, PL, 2012
)
0.38
" Several studies suggest that NAs long-term administration have been associated with low rates of serious adverse events (AEs), including lactic acidosis, renal function impairment, osteopenia and osteoporosis."( Safety of long-term nucleos(t)ide treatment in chronic hepatitis B.
Ridruejo, E; Silva, MO, 2012
)
0.38
" There was no significant increase of any genital adverse event in the tenofovir group."( Safety of tenofovir gel, a vaginal microbicide, in South African women: results of the CAPRISA 004 Trial.
Baxter, C; Frolich, J; Grobler, A; Karim, QA; Karim, SS; Kharsany, AB; Maarshalk, S; Mansoor, LE; Miya, N; Mlisana, K; Sibeko, S; Sokal, DC; Yende-Zuma, N, 2013
)
0.39
" With the increased realization of receptive anal intercourse among heterosexual couples often in conjunction with vaginal intercourse, having a safe and effective microbicide for both mucosal sites is critical."( Safety and efficacy of tenofovir/IQP-0528 combination gels - a dual compartment microbicide for HIV-1 prevention.
Buckheit, KW; Buckheit, RW; Dezzutti, CS; Gwozdz, G; Mahalingam, A; Shetler, C; Ugaonkar, SR, 2012
)
0.38
" Safety endpoints included clinical adverse events (AEs) and mucosal safety parameters."( RMP-02/MTN-006: A phase 1 rectal safety, acceptability, pharmacokinetic, and pharmacodynamic study of tenofovir 1% gel compared with oral tenofovir disoproxil fumarate.
Anton, PA; Bumpus, NN; Carballo-Diéguez, A; Cranston, RD; Cumberland, WG; Dennis, R; Elliott, J; Hendrix, CW; Janocko, L; Ju, C; Kashuba, A; Khanukhova, E; Mauck, C; McGowan, I; Richardson-Harman, N, 2012
)
0.38
" The rings were safe and exhibited sustained release at controlled rates over 28 days."( Safety and pharmacokinetics of intravaginal rings delivering tenofovir in pig-tailed macaques.
Baum, MM; Butkyavichene, I; Cortez, C; Gilman, J; Guenthner, P; Hendry, RM; Holder, A; Kennedy, S; Kopin, E; Malone, AM; Martin, A; McNicholl, J; Mitchell, J; Moss, JA; Nguyen, C; Pau, CP; Sinha, P; Smith, JM; Smith, TJ; Srinivasan, P, 2012
)
0.38
" Laboratory test results, clinical outcomes, and drug-related adverse events were compared among groups."( Long-term efficacy and safety of lamivudine, entecavir, and tenofovir for treatment of hepatitis B virus-related cirrhosis.
Akbal, E; Akin, E; Alkan, E; Ataseven, H; Aygün, C; Başar, O; Baykal, O; Coban, S; Demir, M; Gülşen, MT; Ibiş, M; Koçkar, MC; Köklü, S; Köksal, AŞ; Küçükazman, M; Nadir, I; Ozdil, K; Pürnak, T; Tuna, Y; Yildirim, B; Yüksel, I; Yüksel, O, 2013
)
0.39
"Tenofovir and entecavir are effective and safe for long-term use in patients with compensated or decompensated cirrhosis from HBV infection."( Long-term efficacy and safety of lamivudine, entecavir, and tenofovir for treatment of hepatitis B virus-related cirrhosis.
Akbal, E; Akin, E; Alkan, E; Ataseven, H; Aygün, C; Başar, O; Baykal, O; Coban, S; Demir, M; Gülşen, MT; Ibiş, M; Koçkar, MC; Köklü, S; Köksal, AŞ; Küçükazman, M; Nadir, I; Ozdil, K; Pürnak, T; Tuna, Y; Yildirim, B; Yüksel, I; Yüksel, O, 2013
)
0.39
" Overall incidences of all-causality treatment-related or grade 3/4 adverse events (AEs) or AE-related discontinuations were lower with lersivirine than with efavirenz, and serious AEs occurred at similar rates across treatment groups."( Efficacy and safety of lersivirine (UK-453,061) versus efavirenz in antiretroviral treatment-naive HIV-1-infected patients: week 48 primary analysis results from an ongoing, multicenter, randomized, double-blind, phase IIb trial.
Cooper, DA; Craig, C; Goodrich, J; Kaplan, R; Lazzarin, A; Mori, J; Pozniak, A; Pulik, P; Tawadrous, M; Valdez, H; Vernazza, P; Wang, C; Weil, E, 2013
)
0.39
" No severe adverse events associated with entecavir or tenofovir were reported."( Efficacy and safety of entecavir and/or tenofovir in hepatitis B compensated and decompensated cirrhotic patients in clinical practice.
Arenas, J; Canós, AP; Díaz-Sánchez, A; Jiménez, M; Miquel, M; Núñez, Ó; Trapero-Marugán, M,
)
0.13
"Overall, 71 of 281 raltegravir recipients (25%) and 98 of 282 efavirenz recipients (35%) discontinued the study; discontinuations due to adverse events occurred in 14 (5%) and 28 (10%) patients in the respective groups."( Durable efficacy and safety of raltegravir versus efavirenz when combined with tenofovir/emtricitabine in treatment-naive HIV-1-infected patients: final 5-year results from STARTMRK.
DeJesus, E; DiNubile, MJ; Leavitt, R; Lennox, JL; Miller, M; Nguyen, BY; Rockstroh, JK; Rodgers, AJ; Saag, MS; Sklar, P; Teppler, H; Walker, ML; Wan, H; Yazdanpanah, Y, 2013
)
0.39
" Over the entire study, fewer patients experienced neuropsychiatric and drug-related adverse events in the raltegravir group than in the efavirenz group."( Durable efficacy and safety of raltegravir versus efavirenz when combined with tenofovir/emtricitabine in treatment-naive HIV-1-infected patients: final 5-year results from STARTMRK.
DeJesus, E; DiNubile, MJ; Leavitt, R; Lennox, JL; Miller, M; Nguyen, BY; Rockstroh, JK; Rodgers, AJ; Saag, MS; Sklar, P; Teppler, H; Walker, ML; Wan, H; Yazdanpanah, Y, 2013
)
0.39
" HIV serostatus, clinical and laboratory adverse events (AEs), adherence (pill count, Medication Event Monitoring System, and self-report), and sexual and other sociobehavioral data were assessed at 3-month intervals for 24 months."( Randomized trial of clinical safety of daily oral tenofovir disoproxil fumarate among HIV-uninfected men who have sex with men in the United States.
Ackers, ML; Buchbinder, SP; Chillag, KL; Collins, BM; Grant, RM; Grohskopf, LA; Gvetadze, R; Liu, AY; Mayer, KH; Oʼhara, B; Pathak, SR; Paxton, LA; Rose, CE; Thompson, M, 2013
)
0.39
" There were no significant differences between the numbers of ≥ Grade 2 adverse events across the arms of the study."( A phase 1 randomized, double blind, placebo controlled rectal safety and acceptability study of tenofovir 1% gel (MTN-007).
Andrew, P; Ayudhya, RK; Carballo-Dieguez, A; Cranston, RD; Dai, JY; Hladik, F; Hoesley, C; Janocko, L; Mayer, K; McGowan, I; Piper, J, 2013
)
0.39
"The reduced glycerin formulation of tenofovir 1% gel was safe and well tolerated rectally and should be advanced to Phase 2 development."( A phase 1 randomized, double blind, placebo controlled rectal safety and acceptability study of tenofovir 1% gel (MTN-007).
Andrew, P; Ayudhya, RK; Carballo-Dieguez, A; Cranston, RD; Dai, JY; Hladik, F; Hoesley, C; Janocko, L; Mayer, K; McGowan, I; Piper, J, 2013
)
0.39
" We compared rates of upper digestive serious adverse events (sAEs) between TDF/FTC+EFV and TDF/FTC+ZDV patients during the first six months of treatment."( Early upper digestive tract side effects of zidovudine with tenofovir plus emtricitabine in West African adults with high CD4 counts.
Anglaret, X; Bohoussou, F; Carrou, JL; Danel, C; Eholie, SP; Gabillard, D; Konan, R; Moh, R; Ouattara, E; Peytavin, G, 2013
)
0.39
" We suggest that further early prescriptions of TDF+XTC+ZDV should be carefully monitored and that whenever possible, the rate of early upper digestive adverse events should be compared to that occurring in-patients taking other drug regimens."( Early upper digestive tract side effects of zidovudine with tenofovir plus emtricitabine in West African adults with high CD4 counts.
Anglaret, X; Bohoussou, F; Carrou, JL; Danel, C; Eholie, SP; Gabillard, D; Konan, R; Moh, R; Ouattara, E; Peytavin, G, 2013
)
0.39
"There were no colposcopic findings or adverse events attributable to either applicator."( A randomized, comparative safety study of a prefilled plastic and user-filled paper applicator with candidate microbicide tenofovir 1% gel.
Brache, V; Callahan, M; Cochon, L; Cohen, JA; Foster, J; Schwartz, J, 2013
)
0.39
" Tenofovir gel, when used intermittently, was safe to use in women with HBV infection."( Safety of coitally administered tenofovir 1% gel, a vaginal microbicide, in chronic hepatitis B virus carriers: results from the CAPRISA 004 trial.
Abdool Karim, Q; Abdool Karim, SS; Baxter, C; Tshabalala, P; Yende-Zuma, N, 2013
)
0.39
"Combined prophylaxis with TDF/ETV nucleoside plus nucleotide analogs and cessation of immunoglobulin after liver transplantation in chronic hepatitis B is safe and effective."( Nucleoside plus nucleotide analogs and cessation of hepatitis B immunoglobulin after liver transplantation in chronic hepatitis B is safe and effective.
Braat, AE; Claas, EC; Coenraad, MJ; Knoester, M; van Hoek, B; Vossen, AC; Wesdorp, DJ, 2013
)
0.39
" We assessed adherence (compared between groups and with nonstudy controls) and clinical and adverse events at weeks 1, 2 and 4, and efficacy at week 12."( Raltegravir-emtricitabine-tenofovir as HIV nonoccupational post-exposure prophylaxis in men who have sex with men: safety, tolerability and adherence.
Carr, A; Ingersoll, A; McAllister, J; McNulty, A; Read, P; Tong, WW, 2014
)
0.4
" Although information is limited, TDF appears to be safe during pregnancy."( Safety of tenofovir during pregnancy for the mother and fetus: a systematic review.
Bulterys, M; Ellington, S; Kourtis, AP; Legardy-Williams, J; Wang, L, 2013
)
0.39
"6% interrupted cART due to adverse events,19."( Safety, efficacy, and persistence of emtricitabine/tenofovir versus other nucleoside analogues in naive subjects aged 50 years or older in Spain: the TRIP study.
Aguirrebengoa, K; Arazo, P; Blanco, JR; Caro-Murillo, AM; Castaño, MA; Domingo, P; Ferrer, P; Gómez-Sirvent, JL; Olalla, J; Pedrol, E; Portilla, J; Pulido, F; Riera, M; Romero-Palacios, A; Vera, F,
)
0.13
"In a population of HIV-infected subjects who were ≥50 years old, our study suggests that the use of FTC/TDF is generally safe and effective, with a longer persistence as compared to other regimens."( Safety, efficacy, and persistence of emtricitabine/tenofovir versus other nucleoside analogues in naive subjects aged 50 years or older in Spain: the TRIP study.
Aguirrebengoa, K; Arazo, P; Blanco, JR; Caro-Murillo, AM; Castaño, MA; Domingo, P; Ferrer, P; Gómez-Sirvent, JL; Olalla, J; Pedrol, E; Portilla, J; Pulido, F; Riera, M; Romero-Palacios, A; Vera, F,
)
0.13
"Due to ongoing neuropsychiatric adverse events in some efavirenz (EFV)-treated patients, a switch to an alternative non-nucleoside reverse transcriptase inhibitor may be considered."( Efficacy and safety 48 weeks after switching from efavirenz to rilpivirine using emtricitabine/tenofovir disoproxil fumarate-based single-tablet regimens.
Brinson, C; Cheng, AK; Chuck, SK; Cohen, C; Dejesus, E; Mills, AM; Ramanathan, S; Wang, MH; White, K; Williams, S; Yale, KL,
)
0.13
" No subjects discontinued the study due to an adverse event."( Efficacy and safety 48 weeks after switching from efavirenz to rilpivirine using emtricitabine/tenofovir disoproxil fumarate-based single-tablet regimens.
Brinson, C; Cheng, AK; Chuck, SK; Cohen, C; Dejesus, E; Mills, AM; Ramanathan, S; Wang, MH; White, K; Williams, S; Yale, KL,
)
0.13
" No significant adverse event was observed due to TDF administration; renal function pre- and post-LT were also acceptably preserved."( One year of hepatitis B immunoglobulin plus tenofovir therapy is safe and effective in preventing recurrent hepatitis B post-liver transplantation.
Lilly, LB; Renner, EL; Selzner, N; Tanaka, T; Therapondos, G, 2014
)
0.4
" Factors associated with these drug-related adverse events are poorly characterized."( Low body weight in females is a risk factor for increased tenofovir exposure and drug-related adverse events.
Baldelli, S; Castagnoli, L; Cattaneo, D; Clementi, E; Fucile, S; Galli, M; Gervasoni, C; Landonio, S; Meraviglia, P; Riva, A; Rizzardini, G, 2013
)
0.39
" There were no differences between the groups in terms of adverse events in mothers or congenital deformities, gestational age, height, or weight in infants."( Efficacy and safety of tenofovir disoproxil fumarate in pregnancy for the prevention of vertical transmission of HBV infection.
Ay, M; Ayaz, C; Barcin, T; Celen, MK; Dal, MS; Dal, T; Gulsun, S; Kalkanli, S; Kaya, S; Mert, D; Yildirim, N, 2013
)
0.39
"TDF therapy during the second or third trimester reduced perinatal transmission rates of HBV and no adverse events were observed in mothers or infants."( Efficacy and safety of tenofovir disoproxil fumarate in pregnancy for the prevention of vertical transmission of HBV infection.
Ay, M; Ayaz, C; Barcin, T; Celen, MK; Dal, MS; Dal, T; Gulsun, S; Kalkanli, S; Kaya, S; Mert, D; Yildirim, N, 2013
)
0.39
" The most commonly observed adverse events were headache, nausea and flatulence, which occurred similarly across the three groups."( Phase I/II study of the pharmacokinetics, safety and antiretroviral activity of tenofovir alafenamide, a new prodrug of the HIV reverse transcriptase inhibitor tenofovir, in HIV-infected adults.
Coakley, D; Kearney, B; Lee, WA; Markowitz, M; Miller, MD; Ruane, P; Squires, K; Wulfsohn, M; Zhong, L; Zolopa, A, 2014
)
0.4
"TDF-based rescue treatment is effective in reducing HBV DNA levels and is safe for patients with CHB who failed prior antiviral treatments."( Efficacy and safety of tenofovir-based rescue therapy for chronic hepatitis B patients with previous nucleo(s/t)ide treatment failure.
Byun, KS; Choe, WH; Kim, JH; Kim, YS; Kwon, SY; Lee, CH; Lee, CI; Yeon, JE; Yoon, EL, 2014
)
0.4
" Most adverse events were mild in severity and considered unrelated to study drug."( Efficacy and safety of tenofovir disoproxil fumarate in Asian-Americans with chronic hepatitis B in community settings.
Bae, H; Chan, S; Lou, L; Pan, CQ; Trinh, H; Yao, A, 2014
)
0.4
" Tenofovir released from TDF undergoes active renal secretion via organic anion transporters (OAT1 and OAT3), leading to higher exposure of renal proximal tubules to tenofovir and a potential for renal adverse effects in a small subset of TDF-treated patients."( Tenofovir alafenamide is not a substrate for renal organic anion transporters (OATs) and does not exhibit OAT-dependent cytotoxicity.
Bam, RA; Cihlar, T; Yant, SR, 2014
)
0.4
"TDF and ETV are similarly effective and safe in chronic HBV patients after 24 weeks and 48 weeks of anti-viral therapy."( Comparison of efficacy and safety of tenofovir and entecavir in chronic hepatitis B virus infection: a systematic review and meta-analysis.
Gao, Y; Ke, W; Liu, L; Yang, Y; Ye, X; Zhang, C; Zhou, S, 2014
)
0.4
" No adverse events were observed, and there were no toxicological findings."( Pharmacokinetics and preliminary safety study of pod-intravaginal rings delivering antiretroviral combinations for HIV prophylaxis in a macaque model.
Baum, MM; Brooks, AA; Butkyavichene, I; Dinh, CT; Lopez, G; Martin, A; Moss, JA; Smith, JM; Smith, TJ; Srinivasan, P, 2014
)
0.4
" Combination therapy with tenofovir plus entecavir in this setting with multidrug resistance is safe and effective."( Efficacy and safety of tenofovir in a kidney transplant patient with chronic hepatitis B and nucleos(t)ide multidrug resistance: a case report.
Shan, C; Wu, P; Yin, GQ, 2014
)
0.4
" Bayesian fixed-effect network meta-analysis models adjusting for the type of nucleoside reverse transcriptase inhibitor backbone (tenofovir disoproxil fumarate/emtricitabine [TDF/FTC] or abacavir/lamivudine [ABC/3TC]) were used to evaluate week 48 efficacy (HIV-RNA suppression to <50 copies/mL and change in CD4+ cells/µL) and safety (lipid changes, adverse events, and discontinuations due to adverse events) of DTG relative to all other treatments."( 48-week efficacy and safety of dolutegravir relative to commonly used third agents in treatment-naive HIV-1-infected patients: a systematic review and network meta-analysis.
Camejo, RR; Cuffe, R; Gilchrist, KA; Lim, JW; Nichols, G; Patel, DA; Pulgar, S; Snedecor, SJ; Stephens, J; Sudharshan, L; Tang, WY, 2014
)
0.4
" Dolutegravir had better or equivalent changes in total cholesterol, LDL, triglycerides, and lower odds of adverse events and discontinuation due to adverse events compared to all treatments."( 48-week efficacy and safety of dolutegravir relative to commonly used third agents in treatment-naive HIV-1-infected patients: a systematic review and network meta-analysis.
Camejo, RR; Cuffe, R; Gilchrist, KA; Lim, JW; Nichols, G; Patel, DA; Pulgar, S; Snedecor, SJ; Stephens, J; Sudharshan, L; Tang, WY, 2014
)
0.4
" This meta-analysis explored the frequency of discontinuation attributed to renal adverse events (AEs) in randomized, controlled clinical studies that used TDF-containing regimens for ART-naïve, HIV-infected patients."( Discontinuation of tenofovir disoproxil fumarate for presumed renal adverse events in treatment-naïve HIV-1 patients: meta-analysis of randomized clinical studies.
Canada, RB; Chonchol, M; Durr, J; Gallant, J; Hindman, J; Liu, H; Martin, P; Patel, K; Piontkowsky, D; Winston, J,
)
0.13
"One of the most common in vitro assays to evaluate the probability of a compound to cause adverse effects is a cytotoxicity assay."( Intracellular concentrations determine the cytotoxicity of adefovir, cidofovir and tenofovir.
Leach, KL; Piotrowski, M; Wang, R; Zhang, H; Zhang, X, 2015
)
0.42
" No subject experienced an adverse event that was serious or severe (grade 3/4)."( Twenty-eight day safety, antiviral activity, and pharmacokinetics of tenofovir alafenamide for treatment of chronic hepatitis B infection.
Agarwal, K; Cheng, W; Flaherty, JF; Foster, GR; Fung, SK; Gane, EJ; Lawson, E; McHutchison, JG; Nguyen, TT; Ryder, SD; Sicard, E; Subramanian, GM; Zhao, S, 2015
)
0.42
"Tenofovir alafenamide was safe and well tolerated; declines in HBV DNA were similar to tenofovir disoproxil fumarate at all doses evaluated."( Twenty-eight day safety, antiviral activity, and pharmacokinetics of tenofovir alafenamide for treatment of chronic hepatitis B infection.
Agarwal, K; Cheng, W; Flaherty, JF; Foster, GR; Fung, SK; Gane, EJ; Lawson, E; McHutchison, JG; Nguyen, TT; Ryder, SD; Sicard, E; Subramanian, GM; Zhao, S, 2015
)
0.42
" No cases of acute renal failure associated with TDF or LAM, mild or serious adverse events, or HBV recurrence were observed among the patients."( The efficacy and safety of tenofovir in the prevention of hepatitis B virus recurrence following liver transplantation.
Akarsu, M; Astarcıoğlu, İ; Hakim, GD; Karademir, S; Unek, T, 2014
)
0.4
"The results of this study, after a 36-month follow-up period, were encouraging and demonstrated that TDF therapy is safe and efficacious in treating HBV-positive organ transplant patients."( The efficacy and safety of tenofovir in the prevention of hepatitis B virus recurrence following liver transplantation.
Akarsu, M; Astarcıoğlu, İ; Hakim, GD; Karademir, S; Unek, T, 2014
)
0.4
" No subjects discontinued study drug because of an adverse event in the 48 weeks of randomized phase."( A randomized, open-label study of the safety and efficacy of switching stavudine or zidovudine to tenofovir disoproxil fumarate in HIV-1-infected children with virologic suppression.
Arterburn, S; Castaño, E; Cheng, AK; Chuck, SL; Church, J; Deville, J; Enejosa, JV; Estripeaut, D; Gaur, A; Rathore, M; Rhee, MS; Saez-Llorens, X; White, K, 2015
)
0.42
" No serious adverse event related to tenofovir."( Efficacy, safety and pharmacokinetics of tenofovir disoproxil fumarate in virologic-suppressed HIV-infected children using weight-band dosing.
Aurpibul, L; Chokephaibulkit, K; Cressey, TR; Phongsamart, W; Sirisanthana, V; Sricharoenchai, S; Sudjaritruk, T; Wittawatmongkol, O, 2015
)
0.42
"TDF substitution in children and adolescents who were otherwise stable while receiving a first-line nonnucleoside reverse transcriptase inhibitor-based regimen achieved adequate exposure without clinically significant renal or bone adverse events over 96 weeks."( Efficacy, safety and pharmacokinetics of tenofovir disoproxil fumarate in virologic-suppressed HIV-infected children using weight-band dosing.
Aurpibul, L; Chokephaibulkit, K; Cressey, TR; Phongsamart, W; Sirisanthana, V; Sricharoenchai, S; Sudjaritruk, T; Wittawatmongkol, O, 2015
)
0.42
" The FDA-recommended rabbit vaginal irritation (RVI) model serves as a first line selection tool for vaginal products; however, for decades it has been limited to histopathology scoring, insufficient to select safe anti-HIV microbicides."( A quantitative multiplex nuclease protection assay reveals immunotoxicity gene expression profiles in the rabbit model for vaginal drug safety evaluation.
Chandra, N; Doncel, GF; Fichorova, RN; Mendonca, K; Murray, R; Yamamoto, HS, 2015
)
0.42
" Adverse events and serious adverse events were summarised by treatment group."( Efficacy and safety of efavirenz 400 mg daily versus 600 mg daily: 96-week data from the randomised, double-blind, placebo-controlled, non-inferiority ENCORE1 study.
Amin, J; Belloso, W; Carey, D; Cooper, DA; Crabtree-Ramirez, B; Emery, S; Foulkes, S; Jessen, H; Kumar, S; Lee, MP; Losso, M; Mohapi, L; Phanupak, P; Puls, R; Winston, A, 2015
)
0.42
" Adverse events were reported by 291 (91%) of 321 patients in the efavirenz 400 mg group and by 285 (92%) of 309 in the 600 mg group (p=0·48)."( Efficacy and safety of efavirenz 400 mg daily versus 600 mg daily: 96-week data from the randomised, double-blind, placebo-controlled, non-inferiority ENCORE1 study.
Amin, J; Belloso, W; Carey, D; Cooper, DA; Crabtree-Ramirez, B; Emery, S; Foulkes, S; Jessen, H; Kumar, S; Lee, MP; Losso, M; Mohapi, L; Phanupak, P; Puls, R; Winston, A, 2015
)
0.42
" Fewer efavirenz-related adverse events were reported with the 400 mg efavirenz dose than with the 600 mg dose."( Efficacy and safety of efavirenz 400 mg daily versus 600 mg daily: 96-week data from the randomised, double-blind, placebo-controlled, non-inferiority ENCORE1 study.
Amin, J; Belloso, W; Carey, D; Cooper, DA; Crabtree-Ramirez, B; Emery, S; Foulkes, S; Jessen, H; Kumar, S; Lee, MP; Losso, M; Mohapi, L; Phanupak, P; Puls, R; Winston, A, 2015
)
0.42
"Intramuscular hepatitis B immunoglobulin in combination with lamivudine or tenofovir and discontinuation of hepatitis B immunoglobulin after 1 year posttransplant may provide safe and cost-effective protection against posttransplant hepatitis B reinfection."( Efficacy and safety of lamivudine or tenofovir plus intramuscular hepatitis B immunoglobulin in prevention of hepatitis B virus reinfection after liver transplant.
Ahmadinejad, Z; Dashti, H; Jafarian, A; Kasraianfard, A; Moini, M; Najafi, A; Nassiri-Toosi, M; Salimi, J, 2015
)
0.42
"All three gels were found to be safe and acceptable."( A Phase 1 Randomized, Open Label, Rectal Safety, Acceptability, Pharmacokinetic, and Pharmacodynamic Study of Three Formulations of Tenofovir 1% Gel (the CHARM-01 Study).
Abebe, K; Anton, PA; Cranston, RD; Dezzutti, CS; Duffill, K; Elliott, J; Engstrom, JC; Hendrix, CW; Hiruy, H; Jacobson, C; Khanukhova, E; Marzinke, MA; Mauck, C; Mcgowan, I; Nikiforov, A; Rehman, KK; Richardson-Harman, N; Rohan, LC; Siegel, A; Spiegel, HM, 2015
)
0.42
"All three formulations were found to be safe and acceptable."( A Phase 1 Randomized, Open Label, Rectal Safety, Acceptability, Pharmacokinetic, and Pharmacodynamic Study of Three Formulations of Tenofovir 1% Gel (the CHARM-01 Study).
Abebe, K; Anton, PA; Cranston, RD; Dezzutti, CS; Duffill, K; Elliott, J; Engstrom, JC; Hendrix, CW; Hiruy, H; Jacobson, C; Khanukhova, E; Marzinke, MA; Mauck, C; Mcgowan, I; Nikiforov, A; Rehman, KK; Richardson-Harman, N; Rohan, LC; Siegel, A; Spiegel, HM, 2015
)
0.42
" Safety and tolerability were evaluated by the occurrence of adverse events (AEs), serious AEs, laboratory abnormalities, discontinuation of the study drug due to AEs, or death."( Similar efficacy and safety of tenofovir in Asians and non-Asians with chronic hepatitis B.
Bae, H; Chan, S; Lou, L; Pan, CQ; Trinh, H; Yao, A, 2015
)
0.42
" There was no case with serious adverse event."( Virologic response and safety of tenofovir versus entecavir in treatment-naïve chronic Hepatitis B patients.
An, SH; Choe, WH; Chung, HA; Jeong, GW; Jeong, TG; Kim, J; Kim, JH; Kwon, SW; Kwon, SY; Min, JK; Yu, HM; Yun, SU,
)
0.13
" The study limitations include its retrospective design, the relatively short follow-up, and the absence of data concerning the severity of clinical adverse events; however, it does provide new information concerning the laboratory changes that occur in patients switching from PI-based or PI-sparing regimens to RTE STR."( Efficacy and safety in clinical practice of a rilpivirine, tenofovir and emtricitabine single-tablet regimen in virologically suppressed HIV-positive patients on stable antiretroviral therapy.
Bossolasco, S; Castagna, A; Cernuschi, M; Cinque, P; Galli, L; Gianotti, N; Lazzarin, A; Maillard, M; Nozza, S; Poli, A; Spagnuolo, V; Tambussi, G, 2015
)
0.42
" No adverse effects were observed or dose reductions required associated with ETV or TDF."( Tenofovir/entecavir monotherapy after hepatitis B immunoglobulin withdrawal is safe and effective in the prevention of hepatitis B in liver transplant recipients.
Abradelo, M; Calvo, J; Cambra, F; Castellano, G; Fernández, I; García, A; Hernández, O; Jiménez, C; Loinaz, C; Manrique, A; Manzano, M, 2015
)
0.42
"Maintenance therapy with newer NAs, after discontinuation of HBIG prophylaxis, was safe and effective, with a low rate of serological recurrence and no evident clinical, biochemical, or virological consequences."( Tenofovir/entecavir monotherapy after hepatitis B immunoglobulin withdrawal is safe and effective in the prevention of hepatitis B in liver transplant recipients.
Abradelo, M; Calvo, J; Cambra, F; Castellano, G; Fernández, I; García, A; Hernández, O; Jiménez, C; Loinaz, C; Manrique, A; Manzano, M, 2015
)
0.42
" Most of the adverse events were mild in severity."( Efficacy and safety of tenofovir in nucleos(t)ide-naïve patients with genotype C chronic hepatitis B in real-life practice.
Byun, SS; Jung, SW; Kim, CJ; Kim, JH; Kim, MH; Park, BR; Park, NH; Shin, JW, 2015
)
0.42
" Safety data were consistent with the known TDF safety profile; the most commonly reported adverse events possibly related to TDF were fatigue (2."( Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year Prospective Field Practice Study in Germany.
Boeker, K; Eisenbach, C; Felten, G; Hartmann, H; Heyne, R; Hueppe, D; John, C; Krause, W; Leuschner, M; Loehr, HF; Mauss, S; Petersen, J; Ruppert, S; Schiffelholz, W; Schlaak, J; Trautwein, C; Trein, A; Warger, T; Wiese, M, 2016
)
0.43
"There were 43 total, 23 reproductive tract, and eight product-related grade 1 adverse events."( A phase 1 randomized placebo-controlled safety and pharmacokinetic trial of a tenofovir disoproxil fumarate vaginal ring.
Anderson, PL; Atrio, JM; Espinoza, L; Frank, B; Fredricks, DN; Hendrix, CW; Herold, BC; Keller, MJ; Kiser, PF; Lo, Y; Marzinke, MA; Mesquita, PM; Rabe, L; Srinivasan, S; Teller, R, 2016
)
0.43
" For any biomedical prevention intervention, the bar for tolerating adverse effects in healthy persons is high compared to therapeutic interventions."( Safety of oral tenofovir disoproxil fumarate-based pre-exposure prophylaxis for HIV prevention.
Baeten, JM; Mugwanya, KK, 2016
)
0.43
"TDF-based pre-exposure prophylaxis is a potent intervention against HIV acquisition when taken which is generally safe and well tolerated."( Safety of oral tenofovir disoproxil fumarate-based pre-exposure prophylaxis for HIV prevention.
Baeten, JM; Mugwanya, KK, 2016
)
0.43
"The aim of this study was to systematically review and critically appraise the literature relating to the reported renal and bone adverse effects of TDF-based regimens in the treatment of HIV-infected children from 2 to 19 years old."( Renal and Bone Adverse Effects of a Tenofovir-Based Regimen in the Treatment of HIV-Infected Children: A Systematic Review.
Effa, EE; Okonkwo, RI; Weidmann, AE, 2016
)
0.43
" Data on study characteristics, participant's characteristics, therapeutic intervention and adverse effects were extracted using a piloted tool."( Renal and Bone Adverse Effects of a Tenofovir-Based Regimen in the Treatment of HIV-Infected Children: A Systematic Review.
Effa, EE; Okonkwo, RI; Weidmann, AE, 2016
)
0.43
"We identified 19 studies that reported the presence of renal and bone adverse effects of TDF and these included a total of 1100 study participants."( Renal and Bone Adverse Effects of a Tenofovir-Based Regimen in the Treatment of HIV-Infected Children: A Systematic Review.
Effa, EE; Okonkwo, RI; Weidmann, AE, 2016
)
0.43
"This systematic review summarises the reports of renal and bone adverse effects of a TDF-containing regimen in the treatment of HIV-infected children."( Renal and Bone Adverse Effects of a Tenofovir-Based Regimen in the Treatment of HIV-Infected Children: A Systematic Review.
Effa, EE; Okonkwo, RI; Weidmann, AE, 2016
)
0.43
"Tenofovir disoproxil fumarate is effective and safe for NA-naïve and NA-experienced CHB patients and should be used cautiously in patients with comorbidities because of a renal dysfunction risk."( Three-year efficacy and safety of tenofovir in nucleos(t)ide analog-naïve and nucleos(t)ide analog-experienced chronic hepatitis B patients.
Chang, KC; Chen, CH; Hu, TH; Hung, CH; Kee, KM; Lee, CM; Lu, SN; Tseng, PL; Wang, HM; Wang, JH; Yen, YH, 2016
)
0.43
"This combination ART regimen is safe and effective for patients with HIV/HBV co-infection."( Efficacy and Safety of Tenofovir and Lamivudine in Combination with Efavirenz in Patients Co-infected with Human Immunodeficiency Virus and Hepatitis B Virus in China.
Cai, WP; He, HL; Huang, SB; Ling, XM; Liu, YF; Wang, H; Wang, M; Wang, XC; Wei, FL; Wu, H; Wu, YS; Wu, ZY; Yang, L; Zhang, FJ; Zhang, WW, 2016
)
0.43
"This study indicates that newer antivirals are effective and safe in HTR with CHB."( Efficacy and safety of tenofovir, entecavir, and telbivudine for chronic hepatitis B in heart transplant recipients.
Andini, R; Durante-Mangoni, E; Falco, E; Iossa, D; Maiello, C; Parrella, A; Ragone, E; Utili, R; Vitrone, M; Zampino, R, 2016
)
0.43
" However, tenofovir disoproxil fumarate is associated with renal and bone toxic effects; the novel prodrug tenofovir alafenamide achieves 90% lower plasma tenofovir concentrations."( Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, activ
Abram, ME; Brinson, C; Cheng, AK; Clumeck, N; Daar, ES; DeJesus, E; Gallant, JE; Johnson, M; Morales-Ramirez, J; Osiyemi, O; Plummer, A; Raffi, F; Rhee, MS; Ruane, P; Ward, D; Yan, M, 2016
)
0.43
" Seven patients in the tenofovir alafenamide (2%) and three (1%) in the tenofovir disoproxil fumarate group discontinued due to adverse events."( Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, activ
Abram, ME; Brinson, C; Cheng, AK; Clumeck, N; Daar, ES; DeJesus, E; Gallant, JE; Johnson, M; Morales-Ramirez, J; Osiyemi, O; Plummer, A; Raffi, F; Rhee, MS; Ruane, P; Ward, D; Yan, M, 2016
)
0.43
" This systematic review and meta-analysis evaluated the evidence for use of oral PrEP containing tenofovir disoproxil fumarate as an additional HIV prevention strategy in populations at substantial risk for HIV based on HIV acquisition, adverse events, drug resistance, sexual behavior, and reproductive health outcomes."( Effectiveness and safety of oral HIV preexposure prophylaxis for all populations.
Baggaley, R; Dalglish, SL; Fonner, VA; Grant, RM; Hodges-Mameletzis, I; Kennedy, CE; Koechlin, FM; O'Reilly, KR; Rodolph, M, 2016
)
0.43
" Adverse events were similar between PrEP and placebo groups."( Effectiveness and safety of oral HIV preexposure prophylaxis for all populations.
Baggaley, R; Dalglish, SL; Fonner, VA; Grant, RM; Hodges-Mameletzis, I; Kennedy, CE; Koechlin, FM; O'Reilly, KR; Rodolph, M, 2016
)
0.43
" There was no statistically significant differences in the risk difference for serious adverse events (5."( An Indirect Comparison of Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate and Abacavir/Lamivudine + Dolutegravir in Initial Therapy.
Behrens, G; Borg, P; Bouee, S; M Llibre, J; Moyle, G; Piontkowsky, D; Raffi, F; Reilly, G; Rogatto, F, 2016
)
0.43
" There were no discontinuations due to adverse events."( Pharmacokinetics and Safety of Tenofovir Alafenamide in HIV-Uninfected Subjects with Severe Renal Impairment.
Custodio, JM; Fordyce, M; Garner, W; Kearney, BP; Ling, KH; Ramanathan, S; Vimal, M, 2016
)
0.43
" The majority of adverse events (AEs) were infections (N = 56) or gastrointestinal (N = 46) and were mild (69."( Project Gel a Randomized Rectal Microbicide Safety and Acceptability Study in Young Men and Transgender Women.
Brand, RM; Carballo-Diéguez, A; Cranston, RD; Dolezal, C; Duffill, K; Engstrom, JC; Febo, I; Frasca, T; Giguere, R; Jacobson, C; Leu, CS; Mayer, KH; McGowan, I; Nikiforov, A; Park, SY; Schwartz, JL; Siegel, A, 2016
)
0.43
" TFV gel was safe and acceptable and should be further developed as an alternative HIV prevention intervention for this population."( Project Gel a Randomized Rectal Microbicide Safety and Acceptability Study in Young Men and Transgender Women.
Brand, RM; Carballo-Diéguez, A; Cranston, RD; Dolezal, C; Duffill, K; Engstrom, JC; Febo, I; Frasca, T; Giguere, R; Jacobson, C; Leu, CS; Mayer, KH; McGowan, I; Nikiforov, A; Park, SY; Schwartz, JL; Siegel, A, 2016
)
0.43
" We postulate that this adverse drug reaction may have been secondary to the known interaction between ledipasvir and TDF, which results in increased TDF exposure."( Nephrotoxicity Associated with Concomitant Use of Ledipasvir-Sofosbuvir and Tenofovir in a Patient with Hepatitis C Virus and Human Immunodeficiency Virus Coinfection.
Bunnell, KL; Gallagher, MA; Glowacki, RC; Huhn, G; Osei, AM; Vibhakar, S, 2016
)
0.43
"WHO recommends tenofovir, efavirenz, and lamivudine or emtricitabine for first-line antiretroviral therapy (ART) in adults, which replaced more toxic regimens using stavudine, zidovudine or nevirapine."( Key toxicity issues with the WHO-recommended first-line antiretroviral therapy regimen.
Cohen, K; Maartens, G; Mouton, JP, 2016
)
0.43
" Secondary endpoints are maternal and infant adverse events, acute exacerbations of maternal hepatitis B disease (ALT >300 IU/L, defined as a "flare") following discontinuation of study treatment, infant HBV infection status and growth up to 12 months of age."( Prevention of mother-to-child transmission of hepatitis B virus: a phase III, placebo-controlled, double-blind, randomized clinical trial to assess the efficacy and safety of a short course of tenofovir disoproxil fumarate in women with hepatitis B virus
Achalapong, J; Bowonwatanuwong, C; Chotivanich, N; Chung, RT; Cressey, TR; Decker, L; Harrison, L; Hongsiriwon, S; Hua, L; Jourdain, G; Khamduang, W; Klinbuayaem, V; Murphy, TV; Ngo-Giang-Huong, N; Pol, S; Puthanakit, T; Salvadori, N; Siberry, GK; Sirirungsi, W; Thongsawat, S; Tierney, C; Traisathit, P; Watts, DH, 2016
)
0.43
" Moreover, histological analysis of genital tissues and cytokine/chemokine levels in vaginal lavages upon 14days of daily vaginal administration to mice confirmed that tenofovir-loaded NPs-in-film was safe and did not induce any apparent histological changes or pro-inflammatory response."( Development and in vivo safety assessment of tenofovir-loaded nanoparticles-in-film as a novel vaginal microbicide delivery system.
Araújo, F; Cunha-Reis, C; das Neves, J; Ferreira, D; Machado, A; Nunes, R; Sarmento, B; Seabra, V, 2016
)
0.43
" Results, including those from in vivo testing, sustain that the proposed system is safe and holds potential for further development as a vaginal microbicide product."( Development and in vivo safety assessment of tenofovir-loaded nanoparticles-in-film as a novel vaginal microbicide delivery system.
Araújo, F; Cunha-Reis, C; das Neves, J; Ferreira, D; Machado, A; Nunes, R; Sarmento, B; Seabra, V, 2016
)
0.43
"TAF has a similar tolerability, safety, and effectiveness to TDF and probably less adverse events related to renal and bone density outcomes in the treatment of naive and experienced patients with HIV-1."( The efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate in antiretroviral regimens for HIV-1 therapy: Meta-analysis.
Lu, X; Wang, H; Xu, N; Yang, X, 2016
)
0.43
" The regimen was well tolerated and no discontinuations related to adverse events occurred."( Safety, efficacy, and pharmacokinetics of a single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in treatment-naive, HIV-infected adolescents: a single-arm, open-label trial.
Batra, J; Chakraborty, R; Gaur, AH; Kizito, H; Kosalaraksa, P; Luesomboon, W; Myers, M; Porter, D; Prasitsueubsai, W; Quirk, E; Rakhmanina, N; Rassool, M; Rhee, MS; SenGupta, D; Shao, Y; Ting, L, 2016
)
0.43
"To develop a seminal enzyme bioresponsive, mucoadhesive nanofibers (NFs) as safe and effective nanocarriers for the prevention of HIV vaginal transmission."( Stimuli-sensitive thiolated hyaluronic acid based nanofibers: synthesis, preclinical safety and in vitro anti-HIV activity.
Agrahari, V; Christenson, LK; Dim, DC; Ezoulin, MJ; Hung, WT; Meng, J; Molteni, A; Youan, BC; Youm, I, 2016
)
0.43
"HA-SH-NFs developed in this study could potentially serve as a safe nanotemplate for topical intravaginal delivery of HIV/AIDS microbicides."( Stimuli-sensitive thiolated hyaluronic acid based nanofibers: synthesis, preclinical safety and in vitro anti-HIV activity.
Agrahari, V; Christenson, LK; Dim, DC; Ezoulin, MJ; Hung, WT; Meng, J; Molteni, A; Youan, BC; Youm, I, 2016
)
0.43
" Relevant articles were hand-searched for renal (Grade 3-4 serum creatinine/estimated glomerular filtration rate elevations, renal adverse events [AEs], discontinuation due to renal AEs, and urinary biomarkers) and bone outcomes (bone mineral density [BMD] reductions, bone turnover markers, and fracture), and results compiled qualitatively."( Systematic review of renal and bone safety of the antiretroviral regimen efavirenz, emtricitabine, and tenofovir disoproxil fumarate in patients with HIV infection.
Bedimo, R; Myers, J; Rosenblatt, L, 2016
)
0.43
"We reviewed research reports/conference abstracts with maternal/child adverse outcome data in HIV-infected and HIV-uninfected pregnant/lactating women receiving TDF alone or in combination with other drugs compared with non-TDF regimens."( Tenofovir disoproxil fumarate safety for women and their infants during pregnancy and breastfeeding.
Baggaley, RC; Mameletzis, I; Mofenson, LM, 2017
)
0.46
"Long-term TDF treatment appears to be safe and effective in patients with prior failure of LAM and a suboptimal response to ADV therapy."( Five-year efficacy and safety of tenofovir-based salvage therapy for patients with chronic hepatitis B who previously failed LAM/ADV therapy.
Angus, P; Bowden, S; Desmond, P; George, J; Lee, A; Lim, L; Locarnini, S; Marion, K; Nicoll, A; Patterson, S; Roberts, S; Sievert, W; Strasser, S; Thompson, A, 2017
)
0.46
"To improve biosafety of clinical analysis, we used antiviral drugs of adefovir and tenofovir as model drugs and developed a safe pretreatment method combining sealing technique with direct injection technique."( A novel pretreatment method combining sealing technique with direct injection technique applied for improving biosafety.
An, J; Du, C; Gao, JL; Jiang, Y; Li, M; Ma, H; Wang, X; Zhang, L, 2017
)
0.46
" Safe and acceptable topical HIV prevention methods that target the rectum are needed."( MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel.
Bekker, LG; Carballo-Diéguez, A; Chariyalertsak, S; Chitwarakorn, A; Cranston, RD; Galaska, B; Gonzales, P; Grossman, C; Hendrix, CW; Ho, KS; Holtz, TH; Jacobson, CE; Johnson, S; Kunjara Na Ayudhya, RP; Lama, JR; Leu, CS; Liu, AY; Liu, K; Lucas, J; Marzinke, MA; Mayer, KH; McGowan, I; Parikh, UM; Patterson, KB; Pickett, J; Piper, JM; Richardson, BA; Rooney, J; Schwartz, JL; Zorrilla, C, 2017
)
0.46
"Rectal application of RG TFV gel was safe in MSM and TGW."( MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel.
Bekker, LG; Carballo-Diéguez, A; Chariyalertsak, S; Chitwarakorn, A; Cranston, RD; Galaska, B; Gonzales, P; Grossman, C; Hendrix, CW; Ho, KS; Holtz, TH; Jacobson, CE; Johnson, S; Kunjara Na Ayudhya, RP; Lama, JR; Leu, CS; Liu, AY; Liu, K; Lucas, J; Marzinke, MA; Mayer, KH; McGowan, I; Parikh, UM; Patterson, KB; Pickett, J; Piper, JM; Richardson, BA; Rooney, J; Schwartz, JL; Zorrilla, C, 2017
)
0.46
"Switching from ATV/r to unboosted ATV appears to be safe and effective in selected virologically suppressed patients receiving TDF-containing regimens, and may have favorable effects on bilirubin and renal function."( Efficacy and safety of "unboosting" atazanavir in a randomized controlled trial among HIV-infected patients receiving tenofovir DF.
Ganase, B; Guillemi, SA; Harrigan, PR; Harris, M; Hull, MW; Saeedi, R; Watson, B; Zhang, W, 2017
)
0.46
"Tenofovir (TDF) has been associated with renal function deterioration, but local data regarding the incidence and risk factors for this adverse event were lacking."( Tenofovir-induced nephrotoxicity: A retrospective cohort study.
Koh, HM; Suresh, K, 2016
)
0.43
" Given that the use of tenofovir is escalating in Malaysia, increased awareness about this adverse event is essential."( Tenofovir-induced nephrotoxicity: A retrospective cohort study.
Koh, HM; Suresh, K, 2016
)
0.43
" We reviewed participants weekly for the first month for adverse events followed by 4 weekly visits for renal function assessment, adverse event monitoring and adherence."( Renal safety of lithium in HIV-infected patients established on tenofovir disoproxil fumarate containing antiretroviral therapy: analysis from a randomized placebo-controlled trial.
Decloedt, EH; Joska, JA; Lesosky, M; Maartens, G, 2017
)
0.46
"Our results demonstrate the efficacy of switching to TDF monotherapy in virologically suppressed CHB patients receiving long-term LAM+ADV therapy, with a low rate of adverse events."( Long-term efficacy and safety of switching from lamivudine+adefovir to tenofovir disoproxil fumarate in virologically suppressed patients.
Angarano, G; Fasano, M; Fiore, JR; Leone, A; Maggi, P; Santantonio, TA; Volpe, A, 2017
)
0.46
"There are limited data on adverse effects of tenofovir disoproxil fumarate (TDF)-based antiretroviral therapy (ART) on pregnant women and their infants."( Safety of Tenofovir Disoproxil Fumarate-Based Antiretroviral Therapy Regimens in Pregnancy for HIV-Infected Women and Their Infants: A Systematic Review and Meta-Analysis.
Anderson, JR; Doherty, MC; Essajee, S; Ford, N; Kanters, S; Mills, EJ; Mofenson, LM; Nachega, JB; Renaud, F; Uthman, OA, 2017
)
0.46
"We conducted a systematic review of studies published between January 1980 and January 2017 that compared adverse outcomes in HIV-infected women receiving TDF- vs."( Safety of Tenofovir Disoproxil Fumarate-Based Antiretroviral Therapy Regimens in Pregnancy for HIV-Infected Women and Their Infants: A Systematic Review and Meta-Analysis.
Anderson, JR; Doherty, MC; Essajee, S; Ford, N; Kanters, S; Mills, EJ; Mofenson, LM; Nachega, JB; Renaud, F; Uthman, OA, 2017
)
0.46
"TDF-based ART in pregnancy seems generally safe for women and their infants."( Safety of Tenofovir Disoproxil Fumarate-Based Antiretroviral Therapy Regimens in Pregnancy for HIV-Infected Women and Their Infants: A Systematic Review and Meta-Analysis.
Anderson, JR; Doherty, MC; Essajee, S; Ford, N; Kanters, S; Mills, EJ; Mofenson, LM; Nachega, JB; Renaud, F; Uthman, OA, 2017
)
0.46
" Concerning safety, the study found that no adverse events were observed during the 48 weeks."( Efficacy and Safety of Tenofovir Disoproxil Treatment for Chronic Hepatitis B Patients with Genotypic Resistance to Other Nucleoside Analogues: A Prospective Study.
Huang, JR; Lian, JS; Liu, YY; Pan, LF; Yang, JL; Zhou, J, 2017
)
0.46
"TDF monotherapy is an effective and safe salvage treatment for CHB patients who are resistant to other NAs."( Efficacy and Safety of Tenofovir Disoproxil Treatment for Chronic Hepatitis B Patients with Genotypic Resistance to Other Nucleoside Analogues: A Prospective Study.
Huang, JR; Lian, JS; Liu, YY; Pan, LF; Yang, JL; Zhou, J, 2017
)
0.46
" In this report, we use metabolomics and proteomics with HK-2 cells and animal models to dissect the molecular pathways underlying nephropathy caused by TFV and its more toxic analog, adefovir (ADV)."( Tenofovir and adefovir down-regulate mitochondrial chaperone TRAP1 and succinate dehydrogenase subunit B to metabolically reprogram glucose metabolism and induce nephrotoxicity.
Chen, J; Chen, L; Cheng, L; Chi, W; Deng, H; Huo, Y; Lan, Z; Liu, X; Siegenthaler, JA; Song, W; Sun, K; Xu, L; Zhao, X, 2017
)
0.46
" Tenofovir is safe and tolerable for both the mother and foetus."( Systematic review with meta-analysis: the efficacy and safety of tenofovir to prevent mother-to-child transmission of hepatitis B virus.
Byun, KS; Hyun, MH; Je, JH; Kim, JH; Lee, YS; Yeon, JE; Yoo, YJ, 2017
)
0.46
" Phase II and III randomized clinical trials evaluate the efficacy and safety of EVG/c/TAF/FTC and tenofovir disoproxil fumerate (TDF)-containing arms; renal impairment, bone mineral density, metabolic effects, and other adverse events are topics explored within this review."( A Review of the Efficacy and Safety of Genvoya® (Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide) in the Management of HIV-1 Infection.
Angione, SA; Cherian, SM; Özdener, AE, 2018
)
0.48
" The most common adverse events were diarrhea, nausea, and headache."( A Review of the Efficacy and Safety of Genvoya® (Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide) in the Management of HIV-1 Infection.
Angione, SA; Cherian, SM; Özdener, AE, 2018
)
0.48
" Data seem to suggest it may also be effective and safe in patients with mild to moderate renal impairment."( A Review of the Efficacy and Safety of Genvoya® (Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide) in the Management of HIV-1 Infection.
Angione, SA; Cherian, SM; Özdener, AE, 2018
)
0.48
"Patients initiating EVG/COBI/FTC/TDF were enrolled in the SCOLTA project, a multicenter observational study reporting grade 3-4 Adverse Events in subjects beginning new antiretroviral drug regimens."( Safety and tolerability of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil fumarate in a real life setting: Data from surveillance cohort long-term toxicity antiretrovirals/antivirals (SCOLTA) project.
Bandera, A; Bonfanti, P; Calza, L; Carenzi, L; Celesia, BM; Cordier, L; De Socio, GV; Di Biagio, A; Falasca, K; Gori, A; Madeddu, G; Maggi, P; Martinelli, C; Orofino, G; Pellicanò, GF; Quirino, T; Ricci, E; Rusconi, S; Squillace, N; Vichi, F, 2017
)
0.46
" However, TDF induced more drug-related adverse events (OR = 2."( Efficacy and safety of tenofovir disoproxil fumarate in preventing vertical transmission of hepatitis B in pregnancies with high viral load.
Chen, JQ; Chen, JZ; Cheng, XY; Huang, FL; Huang, Z; Liao, ZW; Liu, JQ; Su, RK; Wang, WB, 2017
)
0.46
" The toxic and genotoxic potential of EFV and TDF alone and in combinations {EFV+combivir [zidovudine (AZT)+lamivudine (3TC)] and TDF+3TC} were assessed using the comet assay and the somatic mutation and recombination test (SMART) in Drosophila melanogaster."( In vivo genotoxicity evaluation of efavirenz (EFV) and tenofovir disoproxil fumarate (TDF) alone and in their clinical combinations in Drosophila melanogaster.
Chen-Chen, L; Cunha, KS; de Jesus Silva Carvalho, C; de Melo E Silva, D; de Moraes Filho, AV; Gonçalves, MW; Rohde, C; Verçosa, CJ, 2017
)
0.46
" The safety of RPV/FTC/TDF (incidence of adverse events leading to discontinuation and laboratory abnormalities) and adherence to this regimen were evaluated, and the cost of switching was analysed."( Switching to a rilpivirine/emtricitabine/tenofovir single-tablet regimen in RNA-suppressed patients infected with human immunodeficiency virus 1: Effectiveness, safety and costs at 96 weeks.
Arrabal-Durán, P; Chamorro-de-Vega, E; Gijón-Vidaurreta, P; Herranz-Alonso, A; Rodríguez-González, CG; Sanjurjo-Sáez, M, 2017
)
0.46
" However, the relatively high rates of virological failure and treatment discontinuation because of adverse events make this combination a less favourable choice over other regimens currently available."( Switching to a rilpivirine/emtricitabine/tenofovir single-tablet regimen in RNA-suppressed patients infected with human immunodeficiency virus 1: Effectiveness, safety and costs at 96 weeks.
Arrabal-Durán, P; Chamorro-de-Vega, E; Gijón-Vidaurreta, P; Herranz-Alonso, A; Rodríguez-González, CG; Sanjurjo-Sáez, M, 2017
)
0.46
" However, the overall impact of this adverse effect has not comprehensively evaluated."( Reversal of tenofovir induced nephrotoxicity: case reports of two patients.
Chesire, E; Kigen, G; Koech, M; Some, F, 2017
)
0.46
" Numbers of discontinuations related to adverse events (11 [1%] of 763 patients in the study group vs four [1%] of 378 patients in the control group) and grade 3-4 adverse events (52 [7%] patients vs 31 [8%] patients) were similar between the two groups."( Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppr
Arribas, JR; Eron, JJ; Gathe, J; Hufkens, V; Lathouwers, E; Molina, JM; Negredo, E; Opsomer, M; Orkin, C; Petrovic, R; Van Landuyt, E; Vanveggel, S, 2018
)
0.48
" Investigators monitored adverse events to assess safety."( Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies.
Aboud, M; Angelis, K; Blair, EA; Brinson, C; Castelli, F; Gartland, M; Girard, PM; Hung, CC; Kahl, LP; Llibre, JM; Smith, K; Underwood, M; Vandermeulen, K; Wynne, B, 2018
)
0.48
" 395 (77%) of 513 participants in the dolutegravir-rilpivirine group and 364 (71%) of 511 participants in the CAR group reported adverse events."( Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies.
Aboud, M; Angelis, K; Blair, EA; Brinson, C; Castelli, F; Gartland, M; Girard, PM; Hung, CC; Kahl, LP; Llibre, JM; Smith, K; Underwood, M; Vandermeulen, K; Wynne, B, 2018
)
0.48
" The form is designed to obtain information on the demographics of the patients, WHO clinical stage of their HIV infection, HAART regimen for the patients, and suspected adverse events associated with the antiretroviral drugs used by the patients."( A prospective study of adverse events to antiretroviral therapy in HIV- infected adults in Ekiti State, Nigeria.
Awodele, O; Oshikoya, KA; Popoola, TD, 2016
)
0.43
" About half (57%) of the participants reported clinical adverse events; 92% of which were reported within two weeks of HAART initiation."( A prospective study of adverse events to antiretroviral therapy in HIV- infected adults in Ekiti State, Nigeria.
Awodele, O; Oshikoya, KA; Popoola, TD, 2016
)
0.43
"Antiretroviral drugs exposure often presents with adverse events, an observation similar to other studies."( A prospective study of adverse events to antiretroviral therapy in HIV- infected adults in Ekiti State, Nigeria.
Awodele, O; Oshikoya, KA; Popoola, TD, 2016
)
0.43
" However, this side effect is not due to a direct dysfunction of the kidneys."( [Nephrotoxicity of antiretrovirals other than tenofovir].
Amet, S; Deray, G; Isnard-Bagnis, C; Loens, C; Tourret, J, 2018
)
0.48
"Tenofovir is less toxic than other nucleoside reverse-transcriptase inhibitors used in antiretroviral therapy (ART) and may improve retention of human immunodeficiency virus (HIV)-infected patients on ART."( Medication Side Effects and Retention in HIV Treatment: A Regression Discontinuity Study of Tenofovir Implementation in South Africa and Zambia.
Bärnighausen, T; Bor, J; Boulle, A; Brennan, AT; Davies, MA; Fatti, G; Fox, MP; Prozesky, H; Sikazwe, I; Stinson, K; Tanser, F; Wandeler, G; Wood, R; Zanolini, A, 2018
)
0.48
"1%) experienced ≥1 treatment-emergent adverse event; the majority were mild or moderate in severity."( Safety and efficacy of vesatolimod (GS-9620) in patients with chronic hepatitis B who are not currently on antiviral treatment.
Agarwal, K; Ahn, SH; Andreone, P; Bulusu, A; Cathcart, AL; Chuang, WL; Elkhashab, M; Gaggar, A; Kim, HJ; Lau, AH; Nguyen, MH; Subramanian, GM; Tian, X; Woo, J, 2018
)
0.48
" The overall incidence and severity of adverse events was similar between groups, although headache occurred more frequently in the bictegravir group than in the boosted protease inhibitor group."( Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, ph
Andreatta, K; Cheng, A; Creticos, C; Crofoot, G; Custodio, J; Daar, ES; DeJesus, E; Graham, H; Koenig, E; Liu, YP; Martin, H; Molina, JM; Oguchi, G; Quirk, E; Rockstroh, JK; Ruane, P, 2018
)
0.48
"Fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide might be a safe and efficacious alternative to continued boosted protease inhibitor therapy in adults with HIV-1 infection."( Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, ph
Andreatta, K; Cheng, A; Creticos, C; Crofoot, G; Custodio, J; Daar, ES; DeJesus, E; Graham, H; Koenig, E; Liu, YP; Martin, H; Molina, JM; Oguchi, G; Quirk, E; Rockstroh, JK; Ruane, P, 2018
)
0.48
" We assessed safety by adverse events, colposcopy, vaginal microbiota, epithelial integrity, mucosal histology and immune cell numbers and phenotype, cervicovaginal [CV] cytokines and antimicrobial proteins and changes in systemic laboratory measurements, and LNG and TFV pharmacokinetics in multiple compartments."( Randomized, placebo controlled phase I trial of safety, pharmacokinetics, pharmacodynamics and acceptability of tenofovir and tenofovir plus levonorgestrel vaginal rings in women.
Asin, SN; Brache, V; Chandra, N; Clark, MR; Dezzutti, CS; Doncel, GF; Fichorova, R; Herold, BC; Hillier, SL; Kiser, P; Marzinke, MA; McCormick, T; Rollenhagen, C; Schwartz, JL; Stanczyk, FZ; Thurman, AR; Weiner, D, 2018
)
0.48
" Moreover, tenofovir was safe and tolerable for both mothers and their infants."( Efficacy and safety of tenofovir in preventing mother-to-infant transmission of hepatitis B virus: a meta-analysis based on 6 studies from China and 3 studies from other countries.
Jia, L; Li, W; Tang, H; Wu, X; Zhao, X, 2018
)
0.48
" Grade 2 and higher adverse events (AEs) related to study product were compared across study arms using Fisher's exact test."( FAME-04: A Phase 1 trial to assess the safety, acceptability, pharmacokinetics and pharmacodynamics of film and gel formulations of tenofovir.
Bunge, KE; Dezzutti, CS; Hendrix, CW; Hillier, SL; Marzinke, MA; Meyn, LA; Moncla, BJ; Richardson-Harman, N; Rohan, LC; Schwartz, JL; Spiegel, HML, 2018
)
0.48
"Films were safe and well tolerated."( FAME-04: A Phase 1 trial to assess the safety, acceptability, pharmacokinetics and pharmacodynamics of film and gel formulations of tenofovir.
Bunge, KE; Dezzutti, CS; Hendrix, CW; Hillier, SL; Marzinke, MA; Meyn, LA; Moncla, BJ; Richardson-Harman, N; Rohan, LC; Schwartz, JL; Spiegel, HML, 2018
)
0.48
" Safety was assessed by adverse events (AEs), colposcopy, and culture-independent analysis of the vaginal microbiome (VMB)."( Safety and pharmacokinetics of single, dual, and triple antiretroviral drug formulations delivered by pod-intravaginal rings designed for HIV-1 prevention: A Phase I trial.
Anton, PA; Baum, MM; Butkyavichene, I; Churchman, SA; Cortez, JM; Dawson, L; Fanter, R; Gunawardana, M; Guthrie, KM; Hendrix, CW; Marzinke, MA; Miller, CS; Moss, JA; Olive, TJ; Pyles, RB; Rosen, RK; Vargas, SE; Vincent, KL; Yang, F, 2018
)
0.48
"An innovative pod-IVR delivery device with 3 different formulations delivering different regimens of ARV drugs vaginally appeared to be safe and acceptable and provided drug concentrations in CVFs and tissues exceeding concentrations achieved by highly protective oral dosing, suggesting that efficacy for vaginal HIV PrEP is achievable."( Safety and pharmacokinetics of single, dual, and triple antiretroviral drug formulations delivered by pod-intravaginal rings designed for HIV-1 prevention: A Phase I trial.
Anton, PA; Baum, MM; Butkyavichene, I; Churchman, SA; Cortez, JM; Dawson, L; Fanter, R; Gunawardana, M; Guthrie, KM; Hendrix, CW; Marzinke, MA; Miller, CS; Moss, JA; Olive, TJ; Pyles, RB; Rosen, RK; Vargas, SE; Vincent, KL; Yang, F, 2018
)
0.48
" EFV, relative to GSK3532795, had more serious adverse events (9% versus 5%) and adverse events leading to discontinuation (17% versus 5%)."( Safety, efficacy, and dose response of the maturation inhibitor GSK3532795 (formerly known as BMS-955176) plus tenofovir/emtricitabine once daily in treatment-naive HIV-1-infected adults: Week 24 primary analysis from a randomized Phase IIb trial.
Bogner, JR; DeGrosky, M; Dicker, IB; Gartland, M; Joshi, SR; Lataillade, M; Llamoso, C; Lombaard, J; Min, S; Molina, JM; Morales-Ramirez, J; Pene Dumitrescu, T; Stock, DA, 2018
)
0.48
" The elvitegravir group showed more discontinuations because of renal adverse events (2."( Efficacy and safety of switching to dolutegravir plus emtricitabine/tenofovir disoproxil fumarate (TDF) or elvitegravir/cobicistat/emtricitabine/TDF in virologically suppressed HIV-infected patients in clinical practice: results from a multicentre, observ
Bagella, P; Baldin, G; Capetti, A; Ciccullo, A; Cossu, MV; De Luca, A; Di Giambenedetto, S; Giacomelli, A; Lagi, F; Latini, A; Madeddu, G; Rusconi, S; Sterrantino, G, 2019
)
0.51
" Adverse events assessments included measures of bone density and body fat."( Efficacy and Safety of Tenofovir Disoproxil Fumarate Versus Low-Dose Stavudine Over 96 Weeks: A Multicountry Randomized, Noninferiority Trial.
Akpomiemie, G; Arulappan, N; Becker, S; Chersich, MF; Duncombe, C; Feldman, C; Hill, A; Kambugu, A; Kumarasamy, N; Majam, M; Moorhouse, M; Poongulali, S; Ripin, DHB; Sokhela, S; Venter, WDF; Vos, A, 2019
)
0.51
" Drug-related adverse event discontinuations were higher with d4T (6."( Efficacy and Safety of Tenofovir Disoproxil Fumarate Versus Low-Dose Stavudine Over 96 Weeks: A Multicountry Randomized, Noninferiority Trial.
Akpomiemie, G; Arulappan, N; Becker, S; Chersich, MF; Duncombe, C; Feldman, C; Hill, A; Kambugu, A; Kumarasamy, N; Majam, M; Moorhouse, M; Poongulali, S; Ripin, DHB; Sokhela, S; Venter, WDF; Vos, A, 2019
)
0.51
" What is known of the differences in adverse effects between zidovudine, tenofovir and abacavir? How should their respective adverse effect profiles influence the choice between available combinations? We sought answers to these questions by reviewing the literature using the standard Prescrire methodology."( Zidovudine, tenofovir or abacavir? Different adverse effect profiles.
, 2016
)
0.43
" Overall, 32 (26%) patients reported an adverse event."( Safety and efficacy of stopping tenofovir disoproxil fumarate in patients with chronic hepatitis B following at least 8 years of therapy: a prespecified follow-up analysis of two randomised trials.
Buti, M; Crans, G; Flaherty, J; Flisiak, R; Gaggar, A; Gane, E; Janssen, HLA; Jump, B; Kaita, K; Kitrinos, K; Manns, M; Marcellin, P; Op den Brouw, M; Wong, DK, 2019
)
0.51
"We pooled clinical renal safety data across 26 treatment-naive and antiretroviral switch studies to compare the incidence of proximal renal tubulopathy and discontinuation due to renal adverse events between participants taking TAF-containing regimens vs."( Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials.
Arribas, JR; Brainard, D; Carter, C; Clarke, AE; Das, M; Elion, RA; Eron, JJ; Esser, S; Guo, S; Gupta, SK; Martin, H; Mudrikova, T; Negredo, E; Orkin, C; Podzamczer, D; Post, FA; Pozniak, AL; Rockstroh, JK; Sax, PE; SenGupta, D; Stellbrink, HJ; Waters, L; Wohl, DA; Zhong, L, 2019
)
0.51
"001) discontinued due to a renal adverse event."( Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials.
Arribas, JR; Brainard, D; Carter, C; Clarke, AE; Das, M; Elion, RA; Eron, JJ; Esser, S; Guo, S; Gupta, SK; Martin, H; Mudrikova, T; Negredo, E; Orkin, C; Podzamczer, D; Post, FA; Pozniak, AL; Rockstroh, JK; Sax, PE; SenGupta, D; Stellbrink, HJ; Waters, L; Wohl, DA; Zhong, L, 2019
)
0.51
" The incidence of adverse events was similar in both groups (TDF-TDF, 56."( Long-term efficacy and safety of tenofovir disoproxil fumarate in Chinese patients with chronic hepatitis B: 5-year results.
Chen, C; Chen, S; Cheng, J; Gao, Z; Hou, J; Jia, J; Li, J; Liang, X; Mao, Q; Mao, Y; Ning, Q; Niu, J; Pan, C; Ren, H; Sheng, J; Tan, D; Tang, H; Wang, H; Wu, S; Xie, Q; Xiong, C; Xu, M; Zhang, J; Zhang, W; Zhang, X; Zhao, W, 2019
)
0.51
" Entecavir and tenofovir were safe and well tolerated, while treatment with telbivudine was associated with development of myopathy in 13% of cases."( Efficacy and safety of long-term therapy with nucleos(t)ide analogues in chronic hepatitis B.
Abdurakhmanov, DT; Ibragimov, EK; Moiseev, SV; Nikulkina, EN; Odintsov, AV; Panevkina, SV; Rozina, TP; Tanaschuk, EL, 2019
)
0.51
"In this small group of patients, the generic scheme 3TC/TDF/EFV is effective and safe in the treatment of patients with HIV/AIDS naïve, and its effectiveness and safety profile is similar to show by innovator scheme 3TC/TDF/EFV in patients with similar clinical conditions."( [Effectiveness and safety of generic version of lamivudine/tenofovir and efavirenz in treatment naïve HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2012-2014].
Amariles, P; Castañeda, C; Galindo, J; Mueses-Marín, HF, 2019
)
0.51
" The primary endpoint was the proportion of participants discontinuing due to adverse events (AEs) through Week 48."( Once-daily Doravirine for Initial Treatment of Adults Living With Human Immunodeficiency Virus-1: An Integrated Safety Analysis.
Cahn, P; Hanna, G; Hwang, C; Kumar, S; Martin, E; Molina, JM; Orkin, C; Rodgers, A; Sax, P; Squires, K; Teppler, H; Thompson, M; Xu, X, 2020
)
0.56
" In the period between Year 8 and Year 10, the safety profile of TDF was similar to previous reports, with few patients experiencing renal- or bone-related adverse events."( Ten-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection.
Buggisch, P; Buti, M; Cathcart, AL; Crans, G; Flaherty, J; Flisiak, R; Gaggar, A; Jump, B; Kaita, K; Krastev, Z; Lee, SS; Manns, M; Marcellin, P; Op den Brouw, M; Petersen, J; Sievert, W; Wong, DK, 2019
)
0.51
" However, less attention has been put on their adverse events."( Bayesian Network Meta-Analysis for Assessing Adverse Effects of Anti-hepatitis B Drugs.
Ji, J; Jia, Y; Shen, Y; Xun, P; Zhou, J, 2019
)
0.51
" Poisson-prior-based Bayesian NMA was performed to synthesize both direct and indirect evidence with reporting hazard ratios (HRs) and 95% credible intervals (CrIs) for serious adverse events (SAEs) and hepatic/renal impairments."( Bayesian Network Meta-Analysis for Assessing Adverse Effects of Anti-hepatitis B Drugs.
Ji, J; Jia, Y; Shen, Y; Xun, P; Zhou, J, 2019
)
0.51
" Few discontinued due to adverse events (2% D/C/F/TAF arm)."( Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/
Brown, K; Cunningham, D; De Wit, S; Eron, JJ; Hufkens, V; Jezorwski, J; Lathouwers, E; Opsomer, M; Orkin, C; Petrovic, R; Post, FA; Pulido, F; Van Landuyt, E, 2019
)
0.51
"Short-term administration of the entry inhibitor myrcludex-B (MyrB) has been shown to be safe and effective in phase II studies in patients coinfected with hepatitis B virus (HBV) and hepatitis delta virus (HDV)."( Excellent safety and effectiveness of high-dose myrcludex-B monotherapy administered for 48 weeks in HDV-related compensated cirrhosis: A case report of 3 patients.
Bertoletti, A; Borghi, M; Ceriotti, F; Ferenci, P; Giovanelli, S; Greco, L; Holzmann, H; Lampertico, P; Loglio, A; Lunghi, G; Perbellini, R; Porretti, L; Prati, D; Tham, CYL; Trombetta, E; Uceda Renteria, SC; van Bömmel, F, 2019
)
0.51
" Proportions of women engaged in care, incidence of DAIDS grade ≥ 2 laboratory toxicity, grade ≥ 3 adverse events (AEs), viral suppression (<1000 copies/mL), birth outcomes and infant HIV infections are reported."( Safety and efficacy of Option B+ ART in Malawi: few severe maternal toxicity events or infant HIV infections among pregnant women initiating tenofovir/lamivudine/efavirenz.
Chagomerana, MB; DiPrete, BL; Harrington, BJ; Hosseinipour, MC; Jumbe, AN; Limarzi, L; Ngongondo, M; Wallie, SD, 2019
)
0.51
" While some women experienced adverse laboratory events, clinical symptom monitoring is likely reasonable."( Safety and efficacy of Option B+ ART in Malawi: few severe maternal toxicity events or infant HIV infections among pregnant women initiating tenofovir/lamivudine/efavirenz.
Chagomerana, MB; DiPrete, BL; Harrington, BJ; Hosseinipour, MC; Jumbe, AN; Limarzi, L; Ngongondo, M; Wallie, SD, 2019
)
0.51
" However, there are several reasons as to why patients may discontinue their antiretroviral therapy, with adverse events being one of the main reasons reported in the literature."( Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS.
Azevedo, LN; Miranda-Filho, DB; Montarroyos, UR; Monteiro, P; Ximenes, RAA,
)
0.13
" No subject experienced a serious adverse event or nephrotoxicity."( Safety, efficacy, and pharmacokinetics of pradefovir for the treatment of chronic hepatitis B infection.
Chen, H; Ding, Y; Jin, W; Li, C; Li, X; Liu, C; Liu, J; Niu, J; Wu, M; Zhang, D; Zhang, H; Zhu, X, 2020
)
0.56
" Drug-related grade ≥2 adverse events and withdrawals due to adverse events occurred in 17 (4."( Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phas
Aboud, M; Ait-Khaled, M; Ajana, F; Bisshop, F; De Wit, S; Gartland, MJ; Nascimento, MC; Osiyemi, O; Pappa, KA; Portilla Sogorb, J; Routy, JP; Smith, KY; Tenorio, AR; van Wyk, J; Wang, R; Wright, J; Wyen, C; Wynne, B, 2020
)
0.56
" Both treatments were safe and well-tolerated, and most adverse events were similar as mild to moderate in severity."( Efficacy and safety of the regimens containing tenofovir alafenamide versus tenofovir disoproxil fumarate in fixed-dose single-tablet regimens for initial treatment of HIV-1 infection: A meta-analysis of randomized controlled trials.
Chen, Y; Lu, Y; Tao, X; Zhang, L; Zhou, Y, 2020
)
0.56
" However, gastrointestinal adverse effects (vomiting) occurred more frequently in TDF-treated than LdT-treated patients (6."( Clinical efficacy and safety in telbivudine- or tenofovir-treated hepatitis B e antigen-positive pregnant women.
Chen, K; Deng, H; Gao, H; Jiao, Q; Lei, Y; Li, H; Liang, S; Lin, L; Liu, H; Shi, Y; Xu, M; Zhuo, L, 2020
)
0.56
"This study revealed that the clinical efficacy in LdT- or TDF-treated HBeAg-positive Chinese pregnant women is similar, and gastrointestinal adverse effects occurred more frequently in TDF-treated patients."( Clinical efficacy and safety in telbivudine- or tenofovir-treated hepatitis B e antigen-positive pregnant women.
Chen, K; Deng, H; Gao, H; Jiao, Q; Lei, Y; Li, H; Liang, S; Lin, L; Liu, H; Shi, Y; Xu, M; Zhuo, L, 2020
)
0.56
"The combination of hepatitis B virus RNA and hepatitis B core-related antigen performed satisfactorily in predicting clinical relapse and hepatitis B surface antigen loss after stopping nucleos(t)ide analogue treatment among noncirrhotic hepatitis B e antigen-positive patients with chronic hepatitis B and could be used to guide safe discontinuation."( Combining Hepatitis B Virus RNA and Hepatitis B Core-Related Antigen: Guidance for Safely Stopping Nucleos(t)ide Analogues in Hepatitis B e Antigen-Positive Patients With Chronic Hepatitis B.
Bai, X; Chen, X; Fan, R; Hou, J; Niu, J; Peng, J; Ren, H; Sheng, J; Sun, J; Tan, D; Tang, H; Wang, H; Wang, M; Wu, Y; Xie, Q; Xu, M; Zhou, B, 2020
)
0.56
" Drug-related adverse events occurred more frequently in the participants receiving the standard dose regimen compared with the lower dose one (63."( Efficacy and safety of lower dose tenofovir disoproxil fumarate and efavirenz versus standard dose in HIV-infected, antiretroviral-naive adults: a multicentre, randomized, noninferiority trial.
Chen, J; Chen, R; Hu, Z; Huang, Q; Liu, L; Lu, H; Qi, T; Shen, Y; Song, W; Sun, J; Tang, Y; Wang, J; Wang, X; Wang, Z; Wei, H; Xie, R; Zhang, R, 2020
)
0.56
" These findings provide reassurance that the combination of TAF, boosted PIs and ledipasvir/sofosbuvir is safe in HIV/HCV-coinfected populations."( Pharmacokinetics and renal safety of tenofovir alafenamide with boosted protease inhibitors and ledipasvir/sofosbuvir.
Anderson, PL; Blum, J; Brooks, KM; Bushman, LR; Castillo-Mancilla, JR; Cendali, F; Choi, YJ; Gomez, J; Haas, H; Ibrahim, ME; Johnson, B; Kiser, JJ; MaWhinney, S; Morrow, M; Roon, L; Rowan, SE; Wyles, DL; Zheng, JH, 2020
)
0.56
" We included studies that enrolled pregnant women with chronic infection with HBV who received antiviral prophylaxis anytime during pregnancy; that included any of the following antivirals: adefovir, emtricitabine, entecavir, lamivudine, telbivudine, tenofovir alafenamide fumarate, and tenofovir disoproxil fumarate; and that reported the following outcomes: MTCT, indicated by infant HBsAg positivity or HBV DNA positivity, or both, at age 6-12 months, and any infant or maternal adverse events."( Efficacy and safety of antiviral prophylaxis during pregnancy to prevent mother-to-child transmission of hepatitis B virus: a systematic review and meta-analysis.
Boucheron, P; Bulterys, M; Chou, R; Funk, AL; Lu, Y; Shimakawa, Y; van Holten, J; Yoshida, K; Zhao, T, 2021
)
0.62
" Secondary assessments included maternal HBV DNA reduction at delivery, and maternal or infant adverse events during follow up."( Efficacy and safety of tenofovir alafenamide fumarate for preventing mother-to-child transmission of hepatitis B virus: a national cohort study.
Cao, L; Chen, B; Chen, R; Ding, Y; Fan, J; Gan, W; Huang, Y; Lin, C; Liu, Y; Pan, CQ; Sheng, Q; Wang, S; Wang, Y; Zhu, L, 2020
)
0.56
" No severe adverse effects were reported in either mothers or infants."( Efficacy and safety of tenofovir alafenamide fumarate for preventing mother-to-child transmission of hepatitis B virus: a national cohort study.
Cao, L; Chen, B; Chen, R; Ding, Y; Fan, J; Gan, W; Huang, Y; Lin, C; Liu, Y; Pan, CQ; Sheng, Q; Wang, S; Wang, Y; Zhu, L, 2020
)
0.56
" Women treated with TDF and their infants did not result in serious adverse events that are statistically different as compared to the women who did not receive any treatment."( Efficacy and Safety of Tenofovir in the Prevention of Perinatal Transmission of Hepatitis B, a Meta-Analysis.
Flomo, KT; Ma, Y; Yang, Q; Yang, Y; Zhong, Z, 2020
)
0.56
" Throughout the study, tolerability was assessed based on adverse events, vital signs, and clinical laboratory tests."( A randomized, open-label, crossover study to compare the safety and pharmacokinetics of two tablet formulations of tenofovir (tenofovir disoproxil and tenofovir disoproxil fumarate) in healthy subjects.
Choi, YS; Hoe, KL; Hong, JH; Kan, HS; Kim, N; Kwon, IS; Lee, M; Nam, SK; Oh, TY; Yeun, JS; Yun, JN, 2020
)
0.56
" Grade 3/4 adverse events (especially efavirenz-related neuropsychiatric adverse events) leading to regimen discontinuation were also noted."( Efficacy and safety of a single-tablet regimen containing tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg and efavirenz 400 mg as a switch strategy in virologically suppressed HIV-1-infected subjects on nonnucleoside reverse transcriptase inhibito
Betha, TP; Dravid, A; Dravid, M; Gawali, R; Kore, S; Kulkarni, M; Mahajan, U; Rathod, N; Saraf, C; Sharma, AK, 2020
)
0.56
" Grade 3/4 adverse events leading to TLE400 STR discontinuation were seen in 11 (2."( Efficacy and safety of a single-tablet regimen containing tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg and efavirenz 400 mg as a switch strategy in virologically suppressed HIV-1-infected subjects on nonnucleoside reverse transcriptase inhibito
Betha, TP; Dravid, A; Dravid, M; Gawali, R; Kore, S; Kulkarni, M; Mahajan, U; Rathod, N; Saraf, C; Sharma, AK, 2020
)
0.56
" Despite a safe renal profile in the clinical trials, long-term use of tenofovir disoproxil fumarate (TDF) has been associated with proximal renal tubulopathy although the underlying mechanisms remain undetermined."( Design and methods of the prevalence and pharmacogenomics of tenofovir nephrotoxicity in HIV-positive adults in south-western Nigeria study.
Dickens, C; Duarte, R; Hassan, MO; Lasisi, AO; Mabayoje, VO; Naicker, S, 2020
)
0.56
"Nephrotoxicity is a dose-limiting side effect of long-term use of tenofovir, a reverse transcriptase inhibitor that is used for the treatment of HIV infection and chronic hepatitis B infection."( Melatonin protects against tenofovir-induced nephrotoxicity in rats by targeting multiple cellular pathways.
Abraham, P; Isaac, B; Ramamoorthy, H, 2021
)
0.62
" Because TDF can lead to renal impairment and a decrease in bone mineral density (BMD), the prodrug tenofovir alafenamide (TAF) may be considered a viable alternative with fewer adverse effects."( Safety and efficacy of tenofovir alafenamide in liver transplant recipients: A single center experience.
Achterfeld, A; Herzer, K; Rashidi-Alavijeh, J; Straub, K; Wedemeyer, H; Willuweit, K, 2021
)
0.62
" After 1 year, 22 patients were still taking TAF; two patients had been lost to follow-up; one patient had died; and four patients had discontinued therapy because of TAF-related adverse effects."( Safety and efficacy of tenofovir alafenamide in liver transplant recipients: A single center experience.
Achterfeld, A; Herzer, K; Rashidi-Alavijeh, J; Straub, K; Wedemeyer, H; Willuweit, K, 2021
)
0.62
" PrEP was well tolerated with only minor adverse events (grade 2) thought to be related to study drug, which included headache (n=4, 3%), gastrointestinal upset (n=8, 5%), and skin rash (n=2, 1%)."( Acceptability, safety, and patterns of use of oral tenofovir disoproxil fumarate and emtricitabine for HIV pre-exposure prophylaxis in South African adolescents: an open-label single-arm phase 2 trial.
Bekker, LG; Dietrich, J; Fynn, L; Gill, K; Gray, G; Hosek, S; Johnson, L; Jones, K; Marcus, R; Mendel, E; Myer, L; Pidwell, T; Rooney, J; Slack, C; Spiegel, H; Strode, A; Wallace, M; Wiesner, L, 2020
)
0.56
"In this cohort of self-selected South African adolescents at risk of HIV acquisition, PrEP appears safe and tolerable in those who continued use."( Acceptability, safety, and patterns of use of oral tenofovir disoproxil fumarate and emtricitabine for HIV pre-exposure prophylaxis in South African adolescents: an open-label single-arm phase 2 trial.
Bekker, LG; Dietrich, J; Fynn, L; Gill, K; Gray, G; Hosek, S; Johnson, L; Jones, K; Marcus, R; Mendel, E; Myer, L; Pidwell, T; Rooney, J; Slack, C; Spiegel, H; Strode, A; Wallace, M; Wiesner, L, 2020
)
0.56
"6%) patients because of adverse effects."( Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide as Maintenance Treatment in HIV/HBV-Coinfected Patients.
Cheng, CY; Cheng, SH; Ho, MW; Huang, SH; Huang, YS; Hung, CC; Lee, CH; Lee, YT; Lin, SP; Liou, BH; Liu, CE; Lu, PL; Sun, HY; Tang, HJ; Tsai, HC; Yang, CJ, 2021
)
0.62
" No drug-related adverse events were observed within a 48-week observation period."( The 48-week safety and therapeutic effects of tenofovir alafenamide in hbv-related acute-on-chronic liver failure: A prospective cohort study.
Lai, J; Li, J; Li, X; Peng, L; Shu, X; Xie, C; Xie, J; Xu, W; Zhang, Y; Zhu, X, 2021
)
0.62
" Former participants from The Ring Study, who remained HIV-negative and who did not discontinue the study due to an adverse event or safety concern that was considered to be related to the investigational product, were eligible."( Safety, adherence, and HIV-1 seroconversion among women using the dapivirine vaginal ring (DREAM): an open-label, extension study.
Bekker, LG; Carter, A; Craig, C; Devlin, B; Gill, K; Gwetu, T; Kotze, P; Kusemererwa, S; Louw, C; Mabude, Z; Malherbe, M; Mans, W; Moraba, R; Nel, A; Rosenberg, Z; Steytler, J; Tempelman, H; Van Baelen, B; van der Ryst, E; van Niekerk, N, 2021
)
0.62
" 616 (65·5%) of 941 participants reported treatment-emergent adverse events."( Safety, adherence, and HIV-1 seroconversion among women using the dapivirine vaginal ring (DREAM): an open-label, extension study.
Bekker, LG; Carter, A; Craig, C; Devlin, B; Gill, K; Gwetu, T; Kotze, P; Kusemererwa, S; Louw, C; Mabude, Z; Malherbe, M; Mans, W; Moraba, R; Nel, A; Rosenberg, Z; Steytler, J; Tempelman, H; Van Baelen, B; van der Ryst, E; van Niekerk, N, 2021
)
0.62
" No serious adverse events or grade 3 or higher adverse events observed were assessed as related to the DVR."( Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study.
Baeten, JM; Balán, IC; Brown, ER; Bunge, K; Chinula, L; Chirenje, ZM; Garcia, M; Gati Mirembe, B; Govender, V; Hendrix, CW; Hillier, SL; Hunidzarira, P; Jacobson, C; Jiao, Y; Jones, J; Livant, E; Makanani, B; Mansoor, LE; Mayo, AJ; Mellors, JW; Mgodi, NM; Mhlanga, F; Naidoo, L; Nair, G; Nakabiito, C; Nel, A; Ngure, K; Palanee-Phillips, T; Parikh, UM; Patterson, K; Peda, M; Ramjee, G; Rosenberg, Z; Scheckter, R; Singh, D; Singh, N; Siva, S; Soto-Torres, LE; Szydlo, DW; Taha, TE; Torjesen, K; van der Straten, A, 2021
)
0.62
" No cases of renal injury or other obstetric adverse events occurred in either group of women."( Analysis of long-term safety and efficacy of nucleos(t)ide analogue therapy for chronic hepatitis B throughout pregnancy.
Bai, L; Liu, H; M Ise, R; Shang, J; Tang, H; Tu, Y; Wen, Q, 2021
)
0.62
" Primary safety outcomes, compared pairwise among treatment groups, were the occurrence of a composite adverse pregnancy outcome (ie, either preterm delivery, the infant being born small for gestational age, stillbirth, or spontaneous abortion) in all participants with a pregnancy outcome, and the occurrence of grade 3 or higher maternal and infant adverse events in all randomised participants."( Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2
Amico, KR; Brummel, SS; Cassim, H; Chakhtoura, N; Chinula, L; Coletti, A; Currier, J; Fairlie, L; Frenkel, LM; Hanley, S; Hoffman, RM; Holmes, LB; Jean-Philippe, P; João, E; Johnston, B; Korutaro, V; Krotje, C; Lockman, S; Masheto, G; McCarthy, K; Mmbaga, BT; Momper, JD; Moyo, S; Purdue, L; Rooney, JF; Sax, PE; Shapiro, RL; Stranix-Chibanda, L; Stringer, JS; Thoofer, NK; Ziemba, L, 2021
)
0.62
" Significantly fewer participants in the dolutegravir, emtricitabine, and tenofovir alafenamide fumarate group (52 [24%] of 216) had a composite adverse pregnancy outcome than those in the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group (70 [33%] of 213; estimated difference -8·8% [95% CI -17·3 to -0·3], p=0·043) or the efavirenz, emtricitabine, and tenofovir disoproxil fumarate group (69 [33%] of 211; -8·6% [-17·1 to -0·1], p=0·047)."( Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2
Amico, KR; Brummel, SS; Cassim, H; Chakhtoura, N; Chinula, L; Coletti, A; Currier, J; Fairlie, L; Frenkel, LM; Hanley, S; Hoffman, RM; Holmes, LB; Jean-Philippe, P; João, E; Johnston, B; Korutaro, V; Krotje, C; Lockman, S; Masheto, G; McCarthy, K; Mmbaga, BT; Momper, JD; Moyo, S; Purdue, L; Rooney, JF; Sax, PE; Shapiro, RL; Stranix-Chibanda, L; Stringer, JS; Thoofer, NK; Ziemba, L, 2021
)
0.62
" The dolutegravir, emtricitabine, and tenofovir alafenamide fumarate regimen had the lowest frequency of composite adverse pregnancy outcomes and of neonatal deaths."( Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2
Amico, KR; Brummel, SS; Cassim, H; Chakhtoura, N; Chinula, L; Coletti, A; Currier, J; Fairlie, L; Frenkel, LM; Hanley, S; Hoffman, RM; Holmes, LB; Jean-Philippe, P; João, E; Johnston, B; Korutaro, V; Krotje, C; Lockman, S; Masheto, G; McCarthy, K; Mmbaga, BT; Momper, JD; Moyo, S; Purdue, L; Rooney, JF; Sax, PE; Shapiro, RL; Stranix-Chibanda, L; Stringer, JS; Thoofer, NK; Ziemba, L, 2021
)
0.62
" Adverse events were reported in 8 (7%) patients."( [Effectiveness, safety, and economic impact of the bictegravir/emtricitabine/tenofovir alafenamide regimen in real clinical practice cohort of HIV-1 infected adult patients].
Gutiérrez-Lorenzo, M; Rubio-Calvo, D; Urda-Romacho, J, 2021
)
0.62
" However, we found a large difference between the high percentages of patients reporting an adverse event in three phase 3 clinical trials and our results."( [Effectiveness, safety, and economic impact of the bictegravir/emtricitabine/tenofovir alafenamide regimen in real clinical practice cohort of HIV-1 infected adult patients].
Gutiérrez-Lorenzo, M; Rubio-Calvo, D; Urda-Romacho, J, 2021
)
0.62
" TAF was well tolerated and only 4 patients discontinued therapy due to adverse event during a median duration of TAF dosing of 74 weeks."( Safety and Effectiveness of Tenofovir Alafenamide in Usual Clinical Practice Confirms Results of Clinical Trials: TARGET-HBV.
Bernstein, DE; Fried, MW; Lok, AS; Mospan, AR; Schiff, ER; Smith, CI; Trinh, HN; Zink, RC, 2022
)
0.72
" The treatment using NAs was well-tolerated and there was no serious drug-related adverse event reported."( Short-term and long-term safety and efficacy of tenofovir alafenamide, tenofovir disoproxil fumarate and entecavir treatment of acute-on-chronic liver failure associated with hepatitis B.
Chen, T; Chen, Y; Fu, M; Fu, S; Gao, Z; He, Y; Hu, C; Li, J; Liu, J; Yan, T; Yang, Y; Zhang, R; Zhao, Y; Zhou, M, 2021
)
0.62
" In rats, systemic and local findings were considered not adverse due to their low severity and reversibility; therefore, the "no observed adverse effect level" (NOAEL) was set at 1,000 μg/kg/day."( A 28-Day Toxicity Study of Tenofovir Alafenamide Hemifumarate by Subcutaneous Infusion in Rats and Dogs.
Alessi, T; Feldman, PL; Felx, M; Jain, R; Roller, S; Shelton, J; Singh, R; Wang, Y; Yang, B; Zane, D, 2021
)
0.62
"Emtricitabine and tenofovir alafenamide is safe and effective for longer-term pre-exposure prophylaxis in cisgender men and transgender women who have sex with men."( Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial.
Asmuth, DM; Baeten, JM; Brainard, DM; Brunetta, JM; Carter, C; Cox, S; Das, M; Ebrahimi, R; Gilson, R; Henry, K; Kintu, A; Kronborg, G; Ogbuagu, O; Podzamczer, D; Ruane, PJ; Salazar, LC; Shao, Y; Spinner, CD; Whitlock, G; Wohl, D, 2021
)
0.62
" Week 48 virologic suppression (HIV-1 RNA <50 copies/mL), resistance, adverse events (AEs), and laboratory parameters were assessed."( Brief Report: Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Females Living With HIV: An Integrated Analysis of 5 Trials.
Ajana, F; Brainard, D; Chuck, SK; Collins, SE; Gandhi-Patel, B; Kityo, C; Koenig, E; Liu, Y; Makadzange, T; McNicholl, I; Natukunda, E; Orkin, C; Pikora, C; Wang, H; Wei, X; White, K, 2021
)
0.62
"In individuals with a history of PRT on TDF, 96 weeks of TAF was not associated with recurrent PRT or adverse effects on renal tubular function, bone turnover, or BMD."( Safety of Tenofovir Alafenamide in People With HIV Who Experienced Proximal Renal Tubulopathy on Tenofovir Disoproxil Fumarate.
Barbini, B; Burling, K; Campbell, L; Cromarty, B; Hamzah, L; Johnson, M; Jones, R; Post, FA; Samarawickrama, A; Williams, D; Winston, A, 2021
)
0.62
" Treatment-related adverse events occurred in 51 (15%) patients (all Grade 1-2) and led to 8 discontinuations."( Real-world efficacy and safety of switching to bictegravir/emtricitabine/tenofovir alafenamide in older people living with HIV.
Cruz, D; DeJesus, E; Hinestrosa, F; Nguyen, V; Patel, K; Rolle, CP, 2021
)
0.62
"ETV, TDF, and TAF were safe antiviral agents and showed similar antiviral effect for CHB at 48 weeks."( Real-World Single-Center Comparison of the Safety and Efficacy of Entecavir, Tenofovir Disoproxil Fumarate, and Tenofovir Alafenamide in Patients with Chronic Hepatitis B.
Jeong, S; Kim, HI; Shin, HP, 2022
)
0.72
" However, no serious adverse events were observed in infants and mothers of all groups."( Comparison of the efficacy and safety of tenofovir and telbivudine in interrupting mother-to-child transmission of hepatitis B virus.
Chen, L; Chen, X; Dai, E; Li, C; Li, S; Lv, X; Zhao, Z; Zhu, B, 2021
)
0.62
" Drug-related adverse events were more frequent with DTG/3TC (15%; leading to discontinuation in 4%) than TAF-based regimens (5%; leading to discontinuation in 1%) through week 144, but rates were comparable after week 48 (4%; leading to discontinuation in 1% in both groups)."( Efficacy and Safety of Switching to Dolutegravir/Lamivudine Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Results Through Week 144 F
Aboud, M; Ait-Khaled, M; Ajana, F; Bisshop, F; De Wit, S; George, N; Leone, P; Osiyemi, O; Pappa, KA; Portilla, J; Routy, JP; Smith, KY; van Wyk, J; Wang, R; Wright, J; Wyen, C; Wynne, B, 2022
)
0.72
" Despite its effectiveness and few adverse effects, it is related to renal and bone toxicity."( Tenofovir-induced renal and bone toxicity: report of two cases and literature review.
Distenhreft, JIQ; Fioroti, CEA; Lacchine, K; Luchi, WM; Paulino, BB; Ramos, DR; Seguro, AC, 2022
)
0.72
" Adverse events were observed in 15% of the patients, and the regimen was discontinued in only six patients."( Effectiveness and safety of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate single-tablet combination among HIV-infected patients in Turkey: results from a real world setting.
Aydin, OA; Bilge, B; Bolukcu, S; Dokmetas, I; Gumuser, F; Gunduz, A; Karaosmanoglu, HK; Mete, B; Tabak, F; Yildiz, DS, 2021
)
0.62
"Real world data on the effectiveness and safety of E/C/F/TDF is comparable with the phase 3 trial results Adverse events are uncommon and manageable."( Effectiveness and safety of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate single-tablet combination among HIV-infected patients in Turkey: results from a real world setting.
Aydin, OA; Bilge, B; Bolukcu, S; Dokmetas, I; Gumuser, F; Gunduz, A; Karaosmanoglu, HK; Mete, B; Tabak, F; Yildiz, DS, 2021
)
0.62
" The proportions of participants with any grade 3-4 adverse event were similar between the dolutegravir (26 [11%]) and darunavir (28 [12%]) groups and between the tenofovir (22 [9%]) and zidovudine (32 [14%]) groups."( Efficacy and safety of dolutegravir or darunavir in combination with lamivudine plus either zidovudine or tenofovir for second-line treatment of HIV infection (NADIA): week 96 results from a prospective, multicentre, open-label, factorial, randomised, non
Asienzo, J; Ategeka, G; Balyegisawa, A; Borok, M; Castelnuovo, B; Hoppe, A; Kaimal, A; Kambugu, A; Kiragga, A; Kityo, C; Lugemwa, A; Mirembe, G; Mugerwa, H; Musaazi, J; Odongpiny, ELA; Paton, NI; Siika, A; Walimbwa, S, 2022
)
0.72
" This post hoc analysis evaluated gastrointestinal adverse events of interest (AEOIs; diarrhea, nausea, abdominal discomfort, flatulence [MedDRAv21]) through Wk96 among patients enrolled in the phase 3 AMBER (treatment-naïve) and EMERALD (virologically suppressed) studies of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg."( Low Incidence and Brief Duration of Gastrointestinal Adverse Events with Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Over 96 Weeks: Post hoc Analyses of AMBER and EMERALD.
Anderson, D; Baugh, B; Bejou, N; Campbell, J; Dunn, K; Luo, D; Seyedkazemi, S,
)
0.13
"PrEP is safe and effective in MSM, serodiscordant couples and PWIDs."( Oral pre-exposure prophylaxis (PrEP) to prevent HIV: a systematic review and meta-analysis of clinical effectiveness, safety, adherence and risk compensation in all populations.
Harrington, P; Hayes, C; Marshall, L; Moran, P; O Murchu, E; Ryan, M; Teljeur, C, 2022
)
0.72
" As, this product is proposed for adults and adolescents safe from HIV but at high risk of infection, the question is to know if there is a safety concern about this use."( [HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine: What about safety?]
Davani, S; Grandvuillemin, A; Jacomet, C; Lebeller, C; Schiestel, T; Valnet-Rabier, MB,
)
0.13
"In both database, 808 cases correspond to an indication of HIV prexposure prophylaxis who represent 2058 adverse effects (AEs) mainly distributed in gastro-intestinal disorders (38."( [HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine: What about safety?]
Davani, S; Grandvuillemin, A; Jacomet, C; Lebeller, C; Schiestel, T; Valnet-Rabier, MB,
)
0.13
" We identify 24% of unexpected and potentially serious adverse effects in France mainly among chemsex users."( [HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine: What about safety?]
Davani, S; Grandvuillemin, A; Jacomet, C; Lebeller, C; Schiestel, T; Valnet-Rabier, MB,
)
0.13
"Gastrointestinal adverse events are common after treatment initiation but usually resolve within weeks."( Safety of oral tenofovir disoproxil - emtricitabine for HIV preexposure prophylaxis in adults.
Liegeon, G, 2022
)
0.72
"Oral tenofovir disoproxil-FTC for HIV PrEP appears safe and well tolerated for most individuals."( Safety of oral tenofovir disoproxil - emtricitabine for HIV preexposure prophylaxis in adults.
Liegeon, G, 2022
)
0.72
" Consistent with previous findings, we observed adverse local toxicity and necrosis near the tenofovir alafenamide implant site."( Safety and efficacy of a biodegradable implant releasing tenofovir alafenamide for vaginal protection in a macaque model.
Dobard, C; García-Lerma, JG; Gary, J; Gatto, G; Heneine, W; Holder, A; Johnson, L; Khalil, G; Krovi, A; Li, L; Luecke, E; Massud, I; Mills, P; Mitchell, J; Nishiura, K; Pan, Y; Ruone, S; van der Straten, A, 2022
)
0.72
" Safety was assessed by adverse event (AE) reporting."( Brief Report: Efficacy and Safety of Oral Islatravir Once Daily in Combination With Doravirine Through 96 Weeks for Treatment-Naive Adults With HIV-1 Infection Receiving Initial Treatment With Islatravir, Doravirine, and Lamivudine.
Afani Saud, A; Bettacchi, C; Chahin Anania, C; Correll, T; Eves, K; Grandhi, A; Hanna, GJ; Hepler, D; Hwang, C; Klopfer, SO; Molina, JM; Robertson, MN; Yazdanpanah, Y, 2022
)
0.72
"Previous clinical data have shown that raltegravir-based antiretroviral therapy (ART) with fewer drug-drug interactions (DDIs) and adverse events (AEs) is a good regimen in patients with HIV infection who need cancer chemotherapy."( Safety and efficacy of pharmacotherapy containing INSTIs and chemotherapy drugs in people living with HIV and concomitant colorectal cancer.
Chen, T; Gui, F; Tan, J; Wei, G; Yang, J; Zhao, Y, 2022
)
0.72
" Safety was assessed by adverse events and changes from baseline in mucosal histology and immune mediators."( Randomized, placebo controlled phase I trial of the safety, pharmacokinetics, pharmacodynamics and acceptability of a 90 day tenofovir plus levonorgestrel vaginal ring used continuously or cyclically in women: The CONRAD 138 study.
Brache, V; Chandra, N; Clark, MR; Cochon, L; Doncel, GF; Erikson, DW; Fichorova, RN; Hanif, H; Herold, BC; Jacot, T; Ju, S; Marzinke, MA; Ouattara, LA; Parikh, U; Peet, M; Schwartz, JL; Thurman, AR; Tolley, E; Yousefieh, N, 2022
)
0.72
" No drug-related serious or grade 3 or 4 adverse events occurred."( Pharmacokinetics, Tolerability, and Safety of Doravirine and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination Tablets in Adolescents Living With HIV: Week 24 Results From IMPAACT 2014.
Aurpibul, L; Best, BM; Campbell, H; Cassim, H; Cooper, E; Flynn, P; Gray, KP; Krotje, C; McCarthy, K; McFarland, E; Melvin, AJ; Moye, J; Ounchanum, P; Rungmaitree, S; Scheckter, R; Teppler, H; Tobin, NH; Townley, E; Wan, H; Yedla, M; Yee, KL, 2023
)
0.91
" DTG + 3TC achieved virological suppression more rapidly and stably versus TDF + 3TC + EFV in ART-naïve HIV-1-infected adults, with better immunological response and less adverse drug effect, and reduced total HIV-1 DNA effectively."( Real-world efficacy and safety of dolutegravir plus lamivudine versus tenofovir plus lamivudine and efavirenz in ART-naïve HIV-1-infected adults.
Chen, D; Du, Y; Huang, Z; Li, J; Wang, Y; Wen, Z; Yin, S; Zhong, H, 2022
)
0.72
" Bulevirtide was well tolerated, there was no deterioration in tolerability compared with patients without cirrhosis, there were no serious adverse events and cases of treatment cancellation due to adverse events."( [Efficacy and safety of bulevirtide in patients with chronic hepatitis D and compensated cirrhosis].
Bogomolov, PO; Bueverov, AO; Chulanov, VP; Gusev, DA; Ivashkin, VT; Maev, IV; Sagalova, OI; Sleptsova, SS; Yushuk, ND; Zhdanov, KV, 2021
)
0.62
" Significantly lower study drug-related adverse events were observed in TLE 400 group compared to TLE 600 group (52."( Efficacy and safety of 400 mg efavirenz versus standard 600 mg dose when taken with tenofovir and lamivudine combination in Indian adult patients with HIV-1 infection: An open-label, interventional, randomized, non-inferiority trial.
Bhrusundi, M; Dravid, A; K R, R; Kulkarni, V; Madhukarrao, KM; Morkar, DN; Nageswaramma, S; Naik, KS; Pilawan, AS; Ramapuram, JT; S, A, 2022
)
0.72
"ETV, TDF, and TAF are comparably safe and effective antiviral agents against CHB."( Comparison of the side effects of antivirals in chronic hepatitis B patients: a single-center experience.
Celik, U; Dusunceli, I; Gok Sargin, Z; Ustundag, Y,
)
0.13
" Across the studies, one grade 3/4 adverse event was considered drug-related (intermediate uveitis)."( Effectiveness and safety of tenofovir alafenamide in children and adolescents living with HIV: a systematic review.
Castro, H; Collins, IJ; Jesson, J; Judd, A; Leroy, V; Milanzi, E; O'Rourke, J; Penazzato, M; Renaud, F; Townsend, CL; Vicari, M, 2023
)
0.91
" Safety was assessed by treatment-emergent adverse events (TEAEs)."( A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir.
Anderson, PL; Bushman, LR; Clark, M; Doncel, GF; Fang, X; Hanif, H; Ouattara, LA; Singh, O; Thurman, AR; Yousefieh, N, 2023
)
0.91
" The inserts were safe and highly acceptable."( A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir.
Anderson, PL; Bushman, LR; Clark, M; Doncel, GF; Fang, X; Hanif, H; Ouattara, LA; Singh, O; Thurman, AR; Yousefieh, N, 2023
)
0.91
" Primary safety analyses were pairwise comparisons between ART regimens of the proportion of maternal and infant adverse events of grade 3 or higher up to 50 weeks post partum."( Efficacy and safety of three antiretroviral therapy regimens started in pregnancy up to 50 weeks post partum: a multicentre, open-label, randomised, controlled, phase 3 trial.
Amico, KR; Boyce, C; Brummel, S; Cassim, H; Chakhtoura, N; Chinula, L; Coletti, A; Currier, JS; Fairlie, L; Frenkel, LM; Hoffman, R; Jean-Philippe, P; Johnston, B; Knowles, K; Korutaro, V; Krotje, C; Lockman, S; Masheto, G; McCarthy, K; Mmbaga, BT; Moyo, S; Patel, F; Purdue, L; Rooney, JF; Sax, PE; Shapiro, R; Stranix-Chibanda, L; Stringer, J; van Wyk, J; Ziemba, L, 2023
)
0.91
" Up to the week 50 post-partum visit, the estimated probability of experiencing an adverse event of grade 3 or higher was 25% in the dolutegravir, emtricitabine, and tenofovir alafenamide group; 31% in the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group; and 28% in the efavirenz, emtricitabine, and tenofovir disoproxil fumarate group (no significant difference between groups)."( Efficacy and safety of three antiretroviral therapy regimens started in pregnancy up to 50 weeks post partum: a multicentre, open-label, randomised, controlled, phase 3 trial.
Amico, KR; Boyce, C; Brummel, S; Cassim, H; Chakhtoura, N; Chinula, L; Coletti, A; Currier, JS; Fairlie, L; Frenkel, LM; Hoffman, R; Jean-Philippe, P; Johnston, B; Knowles, K; Korutaro, V; Krotje, C; Lockman, S; Masheto, G; McCarthy, K; Mmbaga, BT; Moyo, S; Patel, F; Purdue, L; Rooney, JF; Sax, PE; Shapiro, R; Stranix-Chibanda, L; Stringer, J; van Wyk, J; Ziemba, L, 2023
)
0.91
"01), but more tolerated injection sites adverse events (p < 0."( Efficacy and safety of long-acting cabotegravir versus oral tenofovir disoproxil fumarate-emtricitabine as HIV pre-exposure prophylaxis: A systematic review and meta-analysis.
Chen, X; Kou, L; Li, J; Li, Y; Wei, D; Xie, X, 2023
)
0.91
" Tenofovir disoproxil fumarate (TDF) increases the risk of renal tubular toxicity and adverse effects on bone, but Tenofovir alafenamide (TAF) and Tenofovir amibufenamide (TMF) have favorable safety profile on the kidneys and bones."( Medication safety in chronic kidney disease.
Singh, S, 2023
)
0.91
" Frequency of adverse events was similar between the treatment groups."( Efficacy, safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis in transgender women: a secondary analysis of the HPTN 083 trial.
Adeyeye, A; Cardozo, N; Cohen, MS; Coutinho, C; Donnell, D; Eshleman, SH; Feliciano, KG; Ford, S; Franks, J; Grinsztejn, B; Hanscom, B; Jalil, E; Jennings, A; Khan, T; Landovitz, RJ; Lucas, J; Maia, B; Marzinke, MA; McCauley, M; Middelkoop, K; Psaros, C; Richardson, PA; Rinehart, AR; Rooney, JF; Safren, SA; Sanchez, N; Singh, Y; Sullivan, P; Valencia, J; Wang, Z, 2023
)
0.91
" Our results suggest that injectable cabotegravir is a safe and effective pre-exposure prophylaxis option for transgender women."( Efficacy, safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis in transgender women: a secondary analysis of the HPTN 083 trial.
Adeyeye, A; Cardozo, N; Cohen, MS; Coutinho, C; Donnell, D; Eshleman, SH; Feliciano, KG; Ford, S; Franks, J; Grinsztejn, B; Hanscom, B; Jalil, E; Jennings, A; Khan, T; Landovitz, RJ; Lucas, J; Maia, B; Marzinke, MA; McCauley, M; Middelkoop, K; Psaros, C; Richardson, PA; Rinehart, AR; Rooney, JF; Safren, SA; Sanchez, N; Singh, Y; Sullivan, P; Valencia, J; Wang, Z, 2023
)
0.91
" The primary safety endpoint was grade 2 or higher adverse events during each randomised period of 24 weeks of ring and oral PrEP."( Adherence, safety, and choice of the monthly dapivirine vaginal ring or oral emtricitabine plus tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis among African adolescent girls and young women: a randomised, open-label, crossover trial.
Akello, CA; Anderson, P; Baeten, JM; Bekker, LG; Brown, ER; Bunge, K; Celum, C; Garcia, M; Hendrix, C; Hillier, SL; Hosek, S; Jacobson, C; Johnson, S; Levy, L; Livant, E; Macdonald, P; McClure, T; Milan, G; Muhlanga, F; Nair, G; Nakabiito, C; Nakalega, R; Ngure, K; Palanee-Phillips, T; Parikh, U; Reddy, K; Rooney, JF; Siziba, B; Soto-Torres, L; Steytler, J; Szydlo, D; Tahuringana, E; van der Straten, A, 2023
)
0.91
" 54 grade 2 or higher product-related adverse events were reported during oral PrEP and five during dapivirine ring use, with no product-related serious adverse events."( Adherence, safety, and choice of the monthly dapivirine vaginal ring or oral emtricitabine plus tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis among African adolescent girls and young women: a randomised, open-label, crossover trial.
Akello, CA; Anderson, P; Baeten, JM; Bekker, LG; Brown, ER; Bunge, K; Celum, C; Garcia, M; Hendrix, C; Hillier, SL; Hosek, S; Jacobson, C; Johnson, S; Levy, L; Livant, E; Macdonald, P; McClure, T; Milan, G; Muhlanga, F; Nair, G; Nakabiito, C; Nakalega, R; Ngure, K; Palanee-Phillips, T; Parikh, U; Reddy, K; Rooney, JF; Siziba, B; Soto-Torres, L; Steytler, J; Szydlo, D; Tahuringana, E; van der Straten, A, 2023
)
0.91
" Safety endpoints assessed included all the adverse events (AEs) related to the study treatment (TLE400 and TLE600)."( Safety of low dose efavirenz regimen in Indian adults with HIV-1 infection: Insights from a phase 4 interventional randomised trial.
Anuradha, S; Bhrusundi, M; Dravid, AN; Kulkarni, V; Madhukarrao, KM; Morkar, DN; Nageswaramma, S; Naik, KS; Pilawan, AS; Ramapuram, JT; Raveendra, KR, 2023
)
0.91
" However, greater adverse effects on renal function were observed for TDF than ETV at 60 months compared to 12 months."( Renal and bone side effects of long-term use of entecavir, tenofovir disoproxil fumarate, and tenofovir alafenamide fumarate in patients with Hepatitis B: a network meta-analysis.
Liu, S; Liu, Z; Ma, X; Xin, Y; Zhao, Z, 2023
)
0.91
"Long-term administration of TDF has resulted in stronger adverse effects than TAF and ETV in regard to both renal function and bone tissue in CHB patients."( Renal and bone side effects of long-term use of entecavir, tenofovir disoproxil fumarate, and tenofovir alafenamide fumarate in patients with Hepatitis B: a network meta-analysis.
Liu, S; Liu, Z; Ma, X; Xin, Y; Zhao, Z, 2023
)
0.91
" Adverse events were compared across treatment groups and time periods (blinded vs unblinded)."( Efficacy and safety of long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary anal
Adeyeye, A; Anderson, PL; Berman, R; Clement, ME; Cohen, MS; Del Rio, C; Donnell, D; Eron, JJ; Eshleman, SH; Fields, SD; Grinsztejn, B; Hanscom, BS; Hendrix, CW; Kallas, EG; Kofron, RM; Landovitz, RJ; Lucas, JP; Magnus, M; Marzinke, MA; McCauley, M; Piwowar-Manning, EM; Richardson, PA; Rinehart, AR; Rooney, JF; Sanchez, J; Scott, H; Spinelli, MA; Sued, O; Sullivan, PA; Tran, HV, 2023
)
0.91
" Adverse events were generally consistent with previous reports; incident hypertension in the long-acting PrEP group requires further investigation."( Efficacy and safety of long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary anal
Adeyeye, A; Anderson, PL; Berman, R; Clement, ME; Cohen, MS; Del Rio, C; Donnell, D; Eron, JJ; Eshleman, SH; Fields, SD; Grinsztejn, B; Hanscom, BS; Hendrix, CW; Kallas, EG; Kofron, RM; Landovitz, RJ; Lucas, JP; Magnus, M; Marzinke, MA; McCauley, M; Piwowar-Manning, EM; Richardson, PA; Rinehart, AR; Rooney, JF; Sanchez, J; Scott, H; Spinelli, MA; Sued, O; Sullivan, PA; Tran, HV, 2023
)
0.91
"In this first study of a long-acting HIV prevention agent in pregnancy, adverse pregnancy outcomes and complications were uncommon when DVR and TDF/FTC were used in the third trimester of pregnancy, suggesting a favorable safety profile for both prevention products."( DELIVER: A Safety Study of a Dapivirine Vaginal Ring and Oral PrEP for the Prevention of HIV During Pregnancy.
Balkus, JE; Bunge, K; Chakhtoura, N; Chappell, CA; Fairlie, L; Gadama, L; Hillier, SL; Matrimbira, M; Mayo, AJ; Mgodi, N; Nakabiito, C; Piper, J; Richardson, B; Szydlo, DW, 2024
)
1.44

Pharmacokinetics

Tenofovir is an efficacious drug with a long half-life and high activity against both HIV and HBV. The method was successfully applied to the pharmacokinetic study of two tenofovIR agents.

ExcerptReferenceRelevance
" Pharmacokinetic parameters were dose proportional and demonstrated no change with repeated dosing."( Phase i/ii trial of the pharmacokinetics, safety, and antiretroviral activity of tenofovir disoproxil fumarate in human immunodeficiency virus-infected adults.
Barditch-Crovo, P; Coakley, DF; Coleman, RL; Collier, A; Deeks, SG; Kahn, JO; Kearney, BP; Lamy, PD; Lietman, PS; McGowan, I; Miller, M; Safrin, S, 2001
)
0.31
" A two compartment pharmacokinetic model is employed to determine the time evolution of the intracellular concentrations of the active forms of drugs, and thereby drug efficacy."( Complex patterns of viral load decay under antiretroviral therapy: influence of pharmacokinetics and intracellular delay.
Dixit, NM; Perelson, AS, 2004
)
0.32
"Phase I, open-label, fixed-sequence, pharmacokinetic drug-drug interaction study."( Effect of tenofovir disoproxil fumarate on the pharmacokinetics and pharmacodynamics of total, R-, and S-methadone.
Berenson, CS; Booker, BM; Bullock, JM; Cloen, D; Coakley, DF; Flaherty, JF; Haas, CE; Kearney, BP; Liaw, S; Smith, PF; Yale, K, 2004
)
0.32
" Both AUCss and Cmax met the strict criteria for bioequivalence between the two study periods for total, R-, and S-methadone, indicating a lack of drug interaction when tenofovir DF was coadministered with methadone."( Effect of tenofovir disoproxil fumarate on the pharmacokinetics and pharmacodynamics of total, R-, and S-methadone.
Berenson, CS; Booker, BM; Bullock, JM; Cloen, D; Coakley, DF; Flaherty, JF; Haas, CE; Kearney, BP; Liaw, S; Smith, PF; Yale, K, 2004
)
0.32
"On day 1, 12 h pharmacokinetic profiles for saquinavir/ritonavir (1000/100 mg given twice daily) were obtained for 18 subjects."( Pharmacokinetics of saquinavir hard gel/ritonavir (1000/100 mg twice daily) when administered with tenofovir diproxil fumarate in HIV-1-infected subjects.
Back, D; Boffito, M; Di Perri, G; Gazzard, B; Hill, A; Moyle, G; Nelson, M; Pozniak, A; Stainsby-Tron, M; Tomkins, J, 2005
)
0.33
" Pharmacokinetic data for 23 subjects were thus evaluable."( Pharmacokinetic study of tenofovir disoproxil fumarate combined with rifampin in healthy volunteers.
Buffels, R; Burger, DM; Droste, JA; Hekster, YA; Kearney, BP; Vanhorssen, PJ; Verweij-van Wissen, CP, 2005
)
0.33
"The nucleotide analogue, tenofovir, has been shown to lower plasma atazanavir levels in pharmacokinetic trials, an interaction that may be partly reversed by the addition of ritonavir, whereas plasma tenofovir levels are themselves raised when the drug is combined with lopinavir/ritonavir."( The steady-state pharmacokinetics of nelfinavir in combination with tenofovir in HIV-infected patients.
Becker, M; Breske, A; Esser, S; Hill, A; Koerber, A; Kopperman, M; Kruse, G; Kurowski, M; Möcklinghoff, C; Ross, B; Stocker, H; Wiehler, H, 2005
)
0.33
"Eighteen patients received nelfinavir 1250 mg twice daily plus prescribed nucleoside reverse transcriptase inhibitors for at least 14 days, with pharmacokinetic measurements performed on day 15."( The steady-state pharmacokinetics of nelfinavir in combination with tenofovir in HIV-infected patients.
Becker, M; Breske, A; Esser, S; Hill, A; Koerber, A; Kopperman, M; Kruse, G; Kurowski, M; Möcklinghoff, C; Ross, B; Stocker, H; Wiehler, H, 2005
)
0.33
" TFV-DP also had persistent intracellular levels on TDF discontinuation (median half-life of 150 hours, range: 60 to >175 hours)."( Intracellular pharmacokinetics of tenofovir diphosphate, carbovir triphosphate, and lamivudine triphosphate in patients receiving triple-nucleoside regimens.
Clark, N; Guyer, B; Hawkins, T; Kearney, BP; St Claire, RL; Veikley, W, 2005
)
0.33
" Steady-state RTV AUCtau and Cmax levels were not significantly altered, whereas Ctau was 23% higher upon coadministration of SQV/RTV and TDF."( Pharmacokinetics of tenofovir disoproxil fumarate and ritonavir-boosted saquinavir mesylate administered alone or in combination at steady state.
Adda, N; Begley, JA; Blum, MR; Chittick, GE; Kearney, BP; Sorbel, JJ; Zong, J, 2006
)
0.33
" Pharmacokinetic sampling was performed on days 1 through 4 and 22 through 25."( Absence of clinically relevant pharmacokinetic interaction between ribavirin and tenofovir in healthy subjects.
Cheng, A; Ebrahimi, R; Kearney, BP; Mittan, A; Ramanathan, S, 2006
)
0.33
"A population pharmacokinetic analysis was performed in the context of therapeutic drug monitoring (87 patients, 121 samples)."( Influence of tenofovir, nevirapine and efavirenz on ritonavir-boosted atazanavir pharmacokinetics in HIV-infected patients.
Arvieux, C; Dailly, E; Jolliet, P; Perré, P; Raffi, F; Tattevin, P; Tribut, O, 2006
)
0.33
"We evaluated the impact of modelling intra-subject variability on the likelihood ratio test (LRT) and the Wald test based on non-linear mixed effects models in pharmacokinetic interaction and bioequivalence cross-over trials."( Impact of modelling intra-subject variability on tests based on non-linear mixed-effects models in cross-over pharmacokinetic trials with application to the interaction of tenofovir on atazanavir in HIV patients.
Mentré, F; Panhard, X; Piketti, C; Taburet, AM, 2007
)
0.34
" A pharmacokinetic study in healthy volunteers was conducted to assess the potential for a drug interaction between these agents."( Pharmacokinetics and safety of tenofovir disoproxil fumarate on coadministration with lopinavir/ritonavir.
Cheng, AK; Ebrahimi, R; Kearney, BP; Mathias, A; Mittan, A; Sayre, J, 2006
)
0.33
" Pharmacokinetic assessments were performed over 24 hours on days 7, 21, and 35."( Pharmacokinetics and safety of tenofovir disoproxil fumarate on coadministration with lopinavir/ritonavir.
Cheng, AK; Ebrahimi, R; Kearney, BP; Mathias, A; Mittan, A; Sayre, J, 2006
)
0.33
" Pharmacokinetic (PK) blood draws were performed on days 7, 17, and 27."( Pharmacokinetics of emtricitabine, tenofovir, and GS-9137 following coadministration of emtricitabine/tenofovir disoproxil fumarate and ritonavir-boosted GS-9137.
Cheng, A; Kearney, BP; Ramanathan, S; Shen, G, 2007
)
0.34
" We evaluated the possibility of a pharmacokinetic interaction between TFV and EFV by assessing cross-sectional and longitudinal data in 169 individuals receiving EFV."( Does tenofovir influence efavirenz pharmacokinetics?
Buclin, T; Colombo, S; Décosterd, L; Furrer, H; Rotger, M; Telenti, A, 2007
)
0.34
"Although there is no clear evidence for a pharmacokinetic interaction between TFV and EFV, we cannot rule out an interaction between these drugs restricted to individuals who are slow EFV metabolizers."( Does tenofovir influence efavirenz pharmacokinetics?
Buclin, T; Colombo, S; Décosterd, L; Furrer, H; Rotger, M; Telenti, A, 2007
)
0.34
" As both drugs are extensively renally eliminated, a randomized, 3-way crossover study was conducted in 19 healthy volunteers to formally evaluate the potential pharmacokinetic interaction when the drugs are administered alone and together (ie, 200 mg emtricitabine qd for 7 days, 300 mg tenofovir disoproxil fumarate qd for 7 days, and 200 mg emtricitabine plus 300 mg tenofovir disoproxil fumarate qd for 7 days) with no washout between treatments."( Steady-state pharmacokinetics of emtricitabine and tenofovir disoproxil fumarate administered alone and in combination in healthy volunteers.
Begley, JA; Blum, MR; Chittick, GE; Zong, J, 2007
)
0.34
"The effect of tenofovir disoproxil fumarate (TDF) in combination with two boosted fosamprenavir regimens on amprenavir pharmacokinetic parameters was assessed in this prospective phase I crossover study with 30 healthy volunteers."( Fosamprenavir/ritonavir plus tenofovir does not affect amprenavir pharmacokinetics: no effect of tenofovir.
Banik, N; Breske, A; Kruse, G; Kurowski, M; Mazur, D; Richter, H; Stocker, H; Walli, RK, 2007
)
0.34
"TMC114 is a new HIV protease inhibitor, used in combination with low-dose ritonavir (TMC114/r) as a pharmacokinetic enhancer."( Pharmacokinetic interaction between TMC114/ritonavir and tenofovir disoproxil fumarate in healthy volunteers.
De Doncker, P; De Pauw, M; Hill, A; Hoetelmans, RM; Lefebvre, E; Mariën, K; Peeters, M; Sekar, V; Woodfall, B, 2007
)
0.34
" Pharmacokinetic parameters estimated by noncompartmental method were reported as 90% confidence intervals (CIs) about the geometric mean ratio (GMR)."( Lopinavir/Ritonavir pharmacokinetic profile: impact of sex and other covariates following a change from twice-daily to once-daily therapy.
Acosta, EP; Binongo, JN; Chuck, SK; Lennox, JL; Ofotokun, I; Palau, M, 2007
)
0.34
"Atazanavir/ritonavir plasma concentrations were measured by liquid chromatography tandem mass spectrometry, and the geometric means of minimum and maximum concentrations (C(min), C(max)), the area under the time-concentration curve (AUC), half-life (t(1/2)) and total clearance (CL(tot)) were subject to a matched pairs-analysis."( Tenofovir comedication does not impair the steady-state pharmacokinetics of ritonavir-boosted atazanavir in HIV-1-infected adults.
Dauer, B; Haberl, A; Harder, S; Klauke, S; Lutz, T; Staszewski, S; von Hentig, N, 2007
)
0.34
"The coadministration of tenofovir-DF did not impair the plasma concentrations of ritonavir-boosted atazanavir in a pharmacokinetic analysis of patient pairs matched for gender, ethnicity, weight and CDC status."( Tenofovir comedication does not impair the steady-state pharmacokinetics of ritonavir-boosted atazanavir in HIV-1-infected adults.
Dauer, B; Haberl, A; Harder, S; Klauke, S; Lutz, T; Staszewski, S; von Hentig, N, 2007
)
0.34
" The clinical consequences of these substantial pharmacokinetic changes should be investigated."( Lopinavir-ritonavir dramatically affects the pharmacokinetics of irinotecan in HIV patients with Kaposi's sarcoma.
Corona, G; Innocenti, F; Sandron, S; Sartor, I; Tirelli, U; Toffoli, G; Vaccher, E, 2008
)
0.35
" HIV-infected subjects > or =18 to <25 years old receiving (> or =28 days) 300/100 mg atazanavir-ritonavir plus 300 mg tenofovir disoproxil fumarate (TDF) plus one or more other nucleoside analogs underwent intensive 24-h pharmacokinetic studies following a light meal."( Pharmacokinetics of antiretroviral regimens containing tenofovir disoproxil fumarate and atazanavir-ritonavir in adolescents and young adults with human immunodeficiency virus infection.
Cunningham, CK; Fletcher, CV; Flynn, PM; Harris, DR; Havens, PL; Kapogiannis, BG; Kiser, JJ; Liu, NX; Major-Wilson, H; Muenz, LR; Viani, RM; Wilson, CM, 2008
)
0.35
"A pharmacokinetic study of blood plasma (BP) and GT TFV concentrations in 9 men was conducted after 1 and > or =14 doses of TDF."( The pharmacokinetics and viral activity of tenofovir in the male genital tract.
Chen, YC; Cohen, MS; Fiscus, SA; Hui, J; Kashuba, AD; Kearney, BP; Patterson, KB; Rezk, NL; Rooney, JF; Tappouni, HL; Vourvahis, M, 2008
)
0.35
"To assess the potential of cotrimoxazole and tenofovir, drugs which are inhibitors and/or substrates of renal transporters, to alter the pharmacokinetic profile of maraviroc."( The effects of cotrimoxazole or tenofovir co-administration on the pharmacokinetics of maraviroc in healthy volunteers.
Abel, S; Muirhead, GJ; Ridgway, CE; Russell, D; Whitlock, LA, 2008
)
0.35
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
"An open-label, randomized, 3-way crossover, drug-drug interaction study of the investigational anti-HBV combination agent, emtricitabine/tenofovir DF and the antirejection agent, tacrolimus was conducted in healthy volunteers to evaluate the potential for a pharmacokinetic interaction between these drugs."( Pharmacokinetics of emtricitabine/tenofovir disoproxil fumarate and tacrolimus at steady state when administered alone or in combination.
Alianti, JR; Begley, JA; Blum, MR; Chittick, GE; Sorbel, JJ; Zong, J, 2008
)
0.35
" Drug concentrations were measured by LC/MS/MS and steady state pharmacokinetic parameters were calculated for each drug using noncompartmental methods."( Pharmacokinetics of emtricitabine/tenofovir disoproxil fumarate and tacrolimus at steady state when administered alone or in combination.
Alianti, JR; Begley, JA; Blum, MR; Chittick, GE; Sorbel, JJ; Zong, J, 2008
)
0.35
"The 90% confidence intervals (CIs) of the geometric least-squares mean ratio for AUCtau, Cmax and Ctau for each drug together vs."( Pharmacokinetics of emtricitabine/tenofovir disoproxil fumarate and tacrolimus at steady state when administered alone or in combination.
Alianti, JR; Begley, JA; Blum, MR; Chittick, GE; Sorbel, JJ; Zong, J, 2008
)
0.35
"It was concluded that there was no clinically relevant pharmacokinetic interaction between emtricitabine/tenofovir DF and tacrolimus when administered together."( Pharmacokinetics of emtricitabine/tenofovir disoproxil fumarate and tacrolimus at steady state when administered alone or in combination.
Alianti, JR; Begley, JA; Blum, MR; Chittick, GE; Sorbel, JJ; Zong, J, 2008
)
0.35
"6-h half-life (30%)."( Population pharmacokinetics of emtricitabine in human immunodeficiency virus type 1-infected pregnant women and their neonates.
Arrivé, E; Avit, D; Blanche, S; Coffié, P; Dabis, F; Ekouévi, DK; Hirt, D; Lalsab, S; Leang, SK; McIntyre, J; Nerrienet, E; Rey, E; Tréluyer, JM; Urien, S, 2009
)
0.35
"Two open-label, randomized, cross-over trials in healthy volunteers were conducted to investigate the pharmacokinetic interaction between etravirine and tenofovir disoproxil fumarate."( Assessment of the steady-state pharmacokinetic interaction between etravirine administered as two different formulations and tenofovir disoproxil fumarate in healthy volunteers.
Aharchi, F; Beets, G; De Smedt, G; Hoetelmans, RM; Kakuda, TN; Peeters, MP; Schöller-Gyüre, M; Vandermeulen, K; Woodfall, BJ, 2009
)
0.35
"Etravirine was administered as either 800 mg twice a day (bid) (phase II formulation in Study 1) or 200 mg bid (phase III formulation in Study 2) for 8 days followed by a 12 h pharmacokinetic evaluation."( Assessment of the steady-state pharmacokinetic interaction between etravirine administered as two different formulations and tenofovir disoproxil fumarate in healthy volunteers.
Aharchi, F; Beets, G; De Smedt, G; Hoetelmans, RM; Kakuda, TN; Peeters, MP; Schöller-Gyüre, M; Vandermeulen, K; Woodfall, BJ, 2009
)
0.35
" Statistical analyses were performed on pharmacokinetic parameters: the area under the concentration-time curve from 0 to 4 h (AUC(0-4)), the maximum concentration of the drug (C(max)), and the residual concentration of the drug at the end of the dosing interval (C(trough)) for plasma and the AUC(0-4) and C(trough) for intracellular data."( Pilot pharmacokinetic study of human immunodeficiency virus-infected patients receiving tenofovir disoproxil fumarate (TDF): investigation of systemic and intracellular interactions between TDF and abacavir, lamivudine, or lopinavir-ritonavir.
Ayen, R; Clotet, B; Grassi, J; Levi, M; Negredo, E; Pruvost, A; Puig, J; Théodoro, F, 2009
)
0.35
"Prospective, open-label, pharmacokinetic study in 12 HIV-infected patients stabilized on FPV/RTV 1400 mg/200 mg + tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) 300 mg/200 mg QD (TELEX II)."( Steady-state amprenavir, tenofovir, and emtricitabine pharmacokinetics before and after reducing ritonavir boosting of a fosamprenavir/tenofovir/emtricitabine regimen from 200 mg to 100 mg once daily (TELEX II).
Acosta, EP; Jennings, HC; Pakes, GE; Parks, DA; Taylor, C,
)
0.13
" Four weeks after reducing RTV, changes in Cmin and AUC24h were: APV: +26%, +0."( Steady-state amprenavir, tenofovir, and emtricitabine pharmacokinetics before and after reducing ritonavir boosting of a fosamprenavir/tenofovir/emtricitabine regimen from 200 mg to 100 mg once daily (TELEX II).
Acosta, EP; Jennings, HC; Pakes, GE; Parks, DA; Taylor, C,
)
0.13
"Thirty-day, open-label, fixed-sequence, pharmacokinetic drug-drug interaction study."( Lack of effect of tenofovir disoproxil fumarate on pharmacokinetics of hormonal contraceptives.
Kearney, BP; Mathias, A, 2009
)
0.35
" Geometric mean ratios (90% confidence intervals) for the pharmacokinetic parameters for deacetyl norgestimate and ethinyl estradiol were estimated by using analysis of variance and compared with the no-effect criterion for bioequivalence."( Lack of effect of tenofovir disoproxil fumarate on pharmacokinetics of hormonal contraceptives.
Kearney, BP; Mathias, A, 2009
)
0.35
"Objective An open-label, three-period pharmacokinetic study was conducted to investigate the drug interaction potential between fosamprenavir (FPV) and tenofovir disoproxil fumarate (TDF)."( Steady-state amprenavir and tenofovir pharmacokinetics after coadministration of unboosted or ritonavir-boosted fosamprenavir with tenofovir disoproxil fumarate in healthy volunteers.
Andrews, M; Condoluci, DV; Luber, AD; Olson, K; Pakes, GE; Pappa, KA; Peloquin, CA; Slowinski, PD, 2010
)
0.36
"Nucleoside-sparing combination antiretroviral therapy (cART) regimens might be an attractive therapeutic option for HIV type-1 (HIV-1)-infected patients; however, the pharmacokinetic profiles of such regimens are frequently unknown."( The effects of a nucleoside-sparing antiretroviral regimen on the pharmacokinetics of ritonavir-boosted darunavir in HIV type-1-infected patients.
Back, D; Dickinson, L; Erlwein, OW; Garvey, L; Latch, N; Mackie, NE; McClure, MO; Scullard, G; Walsh, J; Winston, A, 2010
)
0.36
"Fourteen HIV-1-infected patients (age 21-55 years, 64% male) on stable cART with plasma HIV RNA <50 copies/ml entered this Phase I pharmacokinetic study."( The effects of a nucleoside-sparing antiretroviral regimen on the pharmacokinetics of ritonavir-boosted darunavir in HIV type-1-infected patients.
Back, D; Dickinson, L; Erlwein, OW; Garvey, L; Latch, N; Mackie, NE; McClure, MO; Scullard, G; Walsh, J; Winston, A, 2010
)
0.36
"A pharmacokinetic trial was conducted to evaluate the potential for once-daily etravirine in antiretroviral regimens without and with darunavir/ritonavir."( Pharmacokinetics of once-daily etravirine without and with once-daily darunavir/ritonavir in antiretroviral-naive HIV type-1-infected adults.
DeJesus, E; Kakuda, TN; Lalezari, JP; Osiyemi, OO; Ruane, PJ; Ryan, R; Witek, J, 2010
)
0.36
"Of 23 enrolled patients (male 87%, Caucasian 39%), pharmacokinetic profiles for etravirine were available for 21 and 20 patients on day 14 and 28, respectively."( Pharmacokinetics of once-daily etravirine without and with once-daily darunavir/ritonavir in antiretroviral-naive HIV type-1-infected adults.
DeJesus, E; Kakuda, TN; Lalezari, JP; Osiyemi, OO; Ruane, PJ; Ryan, R; Witek, J, 2010
)
0.36
" Pharmacokinetic data were available in 577 patients randomized to receive etravirine."( Pharmacokinetics and pharmacodynamics of the non-nucleoside reverse-transcriptase inhibitor etravirine in treatment-experienced HIV-1-infected patients.
Corbett, C; De Smedt, G; Hoetelmans, RM; Kakuda, TN; Leopold, L; Nijs, S; Peeters, MP; Schöller-Gyüre, M; Snoeck, E; Vingerhoets, J; Vis, P; Wade, JR; Woodfall, BJ, 2010
)
0.36
"Intensive steady-state 24-hour pharmacokinetic profiles were performed during the third trimester and at 6-12 weeks postpartum."( Atazanavir pharmacokinetics with and without tenofovir during pregnancy.
Basar, M; Best, BM; Burchett, SK; Capparelli, EV; Hawkins, E; Hu, C; Mirochnick, M; Read, JS; Rossi, SS; Smith, E; Stek, AM, 2011
)
0.37
" A total of 151 ATV plasma concentrations were obtained, and a population pharmacokinetic model was developed with NONMEM."( Population pharmacokinetics of atazanavir/ritonavir in HIV-1-infected children and adolescents.
Blanche, S; Dollfus, C; Firtion, G; Foissac, F; Hirt, D; Laurent, C; Treluyer, JM; Urien, S, 2011
)
0.37
" We report the pharmacokinetic parameters of tenofovir in combination with efavirenz, darunavir-ritonavir, or atazanavir-ritonavir in HIV-infected children."( Steady-state pharmacokinetics of tenofovir-based regimens in HIV-infected pediatric patients.
Acosta, EP; Britto, P; Carey, V; Graham, B; Hazra, R; Jean-Philippe, P; King, JR; Wiznia, A; Yogev, R, 2011
)
0.37
"Significant pharmacokinetic interactions can result between acid-suppressing agents and some protease inhibitors (PIs) in the management of HIV infection."( Effects of the H2-receptor antagonist famotidine on the pharmacokinetics of atazanavir-ritonavir with or without tenofovir in HIV-infected patients.
Bertz, R; Boffito, M; Child, M; Chung, E; Kashuba, A; Mahnke, L; Patterson, K; Tebas, P; Wang, X; Wu, Y; Zhang, J; Zhu, L, 2011
)
0.37
"Tenofovir concentrations were monitored on a routine basis and measured in 93 children aged 5 to 18 years; 283 tenofovir plasma concentrations were used to perform a population pharmacokinetic analysis."( Population pharmacokinetics of tenofovir in HIV-1-infected pediatric patients.
Benaboud, S; Blanche, S; Bouazza, N; Foissac, F; Frange, P; Hirt, D; Rey, E; Tréluyer, JM; Urien, S, 2011
)
0.37
" The gel also prevents infection in macaques when applied intravaginally or intrarectally prior to challenge with simian-human immunodeficiency virus (SHIV), but very little pharmacokinetic information for macaques is available to help extrapolate the data to humans and thus inform future development activities."( Pharmacokinetics of tenofovir following intravaginal and intrarectal administration of tenofovir gel to rhesus macaques.
Allen, P; Kashuba, A; Nuttall, J; Roberts, J; Romano, J; Wang, R; White, N, 2012
)
0.38
" More comprehensive in vivo pharmacokinetic data are required to justify the potential use of these agents as safe and effective options during pregnancy."( Pharmacokinetics of antiretroviral drugs in anatomical sanctuary sites: the fetal compartment (placenta and amniotic fluid).
Back, DJ; Else, LJ; Khoo, SH; Taylor, S, 2011
)
0.37
"Comparative pharmacokinetic study in sheep."( Tenofovir and tenofovir disoproxil fumarate pharmacokinetics from intravaginal rings.
Baum, MM; Butkyavichene, I; Gilman, J; Kennedy, S; Kopin, E; Malone, AM; Moss, JA; Motamedi, M; Nguyen, C; Smith, TJ; Vincent, KL; Willis, RA, 2012
)
0.38
" The proposed assay method was found to be applicable to a pharmacokinetic study in human male volunteers."( A novel LC-MS/MS method for simultaneous quantification of tenofovir and lamivudine in human plasma and its application to a pharmacokinetic study.
Burugula, L; Inamadugu, JK; J V L N, SR; Matta, MK; Pilli, NR, 2012
)
0.38
" The impact of changing the current gel formulation to reduce its osmolality was evaluated using pharmacokinetic assessments and local tissue effects in the rabbit."( Pharmacokinetics and topical vaginal effects of two tenofovir gels in rabbits.
Clark, MR; Friend, DR, 2012
)
0.38
" We developed a pharmacokinetic model for TDF and its active anabolite tenofovir-diphosphate (TFV-DP) and validated it with data from 4 different trials, including 4 distinct dosing regimes."( Pharmacokinetics and pharmacodynamics of the reverse transcriptase inhibitor tenofovir and prophylactic efficacy against HIV-1 infection.
Duwal, S; Schütte, C; von Kleist, M, 2012
)
0.38
"This study was designed to assess the safety, acceptability, pharmacokinetic (PK), and pharmacodynamic (PD) responses to rectal administration of tenofovir (TFV) 1% vaginally formulated gel and oral tenofovir disoproxil fumarate (TDF)."( RMP-02/MTN-006: A phase 1 rectal safety, acceptability, pharmacokinetic, and pharmacodynamic study of tenofovir 1% gel compared with oral tenofovir disoproxil fumarate.
Anton, PA; Bumpus, NN; Carballo-Diéguez, A; Cranston, RD; Cumberland, WG; Dennis, R; Elliott, J; Hendrix, CW; Janocko, L; Ju, C; Kashuba, A; Khanukhova, E; Mauck, C; McGowan, I; Richardson-Harman, N, 2012
)
0.38
"This is the first pharmacokinetic modelling of antiretroviral disposition in BP and CVF."( Pharmacokinetic modelling of efavirenz, atazanavir, lamivudine and tenofovir in the female genital tract of HIV-infected pre-menopausal women.
Cohen, MS; Dumond, JB; Forrest, A; Garonzik, SM; Kashuba, AD; Kendrick, RN; Nicol, MR; Patterson, KB, 2012
)
0.38
" Twenty-four-hour pharmacokinetic curves were recorded in the third trimester (preferably week 33) and postpartum (preferably week 4-6)."( The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women.
Burger, DM; Colbers, AP; Giaquinto, C; Gingelmaier, A; Hawkins, DA; Ivanovic, J; Kabeya, K; Moltó, J; Rockstroh, JK; Sadiq, ST; Taylor, GP; Weizsäcker, K; Wyen, C, 2013
)
0.39
"Although pharmacokinetic exposure of the NRTIs TDF and FTC during pregnancy is approximately 25% lower, this was not associated with virological failure in this study and did not result in mother-to-child transmission."( The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women.
Burger, DM; Colbers, AP; Giaquinto, C; Gingelmaier, A; Hawkins, DA; Ivanovic, J; Kabeya, K; Moltó, J; Rockstroh, JK; Sadiq, ST; Taylor, GP; Weizsäcker, K; Wyen, C, 2013
)
0.39
" Drug concentrations at two trough values of 12 and 24 h after dosing (C(12) and C(24)), area under the concentration-curve values (AUC), maximum drug concentration (C(max)), and the time at which this concentration occurred (T(max)) in plasma were estimated with noncompartmental pharmacokinetic methods and compared to data from a subset of white subjects randomized to the RAL twice a day (plus TDF/FTC) arm of the QDMRK study, a phase III study of the safety and efficacy of once daily versus twice daily RAL in treatment naive patients."( Raltegravir pharmacokinetics in treatment-naive patients is not influenced by race: results from the raltegravir early therapy in African-Americans living with HIV (REAL) study.
Blevins, S; Dumond, JB; Eron, JJ; Floris-Moore, M; Hudgens, MG; Kashuba, AD; Massengale, K; Pittard, D; Ragan, D; Richardson, A; Walsh, K; Wang, R; Wohl, DA, 2013
)
0.39
" The pharmacokinetic properties and the effects of food intake on tenofovir dipivoxil have not yet been reported in healthy adults."( Pharmacokinetics and food interaction of a novel prodrug of tenofovir, tenofovir dipivoxil fumarate, in healthy volunteers.
Chen, L; Chen, M; Ding, Y; Jia, Y; Lu, C; Song, Y; Sun, X; Wen, A; Yang, J, 2013
)
0.39
" Pharmacokinetic parameters of tenofovir given in each treatment period were calculated using non-compartmental analysis."( Pharmacokinetics and food interaction of a novel prodrug of tenofovir, tenofovir dipivoxil fumarate, in healthy volunteers.
Chen, L; Chen, M; Ding, Y; Jia, Y; Lu, C; Song, Y; Sun, X; Wen, A; Yang, J, 2013
)
0.39
"After a single dose of 150, 300 and 600 mg, the main pharmacokinetic parameters for tenofovir were as follows: Cmax 209·6, 456·7, 989·8 ng/mL; AUClast 1744·9, 2663·5, 6010·2 ng h/mL, respectively."( Pharmacokinetics and food interaction of a novel prodrug of tenofovir, tenofovir dipivoxil fumarate, in healthy volunteers.
Chen, L; Chen, M; Ding, Y; Jia, Y; Lu, C; Song, Y; Sun, X; Wen, A; Yang, J, 2013
)
0.39
"International Maternal Pediatric Adolescent AIDS Clinical Trials Group 1026s is a prospective, nonblinded, pharmacokinetic study of HIV-infected pregnant women taking antiretrovirals for clinical indications, including 2 cohorts (with or without tenofovir) receiving atazanavir/ritonavir 300/100 mg once daily during the second trimester, 400/100 mg during the third trimester, and 300/100 mg postpartum (PP)."( Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy.
Best, BM; Burchett, SK; Byroads, M; Caparelli, E; Cressey, TR; Hawkins, E; Kreitchmann, R; Mirochnick, M; Rossi, S; Shapiro, DE; Smith, E; Stek, A; Wang, J; Watts, DH, 2013
)
0.39
"Atazanavir pharmacokinetic data were available for 37 women without tenofovir, 35 with tenofovir; median (range) pharmacokinetic parameters are presented for second trimester, third trimester, and PP and number who met target/total."( Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy.
Best, BM; Burchett, SK; Byroads, M; Caparelli, E; Cressey, TR; Hawkins, E; Kreitchmann, R; Mirochnick, M; Rossi, S; Shapiro, DE; Smith, E; Stek, A; Wang, J; Watts, DH, 2013
)
0.39
" Noncompartmental pharmacokinetic analysis was used to estimate PK parameters [area under the concentration-time curve over 24 h (AUC0-24h ) and maximal concentration (Cmax )]."( Pharmacokinetics of two common antiretroviral regimens in older HIV-infected patients: a pilot study.
Adams, JL; Corbett, AH; Dumond, JB; Forrest, A; Jennings, SH; Kashuba, AD; Kendrick, RL; Malone, S; Patterson, KB; Prince, HM; Sykes, C; Wang, R; White, N, 2013
)
0.39
" Compared with the general population, these elderly subjects had 8-13% decreased TFV AUC0-24h and Cmax , and 19-78% increased FTC and RTV AUC0-24h and Cmax ."( Pharmacokinetics of two common antiretroviral regimens in older HIV-infected patients: a pilot study.
Adams, JL; Corbett, AH; Dumond, JB; Forrest, A; Jennings, SH; Kashuba, AD; Kendrick, RL; Malone, S; Patterson, KB; Prince, HM; Sykes, C; Wang, R; White, N, 2013
)
0.39
"To investigate pharmacokinetic interactions associated with coadministration of lersivirine with zidovudine, tenofovir disoproxil fumarate (DF)/emtricitabine (Truvada(®)) or abacavir/lamivudine (Epzicom(®)/Kivexa(®))."( Pharmacokinetic interactions between lersivirine and zidovudine, tenofovir disoproxil fumarate/emtricitabine and abacavir/lamivudine.
Choo, HW; Davis, J; Fang, J; Hansson, AG; Langdon, G; Layton, G; Tawadrous, M; Vourvahis, M, 2013
)
0.39
" Pharmacokinetic parameters were calculated by standard non-compartmental methods."( Pharmacokinetic interactions between lersivirine and zidovudine, tenofovir disoproxil fumarate/emtricitabine and abacavir/lamivudine.
Choo, HW; Davis, J; Fang, J; Hansson, AG; Langdon, G; Layton, G; Tawadrous, M; Vourvahis, M, 2013
)
0.39
" Plasma TFV demonstrated triphasic decay with terminal elimination half-life median [interquartile range (IQR)] 69 h (58-77)."( Single dose pharmacokinetics of oral tenofovir in plasma, peripheral blood mononuclear cells, colonic tissue, and vaginal tissue.
Anderson, JR; Bakshi, R; Cao, YJ; Everts, S; Fuchs, EJ; Hendrix, CW; Liberman, RG; Louissaint, NA; Nimmagadda, S; Skipper, PL; Tannenbaum, SR, 2013
)
0.39
" A pharmacokinetic interaction between tenofovir and ritonavir may have resulted in the toxicity."( Tenofovir induced Fanconi syndrome: a possible pharmacokinetic interaction.
Desai, C; Desai, M; Dikshit, RK; Kapadia, J; Patel, S; Shah, AN; Shah, S,
)
0.13
" The method was successfully applied to the pharmacokinetic study of two tenofovir agents."( [Pharmacokinetics of tenofovir in Beagle dogs after oral dosing of tenofovir dipivoxil fumarate using HPLC-MS/MS analysis].
Chen, H; Hu, JP; Li, Y; Sheng, L; Wang, BL, 2013
)
0.39
"The pharmacokinetic data support coadministration of daclatasvir with atazanavir/ritonavir, efavirenz and/or tenofovir."( Assessment of pharmacokinetic interactions of the HCV NS5A replication complex inhibitor daclatasvir with antiretroviral agents: ritonavir-boosted atazanavir, efavirenz and tenofovir.
Bertz, R; Bifano, M; Grasela, D; Hartstra, J; Hwang, C; Kandoussi, H; Oosterhuis, B; Sevinsky, H; Tiessen, R; Velinova-Donga, M, 2013
)
0.39
" Pharmacokinetic sampling was performed on cohort 1 and 3 mothers and all infants."( Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their infants during the first week of life.
Emel, L; Eshleman, SH; Fowler, MG; George, K; Herron, C; Hudelson, SE; Joao, E; Kearney, B; Kreitchmann, R; Kumwenda, N; Mirochnick, M; Mofenson, L; Nielsen-Saines, K; Parsons, T; Pinto, J; Richardson, P; Santos, B; Sato, P; Taha, T, 2014
)
0.4
" Separate pharmacokinetic properties may be associated with distinct TDF toxicities: tenofovir with parathyroid hormone and altered calcium balance and tenofovir diphosphate with hypophosphatemia and FGF23 regulation."( Association of higher plasma vitamin D binding protein and lower free calcitriol levels with tenofovir disoproxil fumarate use and plasma and intracellular tenofovir pharmacokinetics: cause of a functional vitamin D deficiency?
Baker, A; Bethel, J; Flynn, PM; Gordon, CM; Havens, PL; Hazra, R; Kapogiannis, BG; Kiser, JJ; Liu, N; Lujan-Zilbermann, J; Mulligan, K; Pan, CG; Rutledge, B; Stephensen, CB; Van Loan, MD; Wilson, CM; Woodhouse, LR, 2013
)
0.39
" Increasing epithelial thickness delayed initial TFV delivery to stroma and its decline: tmax increased but AUC at 24 hours was not significantly altered."( Multicompartmental pharmacokinetic model of tenofovir delivery by a vaginal gel.
Gao, Y; Katz, DF, 2013
)
0.39
" Although its use for the treatment of HIV has been approved by the Chinese State Food and Drug Administration, there are no data on the pharmacokinetic profile of TDF in Chinese individuals."( Pharmacokinetics and tolerability of Tenofovir disoproxil fumarate 300 mg once daily: an open-label, single- and multiple-dose study in healthy Chinese subjects.
Chen, Q; Dong, J; Hu, CY; Jia, JY; Li, J; Li, X; Liu, Y; Liu, YM; Lu, C; Sun, SX; Wang, W; Wu, K; Yu, C, 2013
)
0.39
"This study aimed to investigate the pharmacokinetic properties and tolerability of TDF in healthy Chinese subjects."( Pharmacokinetics and tolerability of Tenofovir disoproxil fumarate 300 mg once daily: an open-label, single- and multiple-dose study in healthy Chinese subjects.
Chen, Q; Dong, J; Hu, CY; Jia, JY; Li, J; Li, X; Liu, Y; Liu, YM; Lu, C; Sun, SX; Wang, W; Wu, K; Yu, C, 2013
)
0.39
" Pharmacokinetic parameters were estimated using a noncompartmental model."( Pharmacokinetics and tolerability of Tenofovir disoproxil fumarate 300 mg once daily: an open-label, single- and multiple-dose study in healthy Chinese subjects.
Chen, Q; Dong, J; Hu, CY; Jia, JY; Li, J; Li, X; Liu, Y; Liu, YM; Lu, C; Sun, SX; Wang, W; Wu, K; Yu, C, 2013
)
0.39
" TDF exhibited a pharmacokinetic profile similar to that of healthy Western subjects in a historical comparison."( Pharmacokinetics and tolerability of Tenofovir disoproxil fumarate 300 mg once daily: an open-label, single- and multiple-dose study in healthy Chinese subjects.
Chen, Q; Dong, J; Hu, CY; Jia, JY; Li, J; Li, X; Liu, Y; Liu, YM; Lu, C; Sun, SX; Wang, W; Wu, K; Yu, C, 2013
)
0.39
"The objectives of this analysis were to develop a population pharmacokinetic model (PPK) for tenofovir without using potentially unreliable patient reported dosing records and to retrace patient dosing history using pharmacokinetic simulations conditioned on protocol design constraints to assess patient adherence."( Estimation of tenofovir's population pharmacokinetic parameters without reliable dosing histories and application to tracing dosing history using simulation strategies.
Chaturvedula, A; Fossler, MJ; Hendrix, CW, 2014
)
0.4
"Intensive pharmacokinetic studies of tenofovir in a large, diverse cohort of HIV-infected women over 24 h at steady state were performed and factors that influenced exposure [assessed by areas under the concentration-time curves (AUCs)] identified."( Common clinical conditions - age, low BMI, ritonavir use, mild renal impairment - affect tenofovir pharmacokinetics in a large cohort of HIV-infected women.
Anastos, K; Bacchetti, P; Baxi, SM; Cohen, M; Gandhi, M; Gange, SJ; Greenblatt, RM; Huang, Y; Minkoff, H; Scherzer, R; Shlipak, MG; Young, M, 2014
)
0.4
"HIV-infected women (n = 101) on tenofovir-based therapy underwent intensive 24-h pharmacokinetic sampling."( Common clinical conditions - age, low BMI, ritonavir use, mild renal impairment - affect tenofovir pharmacokinetics in a large cohort of HIV-infected women.
Anastos, K; Bacchetti, P; Baxi, SM; Cohen, M; Gandhi, M; Gange, SJ; Greenblatt, RM; Huang, Y; Minkoff, H; Scherzer, R; Shlipak, MG; Young, M, 2014
)
0.4
"Administration of 40 mg of tenofovir alafenamide for 14 days resulted in lower tenofovir Cmax (13 versus 207 ng/mL) and lower systemic exposures (AUC0-t, 383 versus 1810 ng · h/mL) compared with subjects who received tenofovir disoproxil fumarate."( Phase I/II study of the pharmacokinetics, safety and antiretroviral activity of tenofovir alafenamide, a new prodrug of the HIV reverse transcriptase inhibitor tenofovir, in HIV-infected adults.
Coakley, D; Kearney, B; Lee, WA; Markowitz, M; Miller, MD; Ruane, P; Squires, K; Wulfsohn, M; Zhong, L; Zolopa, A, 2014
)
0.4
" In this open-label, randomized, three-way crossover study, the pharmacokinetic profiles of elvitegravir, cobicistat, emtricitabine, and tenofovir were evaluated when administered with a standard breakfast, under fasting conditions, or with a nutritional protein-rich drink."( Effects of a protein-rich drink or a standard meal on the pharmacokinetics of elvitegravir, cobicistat, emtricitabine and tenofovir in healthy Japanese male subjects: a randomized, three-way crossover study.
Ikeda, A; Irie, S; Ishikawa, T; Kimura, M; Matsuki, S; Nishino, N; Shiomi, M, 2014
)
0.4
" The authors studied ATV pharmacokinetic (PK) parameters among children who received atazanavir/ritonavir co-administered with TDF."( Pharmacokinetics of atazanavir/ritonavir among HIV-infected Thai children concomitantly taking tenofovir disoproxil fumarate.
Ananworanich, J; Bunupuradah, T; Keadpudsa, S; Prasitsuebsai, W; Puthanakit, T; Sahakijpicharn, T; Srimuan, A; Techasaensiri, C; Thammajaruk, N, 2014
)
0.4
"The objective of this analysis was to develop and qualify a population pharmacokinetic model describing plasma tenofovir (TFV) concentrations and tenofovir-diphosphate (TFV-DP) concentrations in peripheral blood mononuclear cell (PBMC) in healthy women volunteers from the MTN-001 clinical trial, an open label 3-way crossover study of oral tenofovir disoproxil fumarate 300 mg tablet, TFV 1% vaginal gel, or both."( Population pharmacokinetics of tenofovir and tenofovir-diphosphate in healthy women.
Burns, RN; Chaturvedula, A; Hendrix, CW, 2015
)
0.42
"This was an open-label, three-period, longitudinal pharmacokinetic study with patients serving as their own controls."( Steady-state pharmacokinetics of rilpivirine under different meal conditions in HIV-1-infected Ugandan adults.
Back, DJ; Byakika-Kibwika, P; Else, L; Katwere, M; Khoo, SH; Lamorde, M; Merry, C; Mukisa, L; Sempa, JB; Walimbwa, S, 2015
)
0.42
" Pharmacokinetic parameters were unchanged during administration with a low-fat meal, except for C24, which was significantly increased by 15% (1."( Steady-state pharmacokinetics of rilpivirine under different meal conditions in HIV-1-infected Ugandan adults.
Back, DJ; Byakika-Kibwika, P; Else, L; Katwere, M; Khoo, SH; Lamorde, M; Merry, C; Mukisa, L; Sempa, JB; Walimbwa, S, 2015
)
0.42
"A food effect was observed for steady-state pharmacokinetic parameters of rilpivirine (AUC0-24 and C24) when TDF/FTC/RPV was administered in the fasted state compared with the moderate-fat meal."( Steady-state pharmacokinetics of rilpivirine under different meal conditions in HIV-1-infected Ugandan adults.
Back, DJ; Byakika-Kibwika, P; Else, L; Katwere, M; Khoo, SH; Lamorde, M; Merry, C; Mukisa, L; Sempa, JB; Walimbwa, S, 2015
)
0.42
" The objective of this study was to assess the pharmacokinetic (PK) profile in older HIV-infected subjects (>60 years) switching combination antiretroviral therapy (cART) to a raltegravir (RAL) containing regimen."( The pharmacokinetic profile of raltegravir-containing antiretroviral therapy in HIV-infected individuals over 60 years of age.
Back, D; Barber, T; Boffito, M; Dickinson, L; Else, L; Jackson, A; Mora-Peris, B; Vera, JH; Winston, A,
)
0.13
"2 years, n = 38) based on population pharmacokinetic analysis."( The pharmacokinetic profile of raltegravir-containing antiretroviral therapy in HIV-infected individuals over 60 years of age.
Back, D; Barber, T; Boffito, M; Dickinson, L; Else, L; Jackson, A; Mora-Peris, B; Vera, JH; Winston, A,
)
0.13
" We performed a 3-month general toxicology study, a preliminary pharmacokinetic study using drug-loaded vaginal gel, and a detailed assessment of the kinetics of dapivirine delivery to plasma, vaginal, and rectal fluid and rectal, vaginal, and cervical tissue over 28 days of exposure and 3 and 7 days after removal of the ring."( The sheep as a model of preclinical safety and pharmacokinetic evaluations of candidate microbicides.
Cameron, D; Dias, N; Dreier, P; Holding, J; Holt, JD; Muntendam, A; Nuttall, J; Oostebring, F; Rohan, L, 2015
)
0.42
" From the interaction between atazanavir and DTG via CYP3A4 and UGT1A1 and placental efflux transporter inhibition and considering the infant's probable enzymatic immaturity, the DTG elimination half-life was estimated to be 4-fold longer in neonates than in adults."( Pharmacokinetics of dolutegravir in a premature neonate after HIV treatment intensification during pregnancy.
Amiel, C; Caseris, M; Charpentier, C; Descamps, D; Desnoyer, A; Farnoux, C; Lassel, L; Lê, MP; Pain, JB; Peytavin, G; Pialoux, G, 2015
)
0.42
"This was an open-label pharmacokinetic study."( Plasma and Intracellular Pharmacokinetics of Tenofovir Disoproxil Fumarate 300 mg Every 48 Hours vs 150 mg Once Daily in HIV-Infected Adults With Moderate Renal Function Impairment.
Avihingsanon, A; Bowonwatanuwong, C; Cressey, TR; Fletcher, CV; Halue, G; Jaisieng, N; Jourdain, G; Klinbuayaem, V; Leenasirimakul, P; Podany, AT; Sukrakanchana, PO; Tawon, Y, 2015
)
0.42
"International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) P1026s is a prospective, nonblinded pharmacokinetic study of HIV-infected pregnant women that included a cohort receiving 300 mg TDF once daily."( Pharmacokinetics of tenofovir during pregnancy and postpartum.
Best, BM; Burchett, S; Byroads, M; Capparelli, EV; Fletcher, CV; Hawkins, E; Hu, C; Li, H; Mirochnick, M; Smith, E; Stek, A; Wang, J; Watts, DH, 2015
)
0.42
" Finally the method was successfully applied for human pharmacokinetic study in eight healthy male volunteers after the oral administration of 600 mg darunavir along with 100 mg ritonavir and 100 mg tenofovir as boosters."( Development and validation of a rapid ultra high performance liquid chromatography with tandem mass spectrometry method for the simultaneous determination of darunavir, ritonavir, and tenofovir in human plasma: Application to human pharmacokinetics.
Aris, AB; Jaafar, J; Madhavi, G; Majid, ZA; Reddy, AV; Talib, J; Umar, K, 2015
)
0.42
" Pharmacokinetic sampling was performed over 12-hour periods, 4 weeks after initiation of RAL together with RIF (period 1), 4 weeks after RIF discontinuation (period 2), and after the RAL dose reduction in arm 2 (period 3)."( Pharmacokinetics of Raltegravir in HIV-Infected Patients on Rifampicin-Based Antitubercular Therapy.
Assuied, A; De Castro, N; Fagard, C; Grinsztejn, B; Grondin, C; Molina, JM; Pilotto, JH; Sauvageon, H; Taburet, AM; Veloso, V, 2015
)
0.42
"Tenofovir is an efficacious drug with a long half-life and high activity against both HIV and HBV."( Population pharmacokinetics of tenofovir in HIV/HBV co-infected patients.
Avihingsanon, A; Burger, D; Lewin, SR; Matthews, G; Punyawudho, B; Ruxrungtham, K; Thammajaruk, N; Thongpeang, P, 2015
)
0.42
" The population pharmacokinetic model of tenofovir was developed by a nonlinear mixed-effects modeling approach (NONMEM®)."( Population pharmacokinetics of tenofovir in HIV/HBV co-infected patients.
Avihingsanon, A; Burger, D; Lewin, SR; Matthews, G; Punyawudho, B; Ruxrungtham, K; Thammajaruk, N; Thongpeang, P, 2015
)
0.42
" Thus, we conducted a single-dose pharmacokinetic study of TFV gel applied 1 or 24 hours before or 1 hour before and 1 hour after (BAT) sex and compared results with dosing without sex."( Impact of Sex on the Pharmacokinetics and Pharmacodynamics of 1% Tenofovir Gel.
Chen, BA; Dezzutti, CS; Galaska, B; Hendrix, CW; Herold, BC; Hillier, S; Kelly, CW; Levy, L; Marzinke, MA; McGowan, I; Piper, JM; Salata, RA, 2016
)
0.43
"Transplacental parameters estimated from ex vivo human placenta perfusion experiments were implemented in pregnancy-physiologically based pharmacokinetic (p-PBPK) models in order to predict fetal PK."( Prediction of human fetal pharmacokinetics using ex vivo human placenta perfusion studies and physiologically based models.
Benaboud, S; Blanche, S; Bouazza, N; De Sousa Mendes, M; Foissac, F; Hirt, D; Lê, MP; Lui, G; Peytavin, G; Pressiat, C; Treluyer, JM; Urien, S; Valade, E; Vinot, C, 2016
)
0.43
" MTN-003D, an ancillary study using in-depth interviews (IDIs) and focus group discussions (FGDs), together with retrospective disclosure of plasma tenofovir pharmacokinetic results, explored adherence challenges during VOICE."( Disclosure of pharmacokinetic drug results to understand nonadherence.
Bennie, T; Cheng, H; Etima, J; Grossman, CI; Hartmann, M; Laborde, N; Levy, L; Marrazzo, J; Mensch, B; Montgomery, ET; Musara, P; Naidoo, S; Piper, J; van der Straten, A, 2015
)
0.42
"We systematically recruited participants with pharmacokinetic data (median six plasma samples), categorized as low (0%, N = 79), inconsistent (1-74%, N = 28) or high (≥75%; N = 20) on the basis of frequency of tenofovir detection."( Disclosure of pharmacokinetic drug results to understand nonadherence.
Bennie, T; Cheng, H; Etima, J; Grossman, CI; Hartmann, M; Laborde, N; Levy, L; Marrazzo, J; Mensch, B; Montgomery, ET; Musara, P; Naidoo, S; Piper, J; van der Straten, A, 2015
)
0.42
" The most common reactions to pharmacokinetic results included surprise (41%; low pharmacokinetic), acceptance (39%; inconsistent pharmacokinetic) and happiness (65%; high pharmacokinetic)."( Disclosure of pharmacokinetic drug results to understand nonadherence.
Bennie, T; Cheng, H; Etima, J; Grossman, CI; Hartmann, M; Laborde, N; Levy, L; Marrazzo, J; Mensch, B; Montgomery, ET; Musara, P; Naidoo, S; Piper, J; van der Straten, A, 2015
)
0.42
"Retrospective provision of pharmacokinetic results seemingly promoted candid discussions around nonadherence and study participation."( Disclosure of pharmacokinetic drug results to understand nonadherence.
Bennie, T; Cheng, H; Etima, J; Grossman, CI; Hartmann, M; Laborde, N; Levy, L; Marrazzo, J; Mensch, B; Montgomery, ET; Musara, P; Naidoo, S; Piper, J; van der Straten, A, 2015
)
0.42
" Much attention has focussed on pharmacokinetic interactions attributable to effects on hepatic microsomal enzymes, but not on competition for the renal organic anion transport system."( The pharmacokinetics of high-dose methotrexate in people living with HIV on antiretroviral therapy.
Bendle, M; Boffito, M; Bower, M; Dalla Pria, A; Ramaswami, R, 2016
)
0.43
" MTX elimination half-life was correlated with age, renal function and antiretroviral regimen."( The pharmacokinetics of high-dose methotrexate in people living with HIV on antiretroviral therapy.
Bendle, M; Boffito, M; Bower, M; Dalla Pria, A; Ramaswami, R, 2016
)
0.43
" The median MTX elimination half-life was 21."( The pharmacokinetics of high-dose methotrexate in people living with HIV on antiretroviral therapy.
Bendle, M; Boffito, M; Bower, M; Dalla Pria, A; Ramaswami, R, 2016
)
0.43
"Although there is potential competition for active renal tubular transporters between MTX and tenofovir, no prolongation of MTX half-life was observed."( The pharmacokinetics of high-dose methotrexate in people living with HIV on antiretroviral therapy.
Bendle, M; Boffito, M; Bower, M; Dalla Pria, A; Ramaswami, R, 2016
)
0.43
"In the Microbicide Trial Network MTN-003 (VOICE) study, a Phase IIB pre-exposure prophylaxis trial of daily oral or vaginal tenofovir (TFV), product adherence was poor based on pharmacokinetic (PK) drug detection in a random subsample."( Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study.
Brown, ER; Chirenje, MZ; Gomez, K; Hendrix, CW; Liu, K; Marrazzo, JM; Marzinke, MA; Piper, JM; van der Straten, A, 2016
)
0.43
" Here, we provide the first case series of tenofovir disoproxil fumarate (TDF) pharmacokinetic in four HIV-infected patients before and after sleeve-gastrectomy."( Tenofovir pharmacokinetic after sleeve-gastrectomy in four severely obese patients living with HIV.
Alvarez, JC; Carette, C; Czernichow, S; Gbedo, C; Muzard, L,
)
0.13
" We developed a population pharmacokinetic model for tenofovir and investigated the impacts of different dose reporting methods."( Population Pharmacokinetics of Tenofovir in HIV-1-Uninfected Members of Serodiscordant Couples and Effect of Dose Reporting Methods.
Baeten, JM; Bangsberg, D; Celum, CL; Chaturvedula, A; Fossler, MJ; Goti, V; Haberer, JE; Hendrix, CW; Lu, Y; Sale, ME, 2016
)
0.43
" A precise method is required to quantify the drug concentration in biological matrices to study pharmacokinetic behavior and tissue distribution profile in animals and/or humans."( Simultaneous quantification of tenofovir, emtricitabine, rilpivirine, elvitegravir and dolutegravir in mouse biological matrices by LC-MS/MS and its application to a pharmacokinetic study.
Destache, CJ; Mandal, S; Prathipati, PK, 2016
)
0.43
"Between May 22, 2013, and July 22, 2014, we enrolled 50 participants, and all 50 received the assigned treatment; 24 participated in the intensive pharmacokinetic assessment."( Safety, efficacy, and pharmacokinetics of a single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in treatment-naive, HIV-infected adolescents: a single-arm, open-label trial.
Batra, J; Chakraborty, R; Gaur, AH; Kizito, H; Kosalaraksa, P; Luesomboon, W; Myers, M; Porter, D; Prasitsueubsai, W; Quirk, E; Rakhmanina, N; Rassool, M; Rhee, MS; SenGupta, D; Shao, Y; Ting, L, 2016
)
0.43
"The elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide regimen was well tolerated and achieved component plasma pharmacokinetic exposures similar to those in adults."( Safety, efficacy, and pharmacokinetics of a single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in treatment-naive, HIV-infected adolescents: a single-arm, open-label trial.
Batra, J; Chakraborty, R; Gaur, AH; Kizito, H; Kosalaraksa, P; Luesomboon, W; Myers, M; Porter, D; Prasitsueubsai, W; Quirk, E; Rakhmanina, N; Rassool, M; Rhee, MS; SenGupta, D; Shao, Y; Ting, L, 2016
)
0.43
" Single-dose oral pharmacokinetic studies were performed by concomitant administration of TDF with each of the selected FJs and excipients."( Oral pharmacokinetic interaction of ester rich fruit juices and pharmaceutical excipients with tenofovir disoproxil fumarate in male Wistar rats.
Myneni, S; Ravi, PR; Saha, P; Shailender, J, 2017
)
0.46
" They can also inform interpretations of experimental pharmacokinetic measures such as drug concentrations in biopsies."( Multicompartmental Pharmacokinetic Model of Tenofovir Delivery to the Rectal Mucosa by an Enema.
Gao, Y; Katz, DF, 2017
)
0.46
"Organic anion transporters (OATs) are important in the renal secretion, and thus, the clearance, of many drugs; and their functional change can result in pharmacokinetic variability."( Quantitative Prediction of Human Renal Clearance and Drug-Drug Interactions of Organic Anion Transporter Substrates Using In Vitro Transport Data: A Relative Activity Factor Approach.
Feng, B; Litchfield, J; Mathialagan, S; Piotrowski, MA; Tess, DA; Varma, MV, 2017
)
0.46
" Pharmacokinetic data were analyzed as geometric mean ratios (GMRs) with 90% confidence intervals."( The Effect of Food on Doravirine Bioavailability: Results from Two Pharmacokinetic Studies in Healthy Subjects.
Behm, MO; Fackler, P; Levine, V; Liu, R; Panebianco, D; Yee, KL, 2017
)
0.46
"To our knowledge, there is no published data on the pharmacokinetic (PK) profile of antiretroviral (ART) drugs on patients undergoing extracorporeal membrane oxygenation (ECMO) therapy."( The effect of veno-venous ECMO on the pharmacokinetics of Ritonavir, Darunavir, Tenofovir and Lamivudine.
Ashworth, A; Barker, J; Davies, A; Feddy, L; Fedor, I; Ghazi Suliman, MA; Hayes, T; Kosmidis, C; Malagon, I; Ogungbenro, K; Stirling, S; Szabo-Barnes, A, 2017
)
0.46
"A randomized, open-label, clinical pharmacokinetic study of tenofovir in healthy adult volunteers without HIV or Hepatitis B infection in Thailand."( A randomized clinical pharmacokinetic trial of Tenofovir in blood, plasma and urine in adults with perfect, moderate and low PrEP adherence: the TARGET study.
Baeten, J; Cressey, R; Cressey, TR; Drain, PK; Klinbuayaem, V; Kubiak, RW; Quame-Amaglo, J; Siriprakaisil, O; Sirirungsi, W; Sukrakanchana, PO; Than-In-At, K, 2017
)
0.46
"To develop a population pharmacokinetic model and identify sources of variability, genetic and nongenetic factors, of tenofovir."( Pharmacogenetics-based population pharmacokinetic analysis of tenofovir in Thai HIV-infected patients.
Avihingsanon, A; Burger, DM; Mitruk, S; Punyawudho, B; Rungtivasuwan, K; Ruxrungtham, K; Sukasem, C; Thammajaruk, N, 2017
)
0.46
" A nonlinear mixed effects model was used to develop the population pharmacokinetic model and investigate the influence of these polymorphisms and other patient specific covariates on the pharmacokinetics of tenofovir."( Pharmacogenetics-based population pharmacokinetic analysis of tenofovir in Thai HIV-infected patients.
Avihingsanon, A; Burger, DM; Mitruk, S; Punyawudho, B; Rungtivasuwan, K; Ruxrungtham, K; Sukasem, C; Thammajaruk, N, 2017
)
0.46
" The Data Convergence Interview (DCI) and the Pharmacokinetic Data Convergence Interview (PK-DCI) were brief, collaborative interactions conducted with participants during adherence counseling sessions to improve accurate measurement of adherence to study product use."( Brief Participant-Centered Convergence Interviews Integrate Self-Reports, Product Returns, and Pharmacokinetic Results to Improve Adherence Measurement in MTN-017.
Ayudhya, RPKN; Balán, IC; Brown, W; Carballo-Diéguez, A; Cranston, RD; Giguere, R; Hendrix, CW; Horn, S; Lama, JR; Marzinke, MA; McGowan, I; Patterson, K; Piper, JM, 2018
)
0.48
" Although colonic biopsies should be collected in the absence of medium for accurate TFV concentrations, the presence of medium does not significantly impact TFV-DP-dependent pharmacokinetic or pharmacodynamic assays."( Short Communication: Specimen Processing Impacts Tissue Tenofovir Pharmacokinetic Measurements.
Bakshi, RP; Breakey, J; Fuchs, EJ; Jois, B; Manohar, M; Marzinke, MA, 2018
)
0.48
"Intensive pharmacokinetic sampling of maternal dried blood spots (DBS), dried breast milk spots (DBMS) and infant DBS from 30 Ugandan and 29 Nigerian mothers receiving first-line ART and their infants was conducted."( Plasma and breast milk pharmacokinetics of emtricitabine, tenofovir and lamivudine using dried blood and breast milk spots in nursing African mother-infant pairs.
Khoo, S; Kyohaire, I; Lamorde, M; Nakalema, S; Olagunju, A; Owen, A; Waitt, C, 2018
)
0.48
"A single-arm, prospective, nonrandomized, cross-over, pharmacokinetic study in patients receiving a TDF-containing regimen (TDF 300 mg/FTC 200 mg/EVG 150 mg/COBI 150 mg) switched to a TAF-containing FDC regimen (TAF 10 mg/FTC 200 mg/EVG 150 mg/COBI 150 mg)."( Plasma and intracellular pharmacokinetics of tenofovir in patients switched from tenofovir disoproxil fumarate to tenofovir alafenamide.
Bares, SH; Dyavar, SR; Fletcher, CV; Havens, J; Lee, S; O'Neill, J; Podany, AT; Scarsi, KK; Swindells, S, 2018
)
0.48
" To provide insights into the complex mechanisms of absorption and disposition of TLC-ART101, we constructed novel mechanism-based pharmacokinetic (MBPK) models."( Mechanism-based pharmacokinetic (MBPK) models describe the complex plasma kinetics of three antiretrovirals delivered by a long-acting anti-HIV drug combination nanoparticle formulation.
Collier, AC; Collins, C; Ho, RJY; Kinman, L; Koehn, J; Kraft, JC; McConnachie, LA; Shen, DD; Sun, J, 2018
)
0.48
"In this study of 14 days each of vaginal and rectal application of TFV reduced-glycerin 1% gel, we found only a small degree of cross-compartment distribution of TFV in RF and vaginal fluids and no pharmacodynamic activity in ex vivo testing."( Pharmacokinetics and Pharmacodynamics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women: A Cross-Compartmental Study With Directly Observed Dosing.
Balar, B; Dai, JY; Dezzutti, CS; Galaska, B; Hendrix, CW; Justman, JE; Kunjara Na Ayudhya, RP; Levy, L; Marzinke, MA; McGowan, I; Mushamiri, I; Nair, GL; Pan, Z; Piper, JM; Schwartz, JL, 2018
)
0.48
" TFV pharmacodynamic activity was measured by evaluating CV fluid [CVF] and tissue for antiviral activity using in vitro models."( Randomized, placebo controlled phase I trial of safety, pharmacokinetics, pharmacodynamics and acceptability of tenofovir and tenofovir plus levonorgestrel vaginal rings in women.
Asin, SN; Brache, V; Chandra, N; Clark, MR; Dezzutti, CS; Doncel, GF; Fichorova, R; Herold, BC; Hillier, SL; Kiser, P; Marzinke, MA; McCormick, T; Rollenhagen, C; Schwartz, JL; Stanczyk, FZ; Thurman, AR; Weiner, D, 2018
)
0.48
" Population pharmacokinetic models were developed using measured intracellular metabolite, endogenous nucleotide competitors, and extracellular parent drug concentrations."( A Pharmacokinetic/Pharmacodynamic Model to Predict Effective HIV Prophylaxis Dosing Strategies for People Who Inject Drugs.
Chen, J; Cottrell, ML; Dumond, JB; Garrett, KL; Maas, BM; Prince, HA; Schauer, AP; Sykes, C; White, N, 2018
)
0.48
"We conducted a 3-arm randomized, pharmacokinetic study of tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg among adults living with human immunodeficiency virus."( Urine Tenofovir Concentrations Correlate With Plasma and Relate to Tenofovir Disoproxil Fumarate Adherence: A Randomized, Directly Observed Pharmacokinetic Trial (TARGET Study).
Bacchetti, P; Baeten, JM; Cressey, R; Cressey, TR; Drain, PK; Gandhi, M; Klinbuayaem, V; Kubiak, RW; Okochi, H; Punyati, P; Quame-Amaglo, J; Siriprakaisil, O; Sirirungsi, W; Sukrakanchana, PO; Tanasri, S, 2020
)
0.56
" Using in vitro kinetic parameters for TFV and the OAT1 and OAT3 inhibitor probenecid, a bottom-up physiologically-based pharmacokinetic model was successfully developed for the first time that accurately describes the probenecid-TFV interaction."( Probenecid-Boosted Tenofovir: A Physiologically-Based Pharmacokinetic Model-Informed Strategy for On-Demand HIV Preexposure Prophylaxis.
Desta, Z; Gufford, BT; Liu, SN, 2020
)
0.56
"3) were applied to determine pharmacokinetic parameters and assess demographic covariates and relationships with SNPs (SLCO3A1, SLCO1B1, NR1I2, NR1I3, CYP3A5*3, CYP3A4*22, ABCC2, ABCC10, ABCG2 and SCL47A1)."( Population pharmacokinetics and pharmacogenetics of ritonavir-boosted darunavir in the presence of raltegravir or tenofovir disoproxil fumarate/emtricitabine in HIV-infected adults and the relationship with virological response: a sub-study of the NEAT001
Boffito, M; Bonora, S; Cursley, A; D'Avolio, A; Di Perri, G; Dickinson, L; Fäetkenheuer, G; Gurjar, R; Molina, JM; Owen, A; Pozniak, A; Raffi, F; Richert, L; Stöhr, W; Vandekerckhove, L, 2020
)
0.56
" The half-life of PMEA in the pradefovir group was 11."( Safety, efficacy, and pharmacokinetics of pradefovir for the treatment of chronic hepatitis B infection.
Chen, H; Ding, Y; Jin, W; Li, C; Li, X; Liu, C; Liu, J; Niu, J; Wu, M; Zhang, D; Zhang, H; Zhu, X, 2020
)
0.56
" No differences in TFV pharmacokinetic parameters during the washout were observed across the study arms."( Plasma pharmacokinetics and urinary excretion of tenofovir following cessation in adults with controlled levels of adherence to tenofovir disoproxil fumarate.
Baeten, JM; Cressey, R; Cressey, TR; Drain, PK; Gandhi, M; Klinbuayaem, V; Kubiak, RW; Okochi, H; Quame-Amaglo, J; Siriprakaisil, O; Sukrakanchana, PO; Tawon, Y, 2020
)
0.56
" We used mixed effects linear regression models to compare pharmacodynamic measures for each participant at predrug baseline, after PrEP alone, and after PrEP and DMPA."( Pharmacokinetic and Pharmacodynamic Impacts of Depot Medroxyprogesterone Acetate Use on HIV Pre-exposure Prophylaxis in Women.
Achilles, SL; Chen, BA; Hendrix, CW; Marzinke, MA; Meyn, LA; Tarleton, J, 2020
)
0.56
" Pharmacokinetic sampling, urine biomarker collection [urine protein (UPCR), retinol binding protein (RBP) and β2 microglobulin (β2M) normalized to creatinine] and safety assessments occurred at the end of each phase."( Pharmacokinetics and renal safety of tenofovir alafenamide with boosted protease inhibitors and ledipasvir/sofosbuvir.
Anderson, PL; Blum, J; Brooks, KM; Bushman, LR; Castillo-Mancilla, JR; Cendali, F; Choi, YJ; Gomez, J; Haas, H; Ibrahim, ME; Johnson, B; Kiser, JJ; MaWhinney, S; Morrow, M; Roon, L; Rowan, SE; Wyles, DL; Zheng, JH, 2020
)
0.56
" Data were combined from a pharmacokinetic study of pregnant women with HIV on ART (PANNA), and a study assessing TFV pharmacokinetics in pregnant women with HBV (iTAP)."( Effect of Pregnancy and Concomitant Antiretrovirals on the Pharmacokinetics of Tenofovir in Women With HIV Receiving Tenofovir Disoproxil Fumarate-Based Antiretroviral Therapy Versus Women With HBV Receiving Tenofovir Disoproxil Fumarate Monotherapy.
Bukkems, VE; Burger, DM; Colbers, AP; Cressey, TR; Jourdain, G; Smolders, EJ, 2021
)
0.62
"This study was performed to compare the pharmacokinetic properties and assess bioequivalence for the test formulation (HUG116 tablet; tenofovir disoproxil) and reference formulation (Viread tablet; tenofovir disoproxil fumarate)."( A randomized, open-label, crossover study to compare the safety and pharmacokinetics of two tablet formulations of tenofovir (tenofovir disoproxil and tenofovir disoproxil fumarate) in healthy subjects.
Choi, YS; Hoe, KL; Hong, JH; Kan, HS; Kim, N; Kwon, IS; Lee, M; Nam, SK; Oh, TY; Yeun, JS; Yun, JN, 2020
)
0.56
" Serial blood samples for pharmacokinetic evaluation were collected up to 72 hours post dose, and the pharmacokinetic parameters were estimated by noncompartmental methods."( A randomized, open-label, crossover study to compare the safety and pharmacokinetics of two tablet formulations of tenofovir (tenofovir disoproxil and tenofovir disoproxil fumarate) in healthy subjects.
Choi, YS; Hoe, KL; Hong, JH; Kan, HS; Kim, N; Kwon, IS; Lee, M; Nam, SK; Oh, TY; Yeun, JS; Yun, JN, 2020
)
0.56
"The test formulation showed similar pharmacokinetic profiles to those of the reference formulation."( A randomized, open-label, crossover study to compare the safety and pharmacokinetics of two tablet formulations of tenofovir (tenofovir disoproxil and tenofovir disoproxil fumarate) in healthy subjects.
Choi, YS; Hoe, KL; Hong, JH; Kan, HS; Kim, N; Kwon, IS; Lee, M; Nam, SK; Oh, TY; Yeun, JS; Yun, JN, 2020
)
0.56
"Pregnant women receiving TAF 10 mg with cobicistat or TAF 25 mg without boosting as part of clinical care had intensive pharmacokinetic assessments performed during the second and third trimesters, and 6-12 weeks postpartum."( Pharmacokinetics of tenofovir alafenamide with and without cobicistat in pregnant and postpartum women living with HIV.
Barr, E; Best, BM; Brooks, KM; Capparelli, EV; Chakhtoura, N; Cielo, M; Denson, K; Deville, JG; Espina, R; Febo, IL; George, K; Haubrich, R; Mirochnick, M; Momper, JD; Pinilla, M; Rooney, JF; Rungruengthanakit, K; Shapiro, DE; Smith, E; Stek, AM; Weinberg, A, 2021
)
0.62
" Pharmacokinetic (PK) data from study RMP-02/MTN-006 comparing single dose oral tenofovir disoproxil fumarate with single and multiple dose rectal tenofovir (TFV) gel administration in HIV-1 seronegative adults was used to construct a multicompartment plasma-rectal tissue population PK model for TFV and tenofovir-diphosphate (TFVdp) in plasma and rectal tissue."( A Mechanistic In Vivo/Ex Vivo Pharmacokinetic-Pharmacodynamic Model of Tenofovir for HIV Prevention.
Anton, P; Bumpus, NN; Garcia-Cremades, M; Hendrix, C; Jayachandran, P; Savić, R; Vučićević, K, 2021
)
0.62
" This phase I, open-label, 2-period, 1-way study assessed potential pharmacokinetic (PK) interactions between GSK3640254 and tenofovir alafenamide/emtricitabine (TAF/FTC; including the metabolite tenofovir [TFV]) in healthy volunteers."( A Phase I Evaluation of the Pharmacokinetics and Tolerability of the HIV-1 Maturation Inhibitor GSK3640254 and Tenofovir Alafenamide/Emtricitabine in Healthy Participants.
Butcher, L; Davidson, AM; Johnson, M; Joshi, SR; Lataillade, M; Min, S; Pene Dumitrescu, T; Webster, L; Xu, J; Zhan, J; Zimmerman, E, 2021
)
0.62
"3) ADVAN 13, based on a previously established pharmacokinetic model."( Pharmacokinetic-pharmacodynamic modelling of atazanavir in hair among adolescents on antiretroviral treatment in Zimbabwe.
Chawana, TD; Ngara, B; Nhachi, CFB; Rusakaniko, S; Zvada, S, 2021
)
0.62
" However, no real-world pharmacokinetic (PK) data are available in treatment-experienced patients with antiretroviral resistance receiving BIC/FTC/TAF plus a boosted protease inhibitor."( Brief Report: Pharmacokinetics of Bictegravir and Tenofovir in Combination With Darunavir/Cobicistat in Treatment-Experienced Persons With HIV.
Best, BM; Hill, L; Momper, JD; Patel, N; Salama, E, 2021
)
0.62
"This prospective, single-center, nonrandomized pharmacokinetic study enrolled adult treatment-experienced persons with HIV and creatinine clearance >30 mL/min receiving BIC/FTC/TAF + DRV/c as part of routine clinical care."( Brief Report: Pharmacokinetics of Bictegravir and Tenofovir in Combination With Darunavir/Cobicistat in Treatment-Experienced Persons With HIV.
Best, BM; Hill, L; Momper, JD; Patel, N; Salama, E, 2021
)
0.62
" The median (interquartile range [IQR]) BIC AUC0-tau,exp and Cmax values were 128."( Brief Report: Pharmacokinetics of Bictegravir and Tenofovir in Combination With Darunavir/Cobicistat in Treatment-Experienced Persons With HIV.
Best, BM; Hill, L; Momper, JD; Patel, N; Salama, E, 2021
)
0.62
" Physiologically based pharmacokinetic (PBPK) modelling is a non-invasive solution for understanding lymph node penetration of ARVs across multiple species."( A cross-species comparison of antiretroviral penetration into lymph nodes using novel physiologically based pharmacokinetic models.
Cao, Y; Kashuba, ADM; Scholz, EMB, 2021
)
0.62
" Although TFV exalidex (TXL), a phospholipid-derived prodrug of TFV, was designed to address this issue, clinical pharmacokinetic studies indicated substantial hepatic extraction, redirecting clinical development of TXL toward HBV."( ω-Functionalized Lipid Prodrugs of HIV NtRTI Tenofovir with Enhanced Pharmacokinetic Properties.
Bartsch, PW; Basson, AE; Burton, SL; Bushnev, A; D'Erasmo, M; Dasari, M; Derdeyn, CA; Giesler, KE; Hwang, SS; Iskandar, S; Liotta, DC; Miller, EJ; Pribut, N; Raghuram, A; Sharma, SK, 2021
)
0.62
"The Microbicide Trials Network-017 study was undertaken to characterize the safety, acceptability, pharmacokinetic (PK), and pharmacodynamic profile of the reduced-glycerin (RG) 1% tenofovir (RG-TFV) gel compared to oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)."( An Open-Label Pharmacokinetic and Pharmacodynamic Assessment of Tenofovir Gel and Oral Emtricitabine/Tenofovir Disoproxil Fumarate.
Brand, RM; Chitwarakorn, A; Cranston, RD; Curlin, ME; Doncel, G; Hendrix, CW; Holtz, TH; Johnson, S; Kunjara Na Ayudhya, RP; Marzinke, MA; McGowan, IM; Piper, J; Raengsakulrach, B; Rooney, JF; Schwartz, JL, 2022
)
0.72
"We previously developed a mechanism-based pharmacokinetic (MBPK) model to characterize the PK of a lymphocyte-targeted, long-acting 3 HIV drug-combination nanoparticle (DcNP) formulation of lopinavir, ritonavir, and tenofovir."( Physiologically Based Pharmacokinetic Modeling of 3 HIV Drugs in Combination and the Role of Lymphatic System after Subcutaneous Dosing. Part 2: Model for the Drug-combination Nanoparticles.
Ho, RJY; Perazzolo, S; Shen, DD, 2022
)
0.72
"This is an open-label, randomized, fixed sequence single intravenous dosing study to assess pharmacokinetic interactions between remdesivir and TDF/3TC (Study A, crossover design) or TDF/3TC plus ATV/r (Study B)."( An open-label, randomized, single intravenous dosing study to investigate the effect of fixed-dose combinations of tenofovir/lamivudine or atazanavir/ritonavir on the pharmacokinetics of remdesivir in Ugandan healthy volunteers (RemTLAR).
Byakika-Kibwika, P; D'Avolio, A; Kaboggoza, JP; Lamorde, M; Waitt, C; Walimbwa, SI, 2021
)
0.62
" Furthermore, this study will deliver pharmacokinetic datasets for remdesivir drug concentrations and demographic characteristics which could support pharmacometric approaches for simulation of remdesivir treatment regimens in patients concurrently using tenofovir/lamivudine and/or atazanavir/ritonavir."( An open-label, randomized, single intravenous dosing study to investigate the effect of fixed-dose combinations of tenofovir/lamivudine or atazanavir/ritonavir on the pharmacokinetics of remdesivir in Ugandan healthy volunteers (RemTLAR).
Byakika-Kibwika, P; D'Avolio, A; Kaboggoza, JP; Lamorde, M; Waitt, C; Walimbwa, SI, 2021
)
0.62
" A non-compartmental analysis was performed to estimate the main pharmacokinetic parameters."( Pharmacokinetics and tissue distribution of tenofovir, emtricitabine and dolutegravir in mice.
Barrail-Tran, A; Benzemrane, MS; Bourgeois, C; Gelé, T; Gouget, H; Labarthe, L; Lambotte, O; Le Calvez, P; Le Grand, R; Legrand, N, 2022
)
0.72
"ARV plasma pharmacokinetic parameters in both strains were similar to those estimated in the clinical context."( Pharmacokinetics and tissue distribution of tenofovir, emtricitabine and dolutegravir in mice.
Barrail-Tran, A; Benzemrane, MS; Bourgeois, C; Gelé, T; Gouget, H; Labarthe, L; Lambotte, O; Le Calvez, P; Le Grand, R; Legrand, N, 2022
)
0.72
"Tenofovir alafenamide (TAF) is a key component of HIV treatment, but pharmacokinetic data supporting the use of TAF during pregnancy are limited."( Pharmacokinetics of Tenofovir Alafenamide With Boosted Protease Inhibitors in Pregnant and Postpartum Women Living With HIV: Results From IMPAACT P1026s.
Barr, E; Best, BM; Brooks, KM; Browning, R; Capparelli, EV; Chakhtoura, N; Deville, JG; Febo, IL; George, K; Knowles, K; Mirochnick, M; Paul, ME; Pinilla, M; Rungruengthanakit, K; Shapiro, DE; Stek, AM, 2022
)
0.72
" Intensive pharmacokinetic assessments were performed during the second and third trimesters and 6-12 weeks postpartum."( Pharmacokinetics of Tenofovir Alafenamide With Boosted Protease Inhibitors in Pregnant and Postpartum Women Living With HIV: Results From IMPAACT P1026s.
Barr, E; Best, BM; Brooks, KM; Browning, R; Capparelli, EV; Chakhtoura, N; Deville, JG; Febo, IL; George, K; Knowles, K; Mirochnick, M; Paul, ME; Pinilla, M; Rungruengthanakit, K; Shapiro, DE; Stek, AM, 2022
)
0.72
" TAF was only quantifiable in 2/25 maternal delivery samples and below the limit of quantification in all cord blood and infant washout samples, likely because of the short half-life of TAF."( Pharmacokinetics of Tenofovir Alafenamide With Boosted Protease Inhibitors in Pregnant and Postpartum Women Living With HIV: Results From IMPAACT P1026s.
Barr, E; Best, BM; Brooks, KM; Browning, R; Capparelli, EV; Chakhtoura, N; Deville, JG; Febo, IL; George, K; Knowles, K; Mirochnick, M; Paul, ME; Pinilla, M; Rungruengthanakit, K; Shapiro, DE; Stek, AM, 2022
)
0.72
" Population pharmacokinetic (popPK) models and simulations would aid in understanding potential differences in emtricitabine/tenofovir disproxil fumarate (F/TDF) parent-metabolite concentrations in TGW on GAHT when compared to cisgender men (CGM) not exposed to GAHT."( Population pharmacokinetics of tenofovir, emtricitabine and intracellular metabolites in transgender women.
Bakshi, RP; Chaturvedula, A; Fuchs, EJ; Hendrix, CW; Marzinke, MA; Shieh, E; Tanaudommongkon, A, 2022
)
0.72
" Non-compartmental analyses were performed to quantify the pharmacokinetic parameters."( Plasma and breast milk pharmacokinetics of tenofovir alafenamide in mothers with chronic hepatitis B infection.
Cottrell, M; Crane, H; Di Girolamo, J; Dumond, J; Gane, E; Kashuba, A; Kayes, T; Levy, MT; Lim, TH; Manandhar, S; Symonds, A, 2022
)
0.72
"In this first pharmacokinetic study of TAF monotherapy in breastfeeding women with CHB, concentrations of TAF and TFV were low in breast milk with negligible infant exposure, supporting the use of TAF to prevent MTCT."( Plasma and breast milk pharmacokinetics of tenofovir alafenamide in mothers with chronic hepatitis B infection.
Cottrell, M; Crane, H; Di Girolamo, J; Dumond, J; Gane, E; Kashuba, A; Kayes, T; Levy, MT; Lim, TH; Manandhar, S; Symonds, A, 2022
)
0.72
" Modeled TFV pharmacodynamic antiviral activity was evaluated in vaginal and rectal fluids and cervicovaginal tissue ex vivo."( Randomized, placebo controlled phase I trial of the safety, pharmacokinetics, pharmacodynamics and acceptability of a 90 day tenofovir plus levonorgestrel vaginal ring used continuously or cyclically in women: The CONRAD 138 study.
Brache, V; Chandra, N; Clark, MR; Cochon, L; Doncel, GF; Erikson, DW; Fichorova, RN; Hanif, H; Herold, BC; Jacot, T; Ju, S; Marzinke, MA; Ouattara, LA; Parikh, U; Peet, M; Schwartz, JL; Thurman, AR; Tolley, E; Yousefieh, N, 2022
)
0.72
" Physiologically-based pharmacokinetic (PBPK) modeling offers a unique modality to predict PK in pregnant women."( Physiologically-Based Pharmacokinetic Modeling of Tenofovir Disoproxil Fumarate in Pregnant Women.
He, Q; Luo, T; Ma, WY; Xu, M; Yang, H; Yang, Y; Zhang, X, 2023
)
0.91
" Model-based simulations revealed 294% and 515% increases of median tenofovir Cmin in patients with CLCR of 15-29 mL/min (CKD stage 3), and less than 15 mL/min (stage 4), respectively, compared with normal renal function (CLCR = 90-149 mL/min)."( Population pharmacokinetic modelling to characterize the effect of chronic kidney disease on tenofovir exposure after tenofovir alafenamide administration.
Alves Saldanha, S; Andre, P; Buclin, T; Cavassini, M; Courlet, P; Decosterd, LA; Desfontaine, V; Guidi, M; Kusejko, K; Thoueille, P, 2023
)
0.91
" At steady state, 8-9 blood samples were taken to construct pharmacokinetic curves."( First Pharmacokinetic Data of Tenofovir Alafenamide Fumarate and Tenofovir With Dolutegravir or Boosted Protease Inhibitors in African Children: A Substudy of the CHAPAS-4 Trial.
Bamford, A; Burger, DM; Bwakura-Dangarembizi, M; Chabala, C; Colbers, A; Denti, P; Doerholt, K; Gibb, DM; Griffiths, AL; Makumbi, S; McIlleron, HM; Monkiewicz, LN; Mulenga, V; Mumbiro, V; Musiime, V; Nangiya, J; Szubert, AJ; Waalewijn, H; Wasmann, RE; Wiesner, L, 2023
)
0.91
" For each combination, tenofovir GM (CV%) AUCtau and Cmax remained below reference values in adults taking 25 mg TAF with a boosted protease inhibitors."( First Pharmacokinetic Data of Tenofovir Alafenamide Fumarate and Tenofovir With Dolutegravir or Boosted Protease Inhibitors in African Children: A Substudy of the CHAPAS-4 Trial.
Bamford, A; Burger, DM; Bwakura-Dangarembizi, M; Chabala, C; Colbers, A; Denti, P; Doerholt, K; Gibb, DM; Griffiths, AL; Makumbi, S; McIlleron, HM; Monkiewicz, LN; Mulenga, V; Mumbiro, V; Musiime, V; Nangiya, J; Szubert, AJ; Waalewijn, H; Wasmann, RE; Wiesner, L, 2023
)
0.91
" Peer-reviewed publications were included if they met all criteria: adults (≥ 18 years of age) living with or without HIV; report any pharmacokinetic parameter or plasma concentration of at least one of the following ARVs: tenofovir alafenamide fumarate (TAF); doravirine (DOR), rilpivirine (RIL) and etravirine (ETR); darunavir (DRV), tipranavir (TPV) and fostemsavir (FTR); dolutegravir (DTG), raltegravir (RAL), bictegravir (BIC) and elvitegravir (EVG); maraviroc (MVC); ibalizumab (IBA); cobicistat (COBI)."( Pharmacokinetics of Antiretroviral Drugs in Older People Living with HIV: A Systematic Review.
Cardoso, SW; Castro, T; Estrela, R; Grinsztejn, B; Oliveira, VG; Toledo, T; Torres, TS; Veloso, VG, 2023
)
0.91
"Among 97 studies included, 20 reported pharmacokinetic evaluation in older individuals (age ≥ 50 years)."( Pharmacokinetics of Antiretroviral Drugs in Older People Living with HIV: A Systematic Review.
Cardoso, SW; Castro, T; Estrela, R; Grinsztejn, B; Oliveira, VG; Toledo, T; Torres, TS; Veloso, VG, 2023
)
0.91
" The aim of this study was to investigate the effect of food on the single-dose pharmacokinetic properties of TMF."( Effect of Food on the Pharmacokinetics of Tenofovir Amibufenamide: A Phase I, Randomized, Open-Label, Two-Period Crossover Trial in Healthy Adult Subjects.
Huang, Q; Jiang, Y; Kai, J; Lin, M; Liu, J; Qiu, Y; Wu, M; Zhai, Y; Zheng, Y, 2023
)
0.91

Compound-Compound Interactions

When combined with tenofovir/emtricitabine in treatment-naive patients, raltegravir produced durable viral suppression and immune restoration that was at least equivalent to efavirenz through 156 weeks of therapy. This is the first report of severe hypokalemia and proximal tubular renal dysfunction as a result of a possible drug-drug interaction.

ExcerptReferenceRelevance
" Adefovir and PMPA both demonstrated strong synergistic anti-HIV activity in combination with AZT."( Anti-HIV activity of adefovir (PMEA) and PMPA in combination with antiretroviral compounds: in vitro analyses.
Cherrington, JM; Mulato, AS, 1997
)
0.3
" We tested MPA alone and in combination with abacavir (ABC), didanosine (DDI), lamivudine (3TC) and tenofovir (TFV) against wild-type human immunodeficiency virus type-1 (HIV-1) and nucleoside reverse transcriptase inhibitor (NRTI)-resistant HIV-1."( Dose proportional inhibition of HIV-1 replication by mycophenolic acid and synergistic inhibition in combination with abacavir, didanosine, and tenofovir.
Coull, JJ; Drusano, GL; Hossain, MM; Margolis, DM, 2002
)
0.31
"Mutations selected or deselected during passage of human immunodeficiency virus strain HXB2 or resistant variants with tenofovir (TFV), abacavir (ABC), and lamivudine (3TC) differed depending on the drug combination and virus genotype."( Human immunodeficiency virus type 1 reverse transcriptase mutation selection during in vitro exposure to tenofovir alone or combined with abacavir or lamivudine.
Ait-Khaled, M; Craig, C; Griffin, P; Stone, C; Tisdale, M, 2004
)
0.32
"Tenofovir disoproxil fumarate (tenofovir DF) was studied in combination with rifampin in 24 healthy subjects in a multiple-dose, open-label, single-group, two-period study."( Pharmacokinetic study of tenofovir disoproxil fumarate combined with rifampin in healthy volunteers.
Buffels, R; Burger, DM; Droste, JA; Hekster, YA; Kearney, BP; Vanhorssen, PJ; Verweij-van Wissen, CP, 2005
)
0.33
"The nucleotide analogue, tenofovir, has been shown to lower plasma atazanavir levels in pharmacokinetic trials, an interaction that may be partly reversed by the addition of ritonavir, whereas plasma tenofovir levels are themselves raised when the drug is combined with lopinavir/ritonavir."( The steady-state pharmacokinetics of nelfinavir in combination with tenofovir in HIV-infected patients.
Becker, M; Breske, A; Esser, S; Hill, A; Koerber, A; Kopperman, M; Kruse, G; Kurowski, M; Möcklinghoff, C; Ross, B; Stocker, H; Wiehler, H, 2005
)
0.33
"The drug-drug and drug-food interactions between tenofovir DF and didanosine EC were evaluated in 2 pharmacokinetic studies in healthy adult subjects."( Drug-drug and drug-food interactions between tenofovir disoproxil fumarate and didanosine.
Chen, SS; Cheng, AK; Flaherty, JF; Kaul, S; Kearney, BP; Sayre, JR, 2005
)
0.33
"Tenofovir disoproxil fumarate (DF) has been studied in combination with efavirenz in healthy volunteers and no interaction was found."( Assessment of drug-drug interactions between tenofovir disoproxil fumarate and the nonnucleoside reverse transcriptase inhibitors nevirapine and efavirenz in HIV-infected patients.
Burger, DM; Droste, JA; Hekster, YA; Kearney, BP, 2006
)
0.33
" Six different groups were studied: 200 mg nevirapine twice daily, 400 mg nevirapine once daily, 600 mg efavirenz once daily, all without tenofovir DF (groups 1, 2, and 3, respectively), and the same groups with the drugs combined with tenofovir 300 mg once daily (groups 4, 5, and 6, respectively)."( Assessment of drug-drug interactions between tenofovir disoproxil fumarate and the nonnucleoside reverse transcriptase inhibitors nevirapine and efavirenz in HIV-infected patients.
Burger, DM; Droste, JA; Hekster, YA; Kearney, BP, 2006
)
0.33
" The most common drugs given with tenofovir were ritonavir or lopinavir-ritonavir (21 of 27 patients), atazanavir (5 of 27 patients), and didanosine (9 of 27 patients)."( Tenofovir-associated acute and chronic kidney disease: a case of multiple drug interactions.
Bedford, J; Braden, G; Hoffman, R; Morris, A; Pizzoferrato, T; Zimmermann, AE, 2006
)
0.33
" Together, these in vitro results indicate that combination with other antiretrovirals does not significantly increase the toxic potential of TFV in RPTECs."( In vitro cytotoxicity and mitochondrial toxicity of tenofovir alone and in combination with other antiretrovirals in human renal proximal tubule cells.
Alvarez, ML; Cihlar, T; Cordobilla, B; Domingo, JC; Domingo, P; Giralt, M; Guallar, J; López-Dupla, M; Sánchez de la Rosa, R; Saumoy, M; Torres, F; Vidal, F; Villarroya, F, 2006
)
0.33
"Study 903 is a phase 3 trial with a completed 144-week, double-blind phase comparing tenofovir DF (TDF) to stavudine (d4T) in combination with lamivudine (3TC) and efavirenz (EFV) and an ongoing additional 336-week open-label extension phase."( The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naïve HIV-1-infected patients.
Cassetti, I; Cheng, AK; Enejosa, J; Etzel, A; Madruga, JV; Suleiman, JM; Zhong, L,
)
0.13
"We evaluated the mitochondrial toxicity of tenofovir (TFV), emtricitabine (FTC) and abacavir as carbovir (CBV) alone, with each other, and in combination with additional NRTIs."( Mitochondrial toxicity of tenofovir, emtricitabine and abacavir alone and in combination with additional nucleoside reverse transcriptase inhibitors.
Melkaoui, K; Setzer, B; Venhoff, N; Walker, UA, 2007
)
0.34
"Study 903 is a phase 3 trial with a completed 144-week, double-blind phase comparing tenofovir DF (TDF) with stavudine (d4T), in combination with lamivudine (3TC) and efavirenz (EFV), and an ongoing 336-week open-label extension phase."( The safety and efficacy of switching stavudine to tenofovir df in combination with lamivudine and efavirenz in hiv-1-infected patients: three-year follow-up after switching therapy.
Cassetti, I; Cheng, AK; Enejosa, J; Etzel, A; Holmes, CB; Madruga, JR; Suleiman, JM; Zhong, L,
)
0.13
" Pharmacokinetic profiles were also determined in HIV-1-infected patients dosed with raltegravir monotherapy versus raltegravir in combination with TDF and lamivudine."( Lack of a significant drug interaction between raltegravir and tenofovir.
Breidinger, SA; Chen, J; Friedman, EJ; Gottesdiener, KM; Iwamoto, M; Kost, JT; Lasseter, KC; Stek, JE; Stone, JA; Teppler, H; Wagner, JA; Wenning, LA, 2008
)
0.35
" These mt-QSARs offer also a good opportunity to construct drug-drug Complex Networks (CNs) that can be used to explore large and complex drug-viral species databases."( Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
Chou, KC; González-Díaz, H; Martinez de la Vega, O; Prado-Prado, FJ; Ubeira, FM; Uriarte, E, 2009
)
0.35
" regimen and it's recommended by most of the clinical guidelines as a start regimen in combination with two other drugs."( [Clinical data I. Clinical experience with tenofovir in combination with nonnucleoside analogue transcriptase inhibitors].
Arribas López, JR; Bernardino de la Serna, JI; Mora Rillo, M, 2008
)
0.35
" Most data on safety and efficacy in this scenario initially came from clinical trials in which tenofovir was combined with non-nucleoside reverse transcriptase inhibitors."( [Clinical data II. Clinical experience of tenofovir DF in combination with protease inhibitors].
Fiorante, S; Pulido, F, 2008
)
0.35
"Emtricitabine, a nucleoside reverse transcriptase inhibitor (RTI), and tenofovir disoproxil fumarate (tenofovir DF), a nucleotide RTI, as a fixed-dose combination tablet (emtricitabine/tenofovir DF) for once-daily oral administration, are used as the nucleoside/nucleotide RTI backbone in combination with other antiretroviral agents, including ritonavir-boosted protease inhibitors (PIs), in the treatment of adults with HIV-1 infection."( Emtricitabine/tenofovir disoproxil fumarate: in combination with a protease inhibitor in HIV-1 infection.
Perry, CM, 2009
)
0.35
"A new drug combination regimen, consisting of raltegravir, emtricitabine and tenofovir disoproxil fumarate (TDF), is described for the treatment of HIV-1 infection."( A new drug combination therapy for treatment-naive patients with HIV-1 infection, consisting of raltegravir, emtricitabine and tenofovir disoproxil fumarate.
De Clercq, E, 2009
)
0.35
" However, N348I significantly decreases tenofovir susceptibility when combined with thymidine analogue mutations and etravirine susceptibility when combined with Y181C."( N348I in HIV-1 reverse transcriptase decreases susceptibility to tenofovir and etravirine in combination with other resistance mutations.
Moore, K; Radzio, J; Sluis-Cremer, N; Sonza, S; Tachedjian, G, 2010
)
0.36
"International, multicenter, open-label, 96-week noninferiority randomized trial of atazanavir/ritonavir 300/100 mg once daily vs lopinavir/ritonavir 400/100 mg twice daily, each in combination with fixed-dose tenofovir/emtricitabine 300/200 mg once daily, in antiretroviral-naive, HIV-1-infected patients."( Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study.
Absalon, J; Andrade-Villanueva, J; Chetchotisakd, P; Corral, J; David, N; Echevarria, J; Lataillade, M; Mancini, M; McGrath, D; Molina, JM; Moyle, G; Percival, L; Wirtz, V; Yang, R, 2010
)
0.36
"Forty-eight-week data are presented from this multicenter, randomized, open-label study comparing the safety profiles of abacavir/lamivudine and tenofovir/emtricitabine, both administered with efavirenz, in HLA-B*5701-negative HIV-1-infected adults."( Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study.
Branco, T; Cavassini, M; Domingo, P; Fisher, M; Givens, N; Khuong-Josses, MA; Lim, ML; Moyle, GJ; Norden, AG; Pearce, HC; Podzamczer, D; Post, FA; Rieger, A; Stellbrink, HJ; Vavro, C, 2010
)
0.36
" We investigated the activity of clevudine (CLV) in combination with other nucleoside/nucleotide analogues to determine if these combinations were compatible in vitro."( Evaluation of the in vitro anti-HBV activity of clevudine in combination with other nucleoside/nucleotide inhibitors.
Bao, H; Furman, PA; Korba, B; Micolochick Steuer, HM; Murakami, E; Niu, C; Tolstykh, T, 2010
)
0.36
"Using the HepAD38 cell line, which expresses wild-type HBV, and a real-time PCR assay, we tested the anti-HBV activity of CLV in combination with entecavir, lamivudine, adefovir, tenofovir and telbivudine (TBV)."( Evaluation of the in vitro anti-HBV activity of clevudine in combination with other nucleoside/nucleotide inhibitors.
Bao, H; Furman, PA; Korba, B; Micolochick Steuer, HM; Murakami, E; Niu, C; Tolstykh, T, 2010
)
0.36
"When CLV was combined with entecavir, lamivudine, adefovir or tenofovir, a synergistic antiviral effect was observed; however, the combination of CLV and TBV gave an antagonistic antiviral response."( Evaluation of the in vitro anti-HBV activity of clevudine in combination with other nucleoside/nucleotide inhibitors.
Bao, H; Furman, PA; Korba, B; Micolochick Steuer, HM; Murakami, E; Niu, C; Tolstykh, T, 2010
)
0.36
"We retrospectively evaluated the durability and reasons for discontinuation of nevirapine (NVP) in combination with a tenofovir (TDF) and emtricitabine (FTC) or lamivudine (3TC)-containing antiretroviral therapy (ART) regimen in an Australian outpatient setting."( Clinical experience with nevirapine combined with tenofovir plus emtricitabine or lamivudine-containing regimens in HIV-infected subjects.
Chan, DJ; Jeganathan, S; Maruszak, H; Smith, DE, 2011
)
0.37
" nevirapine on the same background, in naïve HIV-1-infected patients) study compared prospectively ritonavir-boosted atazanavir (ATZ/r) 300 mg/100 mg once daily (qd) with immediate release nevirapine (NVP) 200 mg twice daily or 400 mg qd, each combined with fixed-dose tenofovir 300 mg/emtricitabine 200 mg qd in 569 ARV-naïve HIV-1-infected patients."( Lipid profiles for nevirapine vs. atazanavir/ritonavir, both combined with tenofovir disoproxil fumarate and emtricitabine over 48 weeks, in treatment-naïve HIV-1-infected patients (the ARTEN study).
Andrade-Villanueva, J; Cairns, V; Clotet, B; de Rossi, L; Domingo, P; Gellermann, HJ; Podzamczer, D; Reiss, P; Rockstroh, JK; Soriano, V; Taylor, S, 2011
)
0.37
"ARTEN is a randomized, open-label, non-inferiority trial that compares nevirapine (NVP) 200 mg twice daily or 400 mg once daily to atazanavir/ritonavir (ATZ/r) 300 mg/100 mg once daily, each combined with fixed-dose tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg once daily, in antiretroviral-naive HIV-1 patients with CD4(+) T-cell counts <400 (men) and <250 cells/mm(3) (women)."( Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial.
Andrade-Villanueva, J; Antunes, F; Arastéh, K; de Rossi, L; Di Perri, G; Domingo, P; Gellermann, H; Lutz, T; Migrone, H; Opravil, M; Podzamczer, D; Soriano, V; Taylor, S, 2011
)
0.37
"NVP demonstrated at week 48 non-inferior antiviral efficacy compared with ATZ/r when given along with TDF/FTC, despite more drug-related discontinuations with NVP than ATZ/r."( Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial.
Andrade-Villanueva, J; Antunes, F; Arastéh, K; de Rossi, L; Di Perri, G; Domingo, P; Gellermann, H; Lutz, T; Migrone, H; Opravil, M; Podzamczer, D; Soriano, V; Taylor, S, 2011
)
0.37
" In order to improve ATV exposure, plasma and intracellular (IC) PK of ATV in patients administered with ATV 400 mg once daily and TDF/emtricitabine (FTC) and switched to ATV 200 mg twice daily were studied."( Pharmacokinetics of switching unboosted atazanavir coadministered with tenofovir disoproxil fumarate from 400 mg once daily to 200 mg twice daily in HIV-positive patients.
Baietto, L; Bonora, S; Calcagno, A; D'Avolio, A; Di Perri, G; Gonzalez de Requena, D; Siccardi, M; Simiele, M; Tettoni, M; Trentini, L, 2011
)
0.37
"Limited data are available on the use of unboosted atazanavir in combination with nucleoside reverse transcriptase inhibitors (NRTIs) in treatment-experienced HIV-infected patients."( Efficacy and safety of a switch to unboosted atazanavir in combination with nucleoside analogues in HIV-1-infected patients with virological suppression under antiretroviral therapy.
Ammassari, A; Castagna, A; Delaugerre, C; Ghosn, J; Medrano, J; Molina, JM; Pavie, J; Porcher, R; Rusconi, S; Torti, C; Valin, N, 2011
)
0.37
" NRTIs used in combination with atazanavir were tenofovir, abacavir and emtricitabine/lamivudine in 36."( Efficacy and safety of a switch to unboosted atazanavir in combination with nucleoside analogues in HIV-1-infected patients with virological suppression under antiretroviral therapy.
Ammassari, A; Castagna, A; Delaugerre, C; Ghosn, J; Medrano, J; Molina, JM; Pavie, J; Porcher, R; Rusconi, S; Torti, C; Valin, N, 2011
)
0.37
"In patients with virological suppression and no prior history of virological failure, a switch to unboosted atazanavir in combination with NRTIs is associated with a low probability of virological failure and a good safety profile."( Efficacy and safety of a switch to unboosted atazanavir in combination with nucleoside analogues in HIV-1-infected patients with virological suppression under antiretroviral therapy.
Ammassari, A; Castagna, A; Delaugerre, C; Ghosn, J; Medrano, J; Molina, JM; Pavie, J; Porcher, R; Rusconi, S; Torti, C; Valin, N, 2011
)
0.37
"Eligible patients with HIV-1 RNA (vRNA) levels >5000 copies/mL and without baseline resistance to efavirenz, tenofovir, or emtricitabine were randomized in a double-blind, noninferiority study to receive raltegravir or efavirenz, each combined with tenofovir/emtricitabine."( Long-term treatment with raltegravir or efavirenz combined with tenofovir/emtricitabine for treatment-naive human immunodeficiency virus-1-infected patients: 156-week results from STARTMRK.
Dejesus, E; Dinubile, MJ; Lazzarin, A; Leavitt, R; Lennox, JL; Nguyen, BY; Rockstroh, JK; Rodgers, AJ; Saag, MS; Sklar, P; Teppler, H; Walker, ML; Wan, H; Xu, X; Zhao, J, 2011
)
0.37
"When combined with tenofovir/emtricitabine in treatment-naive patients, raltegravir produced durable viral suppression and immune restoration that was at least equivalent to efavirenz through 156 weeks of therapy."( Long-term treatment with raltegravir or efavirenz combined with tenofovir/emtricitabine for treatment-naive human immunodeficiency virus-1-infected patients: 156-week results from STARTMRK.
Dejesus, E; Dinubile, MJ; Lazzarin, A; Leavitt, R; Lennox, JL; Nguyen, BY; Rockstroh, JK; Rodgers, AJ; Saag, MS; Sklar, P; Teppler, H; Walker, ML; Wan, H; Xu, X; Zhao, J, 2011
)
0.37
" Mean plasma concentration-time profiles for atazanavir, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), darunavir (DRV, administered with ritonavir [RTV]), and drospirenone/ethinylestradiol were similar following co-administration of GSK2248761."( Drug interaction profile for GSK2248761, a next generation non-nucleoside reverse transcriptase inhibitor.
de Serres, M; Gould, E; Johnson, M; Kim, J; Lou, Y; Mayers, D; Pietropaolo, K; Piscitelli, S; White, S; Zhou, XJ, 2012
)
0.38
"The hepatic organic anion transporting polypeptides (OATPs) influence the pharmacokinetics of several drug classes and are involved in many clinical drug-drug interactions."( Classification of inhibitors of hepatic organic anion transporting polypeptides (OATPs): influence of protein expression on drug-drug interactions.
Artursson, P; Haglund, U; Karlgren, M; Kimoto, E; Lai, Y; Norinder, U; Vildhede, A; Wisniewski, JR, 2012
)
0.38
"To explore the durability of three first-line tenofovir/emtricitabine-based regimens in combination with atazanavir/ritonavir, efavirenz or lopinavir/ritonavir in HIV-1-infected patients."( Duration of first-line antiretroviral therapy with tenofovir and emtricitabine combined with atazanavir/ritonavir, efavirenz or lopinavir/ritonavir in the Italian ARCA cohort.
Borghi, V; Capetti, A; Cicconi, P; Di Biagio, A; Di Giambenedetto, S; Francisci, D; Giacometti, A; Giannarelli, D; Maggiolo, F; Monno, L; Penco, G; Prinapori, R; Sterrantino, G; Zoncada, A, 2013
)
0.39
"Drug transporters such as P-glycoprotein and OATPs regulate intestinal permeability of atazanavir and may contribute to its poor oral bioavailability and drug-drug interactions with other protease inhibitors and TDF."( Role of drug efflux and uptake transporters in atazanavir intestinal permeability and drug-drug interactions.
Bendayan, R; Hoque, MT; Kis, O; Walmsley, SL; Zastre, JA, 2013
)
0.39
"Comprehensive information on the effects of cytochrome P450 2B6 (CYP2B6) polymorphisms, clinical factors, and drug-drug interactions on efavirenz concentrations in HIV/tuberculosis-coinfected (HIV/TB) patients is unavailable."( Impact of pharmacogenetic markers of CYP2B6, clinical factors, and drug-drug interaction on efavirenz concentrations in HIV/tuberculosis-coinfected patients.
Lueangniyomkul, A; Mankatitham, W; Manosuthi, S; Manosuthi, W; Nilkamhang, S; Sukasem, C; Sungkanuparph, S; Thongyen, S, 2013
)
0.39
" The objective of this study was to compare changes in body composition between ritonavir-boosted atazanavir (ATV/r) and ritonavir-boosted lopinavir (LPV/r) over 96 weeks using data from a substudy of CASTLE, which compared once-daily ATV/r with twice-daily LPV/r, both in combination with tenofovir disoproxil fumarate/emtricitabine in treatment-naïve patients with HIV-1 infection."( Comparison of body composition changes between atazanavir/ritonavir and lopinavir/ritonavir each in combination with tenofovir/emtricitabine in antiretroviral-naïve patients with HIV-1 infection.
DeGrosky, M; Farajallah, A; Hardy, H; McGrath, D; Moyle, GJ, 2014
)
0.4
" When ATV-LNPs were prepared with ritonavir (RTV), a metabolic and cellular membrane exporter inhibitor, and tenofovir (TFV), an HIV reverse-transcriptase inhibitor, stable, scalable, and reproducible anti-HIV drug combination LNPs were produced."( Evaluation of atazanavir and darunavir interactions with lipids for developing pH-responsive anti-HIV drug combination nanoparticles.
Duan, J; Freeling, JP; Ho, RJ; Koehn, J; Shu, C, 2014
)
0.4
"Electrospun drug-eluting fabrics have enormous potential for the delivery of physicochemically diverse drugs in combination by controlling the underlying material chemistry and fabric microarchitecture."( Delivery of multipurpose prevention drug combinations from electrospun nanofibers using composite microarchitectures.
Blakney, AK; Jiang, YH; Krogstad, EA; Woodrow, KA, 2014
)
0.4
" Finally, we showed that the drug-loaded nanofibers are noncytotoxic and that the antiviral activity of TFV is preserved through the electrospinning process and when combined with LNG."( Delivery of multipurpose prevention drug combinations from electrospun nanofibers using composite microarchitectures.
Blakney, AK; Jiang, YH; Krogstad, EA; Woodrow, KA, 2014
)
0.4
"We report an unusual case of pulmonary aspergillosis in a patient with AIDS and we demonstrated the drug-drug interactions between voriconazole, darunavir/ritonavir and tenofovir/emtricitabine."( Drug interactions between voriconazole, darunavir/ritonavir and tenofovir/emtricitabine in an HIV-infected patient treated for Aspergillus candidus lung abscess.
Becker, A; Desprez, S; Froidure, M; Gagneux, M; Huguet, D; Leduc, D; Legout, L; Sifaoui, F; Vignoli, P, 2015
)
0.42
" Clinical evaluation and laboratory findings excluded the presence of systemic diseases that might have been able to explain the drug inefficacy, while pharmacological evaluation suggested a possible drug-drug interaction."( Reactivation of chronic hepatitis B during treatment with tenofovir disoproxil fumarate: drug interactions or low adherence?
Caroleo, B; Gallelli, L; Perticone, F; Staltari, O, 2015
)
0.42
"International, randomized double-blind active-controlled trial to evaluate the efficacy and safety of COBI vs ritonavir (RTV) as a pharmacoenhancer of atazanavir in combination with emtricitabine/tenofovir disoproxil fumarate in HIV treatment-naive patients followed through week 144."( Brief Report: Cobicistat Compared With Ritonavir as a Pharmacoenhancer for Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate: Week 144 Results.
Abram, ME; Andrade-Villanueva, JF; Antunes, F; Arastéh, K; Cao, H; Chetchotisakd, P; DeJesus, E; Fehr, J; Gallant, JE; Koenig, E; Liu, HC; Rizzardini, G; Szwarcberg, J, 2015
)
0.42
"Compared with zidovudine-lamivudine, the use of tenofovir-lamivudine or emtricitabine in combination with nevirapine was a strong predictor of virologic failure in our cohort, which was not explained by other risk factors or criteria for regimen selection."( Superior Effectiveness of Zidovudine Compared With Tenofovir When Combined With Nevirapine-based Antiretroviral Therapy in a Large Nigerian Cohort.
Agbaji, OO; Darin, KM; Eisen, G; Gashau, W; Kanki, PJ; Meloni, ST; Murphy, RL; Nkado, R; Okonkwo, P; Onwujekwe, DI; Rawizza, HE; Scarsi, KK; Tchetgen Tchetgen, EJ, 2016
)
0.43
" The 3D regimen of 150/100 mg daily paritaprevir/ritonavir, 25 mg daily ombitasvir, and 400 mg twice-daily dasabuvir was administered alone or in combination with 200 mg daily of emtricitabine and 300 mg daily of tenofovir disoproxil fumarate (tenofovir DF), 25 mg daily of rilpivirine, or 400 mg of raltegravir twice daily."( Evaluation of Drug-Drug Interactions between Direct-Acting Anti-Hepatitis C Virus Combination Regimens and the HIV-1 Antiretroviral Agents Raltegravir, Tenofovir, Emtricitabine, Efavirenz, and Rilpivirine.
Awni, W; Dunbar, M; Dutta, S; Khatri, A; Menon, R; Podsadecki, T; Trinh, R, 2016
)
0.43
"To assess the safety and efficacy of rilpivirine in combination with emtricitabine and tenofovir (RPV/FTC/TDF) as a once-daily single-tablet regimen (STR) in HIV-1-infected children and adolescents we performed a multicenter case series study of HIV-1-infected patients."( Off-label use of rilpivirine in combination with emtricitabine and tenofovir in HIV-1-infected pediatric patients: A multicenter study.
Briz, V; De Ory, SJ; Falcon-Neyra, L; Fortuny, C; Frick, MA; González-Tomé, MI; López-Cortés, LF; Moreno, EB; Navarro Gómez, ML; Neth, O; Noguera-Julian, A; Olbrich, P; Palladino, C; Santos, JL; Soler-Palacín, P, 2016
)
0.43
"In general, DTG 50 mg given once daily combined with an active background drug is a better choice in terms of both efficacy and safety."( Dolutegravir(DTG, S/GSK1349572) combined with other ARTs is superior to RAL- or EFV-based regimens for treatment of HIV-1 infection: a meta-analysis of randomized controlled trials.
Chen, H; Guo, W; Huang, J; Jiang, J; Liang, B; Liang, H; Liao, Y; Su, J; Xu, X; Ye, L; Zang, N, 2016
)
0.43
" This mechanistic static approach was further applied to quantitatively predict renal drug-drug interactions (AFE ∼1."( Quantitative Prediction of Human Renal Clearance and Drug-Drug Interactions of Organic Anion Transporter Substrates Using In Vitro Transport Data: A Relative Activity Factor Approach.
Feng, B; Litchfield, J; Mathialagan, S; Piotrowski, MA; Tess, DA; Varma, MV, 2017
)
0.46
" To the best of our knowledge, this is the first report of severe hypokalemia and proximal tubular renal dysfunction as a result of a possible drug-drug interaction between vinblastine, tenofovir and ritonavir-boosted atazanavir."( Severe hypokalemia due to a possible drug-drug interaction between vinblastine and antiretrovirals in a HIV-infected patient with Hodgkin's lymphoma.
Arcondo, F; Cordova, E; Morganti, L; Odzak, A; Rodriguez, C; Silva, M; Zylberman, M, 2017
)
0.46
"A PBPK modelling approach was used to predict organic anion transporter (OAT) mediated drug-drug interactions involving S44121, a substrate and an inhibitor of OAT1 and OAT3."( Prediction of renal transporter-mediated drug-drug interactions for a drug which is an OAT substrate and inhibitor using PBPK modelling.
Ball, K; Chenel, M; Denizot, C; Jamier, T; Mallier, A; Parmentier, Y, 2017
)
0.46
" A single subcutaneous (SC) injection of this first-generation formulation of drug combination nanoparticles (DcNPs), named TLC-ART101, provided persistent ARV levels in macaque lymph node mononuclear cells (LNMCs) for at least 1 week, and in peripheral blood mononuclear cells (PBMCs) and plasma for at least 2 weeks, demonstrating long-acting pharmacokinetics for all three drugs."( Mechanism-based pharmacokinetic (MBPK) models describe the complex plasma kinetics of three antiretrovirals delivered by a long-acting anti-HIV drug combination nanoparticle formulation.
Collier, AC; Collins, C; Ho, RJY; Kinman, L; Koehn, J; Kraft, JC; McConnachie, LA; Shen, DD; Sun, J, 2018
)
0.48
" No clinically relevant differences in the pharmacokinetics (PK) of SOF, SOF metabolite GS-331007, or VEL were observed other than an approximate 50% decrease in VEL exposure when administered with EFV/FTC/TDF."( Drug-Drug Interaction Studies Between Hepatitis C Virus Antivirals Sofosbuvir/Velpatasvir and Boosted and Unboosted Human Immunodeficiency Virus Antiretroviral Regimens in Healthy Volunteers.
Brainard, DM; Ling, KHJ; Mathias, A; Mogalian, E; Osinusi, A; Shen, G; Stamm, LM, 2018
)
0.48
" This case presents the combination of tenofovir disoproxil in combination with a protease inhibitor as a new potential dual treatment regimen."( Dual antiretroviral therapy with tenofovir (TDF) and darunavir/ritonavir (DRV/RTV) in an HIV-1 positive patient: a case report, review, and meta-analysis of the literature on dual treatment strategies using protease inhibitors in combination with an NRTI.
Höring, S; Löffler, B; Pletz, MW; Rößler, S; Schleenvoigt, BT; Weis, S, 2018
)
0.48
" We report a potential drug-drug interaction in 2 female patients both receiving treatment for HIV and cerebral toxoplasmosis: one case between E/C/F/TAF with calcium carbonate and a second case involving leucovorin as calcium salt."( HIV Viral Rebound Due to a Possible Drug-Drug Interaction between Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide and Calcium-Containing Products: Report of 2 Cases.
El-Sayed, D; Kang-Birken, SL; Prichard, J,
)
0.13
"Treatment of individuals coinfected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) requires careful consideration of potential drug-drug interactions."( Assessment of Drug Interaction Potential Between the Hepatitis C Virus Direct-Acting Antiviral Agents Elbasvir/Grazoprevir and the Nucleotide Analog Reverse-Transcriptase Inhibitor Tenofovir Disoproxil Fumarate.
Butterton, JR; Caro, L; Fandozzi, C; Feng, HP; Guo, Z; Hanley, WD; Huang, X; Iwamoto, M; Jumes, P; Mangin, E; Marshall, W; Martinho, M; Panebianco, D; Talaty, JE; Valesky, R; Yeh, WW; Zhu, Y, 2019
)
0.51
" The combination with ACC007 significantly increases the dose reduction index value of lamivudine and tenofovir disoproxil fumarate, compared with two-drug combination."( The New NNRTI ACC007 Combined with Lamivudine and Tenofovir Disoproxil Fumarate Show Synergy Anti-HIV Activity In Vitro.
Chen, H; Hu, XL; Huang, XS; Luo, RH; Shen, XN; Tang, CR; Xiang, SY; Zhang, CT; Zheng, YT, 2020
)
0.56
" Here, we evaluate TDF and FTC in combination with the broadly neutralizing antibody VRC01-N using a highly reproducible humanized mouse model."( Highly synergistic drug combination prevents vaginal HIV infection in humanized mice.
Baum, MM; Bobardt, M; Gallay, PA; Gunawardana, M; Moss, JA; Ramirez, CM, 2020
)
0.56
" Confirmatory clinical trials may further define the in vivo triapine metabolic fate and quantify any drug-drug interactions."( In vitro evaluation of the metabolic enzymes and drug interaction potential of triapine.
Beumer, JH; Chaphekar, N; Chu, E; Guo, J; Jones, R; Joshi, A; Kiesel, BF; Kunos, CA; Taylor, S; Venkataramanan, R, 2020
)
0.56
"Dolutegravir in combination with NRTIs was effective in treating patients with HIV-1 infection, including those with extensive NRTI resistance in whom no NRTIs were predicted to have activity."( Dolutegravir or Darunavir in Combination with Zidovudine or Tenofovir to Treat HIV.
Asienzo, J; Ategeka, G; Balyegisawa, A; Castelnuovo, B; Hakim, J; Hoppe, A; Kaimal, A; Kambugu, A; Kiragga, A; Kityo, C; Mirembe, G; Mugerwa, H; Musaazi, J; Paton, NI; Siika, A; Tukamushabe, P; Walimbwa, S, 2021
)
0.62
" We did not find an elevated risk of AMI when abacavir-lamivudine was combined with efavirenz or raltegravir."( Acute myocardial infarction associated with abacavir and tenofovir based antiretroviral drug combinations in the United States.
Baxi, SM; Choden, T; Desai, M; Dorjee, K; Hubbard, AE; Reingold, AL, 2021
)
0.62
" Because islatravir may be coadministered with other antiretroviral agents, assessment of potential drug-drug interactions are warranted."( Lack of a Clinically Meaningful Drug Interaction Between the HIV-1 Antiretroviral Agents Islatravir, Dolutegravir, and Tenofovir Disoproxil Fumarate.
Armas, D; Fillgrove, KL; Fox-Bosetti, S; Friedman, E; Iwamoto, M; Matthews, RP; Rudd, DJ; Stoch, SA; Zhang, S, 2021
)
0.62
"The aim of this international multicentre study was to review potential drug-drug interactions (DDIs) for real-life coadministration of combination antiretroviral therapy (cART) and coronavirus disease 2019 (COVID-19)-specific medications."( Retrospective evaluation of an observational cohort by the Central and Eastern Europe Network Group shows a high frequency of potential drug-drug interactions among HIV-positive patients receiving treatment for coronavirus disease 2019 (COVID-19).
Antoniak, S; Begovac, J; Dragovic, G; Fleischhans, L; Gokengin, D; Harxhi, A; Hofman, S; Jilich, D; Kase, K; Kowalska, J; Lakatos, B; Matulionyte, R; Oprea, C; Papadopoulus, A; Rukhadze, N; Vassilenko, A; Vasyliev, M; Verhaz, A; Wasilewski, P; Yancheva, N, 2022
)
0.72
" Following a 2 × 2 factorial design and stratified by site and screening HIV-1 RNA concentration, participants were randomly assigned (1:1:1:1) to receive a 96-week regimen containing either dolutegravir (50 mg once daily) or ritonavir-boosted darunavir (800 mg of darunavir plus 100 mg of ritonavir once daily) in combination with either tenofovir (300 mg once daily) plus lamivudine (300 mg once daily) or zidovudine (300 mg twice daily) plus lamivudine (150 mg twice daily)."( Efficacy and safety of dolutegravir or darunavir in combination with lamivudine plus either zidovudine or tenofovir for second-line treatment of HIV infection (NADIA): week 96 results from a prospective, multicentre, open-label, factorial, randomised, non
Asienzo, J; Ategeka, G; Balyegisawa, A; Borok, M; Castelnuovo, B; Hoppe, A; Kaimal, A; Kambugu, A; Kiragga, A; Kityo, C; Lugemwa, A; Mirembe, G; Mugerwa, H; Musaazi, J; Odongpiny, ELA; Paton, NI; Siika, A; Walimbwa, S, 2022
)
0.72
" Patients (n = 303) enrolled were randomly administered peg-IFN-α-2b combined with TDF, GM-CSF, and hepatitis B vaccine (experimental group); peg-IFN-α-2b plus TDF (control group 2); or interferon-α-2b alone (control group 1)."( Pegylated interferon-α-2b combined with tenofovir disoproxil fumarate, granulocyte-macrophage colony-stimulating factor, and hepatitis B vaccine treatment for naïve HBeAg-positive chronic hepatitis B patients: A prospective, multicenter, randomized contro
Bai, L; Gu, J; Jia, H; Kuang, W; Lian, J; Lu, X; Lu, Y; Lv, Y; Wang, K; Yang, D; Yang, Y; Ye, C; Yu, J; Yu, Y; Zhang, J; Zhang, X; Zhang, Y; Zhao, P; Zhao, Y, 2022
)
0.72
"We retrospectively enrolled 70 unresectable HCC patients who were seropositive for HBsAg and accepted tenofovir alafenamide fumarate (TAF) therapy before anti-PD-1 in combination with an antiangiogenic treatment."( Interaction between baseline HBV loads and the prognosis of patients with HCC receiving anti-PD-1 in combination with antiangiogenic therapy undergoing concurrent TAF prophylaxis.
Chen, J; Hu, X; Li, Q; Li, R; Yuan, G; Zang, M, 2022
)
0.72
"Baseline HBV loads do not affect the prognosis of HCC patients receiving anti-PD-1 in combination with an antiangiogenic therapy, while PD-1 inhibitors do not aggravate HBV reactivation and hepatic impairment in patients simultaneously subjected to TAF prophylaxis."( Interaction between baseline HBV loads and the prognosis of patients with HCC receiving anti-PD-1 in combination with antiangiogenic therapy undergoing concurrent TAF prophylaxis.
Chen, J; Hu, X; Li, Q; Li, R; Yuan, G; Zang, M, 2022
)
0.72
"Lenacapavir warrants further investigation as a potential antiretroviral used orally and as injection in combination with other antiretroviral drugs."( Lenacapavir administered every 26 weeks or daily in combination with oral daily antiretroviral therapy for initial treatment of HIV: a randomised, open-label, active-controlled, phase 2 trial.
Baeten, JM; Benson, P; Berhe, M; Crofoot, G; Dvory-Sobol, H; Gupta, SK; Koenig, E; Liu, SY; McDonald, C; Ramgopal, M; Rhee, MS; Ruane, P; Sanchez, WE; Scribner, A; Sims, J; VanderVeen, LA, 2023
)
0.91
" NNRTIs are typically administered in combination with two nucleoside reverse transcriptase inhibitors as first-line recommended regimens in several guidelines."( No Meaningful Drug-Drug Interactions Are Associated with the Coadministration of ACC007, Lamivudine, and Tenofovir Disoproxil Fumarate.
Hao, X; Li, B; Li, L; Ni, J; Tian, Z; Wu, L; Xiao, Y; Zhang, W; Zhao, D; Zhao, X, 2023
)
0.91
" The aim was to investigate the expression of IL-1β in CHB patients treated with Peg-IFN-α combination with TDF and TDF/Peg-IFN-α monotherapy."( The expression of interleukin-1β in patients with chronic hepatitis B treated with pegylated-interferon-alpha combined with tenofovir disoproxil fumarate and monotherapy.
Hu, X; Li, Y; Luo, H; Qin, B; Tan, G, 2023
)
0.91
" A single-center cohort study of prospective recruitment of CHB patients: untreated CHB (Group A), TDF combined with Peg-IFN-α therapy (Group B), Peg-IFN-α monotherapy (Group C), TDF monotherapy (Group D)."( The expression of interleukin-1β in patients with chronic hepatitis B treated with pegylated-interferon-alpha combined with tenofovir disoproxil fumarate and monotherapy.
Hu, X; Li, Y; Luo, H; Qin, B; Tan, G, 2023
)
0.91
"The increased expression of IL-1β may enhance the efficacy of TDF combined with Peg-IFN-α therapy in achieving an early response for CHB patients."( The expression of interleukin-1β in patients with chronic hepatitis B treated with pegylated-interferon-alpha combined with tenofovir disoproxil fumarate and monotherapy.
Hu, X; Li, Y; Luo, H; Qin, B; Tan, G, 2023
)
0.91
" This study aimed to scrutinize the role of TF alone or combined with doxorubicin (DOX) in 7,12-dimethylbenz(a)anthracene (DMBA)-induced breast carcinoma rat model."( Tenofovir alone or combined with doxorubicin abrogates DMBA-induced mammary cell carcinoma: An insight into its modulatory impact on oxidative/Notch/apoptotic signaling.
Abdеlaziz, RR; Abouelezz, HM; El-Kashef, DH; Nader, MA, 2023
)
0.91
" In parallel, histopathological assessment displayed that mammary glands from animals treated with TF alone or combined with DOX showed better histopathological scores."( Tenofovir alone or combined with doxorubicin abrogates DMBA-induced mammary cell carcinoma: An insight into its modulatory impact on oxidative/Notch/apoptotic signaling.
Abdеlaziz, RR; Abouelezz, HM; El-Kashef, DH; Nader, MA, 2023
)
0.91
" Heart transplant (HT) is a very effective therapeutic strategy for end-stage heart failure (HF); however, clinicians may be hesitant due to concerns of complex drug-drug interactions (DDIs) between ART and HT immunosuppressive regimens and the potential impact of ART on long-term HT outcomes."( Heart transplantation and human immunodeficiency virus-navigating drug-drug interactions: a case report.
Almangour, TA; Chang, PP; Corbett, A; Farel, CE; Rodgers, JE; Skersick, PT, 2023
)
0.91

Bioavailability

Nonionic surfactant vesicles (niosomes) were formulated with an aim of enhancing the oral bioavailability of tenofovir disoproxil fumarate (TDF), an anti-HIV drug. The oral bio availability of ten ofovir is enhanced by administration with a high-fat meal, but is similar when administered with or without a typical meal.

ExcerptReferenceRelevance
" Adefovir dipivoxil, an orally bioavailable prodrug of adefovir is currently in phase III clinical trials for the treatment of HIV and phase II clinical trials for the treatment of HBV infections."( Anti-HIV activity of adefovir (PMEA) and PMPA in combination with antiretroviral compounds: in vitro analyses.
Cherrington, JM; Mulato, AS, 1997
)
0.3
"A series of prodrugs designed to enhance the oral bioavailability of the antiretroviral agent 9-[(R)-2-(phosphonomethoxy)propyl]adenine (PMPA; 1) have been synthesized, including a bis-(acyloxymethyl) ester 2 and a series of bis-(alkoxycarbonyloxymethyl) esters 3-9."( Metabolism and pharmacokinetics of novel oral prodrugs of 9-[(R)-2-(phosphonomethoxy)propyl]adenine (PMPA) in dogs.
Arimilli, MN; Cundy, KC; Kim, CU; Lee, WA; Oliyai, R; Shaw, JP; Sueoko, CM, 1997
)
0.3
" Oral bioavailability of PMPA from each prodrug was determined in fasted beagle dogs."( Metabolism and pharmacokinetics of novel oral prodrugs of 9-[(R)-2-(phosphonomethoxy)propyl]adenine (PMPA) in dogs.
Arimilli, MN; Cundy, KC; Kim, CU; Lee, WA; Oliyai, R; Shaw, JP; Sueoko, CM, 1997
)
0.3
" In fasted beagle dogs, bis-[(pivaloyloxy)methyl] PMPA (bis-POM PMPA) 2 had the highest oral bioavailability as PMPA (37."( Metabolism and pharmacokinetics of novel oral prodrugs of 9-[(R)-2-(phosphonomethoxy)propyl]adenine (PMPA) in dogs.
Arimilli, MN; Cundy, KC; Kim, CU; Lee, WA; Oliyai, R; Shaw, JP; Sueoko, CM, 1997
)
0.3
" We recently described the synthesis, metabolism, and biological activities of bis(isopropyloxymethylcarbonyl)PMPA [bis(poc)PMPA] as an orally bioavailable prodrug for PMPA."( Antiviral activities of 9-R-2-phosphonomethoxypropyl adenine (PMPA) and bis(isopropyloxymethylcarbonyl)PMPA against various drug-resistant human immunodeficiency virus strains.
Fridland, A; Srinivas, RV, 1998
)
0.3
" GS-7340 (9-[(R)-2-[[[[(S)-1-(isopropoxycarbonyl)ethyl] amino] phenoxy-phosphinyl]-methoxy] propyl] adenine) is a prodrug which is orally bioavailable in dogs as the intact prodrug and has demonstrated anti-HIV activity in cell culture of over 1000-fold greater than that of PMPA."( Metabolism of GS-7340, a novel phenyl monophosphoramidate intracellular prodrug of PMPA, in blood.
Eisenberg, EJ; He, GX; Lee, WA,
)
0.13
"The practical synthesis of a mixed phenoxy-amidate derivative of PMPA with high oral bioavailability and favorable pharmacokinetics is described."( Practical synthesis, separation, and stereochemical assignment of the PMPA pro-drug GS-7340.
Chapman, H; Kernan, M; Prisbe, E; Rohloff, J; Sparacino, M; Terhorst, T; Yu, R,
)
0.13
" The oral bioavailability of tenofovir is enhanced by administration with a high-fat meal, but is similar at steady state when administered with or without a typical meal."( Tenofovir disoproxil fumarate: clinical pharmacology and pharmacokinetics.
Flaherty, JF; Kearney, BP; Shah, J, 2004
)
0.32
" After a single oral dose of GS 7340 (10 mg-eq/kg tenofovir) to male beagle dogs, the plasma bioavailability of tenofovir compared to an intravenous dose of tenofovir was 17%."( Selective intracellular activation of a novel prodrug of the human immunodeficiency virus reverse transcriptase inhibitor tenofovir leads to preferential distribution and accumulation in lymphatic tissue.
Cihlar, T; Cundy, KC; Eisenberg, E; He, GX; Lee, WA; Mulato, A; Swaminathan, S, 2005
)
0.33
" Physicochemical properties, cellular permeation, renal toxicity, and bioavailability all had to be addressed during the development of these compounds."( Perspectives on the development of acyclic nucleotide analogs as antiviral drugs.
Lee, WA; Martin, JC, 2006
)
0.33
" From these results, additional studies will be needed to determine whether a similar mutation in HIV RT develops in patients receiving PMPA or its orally bioavailable prodrug, tenofovir dipivoxil fumarate."( In vitro selection and characterization of human immunodeficiency virus type 1 resistant to Zidovudine and tenofovir.
Hong, SK; Lee, SG; Paik, SY; Park, SS; Yoo, WC; Yoon, JS, 2007
)
0.34
" Tenofovir is not orally bioavailable but becomes orally active against HIV-1 infection as the disoproxil ester (tenofovir disoproxil fumarate [Viread])."( Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
Aldern, KA; Almond, MR; Beadle, JR; De Clercq, E; Hostetler, KY; Korba, BE; Lampert, BM; Neyts, J; Painter, GR; Trost, LC, 2007
)
0.34
" This drug is administered orally in the form of disoproxil ester, which is deesterified to achieve a bioavailability of more than 20%."( [Tenofovir: pharmacology and interactions].
Azanza, JR; García Quetglas, E; Gómez-Giu, A; Sádaba, B, 2008
)
0.35
"This study evaluated the relative bioavailability and pharmacokinetics of elvitegravir (EVG), emtricitabine (FTC), tenofovir disoproxil fumarate (TDF), and a investigational pharmacoenhancer, cobicistat (GS-9350, COBI) coformulated as a fixed-dose combination tablet (FDC) compared with ritonavir-boosted EVG and FTC + TDF in healthy subjects."( Pharmacokinetics and bioavailability of an integrase and novel pharmacoenhancer-containing single-tablet fixed-dose combination regimen for the treatment of HIV.
German, P; Hui, J; Kearney, BP; Warren, D; West, S, 2010
)
0.36
" The lead candidates, both 1a (PBHBV-001) and 3c (PBHBV-2-15), were well-tolerated in both normal and HBV-transgenic mice and exhibited acceptable pharmacokinetics and bioavailability in Sprague-Dawley rats."( Design, synthesis, and biological evaluation of triazolo-pyrimidine derivatives as novel inhibitors of hepatitis B virus surface antigen (HBsAg) secretion.
Block, TM; Clearfield, E; Cuconati, A; Goddard, C; Guo, H; Mills, C; Morrey, JD; Motter, NE; Xiao, T; Xu, X; Yu, W; Zhao, K, 2011
)
0.37
" A BW allometric scaling was used; and the typical population estimates (interindividual variability), standardized for 70 kg, for apparent clearance, central and peripheral volume of distribution, intercompartmental clearance, and absorption rate constant, were 59."( Population pharmacokinetics of tenofovir in HIV-1-infected pediatric patients.
Benaboud, S; Blanche, S; Bouazza, N; Foissac, F; Frange, P; Hirt, D; Rey, E; Tréluyer, JM; Urien, S, 2011
)
0.37
" In addition, the bioavailability of tenofovir dipivoxil fumarate was evaluated in healthy male fasted subjects after a single comparatively equivalent dose."( Relative bioavailability study of a novel prodrug of tenofovir, tenofovir dipivoxil fumarate, in healthy male fasted volunteers.
Ding, Y; Jia, Y; Liu, W; Lu, C; Song, Y; Sun, X; Wen, A; Yang, J, 2012
)
0.38
" Bioavailability of the drug was assessed in accordance with the State Food and Drug Administration bioequivalence criteria."( Relative bioavailability study of a novel prodrug of tenofovir, tenofovir dipivoxil fumarate, in healthy male fasted volunteers.
Ding, Y; Jia, Y; Liu, W; Lu, C; Song, Y; Sun, X; Wen, A; Yang, J, 2012
)
0.38
"The relative bioavailability of tenofovir dipivoxil was 20% higher compared with tenofovir disoproxil fumarate; this result was consistent with the preclinical data."( Relative bioavailability study of a novel prodrug of tenofovir, tenofovir dipivoxil fumarate, in healthy male fasted volunteers.
Ding, Y; Jia, Y; Liu, W; Lu, C; Song, Y; Sun, X; Wen, A; Yang, J, 2012
)
0.38
"Drug transporters such as P-glycoprotein and OATPs regulate intestinal permeability of atazanavir and may contribute to its poor oral bioavailability and drug-drug interactions with other protease inhibitors and TDF."( Role of drug efflux and uptake transporters in atazanavir intestinal permeability and drug-drug interactions.
Bendayan, R; Hoque, MT; Kis, O; Walmsley, SL; Zastre, JA, 2013
)
0.39
" The bioavailability of tenofovir dipivoxil fumarate was increased by approximately 25% as measured by AUClast after a single dose when taken with food, compared with fasting."( Pharmacokinetics and food interaction of a novel prodrug of tenofovir, tenofovir dipivoxil fumarate, in healthy volunteers.
Chen, L; Chen, M; Ding, Y; Jia, Y; Lu, C; Song, Y; Sun, X; Wen, A; Yang, J, 2013
)
0.39
" These findings suggest that elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate should be administered with food, and that the bioavailability of elvitegravir and tenofovir is not affected by the type of meal ingested."( Effects of a protein-rich drink or a standard meal on the pharmacokinetics of elvitegravir, cobicistat, emtricitabine and tenofovir in healthy Japanese male subjects: a randomized, three-way crossover study.
Ikeda, A; Irie, S; Ishikawa, T; Kimura, M; Matsuki, S; Nishino, N; Shiomi, M, 2014
)
0.4
"Nonionic surfactant vesicles (niosomes) were formulated with an aim of enhancing the oral bioavailability of tenofovir disoproxil fumarate (TDF), an anti-HIV drug."( Formulation and characterization of drug loaded nonionic surfactant vesicles (niosomes) for oral bioavailability enhancement.
Bala, S; Kamboj, S; Saini, V, 2014
)
0.4
"Due to the differences between bioavailability of efavirenz (EFV) and tenofovir (TDF), the single-tablet regimen of EFV/emtricitabine (FTC)/TDF is not approved as initial antiretroviral therapy (ART) in Europe by the European Medical Agency."( Safety and efficacy of coformulated efavirenz/emtricitabine/tenofovir single-tablet regimen in treatment-naive patients infected with HIV-1.
De Castro, N; Delaugerre, C; Flandre, P; Gallien, S; Molina, JM; Nguyen, N, 2015
)
0.42
" An adherence adjustment was included to account for nonadherence by explicitly modeling a bioavailability parameter on the previous day's dose."( Population pharmacokinetics of tenofovir and tenofovir-diphosphate in healthy women.
Burns, RN; Chaturvedula, A; Hendrix, CW, 2015
)
0.42
" Our case-series showed a transient and reversible decrease of TDF bioavailability one month after sleeve-gastrectomy without any consequences on CD4 cells and HIV viral load."( Tenofovir pharmacokinetic after sleeve-gastrectomy in four severely obese patients living with HIV.
Alvarez, JC; Carette, C; Czernichow, S; Gbedo, C; Muzard, L,
)
0.13
" This study investigated the differences in bioavailability between WHO-prequalified first-line antiretroviral generics by means of adjusted indirect comparisons to ensure interchangeability between these generics."( Interchangeability between first-line generic antiretroviral products prequalified by WHO using adjusted indirect comparisons.
García-Arieta, A; Gordon, J; Gwaza, L; Leufkens, H; Potthast, H; Stahl, M; Welink, J, 2017
)
0.46
" HA-SH-NFs significantly enhanced both TFV retention and bioavailability in vaginal tissue compared with the 1% TFV-gel."( Stimuli-sensitive thiolated hyaluronic acid based nanofibers: synthesis, preclinical safety and in vitro anti-HIV activity.
Agrahari, V; Christenson, LK; Dim, DC; Ezoulin, MJ; Hung, WT; Meng, J; Molteni, A; Youan, BC; Youm, I, 2016
)
0.43
" The in vivo studies also showed that both CBJ and GFJ enhanced the oral bioavailability of TDF as the AUC was increased by 24% and 97%, respectively."( Oral pharmacokinetic interaction of ester rich fruit juices and pharmaceutical excipients with tenofovir disoproxil fumarate in male Wistar rats.
Myneni, S; Ravi, PR; Saha, P; Shailender, J, 2017
)
0.46
"Tenofovir disoproxil fumarate (TDF), the bisphosphonate ester prodrug of tenofovir (TFV), has poor bioavailability due to intestinal degradation and efflux transport."( Development of a Novel Formulation That Improves Preclinical Bioavailability of Tenofovir Disoproxil Fumarate.
Domanico, PL; Lutz, L; Nowakowski, M; Park, S; Powell, K; Ramabhadran, R; Randolph, R; Watkins, ME; Wring, S, 2017
)
0.46
" In two open-label, single-dose, randomized, two-period, crossover trials, the bioavailability of doravirine administered alone or in a fixed-dose combination (FDC) was determined under fed and fasted conditions."( The Effect of Food on Doravirine Bioavailability: Results from Two Pharmacokinetic Studies in Healthy Subjects.
Behm, MO; Fackler, P; Levine, V; Liu, R; Panebianco, D; Yee, KL, 2017
)
0.46
" The versatile HA-PQ10 entrapped all drugs and achieved an enhanced relative bioavailability of EFV, TDF, and FTC compared to the market formulation for potentially enhanced HIV treatment."( 3D printed, controlled release, tritherapeutic tablet matrix for advanced anti-HIV-1 drug delivery.
Choonara, YE; du Toit, LC; Kondiah, PPPD; Kumar, P; Pillay, V; Siyawamwaya, M, 2019
)
0.51
" Lactobacillus crispatus actively transported tenofovir leading to a loss in drug bioavailability and culture supernatants from Gardnerella vaginalis, but not Atopobium vaginae, blocked tenofovir endocytosis."( Vaginal microbiome modulates topical antiretroviral drug pharmacokinetics.
Cameron, SA; Cheshenko, N; Frank, B; Fredricks, D; Herold, BC; Keller, MJ; Mesquita, PM; Reagle, K; Sinclair, S; Srinivasan, S; Taneva, E; Weinrick, B, 2018
)
0.48
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" BIC has demonstrated a high genetic barrier to resistance development in vitro, can be administered with or without food, and has a bioavailability of > 70%."( Bictegravir, a novel integrase inhibitor for the treatment of HIV infection.
Bhatia, R; Rizza, S; Temesgen, Z; Zeuli, J, 2019
)
0.51
" Proficient bioavailability coupled with no predicted in silico toxicity rendered them as prospective alternatives for designing and development of novel combinatorial therapy formulations for improving existing treatment regimes to combat COVID-19."( Computational drug re-purposing targeting the spike glycoprotein of SARS-CoV-2 as an effective strategy to neutralize COVID-19.
Banerjee, DI; Darji, SA; Lipsa Rath, S; Toor, HG, 2021
)
0.62
" Tenofovir has a very low oral bioavailability following oral administration."( Treatment of chronic hepatitis B: virological and pharmacological aspects
Foucault, T; Gaudy-Graffin, C; Handala, L; Marlet, J; Paintaud, G, 2022
)
0.72
" The latter was further converted to two orally bioavailable prodrug forms, TDF and TAF, and both TDF and TAF were further combined with other antiviral drugs, thus giving rise to a broad array of antiviral drug combinations for the treatment of HIV infections."( The Elegance of the Acyclic Nucleoside Phosphonates (ANPs), Honorary Tribute to Antonín Holý, Who Passed Away on 16 July 2012, at the 10th Anniversary of His Death.
De Clercq, E, 2022
)
0.72
"0 suggests that an increase in vaginal pH could improve TDF bioavailability at earlier time points."( Chitosan-poly(ethylene oxide) nanofibrous mat as a vaginal platform for tenofovir disoproxyl fumarate - The effect of vaginal pH on drug carrier performance.
Ciach, T; Dąbrowska, J; Krzyżowska, M; Nowicka, M; Szymańska, E; Winnicka, K; Wojasiński, M, 2022
)
0.72
"A crossover, randomized trial in healthy adults (NCT04244448) investigated the bioavailability of two off-label uses of BIC/TAF/FTC (50/200/25 mg), dissolved in water or crushed in apple compote, compared with the solid tablet."( Bioavailability of dissolved and crushed single tablets of bictegravir, emtricitabine, tenofovir alafenamide in healthy adults: the SOLUBIC randomized crossover study.
Alix, A; Bois, J; Brucato, S; Dargere, S; Fournel, F; Fournier, A; Got, L; Gregoire, N; Hocqueloux, L; Lefeuvre, S; McNicholl, I; Parienti, JJ; Peyro-Saint-Paul, L; Prazuck, T; Valentin, C, 2022
)
0.72

Dosage Studied

Tenofovir has emerged as a promising dosage form to prevent sexually transmitted HIV infections. With the exception of didanosine and atazanavir, which require dosage modifications, no clinically significant drug interactions have been observed with tenofovIR DF.

ExcerptRelevanceReference
" Within < or = 2 weeks of treatment, PMPA in both dosing regimens reduced SIV levels by >99% in the plasma or peripheral blood mononuclear cells; in some macaques SIV levels were reduced to below the lower quantitation limit."( Effects of (R)-9-(2-phosphonylmethoxypropyl)adenine monotherapy on chronic SIV infection in macaques.
Beck, TW; Bischofberger, N; Dailey, PJ; Follis, KE; Sabo, A; Tsai, CC, 1997
)
0.3
" All subjects tolerated dosing without significant adverse events."( Safety, pharmacokinetics, and antiretroviral activity of intravenous 9-[2-(R)-(Phosphonomethoxy)propyl]adenine, a novel anti-human immunodeficiency virus (HIV) therapy, in HIV-infected adults.
Barditch-Crovo, P; Cundy, KC; Deeks, SG; Hellmann, NS; Hwang, F; Kahn, JO; Lietman, PS; Rooney, JF; Safrin, S, 1998
)
0.3
" Variables that can be experimentally manipulated to address specific questions relevant to postexposure prophylaxis (PEP) include timing of initiation of treatment, duration of treatment, dosing regimen, virus strain, and virus inoculum."( Animal studies of prophylaxis.
Black, RJ, 1997
)
0.3
" Both prophylactic and therapeutic dosing regimens were effective."( Chemokines, nitric oxide and antiarthritic effects of 9-(2-phosphonomethoxyethyl)adenine (Adefovir).
Franková, D; Holý, A; Zídek, Z, 1999
)
0.3
" Advertising that promoted the improved drug has been withdrawn at the request of Project Inform because of the lack of warning labels necessary due to dosing problems."( Update on antivirals.
, 1997
)
0.3
" Information on tenofovir, such as the dosage normally prescribed and cost of treatment is listed."( What they say about: nucleotide drugs.
,
)
0.13
" The recommended dosage of tenofovir DF in adults is 300 mg/d PO; pharmacokinetic and efficacy studies in children are ongoing."( Tenofovir disoproxil fumarate: a nucleotide reverse transcriptase inhibitor for the treatment of HIV infection.
Fung, HB; Piacenti, FJ; Stone, EA, 2002
)
0.31
" The approved dosage of tenofovir is 300 mg (one tablet) once/day with meals."( Tenofovir: a nucleotide analog for the management of human immunodeficiency virus infection.
Antoniou, T; Park-Wyllie, LY; Tseng, AL, 2003
)
0.32
" The steady-state, geometric mean AUC for the 24-h dosing interval was 2,920 ng."( Single-dose and steady-state pharmacokinetics of tenofovir disoproxil fumarate in human immunodeficiency virus-infected children.
Balis, FM; Blanche, S; Bresson, JL; Coakley, DF; DeCarlo, E; Flaherty, JF; Hazra, R; Kearney, BP; Poblenz, M; Steinberg, SM; Tullio, AN; Worrell, CJ; Yale, K; Zeichner, SL; Zhong, L; Zuckerman, JA, 2004
)
0.32
" Plasma concentration of ddI was prospectively determined in eight of these patients receiving ddI 400 mg + TDF + NVP and 3 weeks after a ddI dosage reduction."( Unexpected CD4 cell count decline in patients receiving didanosine and tenofovir-based regimens despite undetectable viral load.
Burger, D; Clotet, B; Grassi, J; Juan, M; Masmitjà, E; Moltó, J; Negredo, E; Paredes, R; Pruvost, A; Puig, J; Ribera, E; Ruiz, L; Viciana, P, 2004
)
0.32
"Gilead Sciences is developing a fixed-dose co-formulation of two of its reverse transcriptase inhibitors, emtricitabine [Emtriva] and tenofovir disoproxil fumarate [Viread], for once-daily dosing in combination with other antiretrovirals for the treatment of HIV infection."( Emtricitabine/tenofovir disoproxil fumarate.
, 2004
)
0.32
" With the exception of didanosine and atazanavir, which require dosage modifications, no clinically significant drug interactions have been observed with tenofovir DF."( Tenofovir disoproxil fumarate: clinical pharmacology and pharmacokinetics.
Flaherty, JF; Kearney, BP; Shah, J, 2004
)
0.32
" Bioequivalence testing was conducted of total, R-, and S-methadone area under the serum or plasma concentration-time curve during the 24-hour dosing interval at steady state (AUCss) and maximum concentration in serum or plasma (Cmax)."( Effect of tenofovir disoproxil fumarate on the pharmacokinetics and pharmacodynamics of total, R-, and S-methadone.
Berenson, CS; Booker, BM; Bullock, JM; Cloen, D; Coakley, DF; Flaherty, JF; Haas, CE; Kearney, BP; Liaw, S; Smith, PF; Yale, K, 2004
)
0.32
" Didanosine was prescribed at a reduced dosage due to the known interaction with tenofovir."( Acute onset of pancreatitis with concomitant use of tenofovir and didanosine.
Fulco, PP; Higginson, RT; Kirian, MA, 2004
)
0.32
" Reduced didanosine dosage (250 mg) should be used to reduce serum didanosine concentrations and subsequent toxicities."( Acute onset of pancreatitis with concomitant use of tenofovir and didanosine.
Fulco, PP; Higginson, RT; Kirian, MA, 2004
)
0.32
" Tenofovir DF provides a simple and convenient once-daily dosage regimen, and is generally well tolerated and able to produce sustained suppression of viral replication."( Tenofovir disoproxil fumarate: a review of its use in the management of HIV infection.
Lyseng-Williamson, KA; Plosker, GL; Reynolds, NA, 2005
)
0.33
" To limit this interaction, the dosage of ddI may be reduced to 250 mg once daily when co-prescribed with TDF."( The durability of virological success of tenofovir and didanosine dosed at either 400 or 250 mg once daily.
Bower, M; Gazzard, B; Mandalia, S; Nelson, M; Tung, MY, 2005
)
0.33
" The relevance of a dosage adjustment based on BW/S(CR) should be further evaluated."( Population pharmacokinetics of tenofovir in human immunodeficiency virus-infected patients taking highly active antiretroviral therapy.
Dupin, N; Jaffray, P; Jullien, V; Krivine, A; Lescoat, A; Lillo-Le Louet, A; Moachon, L; Pons, G; Rey, E; Salmon, D; Tréluyer, JM; Urien, S, 2005
)
0.33
" When atazanavir 300 mg was coadministered with ritonavir 100 mg on a once-daily dosage regimen, atazanavir AUC from 0 to 24 hours and minimum plasma concentration were increased by 3- to 4-fold and approximately 10-fold, respectively, compared with atazanavir 300 mg alone."( Clinical pharmacokinetics and summary of efficacy and tolerability of atazanavir.
Barrail, A; Goujard, C; Le Tiec, C; Taburet, AM, 2005
)
0.33
" Tenofovir, nelfinavir, and M8 pharmacokinetics was unaltered when tenofovir and nelfinavir were coadministered, and tenofovir administration did not affect the M8/nelfinavir area under the concentration-versus-time curve over the dosing interval (AUC(tau)) ratio."( Lack of pharmacokinetic drug interaction between tenofovir disoproxil fumarate and nelfinavir mesylate.
Boffito, M; Higgs, C; Kearney, BP; Mathias, A; Pozniak, A; Shah, J; Zhong, L, 2005
)
0.33
"Antiretroviral combinations that reduce the number of pills and dosing frequency have the potential to simplify therapy."( Early virologic nonresponse to tenofovir, abacavir, and lamivudine in HIV-infected antiretroviral-naive subjects.
Berger, DS; Gallant, JE; Johnson, J; Liao, Q; Lim, ML; Rodriguez, AE; Ross, L; Shaefer, MS; Weinberg, WG; Young, B, 2005
)
0.33
" When 400 mg was dosed with tenofovir DF, mean didanosine AUC was increased by 44% to 60% following fasted or fed administration."( Drug-drug and drug-food interactions between tenofovir disoproxil fumarate and didanosine.
Chen, SS; Cheng, AK; Flaherty, JF; Kaul, S; Kearney, BP; Sayre, JR, 2005
)
0.33
" We designed this study to provide preliminary pediatric safety and dosing information on tenofovir DF, while also providing potentially efficacious salvage therapy for heavily treatment-experienced, HIV-infected children."( Tenofovir disoproxil fumarate and an optimized background regimen of antiretroviral agents as salvage therapy for pediatric HIV infection.
Balis, FM; DeCarlo, E; Flaherty, J; Gafni, RI; Hazra, R; Kearney, BP; Maldarelli, F; Steinberg, SM; Tullio, AN; Worrell, CJ; Yale, K; Zeichner, SL, 2005
)
0.33
" Blood samples for tenofovir (TFV) and SQV/RTV PK were drawn over respective 24- and 12-h dosing intervals, and drug concentrations were measured by liquid chromatography-tandem mass spectrometry."( Pharmacokinetics of tenofovir disoproxil fumarate and ritonavir-boosted saquinavir mesylate administered alone or in combination at steady state.
Adda, N; Begley, JA; Blum, MR; Chittick, GE; Kearney, BP; Sorbel, JJ; Zong, J, 2006
)
0.33
"Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are nucleoside reverse transcriptase inhibitors (NRTIs) with once-daily dosing approved for use in HIV-1 infection."( In vitro evaluation of the anti-HIV activity and metabolic interactions of tenofovir and emtricitabine.
Borroto-Esoda, K; Miller, MD; Myrick, F; Ray, AS; Vela, JE, 2006
)
0.33
" However, early HAART often consisted of drugs with complex dosing schedules, strict food requirements, treatment-limiting adverse effects, and the need to take 16-20 pills/day."( An update and review of antiretroviral therapy.
Piacenti, FJ, 2006
)
0.33
" The single daily dosing was expected to improve adherence to treatment."( Change to a once-daily combination including boosted atazanavir in HIV-1-infected children.
Blanche, S; Delaugerre, C; Jullien, V; Macassa, E; Rouzioux, C; Teglas, JP; Tréluyer, JM; Veber, F, 2006
)
0.33
" Tenofovir requires surveillance of glomerular filtration rate and dosing interval adjustment when creatinine clearance is less than 50 ml/min and avoidance less than 30 ml/min."( Tenofovir disoproxil fumarate-emtricitabine coformulation for once-daily dual NRTI backbone.
Arribas López, JR; Muñoz de Benito, RM, 2006
)
0.33
"As expected for a renally eliminated drug, subjects with and without hepatic impairment displayed similar tenofovir systemic exposures without evidence of substantial alterations in drug disposition, and therefore no dosage adjustments were warranted in these patients."( Pharmacokinetics and dosing recommendations of tenofovir disoproxil fumarate in hepatic or renal impairment.
Flaherty, JF; Kearney, BP; Shah, J; Yale, K; Zhong, L, 2006
)
0.33
"Tenofovir measurements with an area under the concentration-time curve over the dosing interval, maximum concentration, and concentration at the end of the dosing interval (Ctau) were 32%, 15%, and 51% higher, respectively, when TDF was coadministered with LPV/r (n = 24)."( Pharmacokinetics and safety of tenofovir disoproxil fumarate on coadministration with lopinavir/ritonavir.
Cheng, AK; Ebrahimi, R; Kearney, BP; Mathias, A; Mittan, A; Sayre, J, 2006
)
0.33
" Individually, these agents have long half-lifes that allow for once-daily dosing and may provide a pharmacologic bridge for the occasional missed dose."( Efavirenz/emtricitabine/tenofovir disoproxil fumarate fixed-dose combination: first-line therapy for all?
Best, B; Goicoechea, M, 2007
)
0.34
" Tenofovir is largely prescribed at the standard dosage of 300 mg once daily: therefore, the per kilogram dose is higher in Thailand than in the USA."( No change in calculated creatinine clearance after tenofovir initiation among Thai patients.
Ananworanich, J; Chetchotisakd, P; Gayet-Ageron, A; Hirschel, B; Jupimai, T; Le Braz, M; Prasithsirikul, W; Rooney, JF; Ruxrungtham, K; Ubolyam, S, 2007
)
0.34
" Tenofovir could be safely prescribed at a standard dosage of 300 mg once daily in the Thai population."( No change in calculated creatinine clearance after tenofovir initiation among Thai patients.
Ananworanich, J; Chetchotisakd, P; Gayet-Ageron, A; Hirschel, B; Jupimai, T; Le Braz, M; Prasithsirikul, W; Rooney, JF; Ruxrungtham, K; Ubolyam, S, 2007
)
0.34
" Lack of PK alteration for FTC, tenofovir (TFV), and GS-9137 was defined as a 90% confidence interval (CI) for the estimated ratio of geometric least squares means (coadministration/alone) between 70% and 143% for the primary PK parameters: maximum observed plasma concentration (Cmax), area under the plasma concentration-time curve over dosing interval (AUCtau), and trough concentration (Ctau)."( Pharmacokinetics of emtricitabine, tenofovir, and GS-9137 following coadministration of emtricitabine/tenofovir disoproxil fumarate and ritonavir-boosted GS-9137.
Cheng, A; Kearney, BP; Ramanathan, S; Shen, G, 2007
)
0.34
" We investigated whether tenofovir plus didanosine at a weight-adjusted dosage could be responsible for such an effect, and factors associated with CD4 + T cell count evolution under this combination."( CD4+ T cell evolution and predictors of its trend before and after tenofovir/didanosine backbone in the presence of sustained undetectable HIV plasma viral load.
Antinori, A; Antonucci, F; Barreiro, P; Carosi, G; De Silvestri, A; El Hamad, I; Ladisa, N; Lapadula, G; Maggiolo, F; Mandalia, S; Maserati, R; Migliorino, G; Pierotti, P; Sighinolfi, L; Soriano, V; Suter, F; Torti, C, 2007
)
0.34
" This study evaluated the pharmacokinetics (PK) and bioequivalence of an investigational coformulation of EFV/FTC/TDF (test) single-tablet regimen compared with the commercially available individual dosage forms (EFV+FTC+TDF; reference treatment) in healthy subjects."( Bioequivalence of efavirenz/emtricitabine/tenofovir disoproxil fumarate single-tablet regimen.
Hinkle, J; Hui, J; Kaul, S; Kearney, BP; Mathias, AA; Menning, M, 2007
)
0.34
" Group 1 was treated subcutaneously with a human-equivalent dose of emtricitabine (FTC), group 2 received orally the human-equivalent dosing of both FTC and tenofovir-disoproxil fumarate (TDF), and group 3 received subcutaneously a similar dosing of FTC and a higher dose of tenofovir."( Prevention of rectal SHIV transmission in macaques by daily or intermittent prophylaxis with emtricitabine and tenofovir.
Adams, DR; Cong, ME; Delinsky, D; Folks, TM; García-Lerma, JG; Heneine, W; Jackson, E; Janssen, R; Johnson, JA; Kim, C; Lipscomb, J; Luo, W; Masciotra, S; Monsour, M; Otten, RA; Qari, SH; Schinazi, RF, 2008
)
0.35
" The likelihood of renal toxicity (proximal renal tubular dysfunction [PRTD]) correlated with plasma drug concentrations, which depended on the dosage regimen and age-related changes in drug clearance."( Chronic administration of tenofovir to rhesus macaques from infancy through adulthood and pregnancy: summary of pharmacokinetics and biological and virological effects.
Abel, K; Bischofberger, N; Brignolo, LL; Cihlar, T; Durand-Gasselin, L; Jerome, C; Kearney, BP; Marthas, ML; Moore, J; Ray, AS; Reiser, H; Spinner, A; Van Rompay, KK, 2008
)
0.35
" Pharmacokinetic profiles were also determined in HIV-1-infected patients dosed with raltegravir monotherapy versus raltegravir in combination with TDF and lamivudine."( Lack of a significant drug interaction between raltegravir and tenofovir.
Breidinger, SA; Chen, J; Friedman, EJ; Gottesdiener, KM; Iwamoto, M; Kost, JT; Lasseter, KC; Stek, JE; Stone, JA; Teppler, H; Wagner, JA; Wenning, LA, 2008
)
0.35
" Tenofovir concentrations (median 2; range, 1-5) were measured in 175 patients during several dosing intervals."( Population pharmacokinetics of tenofovir in AIDS patients.
Barkil, ME; Boibieux, A; Cotte, L; Gagnieu, MC; Guitton, J; Livrozet, JM; Miailhes, P; Tod, M, 2008
)
0.35
" When implementing HAART, physicians should be aware of and monitor potential patient misunderstanding of instructions on dosage and administration and for possible complications in medicinal combinations and potential side effects."( [A case of acute renal failure involving high amounts of tenofovir after HAART start].
Kasahara, K; Konishi, M; Maeda, K; Mikasa, K; Nakagawa, C; Uno, K; Yonekawa, S; Yoshimoto, E, 2008
)
0.35
" The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation <2%), while being simple, cheap and less time consuming and can be suitably applied for the estimation of tenofovir disoproxil fumarate in different dosage forms."( Application of UV-spectrophotometric methods for estimation of tenofovir disoproxil fumarate in tablets.
A, SA; H, BC; J, SS, 2009
)
0.35
" Because of this latter characteristic, dosage adjustments are required in patients with renal insufficiency."( [Tenofovir: pharmacology and interactions].
Azanza, JR; García Quetglas, E; Gómez-Giu, A; Sádaba, B, 2008
)
0.35
" The only available formulation is an adult tablet, introducing the possibility of dosing errors in children."( Tenofovir use in human immunodeficiency virus-1-infected children in the United kingdom and Ireland.
Boyd, K; Butler, K; Cliff, D; Doerholt, K; Gibb, D; Judd, A; Lyall, H; Menson, E; Riordan, A, 2009
)
0.35
" Statistical analyses were performed on pharmacokinetic parameters: the area under the concentration-time curve from 0 to 4 h (AUC(0-4)), the maximum concentration of the drug (C(max)), and the residual concentration of the drug at the end of the dosing interval (C(trough)) for plasma and the AUC(0-4) and C(trough) for intracellular data."( Pilot pharmacokinetic study of human immunodeficiency virus-infected patients receiving tenofovir disoproxil fumarate (TDF): investigation of systemic and intracellular interactions between TDF and abacavir, lamivudine, or lopinavir-ritonavir.
Ayen, R; Clotet, B; Grassi, J; Levi, M; Negredo, E; Pruvost, A; Puig, J; Théodoro, F, 2009
)
0.35
" A new combination therapy consisting of the TFV pro-drug (300 mg) and another reverse transcriptase inhibitor, emtricitabine (FTC, 200 mg) has become available in a convenient once-daily dosage form (Truvada)."( The simultaneous assay of tenofovir and emtricitabine in plasma using LC/MS/MS and isotopically labeled internal standards.
Bushman, L; Delahunty, T; Fletcher, CV; Robbins, B, 2009
)
0.35
" We report 12-month changes in renal profiles among 19 such patients (6 patients with history of and 13 patients with current renal disease) in the HIV Outpatient Study (HOPS) who initiated TDF-containing highly active antiretroviral therapy (HAART) during 2001-2005 with TDF dosed mostly at 300 mg once daily."( Renal function in patients with preexisting renal disease receiving tenofovir-containing highly active antiretroviral therapy in the HIV outpatient study.
Brooks, JT; Buchacz, K; Moorman, A; Wood, KC; Young, B, 2009
)
0.35
"Tenofovir DF and norgestimate-ethinyl estradiol are not involved in a clinically significant drug-drug interaction; tenofovir DF did not affect the steady-state pharmacokinetics of norgestimate or ethinyl estradiol, including the concentration at the end of the dosing interval."( Lack of effect of tenofovir disoproxil fumarate on pharmacokinetics of hormonal contraceptives.
Kearney, BP; Mathias, A, 2009
)
0.35
"Once-daily treatment with ritonavir-boosted saquinavir was well tolerated and resulted in similar saquinavir drug exposure despite much lower ritonavir concentrations when compared with a twice-daily dosing schedule."( Once-daily treatment with saquinavir mesylate (2000 mg) and ritonavir (100 mg) together with a fixed-dose combination of abacavir/lamivudine (600/300 mg) or tenofovir/emtricitabine (245/200 mg) in HIV-1-infected patients.
Bickel, M; Bodtländer, A; Gute, P; Klauke, S; Knecht, GK; Kurowski, M; Lutz, T; Stephan, C; von Hentig, N, 2009
)
0.35
" Its favorable profile in terms of high efficacy, low toxicity and once-daily dosing makes TDF one of the most attractive antiretroviral agents, and therefore, it is widely used."( Pharmacogenetics of tenofovir treatment.
Labarga, P; Rodriguez-Novoa, S; Soriano, V, 2009
)
0.35
" No differences were noted in adverse events among dosing periods."( Steady-state amprenavir and tenofovir pharmacokinetics after coadministration of unboosted or ritonavir-boosted fosamprenavir with tenofovir disoproxil fumarate in healthy volunteers.
Andrews, M; Condoluci, DV; Luber, AD; Olson, K; Pakes, GE; Pappa, KA; Peloquin, CA; Slowinski, PD, 2010
)
0.36
" We investigated the relationship of NVP dosing with safety and efficacy."( Safety and efficacy of once-daily nevirapine dosing: a multicohort study.
Battegay, M; Calmy, A; de Wolf, F; Hirschel, B; Hogg, RS; Lange, JM; Lima, VD; Montaner, JS; Nguyen, A; Reiss, P; Vallier, N; Wit, FW; Yip, B, 2009
)
0.35
" Daily drug dosage was 300 mg Tenofovir, 200mg Emtricitabine and 400 mg Nevirapine once daily."( Long-term efficacy and safety of once-daily nevirapine in combination with tenofovir and emtricitabine in the treatment of HIV-infected patients: a 72-week prospective multicenter study (TENOR-trial).
Flux, K; Gholam, P; Hartmann, M; Hueter, E; Weberschock, T, 2009
)
0.35
" We hypothesized that intermittent prophylactic treatment with long-acting antiviral drugs would be as effective as daily dosing in blocking the earliest stages of viral replication and preventing mucosal transmission."( Intermittent prophylaxis with oral truvada protects macaques from rectal SHIV infection.
Barr, JR; Cong, ME; Folks, TM; García-Lerma, JG; Hanson, DL; Heneine, W; Holder, A; Kuklenyik, Z; Lipscomb, J; Martin, A; Masciotra, S; Mitchell, J; Otten, R; Pau, CP; Paxton, L; Youngpairoj, AS; Zheng, Q, 2010
)
0.36
" Following oral dosing (3mg/kg) in Beagle dogs, high levels (>9."( Discovery of GS-9131: Design, synthesis and optimization of amidate prodrugs of the novel nucleoside phosphonate HIV reverse transcriptase (RT) inhibitor GS-9148.
Birkus, G; Boojamra, CG; Cihlar, T; Desai, MC; Douglas, JL; Gao, Y; Grant, D; Hui, HC; Laflamme, G; Lin, KY; Mackman, RL; Markevitch, DY; McDermott, M; Mishra, R; Pakdaman, R; Petrakovsky, OV; Ray, AS; Vela, JE; Zhang, L, 2010
)
0.36
" Irrespective of the dosing strategy used, the rsIL-7gly administration transiently increased proliferation of both central memory and naive cells, in both CD4(+) and CD8(+) subsets, without increasing SIV levels in the blood."( Increased CD4+ T cell levels during IL-7 administration of antiretroviral therapy-treated simian immunodeficiency virus-positive macaques are not dependent on strong proliferative responses.
Assouline, B; Axthelm, MK; Legasse, A; Leone, A; Lifson, JD; Morre, M; Okoye, A; Piatak, M; Picker, LJ; Rohankhedkar, M; Sodora, DL; Villinger, F, 2010
)
0.36
" Emergence of postbaseline resistance mutations occurred at similar low rates in each dosing group."( Short communication: Comparable safety and efficacy with once-daily versus twice-daily dosing of lopinavir/ritonavir tablets with emtricitabine + tenofovir DF in antiretroviral-naïve, HIV type 1-infected subjects: 96 week final results of the randomized t
Bernstein, B; Cohen, D; da Silva, B; Fredrick, L; González-García, J; Johnson, M; Naylor, C; Sloan, L, 2010
)
0.36
" Relative to ritonavir-boosted EVG, the geometric least-squares means ratios (GMR) [90% confidence interval (CI)] for EVG area under plasma concentration-time curve from time zero until the end of the dosing interval (AUC)tau, maximum concentration (Cmax), and trough concentration (Ctau) were 118 (110 to 126), 108 (100 to 116), and 110 (95."( Pharmacokinetics and bioavailability of an integrase and novel pharmacoenhancer-containing single-tablet fixed-dose combination regimen for the treatment of HIV.
German, P; Hui, J; Kearney, BP; Warren, D; West, S, 2010
)
0.36
"Addition of darunavir/ritonavir to etravirine, all dosed once daily, did not have a clinically significant effect on the pharmacokinetics of etravirine."( Pharmacokinetics of once-daily etravirine without and with once-daily darunavir/ritonavir in antiretroviral-naive HIV type-1-infected adults.
DeJesus, E; Kakuda, TN; Lalezari, JP; Osiyemi, OO; Ruane, PJ; Ryan, R; Witek, J, 2010
)
0.36
" This review identifies important cellular pharmacology considerations for tenofovir and emtricitabine, which include drug penetration into relevant tissues and cell types, race/ethnicity/pharmacogenetics, gender, cellular activation state and appropriate episodic or alternative dosing strategies based on pharmacokinetic principles."( Pharmacological considerations for tenofovir and emtricitabine to prevent HIV infection.
Anderson, PL; Gardner, EM; Grant, RM; Kiser, JJ; Meditz, A; Rower, JE, 2011
)
0.37
" Healthy volunteer studies have demonstrated a decrease in glucose disposal associated with dosing with specific antiretrovirals."( Effect of boosted fosamprenavir or lopinavir-based combinations on whole-body insulin sensitivity and lipids in treatment-naive HIV-type-1-positive men.
Back, DJ; Boffito, M; Jackson, AG; Mandalia, S; Moyle, GJ; Randell, PA; Taylor, J; Tjia, JF, 2010
)
0.36
" Dosing was separated by a wash-out period of 14 days."( Bioequivalence study of two oral tablet formulations containing tenofovir disoproxil fumarate in healthy volunteers.
Feleder, EC; Halabe, EK; Yerino, GA; Zini, E, 2011
)
0.37
" Decreases in estimated glomerular filtration rate occurred within the first few weeks of dosing in participants receiving EVG/COBI/FTC/TDF, remained within the normal range and did not progress at week 24 or 48; no participant experienced a clinical adverse event or discontinued study drug due to changes in serum creatinine or renal function."( Randomized, phase 2 evaluation of two single-tablet regimens elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection.
Chuck, SL; Cohen, C; DeJesus, E; Elion, R; Kearney, BP; Liu, HC; Ramanathan, S; Rashbaum, B; Ruane, P; Shamblaw, D; Warren, DR; Yale, K, 2011
)
0.37
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."( FDA-approved drug labeling for the study of drug-induced liver injury.
Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011
)
0.37
" Dosage of 200 mg might provide an option to patients showing suboptimal ATV exposure with standard unboosted dosing."( Pharmacokinetics of switching unboosted atazanavir coadministered with tenofovir disoproxil fumarate from 400 mg once daily to 200 mg twice daily in HIV-positive patients.
Baietto, L; Bonora, S; Calcagno, A; D'Avolio, A; Di Perri, G; Gonzalez de Requena, D; Siccardi, M; Simiele, M; Tettoni, M; Trentini, L, 2011
)
0.37
" Dosing scheme, according BW and LPV/r coadministration were simulated to produce the same 24-hr exposure as adults after 300-mg TDF dose."( Population pharmacokinetics of tenofovir in HIV-1-infected pediatric patients.
Benaboud, S; Blanche, S; Bouazza, N; Foissac, F; Frange, P; Hirt, D; Rey, E; Tréluyer, JM; Urien, S, 2011
)
0.37
"Children without LPV/r should receive: 150 mg TDF from 20 to 30 kg, 225 mg TDF from 30 to 40 kg, and the adult dosage of 300 mg TDF over 40 kg."( Population pharmacokinetics of tenofovir in HIV-1-infected pediatric patients.
Benaboud, S; Blanche, S; Bouazza, N; Foissac, F; Frange, P; Hirt, D; Rey, E; Tréluyer, JM; Urien, S, 2011
)
0.37
" Low concentrations at birth support infant dosing as soon after birth as possible."( Pharmacokinetics and safety of single-dose tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their infants.
Bardeguez, A; Cotter, A; Fiscus, SA; Flynn, PM; Heckman, B; Huang, S; Jean-Philippe, P; Kearney, B; Mirochnick, M; Mofenson, LM; Purswani, M; Robbins, B; Rodman, J; Rooney, JF; Shapiro, DE; Thorpe, E; Van Rompay, KK; Watts, DH, 2011
)
0.37
" At all doses, concentrations at the dosing site were typically 1 to 2 log units higher than those in the opposite compartment and 4 to 5 log units higher than those in plasma."( Pharmacokinetics of tenofovir following intravaginal and intrarectal administration of tenofovir gel to rhesus macaques.
Allen, P; Kashuba, A; Nuttall, J; Roberts, J; Romano, J; Wang, R; White, N, 2012
)
0.38
" Forty-seven were randomized to once (QD) or twice daily (BID) dosing for 2 weeks and to collection of genital tract samples at 4, 8 or 24 hrs after the final dose, but two discontinued prior to gel application."( A multi-compartment, single and multiple dose pharmacokinetic study of the vaginal candidate microbicide 1% tenofovir gel.
Brache, V; Creinin, MD; Kashuba, AD; Kearney, BP; Poindexter, A; Rountree, W; Schwartz, JL, 2011
)
0.37
" Despite continued gel dosing postinfection, neither breakthrough infection had evidence of drug resistance by ultrasensitive testing of SHIV in plasma and vaginal lavage."( Durable protection from vaginal simian-human immunodeficiency virus infection in macaques by tenofovir gel and its relationship to drug levels in tissue.
Dobard, C; García-Lerma, JG; Hanson, DL; Heneine, W; Holder, A; Kuklenyik, Z; Lipscomb, J; Martin, A; Novembre, FJ; Pau, CP; Sharma, S; Smith, J, 2012
)
0.38
"Atazanavir geometric mean (CV%) C(max), C(min) and AUC over the dosing interval were 2897 (46) ng/mL, 526 (57) ng/mL and 28 605 (46) ng · h/mL, respectively, and for lopinavir they were 10 655 (51) ng/mL, 5944 (68) ng/mL and 90 946 (59) ng · h/mL, respectively."( Pharmacokinetics and inhibitory quotient of atazanavir/ritonavir versus lopinavir/ritonavir in HIV-infected, treatment-naive patients who participated in the CASTLE Study.
Bertz, R; Child, M; Eley, T; Farajallah, A; Krystal, M; Liao, S; McGrath, D; Molina, JM; Persson, A; Sevinsky, H; Xu, X; Zhang, J; Zhu, L, 2012
)
0.38
" Dosing antiretroviral agents with kidney metabolism should be adjusted when eGFR is bellow 50 mL/min/1."( [Kidney and HIV infection].
Lescure, FX; Plaisier, E; Ronco, P, 2012
)
0.38
" Dosing strategies (e."( Formulation, pharmacokinetics and pharmacodynamics of topical microbicides.
Adams, JL; Kashuba, AD, 2012
)
0.38
" Although some trial results appear conflicting, behavioral factors, adherence to dosing and pharmacokinetic properties of the different tenofovir formulations and dosing approaches offer plausible explanations for most of the variations in effectiveness observed in different trials."( A drug evaluation of 1% tenofovir gel and tenofovir disoproxil fumarate tablets for the prevention of HIV infection.
Abdool Karim, SS; Baxter, C; Gengiah, TN; Kharsany, AB; Mansoor, LE, 2012
)
0.38
" Median TFV concentrations in iliac lymph nodes ranged from 44 ng/g to 196 ng/g; differences between iliac lymph node TFV concentrations following dosing of the two gels were insignificant."( Pharmacokinetics and topical vaginal effects of two tenofovir gels in rabbits.
Clark, MR; Friend, DR, 2012
)
0.38
" Raltegravir must be dosed twice daily, as once daily raltegravir displays decreased virologic efficacy compared to twice daily dosing."( Role of raltegravir in HIV-1 management.
Bookstaver, PB; Bryant, JE; Millisor, VE; Rokas, KE; Shamroe, CL; Sutton, SS; Weissman, SB, 2012
)
0.38
"Little is known about safety of and adherence to intermittent HIV PrEP regimens, which may be more feasible than daily dosing in some settings."( Safety and adherence to intermittent pre-exposure prophylaxis (PrEP) for HIV-1 in African men who have sex with men and female sex workers.
Anzala, O; Bangsberg, D; Barin, B; Chetty, P; Fast, P; Haberer, JE; Mark, D; Mugo, P; Mutua, G; Priddy, FH; Rooney, JF; Sanders, E, 2012
)
0.38
"Adherence to intermittent dosing regimens, fixed doses, and in particular coitally-dependent doses, may be more difficult than adherence to daily dosing."( Safety and adherence to intermittent pre-exposure prophylaxis (PrEP) for HIV-1 in African men who have sex with men and female sex workers.
Anzala, O; Bangsberg, D; Barin, B; Chetty, P; Fast, P; Haberer, JE; Mark, D; Mugo, P; Mutua, G; Priddy, FH; Rooney, JF; Sanders, E, 2012
)
0.38
" Adherence by type of ART and dosing frequency were compared by Brown-Mood median tests."( Impact of antiretroviral dosing frequency and pill burden on adherence among newly diagnosed, antiretroviral-naive HIV patients.
Buscher, A; Giordano, TP; Hartman, C; Kallen, MA, 2012
)
0.38
" The use of SF and PK-PD disease models can be a valuable tool to predict dose-response of NMEs and support rational dose selection for monotherapy trials."( From in vitro EC₅₀ to in vivo dose-response for antiretrovirals using an HIV disease model. Part I: a framework.
Fang, J; Jadhav, PR, 2012
)
0.38
" We developed a pharmacokinetic model for TDF and its active anabolite tenofovir-diphosphate (TFV-DP) and validated it with data from 4 different trials, including 4 distinct dosing regimes."( Pharmacokinetics and pharmacodynamics of the reverse transcriptase inhibitor tenofovir and prophylactic efficacy against HIV-1 infection.
Duwal, S; Schütte, C; von Kleist, M, 2012
)
0.38
" Optimal PrEP agents and dosing regimens now need to be identified."( Considerations regarding antiretroviral chemoprophylaxis in MSM.
Grulich, AE; Poynten, IM; Zablotska, I, 2012
)
0.38
"The Microbicide Trials Network 003 study, a large phase IIb trial, was unable to show that daily dosing with 1% tenofovir vaginal gel was effective for HIV prevention."( Current status of topical antiretroviral chemoprophylaxis.
Szpir, M; Van Damme, L, 2012
)
0.38
" Phase II and III trials continue to explore different dosing strategies for topical products that contain one or more ARV agents."( Current status of topical antiretroviral chemoprophylaxis.
Szpir, M; Van Damme, L, 2012
)
0.38
" Dosing was discontinued on day 30 and blood was collected on days 35, 45, and 60 during the washout period."( Tenofovir, emtricitabine, and tenofovir diphosphate in dried blood spots for determining recent and cumulative drug exposure.
Anderson, PL; Bushman, LR; Castillo-Mancilla, JR; Fernandez, C; Gardner, EM; Kiser, JJ; Langness, J; Meditz, A; Predhomme, J; Rower, JE; Zheng, JH, 2013
)
0.39
" We conclude that rectal dosing with TFV 1% gel resulted in greater TFV-DP tissue detection than oral dosing with reduced ex vivo biopsy infectibility, enabling PK-PD correlations."( RMP-02/MTN-006: A phase 1 rectal safety, acceptability, pharmacokinetic, and pharmacodynamic study of tenofovir 1% gel compared with oral tenofovir disoproxil fumarate.
Anton, PA; Bumpus, NN; Carballo-Diéguez, A; Cranston, RD; Cumberland, WG; Dennis, R; Elliott, J; Hendrix, CW; Janocko, L; Ju, C; Kashuba, A; Khanukhova, E; Mauck, C; McGowan, I; Richardson-Harman, N, 2012
)
0.38
" Vaginal dosing achieves measurable tenofovir concentrations in the rectum and vice versa."( The clinical pharmacology of antiretrovirals for HIV prevention.
Hendrix, CW, 2012
)
0.38
" Directly observed dosing in a separate study, the STRAND trial, yielded TFV-DP concentrations that, when analyzed according to the iPrEx model, corresponded to an HIV-1 risk reduction of 76% for two doses per week, 96% for four doses per week, and 99% for seven doses per week."( Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men.
Anderson, PL; Bekker, LG; Buchbinder, S; Bushman, LR; Casapía, M; Chariyalertsak, S; Glidden, DV; Grant, RM; Guanira, JV; Kallás, EG; Lama, JR; Liu, A; Mayer, KH; McMahan, V; Montoya-Herrera, O; Schechter, M; Veloso, VG, 2012
)
0.38
" This is the first vaginal dosage form to provide sustained delivery of milligram quantities of TFV for 90 days."( Quantitative evaluation of a hydrophilic matrix intravaginal ring for the sustained delivery of tenofovir.
Clark, JT; Clark, MR; Fabian, J; Friend, DR; Johnson, TJ; Kiser, PF; Nebeker, JS; Ponnapalli, S; Smith, EM; Tuitupou, AL, 2012
)
0.38
"These data demonstrate that children and adolescents receiving standard TDF dosing of 300 mg once daily achieve higher intracellular TFV-DP concentrations than adults, despite lower plasma TFV concentrations."( Age-related differences in plasma and intracellular tenofovir concentrations in HIV-1-infected children, adolescents and adults.
Acosta, EP; Baheti, G; Fletcher, CV; King, JR, 2013
)
0.39
" Use of exact dosing data halved unexplained variability in ATV clearance."( Effect of adherence as measured by MEMS, ritonavir boosting, and CYP3A5 genotype on atazanavir pharmacokinetics in treatment-naive HIV-infected patients.
Barrail-Tran, A; Descamps, D; Duval, X; Goujard, C; Mentré, F; Nembot, G; Panhard, X; Savic, RM; Taburet, AM; Verstuyft, C; Vrijens, B, 2012
)
0.38
" Model-predicated area under the concentration-time curve during the dosing interval (AUC(τ)) and exposure ratios of CVF AUC(τ):BP AUC(τ) were calculated for each drug."( Pharmacokinetic modelling of efavirenz, atazanavir, lamivudine and tenofovir in the female genital tract of HIV-infected pre-menopausal women.
Cohen, MS; Dumond, JB; Forrest, A; Garonzik, SM; Kashuba, AD; Kendrick, RN; Nicol, MR; Patterson, KB, 2012
)
0.38
" Through dose-response experiments, we established relative inhibitory potencies of NRTIs on in vitro telomerase activity as compared to the inhibitory potencies of the corresponding dideoxynucleotide triphosphates."( In vitro and ex vivo inhibition of human telomerase by anti-HIV nucleoside reverse transcriptase inhibitors (NRTIs) but not by non-NRTIs.
Côté, HC; Hukezalie, KR; Thumati, NR; Wong, JM, 2012
)
0.38
" Drug concentrations at two trough values of 12 and 24 h after dosing (C(12) and C(24)), area under the concentration-curve values (AUC), maximum drug concentration (C(max)), and the time at which this concentration occurred (T(max)) in plasma were estimated with noncompartmental pharmacokinetic methods and compared to data from a subset of white subjects randomized to the RAL twice a day (plus TDF/FTC) arm of the QDMRK study, a phase III study of the safety and efficacy of once daily versus twice daily RAL in treatment naive patients."( Raltegravir pharmacokinetics in treatment-naive patients is not influenced by race: results from the raltegravir early therapy in African-Americans living with HIV (REAL) study.
Blevins, S; Dumond, JB; Eron, JJ; Floris-Moore, M; Hudgens, MG; Kashuba, AD; Massengale, K; Pittard, D; Ragan, D; Richardson, A; Walsh, K; Wang, R; Wohl, DA, 2013
)
0.39
"Phase 0 studies can provide initial pharmacokinetics (PKs) data in humans and help to facilitate early drug development, but their predictive value for standard dosing is controversial."( Biphasic elimination of tenofovir diphosphate and nonlinear pharmacokinetics of zidovudine triphosphate in a microdosing study.
Chen, J; Flexner, C; Fuchs, EJ; Hendrix, CW; Liberman, RG; Louissaint, NA; Skipper, PL; Tannenbaum, SR, 2012
)
0.38
" Serum concentrations after vaginal dosing were 56-fold lower than after oral dosing (p<0."( MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments.
Bumpus, NN; Chen, BA; Gandham, S; Gomez, K; Guddera, V; Hendrix, CW; Hoesley, C; Justman, J; Minnis, AM; Nakabiito, C; Patterson, K; Richardson, BA; Salata, R; Soto-Torres, L, 2013
)
0.39
"Compared to oral dosing, vaginal dosing achieved much lower serum concentrations and much higher vaginal tissue concentrations."( MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments.
Bumpus, NN; Chen, BA; Gandham, S; Gomez, K; Guddera, V; Hendrix, CW; Hoesley, C; Justman, J; Minnis, AM; Nakabiito, C; Patterson, K; Richardson, BA; Salata, R; Soto-Torres, L, 2013
)
0.39
" Blood plasma (for TFV, FTC, EFV, ATV and RTV concentrations) and peripheral blood mononuclear cells [PBMCs; for tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) concentrations] were collected at 11 time-points over a 24-hour dosing interval."( Pharmacokinetics of two common antiretroviral regimens in older HIV-infected patients: a pilot study.
Adams, JL; Corbett, AH; Dumond, JB; Forrest, A; Jennings, SH; Kashuba, AD; Kendrick, RL; Malone, S; Patterson, KB; Prince, HM; Sykes, C; Wang, R; White, N, 2013
)
0.39
" The MEMS-defined adherence for correct dosing (-0."( Adherence profiles and therapeutic responses of treatment-naive HIV-infected patients starting boosted atazanavir-based therapy in the ANRS 134-COPHAR 3 trial.
Barrail-Tran, A; Descamps, D; Duval, X; Goujard, C; Mentré, F; Nembot, G; Panhard, X; Parienti, JJ; Taburet, AM; Vigan, M; Vrijens, B, 2013
)
0.39
"HIV seroconversion outcomes in preexposure prophylaxis (PrEP) trials of oral tenofovir (TFV)-containing regimens are highly sensitive to drug concentration, yet less-than-daily dosing regimens are under study."( Single dose pharmacokinetics of oral tenofovir in plasma, peripheral blood mononuclear cells, colonic tissue, and vaginal tissue.
Anderson, JR; Bakshi, R; Cao, YJ; Everts, S; Fuchs, EJ; Hendrix, CW; Liberman, RG; Louissaint, NA; Nimmagadda, S; Skipper, PL; Tannenbaum, SR, 2013
)
0.39
"Possible designs for a PrEP phase 3 efficacy trial are obtained by considering scenarios for potential experimental PrEP and control regimens, including consideration of placebo and active controls, longer acting PrEP and alternate dosing schedules."( Study design considerations for evaluating efficacy of systemic preexposure prophylaxis interventions.
Chen, YQ; Donnell, D; Fleming, TR; Hughes, JP; Wang, L, 2013
)
0.39
"73 log10 copies per milliliter, including a dose-response relationship for viral load decrease up to 25 mg."( Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of tenofovir alafenamide as 10-day monotherapy in HIV-1-positive adults.
Berger, D; Bredeek, UF; Callebaut, C; DeJesus, E; Fordyce, MW; Markowitz, M; Ramanathan, S; Rhee, MS; Ruane, PJ; Yale, K; Zhong, L, 2013
)
0.39
" This may translate into greater antiviral efficacy, a higher barrier to resistance, and an improved safety profile relative to TDF, supporting further investigation of TAF dosed once daily in HIV-infected patients."( Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of tenofovir alafenamide as 10-day monotherapy in HIV-1-positive adults.
Berger, D; Bredeek, UF; Callebaut, C; DeJesus, E; Fordyce, MW; Markowitz, M; Ramanathan, S; Rhee, MS; Ruane, PJ; Yale, K; Zhong, L, 2013
)
0.39
" No clinically relevant interactions between daclatasvir and tenofovir disoproxil fumarate were observed for either drug, and no dosing adjustments were indicated."( Assessment of pharmacokinetic interactions of the HCV NS5A replication complex inhibitor daclatasvir with antiretroviral agents: ritonavir-boosted atazanavir, efavirenz and tenofovir.
Bertz, R; Bifano, M; Grasela, D; Hartstra, J; Hwang, C; Kandoussi, H; Oosterhuis, B; Sevinsky, H; Tiessen, R; Velinova-Donga, M, 2013
)
0.39
"The HIV Prevention Trials Network 057 protocol was a phase 1, open-label study of the pharmacokinetics and safety of tenofovir disoproxil fumarate (TDF) in HIV-infected women during labor and their infants during the first week of life with 4 dosing cohorts: maternal 600 mg doses/no infant dosing; no maternal dosing/infant 4 mg/kg doses on days 0, 3, and 5; maternal 900 mg doses/infant 6 mg/kg doses on days 0, 3, and 5; maternal 600 mg doses/infant 6 mg/kg daily for 7 doses."( Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their infants during the first week of life.
Emel, L; Eshleman, SH; Fowler, MG; George, K; Herron, C; Hudelson, SE; Joao, E; Kearney, B; Kreitchmann, R; Kumwenda, N; Mirochnick, M; Mofenson, L; Nielsen-Saines, K; Parsons, T; Pinto, J; Richardson, P; Santos, B; Sato, P; Taha, T, 2014
)
0.4
"A TDF dosing regimen of 600 mg during labor and daily infant doses of 6 mg/kg maintains infant tenofovir plasma concentration above 50 ng/mL throughout the first week of life and should be used in the studies of TDF efficacy for HIV prevention of mother-to-child transmission and early infant treatment."( Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their infants during the first week of life.
Emel, L; Eshleman, SH; Fowler, MG; George, K; Herron, C; Hudelson, SE; Joao, E; Kearney, B; Kreitchmann, R; Kumwenda, N; Mirochnick, M; Mofenson, L; Nielsen-Saines, K; Parsons, T; Pinto, J; Richardson, P; Santos, B; Sato, P; Taha, T, 2014
)
0.4
" Knowledge of concentrations of Tenofovir and its active form Tenofovir diphosphate, at putative sites of anti-HIV functioning, is central to understanding trial outcomes and design of products and dosage regimens."( Multicompartmental pharmacokinetic model of tenofovir delivery by a vaginal gel.
Gao, Y; Katz, DF, 2013
)
0.39
" Thus contrasts predicted by this model can inform design of gels and dosage regimens in clinical trials, and interpretation of PK data."( Multicompartmental pharmacokinetic model of tenofovir delivery by a vaginal gel.
Gao, Y; Katz, DF, 2013
)
0.39
" As a fixed-dose combination tablet given once daily, EFV/FTC/TDF was the first available STR combining efficacy, tolerability and convenience, with the simplest dosing schedule and smallest numbers of pills of any ART combination therapy."( Single-tablet regimens in HIV: does it really make a difference?
Aldir, I; Horta, A; Serrado, M, 2014
)
0.4
" Intermittently dosed vaginal gels containing the HIV-1 reverse transcriptase inhibitor tenofovir protected pigtailed macaques depending on the timing of viral challenge relative to gel application."( Intravaginal ring eluting tenofovir disoproxil fumarate completely protects macaques from multiple vaginal simian-HIV challenges.
Dinh, CT; Hendry, RM; Herold, BC; Kiser, PF; Martin, A; McNicholl, JM; Mesquita, PM; Nagaraja, U; Rastogi, R; Smith, JM; Srinivasan, P; Teller, RS, 2013
)
0.39
" Once-daily dosing without requirement for a pharmacokinetic booster makes dolutegravir-based therapy an attractive treatment option for HIV-1-infected treatment-naive patients."( Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial.
Albrecht, H; Almond, S; Baril, JG; Belonosova, E; Brennan, C; Domingo, P; Gatell, JM; Jaeger, H; Min, S; Quiros-Roldan, E; Raffi, F, 2013
)
0.39
" Median MEMS adherence rates were 98% (IQR: 93-100) for daily PrEP regimen, 91% (IQR: 73-97) for fixed intermittent dosing and 45% (IQR: 20-63) for post-coital dosing."( Safety, adherence and acceptability of intermittent tenofovir/emtricitabine as HIV pre-exposure prophylaxis (PrEP) among HIV-uninfected Ugandan volunteers living in HIV-serodiscordant relationships: a randomized, clinical trial.
Bahemuka, U; Bangsberg, DR; Barin, B; Bwanika, AN; Chetty, P; Fast, P; Haberer, JE; Kamali, A; Katende, D; Kibengo, FM; Mark, D; Priddy, FH; Rooney, JF; Ruzagira, E, 2013
)
0.39
"Both daily and intermittent oral PrEP dosing regimens were safe."( Safety, adherence and acceptability of intermittent tenofovir/emtricitabine as HIV pre-exposure prophylaxis (PrEP) among HIV-uninfected Ugandan volunteers living in HIV-serodiscordant relationships: a randomized, clinical trial.
Bahemuka, U; Bangsberg, DR; Barin, B; Bwanika, AN; Chetty, P; Fast, P; Haberer, JE; Kamali, A; Katende, D; Kibengo, FM; Mark, D; Priddy, FH; Rooney, JF; Ruzagira, E, 2013
)
0.39
" The 90% confidence interval (CI) of the geometric mean ratio for rilpivirine, emtricitabine, tenofovir exposure was estimated for fed versus fasted dosing and light versus standard meal, with equivalence boundaries of 80 - 125%."( Effect of food on rilpivirine/emtricitabine/tenofovir disoproxil fumarate, an antiretroviral single-tablet regimen for the treatment of HIV infection.
Cheng, A; Custodio, JM; Hepner, M; Kearney, BP; Ling, KH; Ramanathan, S; Yin, X, 2014
)
0.4
"At weeks 12 and 24, all 49 dosed subjects remained suppressed on RPV/FTC/TDF."( Efficacy and safety 48 weeks after switching from efavirenz to rilpivirine using emtricitabine/tenofovir disoproxil fumarate-based single-tablet regimens.
Brinson, C; Cheng, AK; Chuck, SK; Cohen, C; Dejesus, E; Mills, AM; Ramanathan, S; Wang, MH; White, K; Williams, S; Yale, KL,
)
0.13
"The objectives of this analysis were to develop a population pharmacokinetic model (PPK) for tenofovir without using potentially unreliable patient reported dosing records and to retrace patient dosing history using pharmacokinetic simulations conditioned on protocol design constraints to assess patient adherence."( Estimation of tenofovir's population pharmacokinetic parameters without reliable dosing histories and application to tracing dosing history using simulation strategies.
Chaturvedula, A; Fossler, MJ; Hendrix, CW, 2014
)
0.4
"NAs are cleared by kidneys and their dosage should be adjusted in patients with creatinine clearance <50 mL/min."( Review article: nucleos(t)ide analogues in patients with chronic hepatitis B virus infection and chronic kidney disease.
Cholongitas, E; Papatheodoridis, G; Pipili, C, 2014
)
0.4
" Geometric-mean-ratios compared levels between each pair of dosing conditions."( Strong relationship between oral dose and tenofovir hair levels in a randomized trial: hair as a potential adherence measure for pre-exposure prophylaxis (PrEP).
Anderson, PL; Bacchetti, P; Buchbinder, SP; Gandhi, M; Goggin, K; Grant, R; Greenblatt, RM; Huang, Y; Jin, C; Liu, AY; Stojanovski, K; Yang, Q, 2014
)
0.4
"This study found a strong linear relationship between frequency of dosing and tenofovir levels in scalp hair."( Strong relationship between oral dose and tenofovir hair levels in a randomized trial: hair as a potential adherence measure for pre-exposure prophylaxis (PrEP).
Anderson, PL; Bacchetti, P; Buchbinder, SP; Gandhi, M; Goggin, K; Grant, R; Greenblatt, RM; Huang, Y; Jin, C; Liu, AY; Stojanovski, K; Yang, Q, 2014
)
0.4
"Despite improvements in access to antiretroviral therapy and the use of simplified dosing regimens, HIV infection is still an important global public health problem."( An overview of antiretroviral pre-exposure prophylaxis of HIV infection.
McGowan, I, 2014
)
0.4
" Adherence support for the before-and-after dosing strategy (BAT 24) was provided at enrolment and at each monthly study visit."( Adherence in the CAPRISA 004 tenofovir gel microbicide trial.
Abdool Karim, Q; Abdool Karim, SS; Baxter, C; Grobler, A; MacQueen, KM; Madlala, BT; Mansoor, LE; Yende-Zuma, N, 2014
)
0.4
" A dosage form containing DPV must be able to deliver the drug to the tissue site of action."( Increased Dapivirine tissue accumulation through vaginal film codelivery of dapivirine and Tenofovir.
Akil, A; Cost, M; Devlin, B; Rohan, LC, 2014
)
0.4
"Pill burden, dosing frequency, and concerns about safety and tolerability are important obstacles to maintaining adequate medication adherence."( Switching from twice-daily raltegravir plus tenofovir disoproxil fumarate/emtricitabine to once-daily elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate in virologically suppressed, HIV-1-infected subjects: 48 weeks data.
Brinson, C; Cao, H; Cheng, A; Crofoot, G; Ebrahimi, R; Garner, W; Kulkarni, R; Mills, A; Ortiz, R; Rashbaum, B; Szwarcberg, J; Towner, W; Ward, D,
)
0.13
"Plasma concentrations of tenofovir consistent with daily dosing were highly predictive of protection from HIV acquisition."( HIV protective efficacy and correlates of tenofovir blood concentrations in a clinical trial of PrEP for HIV prevention.
Baeten, JM; Bangsberg, DR; Brantley, J; Bumpus, NN; Celum, C; Donnell, D; Haberer, JE; Hendrix, C; Mugo, N; Mujugira, A; Ndase, P, 2014
)
0.4
"Patients with HIV on antiretroviral therapy might benefit from regimen simplification to reduce pill burden and dosing frequency."( Simplification to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of ritonavir-boosted protease inhibitor with emtricitabine and tenofovir in adults with virologically suppressed HIV (STRATEGY-PI): 48 week results o
Arribas, JR; Di Perri, G; Ebrahimi, R; Gathe, J; Nguyen, T; Pialoux, G; Piontkowsky, D; Reynes, J; Tebas, P; White, K, 2014
)
0.4
" The granule form carries a risk of dosing errors and has a particularly strong, unpleasant taste."( Tenofovir in HIV-infected children. Antiretroviral efficacy, but beware of adverse effects on bone and the kidneys.
, 2014
)
0.4
"Atazanavir/ritonavir 200/100 mg dosing provided adequate ATV AUC 0-24 when used with TDF in HIV-infected Thai children weighing between 25 and 50 kg."( Pharmacokinetics of atazanavir/ritonavir among HIV-infected Thai children concomitantly taking tenofovir disoproxil fumarate.
Ananworanich, J; Bunupuradah, T; Keadpudsa, S; Prasitsuebsai, W; Puthanakit, T; Sahakijpicharn, T; Srimuan, A; Techasaensiri, C; Thammajaruk, N, 2014
)
0.4
"Polymeric films can be used as a stable dosage form for the delivery of antiretroviral combinations as microbicides."( Formulation and characterization of polymeric films containing combinations of antiretrovirals (ARVs) for HIV prevention.
Agashe, H; Akil, A; Devlin, B; Dezzutti, CS; Hillier, SL; Moncla, BJ; Rohan, LC; Shi, Y; Uranker, K, 2015
)
0.42
"Electrospun fibers containing antiretroviral drugs have recently been investigated as a new dosage form for topical microbicides against HIV-1."( Manufacturing scale-up of electrospun poly(vinyl alcohol) fibers containing tenofovir for vaginal drug delivery.
Krogstad, EA; Woodrow, KA, 2014
)
0.4
"The difference in binding affinity of tenofovir (more than two orders of magnitude in terms of local concentration), a 30x higher dosage of the (R)-tenofovir enantiomer as compared to conformational isomeric or rotameric adefovir, and the constrained mutational space due to gene overlap in HBV may explain the absence of resistance mutations after 6 years of tenofovir monotherapy."( Differential binding of tenofovir and adefovir to reverse transcriptase of hepatitis B virus.
Berkhout, B; van Hemert, FJ; Zaaijer, HL, 2014
)
0.4
" A dosing regimen according to body-weight-band has been established for pediatric use."( Review of tenofovir use in HIV-infected children.
Aurpibul, L; Puthanakit, T, 2015
)
0.42
" Blood, colonic biopsies and rectal and vaginal mucosal fluids were collected after the single oral TDF, the single topical TFV gel dose, and after 7 days of topical TFV gel dosing for extracellular analysis of TFV and intracellular analysis of the active metabolite tenofovir diphosphate (TFVdp) in peripheral blood mononuclear cells (PBMCs) and isolated mucosal mononuclear cells (MMC), including CD4+ and CD4- cell subsets."( A multi-compartment single and multiple dose pharmacokinetic comparison of rectally applied tenofovir 1% gel and oral tenofovir disoproxil fumarate.
Anton, PA; Bumpus, N; Cranston, R; Elliott, J; Hendrix, C; Kashuba, AD; Mauck, C; McGowan, I; Richardson-Harman, N; Tanner, K; Yang, KH, 2014
)
0.4
"This study was designed to assess the dose-response relationship between tissue, blood, vaginal and rectal compartment concentrations of tenofovir (TFV) and tenofovir diphosphate (TFVdp) and ex vivo rectal HIV suppression following oral tenofovir disoproxil fumarate (TDF) and rectal administration of TFV 1% vaginally-formulated gel."( Correlation between compartmental tenofovir concentrations and an ex vivo rectal biopsy model of tissue infectibility in the RMP-02/MTN-006 phase 1 study.
Anton, PA; Bumpus, NN; Cranston, RD; Elliott, J; Hendrix, CW; Kashuba, A; Mauck, C; McGowan, I; Richardson-Harman, N; Tanner, K; Yang, K, 2014
)
0.4
"There was a significant fit for the TFVdp dose-response model for rectal tissue (p = 0."( Correlation between compartmental tenofovir concentrations and an ex vivo rectal biopsy model of tissue infectibility in the RMP-02/MTN-006 phase 1 study.
Anton, PA; Bumpus, NN; Cranston, RD; Elliott, J; Hendrix, CW; Kashuba, A; Mauck, C; McGowan, I; Richardson-Harman, N; Tanner, K; Yang, K, 2014
)
0.4
" As these anti-HIV lipid nanoparticles also prolonged plasma drug exposure, they hold promise as a long-acting dosage form for HIV patients in addressing residual virus in cells and tissue."( Anti-HIV drug-combination nanoparticles enhance plasma drug exposure duration as well as triple-drug combination levels in cells within lymph nodes and blood in primates.
Freeling, JP; Ho, RJ; Koehn, J; Shu, C; Sun, J, 2015
)
0.42
" Although effective intracellular drug concentrations persist for several days after stopping PrEP, a reasonable recommendation is to continue PrEP dosing for 4 weeks after the last potential HIV exposure, similar to recommendations for postexposure prophylaxis."( Dose response for starting and stopping HIV preexposure prophylaxis for men who have sex with men.
Anderson, PL; Bushman, LR; Castillo-Mancilla, JR; Gardner, EM; Glidden, DV; Guida, LA; Kerr, BJ; Klein, B; Meditz, AL; Predhomme, JA; Rower, C; Seifert, SM; Zheng, JH, 2015
)
0.42
" These results provide a framework for future early investigations of antiretroviral efficacy in HIV prevention to optimize dosing strategies in clinical investigations."( Models for predicting effective HIV chemoprevention in women.
Cohen, MS; Emerson, CW; Fedoriw, Y; Geller, EJ; Kashuba, AD; Nelson, JA; Nicol, MR; Patterson, KB; Prince, HM; Sykes, C, 2015
)
0.42
" Enrolled patients underwent 24 h blood sampling with TDF/FTC/RPV dosing in the fasted state (day 42), with a low-fat meal (11 g of fat/353 kcal, day 49) and with a moderate-fat meal (19 g of fat/589 kcal, day 56; reference)."( Steady-state pharmacokinetics of rilpivirine under different meal conditions in HIV-1-infected Ugandan adults.
Back, DJ; Byakika-Kibwika, P; Else, L; Katwere, M; Khoo, SH; Lamorde, M; Merry, C; Mukisa, L; Sempa, JB; Walimbwa, S, 2015
)
0.42
" Less-than-daily oral dosing regimens and long-acting injectable medications could reduce pill burdens and facilitate adherence, and local delivery of PrEP medications to genital compartments via gels, rings and films may limit systemic drug exposure and potential toxicities."( Pre-exposure prophylaxis to prevent HIV infection: current status, future opportunities and challenges.
Krakower, DS; Mayer, KH, 2015
)
0.42
" These factors should be considered when adjusting tenofovir dosage regimens to ensure the efficacy and safety of a drug."( Influence of ABCC2 and ABCC4 polymorphisms on tenofovir plasma concentrations in Thai HIV-infected patients.
Avihingsanon, A; Burger, DM; Mitruk, S; Pengsuparp, T; Punyawudho, B; Rungtivasuwan, K; Ruxrungtham, K; Thammajaruk, N, 2015
)
0.42
" For each drug, its loaded concentration, gel properties and applied volume, and frequency of dosing can be designed to optimize PK and, thence, PD."( Vaginal deployment and tenofovir delivery by microbicide gels.
Chuchuen, O; Gao, Y; Ham, A; Katz, DF; Yang, KH; Yuan, A, 2015
)
0.42
" Adherence to the dosing regimen has emerged as a critical factor determining efficacy outcomes of clinical trials."( Pharmacokinetics of long-acting tenofovir alafenamide (GS-7340) subdermal implant for HIV prophylaxis.
Baum, MM; Beliveau, M; Fanter, R; Gunawardana, M; Hendrix, CW; Marzinke, MA; Miller, CS; Moss, JA; Remedios-Chan, M; Smith, TJ; Yang, F, 2015
)
0.42
" Net BMD loss by week 24 in participants with TFV-DP levels indicative of consistent dosing averaged -1."( Effects of Emtricitabine/Tenofovir on Bone Mineral Density in HIV-Negative Persons in a Randomized, Double-Blind, Placebo-Controlled Trial.
Anderson, PL; Bekker, LG; Buchbinder, S; Chariyalertsak, S; Chodacki, P; de Mendonca, LM; Glidden, DV; Gonzales, P; Grant, RM; Guanira, JV; Lama, JR; Liu, A; McMahan, V; Mulligan, K; Namwongprom, S; Ramirez-Cardich, ME; Schechter, M; Veloso, VG; Wang, F, 2015
)
0.42
"Tenofovir disoproxil fumarate (TDF) is increasingly used in the highly active antiretroviral therapy (HAART) regimens of pregnant women, but limited data exist on the pregnancy pharmacokinetics of chronically dosed TDF."( Pharmacokinetics of tenofovir during pregnancy and postpartum.
Best, BM; Burchett, S; Byroads, M; Capparelli, EV; Fletcher, CV; Hawkins, E; Hu, C; Li, H; Mirochnick, M; Smith, E; Stek, A; Wang, J; Watts, DH, 2015
)
0.42
" These findings support other clinical research failing to show dose-response relationships for growth and bone outcomes among intrauterine TFV-exposed infants."( Meconium Tenofovir Concentrations and Growth and Bone Outcomes in Prenatally Tenofovir Exposed HIV-Uninfected Children.
Hazra, R; Himes, SK; Huestis, MA; Jacobson, DL; Kacanek, D; Rich, KC; Siberry, GK; Tassiopoulos, K; Van Dyke, RB; Wu, JW, 2015
)
0.42
" These models can be applied to evaluate alternative dosing regimens to optimize drug therapy during pregnancy."( Physiologically-based pharmacokinetic modeling of renally excreted antiretroviral drugs in pregnant women.
Benaboud, S; Blanche, S; Bouazza, N; De Sousa Mendes, M; Foissac, F; Hirt, D; Treluyer, JM; Urien, S; Valade, E, 2015
)
0.42
"The CAPRISA 004 trial showed that coitally dosed tenofovir 1% gel reduced HIV acquisition by 39% overall and 54% when used consistently."( Genital Tenofovir Concentrations Correlate With Protection Against HIV Infection in the CAPRISA 004 Trial: Importance of Adherence for Microbicide Effectiveness.
Abdool Karim, SS; Gengiah, TN; Karim, QA; Kashuba, AD; Werner, L; White, NR; Yang, KH, 2015
)
0.42
" This study confirmed that patients with kidney impairment and the concurrent use of atazanavir/ritonavir will require the dosage of tenofovir to be adjusted to ensure efficacy and prevent unwanted toxicities."( Population pharmacokinetics of tenofovir in HIV/HBV co-infected patients.
Avihingsanon, A; Burger, D; Lewin, SR; Matthews, G; Punyawudho, B; Ruxrungtham, K; Thammajaruk, N; Thongpeang, P, 2015
)
0.42
" HPTN 066 was conducted to establish objective, quantitative benchmarks for discrete, regular levels of adherence using directly observed dosing of tenofovir (TFV) disoproxil fumarate (TDF)/emtricitabine (FTC)."( Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine After Directly Observed Dosing in Healthy Volunteers to Establish Adherence Benchmarks (HPTN 066).
Anderson, PL; Andrade, A; Bakshi, RP; Bumpus, NN; Bushman, LR; Donnell, D; Elharrar, V; Fuchs, EJ; Hendrix, CW; Kashuba, AD; Li, X; Marzinke, MA; Mayer, KH; McKinstry, L; Moore, A; Patterson, KB; Prince, HA; Radebaugh, C; Richardson, P; Shieh, E; Wang, R; Wiggins, I, 2016
)
0.43
" Thus, we conducted a single-dose pharmacokinetic study of TFV gel applied 1 or 24 hours before or 1 hour before and 1 hour after (BAT) sex and compared results with dosing without sex."( Impact of Sex on the Pharmacokinetics and Pharmacodynamics of 1% Tenofovir Gel.
Chen, BA; Dezzutti, CS; Galaska, B; Hendrix, CW; Herold, BC; Hillier, S; Kelly, CW; Levy, L; Marzinke, MA; McGowan, I; Piper, JM; Salata, RA, 2016
)
0.43
"Compared with dosing without sex, median TFV concentrations after sex decreased 72% and 78% (P < ."( Impact of Sex on the Pharmacokinetics and Pharmacodynamics of 1% Tenofovir Gel.
Chen, BA; Dezzutti, CS; Galaska, B; Hendrix, CW; Herold, BC; Hillier, S; Kelly, CW; Levy, L; Marzinke, MA; McGowan, I; Piper, JM; Salata, RA, 2016
)
0.43
" BAT dosing or sustained delivery may be optimal for preexposure prophylaxis."( Impact of Sex on the Pharmacokinetics and Pharmacodynamics of 1% Tenofovir Gel.
Chen, BA; Dezzutti, CS; Galaska, B; Hendrix, CW; Herold, BC; Hillier, S; Kelly, CW; Levy, L; Marzinke, MA; McGowan, I; Piper, JM; Salata, RA, 2016
)
0.43
" On the basis of participants' explanations, we developed a typology of adherence patterns: noninitiation, discontinuation, misimplementation (resulting from visit-driven use, variable taking, modified dosing or regimen) and adherence."( Disclosure of pharmacokinetic drug results to understand nonadherence.
Bennie, T; Cheng, H; Etima, J; Grossman, CI; Hartmann, M; Laborde, N; Levy, L; Marrazzo, J; Mensch, B; Montgomery, ET; Musara, P; Naidoo, S; Piper, J; van der Straten, A, 2015
)
0.42
"Animal models have informed our understanding of early viral transmission events, which help guide event-driven PrEP dosing strategies."( Nondaily preexposure prophylaxis for HIV prevention.
Anderson, PL; García-Lerma, JG; Heneine, W, 2016
)
0.43
"Event-driven dosing for TFV-based PrEP has promise for HIV prevention in MSM."( Nondaily preexposure prophylaxis for HIV prevention.
Anderson, PL; García-Lerma, JG; Heneine, W, 2016
)
0.43
" In May 2014 the Centers for Disease Control and Prevention published updated practice guidelines recommending the use of preexposure prophylaxis (PrEP) with daily oral dosing of tenofovir/emtricitabine to help prevent HIV infection in high-risk individuals (strength of recommendation, A)."( Preexposure Prophylaxis (PrEP) for HIV Prevention: The Primary Care Perspective.
Conniff, J; Evensen, A,
)
0.13
"77), 87 versus 86 % as recent dosing (>10 ng/ml; p = 0."( Does Adherence Change When No One is Looking? Comparing Announced and Unannounced Tenofovir Levels in a PrEP Trial.
Baeten, JM; Bangsberg, DR; Haberer, JE; Musinguzi, N; Muwonge, T; Thomas, K, 2016
)
0.43
" Prevalence of steady-state daily dosing (SSDD; ≥40 ng/ml) was 74% in a random subset of tenofovir samples obtained from 365 participants."( Comparison of subjective and objective adherence measures for preexposure prophylaxis against HIV infection among serodiscordant couples in East Africa.
Baeten, JM; Bangsberg, DR; Boum, Y; Celum, C; Haberer, JE; Hendrix, CW; Marzinke, MA; Muganzi, CD; Musinguzi, N; Ronald, A, 2016
)
0.43
"A new simple, rapid stability indicating assay method has been developed and validated for the determination of emtricitabine, tenofovir disoproxil fumarate, elvitegravir and cobicistat using reverse-phase high-performance liquid chromatography in their pharmaceutical dosage form."( A Validated Stability Indicating RP-HPLC Method for the Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Pharmaceutical Dosage Form.
Avanapu, SR; Kumar, PR; Runja, C,
)
0.13
" Monte-Carlo simulations were then performed to identify minimally effective dosing strategies to protect lower female genital tract and colorectal tissues."( A Translational Pharmacology Approach to Predicting Outcomes of Preexposure Prophylaxis Against HIV in Men and Women Using Tenofovir Disoproxil Fumarate With or Without Emtricitabine.
Cottrell, ML; Dellon, ES; Hudgens, MG; Kashuba, AD; Madanick, RD; Malone, S; Nelson, JA; Patterson, KB; Prince, HM; Shaheen, NJ; Sykes, C; White, N; Wulff, J; Yang, KH, 2016
)
0.43
" These data provide a novel approach for future PrEP investigations that can optimize clinical trial dosing strategies."( A Translational Pharmacology Approach to Predicting Outcomes of Preexposure Prophylaxis Against HIV in Men and Women Using Tenofovir Disoproxil Fumarate With or Without Emtricitabine.
Cottrell, ML; Dellon, ES; Hudgens, MG; Kashuba, AD; Madanick, RD; Malone, S; Nelson, JA; Patterson, KB; Prince, HM; Shaheen, NJ; Sykes, C; White, N; Wulff, J; Yang, KH, 2016
)
0.43
" A significant research thrust in the field has been to characterize different dosage forms for formulation of physicochemically diverse antiretroviral drugs."( Biophysical characterization of small molecule antiviral-loaded nanolipogels for HIV-1 chemoprophylaxis and topical mucosal application.
Golan-Paz, S; Jiang, Y; Ramanathan, R; Read, B; Woodrow, KA, 2016
)
0.43
"Use of TDF/FTC did not appear to affect serum MPA levels, however we found lower than expected MPA concentrations at the end of the dosing interval among DMPA users in the FEM-PrEP trial, the cause of which are unknown."( Medroxyprogesterone acetate levels among Kenyan women using depot medroxyprogesterone acetate in the FEM-PrEP trial.
Agot, K; Callahan, R; Dorflinger, L; Jenkins, D; Nanda, K; Taylor, D; Van Damme, L; Wang, M, 2016
)
0.43
" We evaluated concordance between reports of recent PrEP dosing collected via neutral interviewing and drug quantitation in the iPrEx open-label extension, where participants (n = 1172) had the choice to receive or not receive PrEP."( Self-reported Recent PrEP Dosing and Drug Detection in an Open Label PrEP Study.
Amico, KR; Anderson, P; Avelino-Silva, VI; Grant, R; Guanira, J; McMahan, V; Mehrotra, M; Veloso, VG, 2016
)
0.43
"Uncertainties in parameter values in microbicide pharmacokinetics (PK) models confound the models' use in understanding the determinants of drug delivery and in designing and interpreting dosing and sampling in PK studies."( Sensitivity Analysis of a Pharmacokinetic Model of Vaginal Anti-HIV Microbicide Drug Delivery.
Cogan, NG; Gao, Y; Hussaini, MY; Jarrett, AM; Katz, DF, 2016
)
0.43
" Clinical dosing with TAF vs."( High resistance barrier to tenofovir alafenamide is driven by higher loading of tenofovir diphosphate into target cells compared to tenofovir disoproxil fumarate.
Callebaut, C; Liu, Y; Margot, NA; Miller, MD, 2016
)
0.43
"Antiretroviral preexposure prophylaxis (PrEP) with once-daily dosing of tenofovir and tenofovir-emtricitabine was shown to be effective for preventing HIV-1 infection in individuals who had HIV-1-seropositive partners (the Partners PrEP Study)."( Population Pharmacokinetics of Tenofovir in HIV-1-Uninfected Members of Serodiscordant Couples and Effect of Dose Reporting Methods.
Baeten, JM; Bangsberg, D; Celum, CL; Chaturvedula, A; Fossler, MJ; Goti, V; Haberer, JE; Hendrix, CW; Lu, Y; Sale, ME, 2016
)
0.43
" Depo-Provera-synchronized mice were dosed vaginally or intraperitoneally with (3)H-TFV, with or without MK571 co-administration, to delineate the function of cervicovaginal Mrp4."( Expression, regulation, and function of drug transporters in cervicovaginal tissues of a mouse model used for microbicide testing.
Hu, M; Pearlman, A; Rohan, LC; Zhou, T, 2016
)
0.43
" We determined if emtricitabine triphosphate (FTC-TP) in dried blood spots (DBS) can be used as a marker of recent dosing with tenofovir disoproxil fumarate-emtricitabine (TDF-FTC)."( Emtricitabine-Triphosphate in Dried Blood Spots as a Marker of Recent Dosing.
Anderson, PL; Bushman, LR; Campbell, K; Castillo-Mancilla, J; Coleman, S; Gardner, EM; Glidden, DV; Grant, R; Hosek, S; Liu, A; MaWhinney, S; McAllister, K; Seifert, S; Wilson, CM; Zheng, JH, 2016
)
0.43
"The first-generation integrase inhibitors (INIs) raltegravir (RAL) and elvitegravir (EVG) have shown efficacy against HIV infection, but they have the limitations of once-more daily dosing and extensive cross-resistance."( Dolutegravir(DTG, S/GSK1349572) combined with other ARTs is superior to RAL- or EFV-based regimens for treatment of HIV-1 infection: a meta-analysis of randomized controlled trials.
Chen, H; Guo, W; Huang, J; Jiang, J; Liang, B; Liang, H; Liao, Y; Su, J; Xu, X; Ye, L; Zang, N, 2016
)
0.43
" Peak blood and breast milk samples were obtained 1-2 h after the maternal DOT PrEP dose, while maternal trough samples were obtained at the end of the PrEP dosing interval (i."( Pre-exposure Prophylaxis Use by Breastfeeding HIV-Uninfected Women: A Prospective Short-Term Study of Antiretroviral Excretion in Breast Milk and Infant Absorption.
Baeten, JM; Celum, CL; Hendrix, CW; John-Stewart, G; Katabira, ET; Marzinke, M; Mugo, NR; Mugwanya, KK; Muthuri, G; Muwonge, TR; Ngure, K; Semiyaga, NB; Stergachis, A, 2016
)
0.43
"Hand/wrist and spine radiographs were obtained at 3 days and 12 weeks of age in infants born to HIV-infected pregnant women enrolled in the HIV Prevention Trials Network 057 pharmacokinetic study of TDF conducted in Malawi and Brazil assigned to 3 TDF dosing cohorts."( Bone Age and Mineral Density Assessments Using Plain Roentgenograms in Tenofovir-exposed Infants in Malawi and Brazil Enrolled in HIV Prevention Trials Network 057.
Boechat, MI; Emel, L; George, K; Joao, E; Kreitchmann, R; Kumwenda, N; Mirochnick, M; Mofenson, L; Nielsen-Saines, K; Osorio, LE; Pinto, J; Santos, B; Sato, P; Swenson, M, 2017
)
0.46
" Model simulations of analog:dNTP molar ratios using IPERGAY dosing suggested that FTC significantly contributes to the protective effect of preexposure prophylaxis (PrEP)."( Model Linking Plasma and Intracellular Tenofovir/Emtricitabine with Deoxynucleoside Triphosphates.
Anderson, PL; Bushman, LR; Castillo-Mancilla, JR; Chen, X; Kiser, JJ; MaWhinney, S; Seifert, SM; Zheng, JH, 2016
)
0.43
" This study included once-daily dosing regimens of placebo, oral tenofovir disoproxil fumarate (TDF), and TDF in combination with emtricitabine (FTC), administered to HIV-uninfected members of serodiscordant couples."( Markov Mixed Effects Modeling Using Electronic Adherence Monitoring Records Identifies Influential Covariates to HIV Preexposure Prophylaxis.
Baeten, JM; Bangsberg, D; Celum, C; Chaturvedula, A; Fossler, MJ; Haberer, JE; Hendrix, CW; Madrasi, K; Sale, M, 2017
)
0.46
"Vaginal TFV gel dosing previously shown to provide 100 or 74% protection when applied either 30 min or 3 days before simian HIV(SHIV) challenge was assessed in pigtailed macaques coinfected with Chlamydia trachomatis/Trichomonas vaginalis and challenged twice weekly with SHIV162p3 for up to 10 weeks (two menstrual cycles)."( Topical tenofovir protects against vaginal simian HIV infection in macaques coinfected with Chlamydia trachomatis and Trichomonas vaginalis.
Aubert, R; Dinh, C; Dobard, C; Garcia-Lerma, GJ; Hanson, D; Heneine, W; Henning, T; Kersh, E; Lipscomb, J; Makarova, N; McNicholl, J; Mitchell, J; Papp, J; Phillips, C; Taylor, A, 2017
)
0.46
"Rectal enemas that contain prophylactic levels of anti-HIV microbicides such as tenofovir have emerged as a promising dosage form to prevent sexually transmitted HIV infections."( Multicompartmental Pharmacokinetic Model of Tenofovir Delivery to the Rectal Mucosa by an Enema.
Gao, Y; Katz, DF, 2017
)
0.46
" Monitoring of renal function showed no case of the Fanconi syndrome, no significant alterations of median serum creatinine, eGFR and phosphate levels, although a reduction of TDF dosage was required in five patients (8."( Long-term efficacy and safety of switching from lamivudine+adefovir to tenofovir disoproxil fumarate in virologically suppressed patients.
Angarano, G; Fasano, M; Fiore, JR; Leone, A; Maggi, P; Santantonio, TA; Volpe, A, 2017
)
0.46
" When dosed once-daily, TAF results in approximately 90% lower levels of plasma TFV and a 4-fold increase in intracellular TFV-diphosphate (TFV-DP) in PBMCs compared with the TFV prodrug tenofovir disoproxil fumarate (TDF)."( Viability of primary osteoblasts after treatment with tenofovir alafenamide: Lack of cytotoxicity at clinically relevant drug concentrations.
Babusis, D; Callebaut, C; Kitrinos, K; Liu, Y; Miller, M; Ray, A, 2017
)
0.46
"After tenofovir alafenamide dosing in vivo , tenofovir-dp was unquantifiable in most tissues (91%) although cervical and vaginal epithelial cells efficiently formed tenofovir-dp from tenofovir alafenamide in vitro ."( Single-dose pharmacokinetics of tenofovir alafenamide and its active metabolite in the mucosal tissues.
Cottrell, ML; Emerson, CW; Garrett, KL; Gay, C; Kashuba, ADM; McCallister, S; Peery, A; Prince, HMA; Rooney, JF; Schauer, A; Sykes, C, 2017
)
0.46
" However, adequacy of drug exposures after these administration routes are largely unknown, making dosing recommendations and the attainment of viral suppression challenging in this patient population."( Decreased Absorption of Dolutegravir and Tenofovir Disoproxil Fumarate, But Not Emtricitabine, in an HIV-Infected Patient Following Oral and Jejunostomy-Tube Administration.
Anderson, M; Bailey, B; Balba, G; Brooks, KM; Garrett, KL; George, JM; Kuriakose, SS; Lane, HC; Maldarelli, F; Pau, AK, 2017
)
0.46
" Indeed, achieving the desired therapeutic outcome in the absence of an effective means of targeted delivery must rely on dosage escalation, which frequently causes severe toxicity."( Overcoming the Hydrolytic Lability of a Reaction Intermediate in Production of Protein/Drug Conjugates: Conjugation of an Acyclic Nucleoside Phosphonate to a Model Carrier Protein.
Kaltashov, IA; Xu, S, 2017
)
0.46
"8% discontinued/adjusted dosing of TDF because of nephrotoxicity."( Prevalence of Persistent Renal Dysfunction in Perinatally HIV-infected Thai Adolescents.
Anugulruengkitt, S; Bunupuradah, T; Chanakul, A; Jantarabenjakul, W; Phupitakphol, T; Prasitsuebsai, W; Puthanakit, T; Ruxrungtham, K; Sopa, B; Sophonphan, J, 2018
)
0.48
" The changes in dosing that are needed in the presence of renal impairment, which is a common occurrence with HIV chronic disease progression, will also be discussed."( Factors Contributing to the Antiviral Effectiveness of Tenofovir.
Murphy, RA; Valentovic, MA, 2017
)
0.46
" Topical (vaginal and rectal) dosing is a promising regimen for HIV PrEP as it leads to low systematic drug exposure."( Prevention of vaginal and rectal HIV transmission by antiretroviral combinations in humanized mice.
Baum, MM; Chatterji, U; Gallay, PA; Gandarilla, A; Gunawardana, M; Kirchhoff, A; Marzinke, MA; Moss, JA; Pyles, RB, 2017
)
0.46
" They are critical inputs to deterministic transport models that predict the gels' pharmacokinetic performance, which can guide improved design of products and optimization of their dosing regimens."( Label-free analysis of tenofovir delivery to vaginal tissue using co-registered confocal Raman spectroscopy and optical coherence tomography.
Chuchuen, O; Desoto, M; Henderson, MH; Katz, DF; Maher, JR; Rohan, LC; Wax, A, 2017
)
0.46
"This is the first demonstration that intracellular atazanavir exposure remains unchanged during pregnancy supporting the standard 300/100 mg atazanavir/ritonavir dosing throughout pregnancy."( Atazanavir intracellular concentrations remain stable during pregnancy in HIV-infected patients.
Bonito, A; Bonora, S; Calcagno, A; Casari, S; Castelli, F; D'Avolio, A; Di Perri, G; Domenighini, E; Focà, E; Quiros Roldan, E; Simiele, M; Trentini, L, 2017
)
0.46
"The relative feasibility and acceptability of daily versus non-daily dosing of oral HIV pre-exposure prophylaxis (PrEP) among women are unknown."( Daily and non-daily pre-exposure prophylaxis in African women (HPTN 067/ADAPT Cape Town Trial): a randomised, open-label, phase 2 trial.
Amico, KR; Anderson, PL; Bekker, LG; Dye, BJ; Elharrar, V; Eshleman, SH; Grant, RM; Hendrix, CW; Hughes, JP; Li, M; Marzinke, MA; McKinstry, L; Piwowar-Manning, E; Rooney, JF; Roux, S; Sebastien, E; Stirratt, M; Yola, N, 2018
)
0.48
" Participants were adult women (age ≥18 years) who received directly observed dosing once a week for 5 weeks followed by random assignment (1:1:1) at week 6 to one of three unblinded PrEP regimens for self-administered dosing over 24 weeks: daily; time-driven (twice a week plus a post-sex dose); or event-driven (one tablet both before and after sex)."( Daily and non-daily pre-exposure prophylaxis in African women (HPTN 067/ADAPT Cape Town Trial): a randomised, open-label, phase 2 trial.
Amico, KR; Anderson, PL; Bekker, LG; Dye, BJ; Elharrar, V; Eshleman, SH; Grant, RM; Hendrix, CW; Hughes, JP; Li, M; Marzinke, MA; McKinstry, L; Piwowar-Manning, E; Rooney, JF; Roux, S; Sebastien, E; Stirratt, M; Yola, N, 2018
)
0.48
" 178 (93%) completed directly observed dosing and were randomly assigned one of the three PrEP regimens for the self-administered phase: 59 were allocated the daily regimen, 59 the time-driven regimen, and 60 the event-driven regimen."( Daily and non-daily pre-exposure prophylaxis in African women (HPTN 067/ADAPT Cape Town Trial): a randomised, open-label, phase 2 trial.
Amico, KR; Anderson, PL; Bekker, LG; Dye, BJ; Elharrar, V; Eshleman, SH; Grant, RM; Hendrix, CW; Hughes, JP; Li, M; Marzinke, MA; McKinstry, L; Piwowar-Manning, E; Rooney, JF; Roux, S; Sebastien, E; Stirratt, M; Yola, N, 2018
)
0.48
"Daily PrEP dosing resulted in higher coverage of sex events, increased adherence to the regimen, and augmented drug concentrations than did either time-driven or event-driven dosing."( Daily and non-daily pre-exposure prophylaxis in African women (HPTN 067/ADAPT Cape Town Trial): a randomised, open-label, phase 2 trial.
Amico, KR; Anderson, PL; Bekker, LG; Dye, BJ; Elharrar, V; Eshleman, SH; Grant, RM; Hendrix, CW; Hughes, JP; Li, M; Marzinke, MA; McKinstry, L; Piwowar-Manning, E; Rooney, JF; Roux, S; Sebastien, E; Stirratt, M; Yola, N, 2018
)
0.48
" These factors should be taken into consideration to guide the individual tenofovir disoproxil fumarate dosage regimen in Thai HIV-infected patients."( Pharmacogenetics-based population pharmacokinetic analysis of tenofovir in Thai HIV-infected patients.
Avihingsanon, A; Burger, DM; Mitruk, S; Punyawudho, B; Rungtivasuwan, K; Ruxrungtham, K; Sukasem, C; Thammajaruk, N, 2017
)
0.46
" Areas covered: The favourable pharmacological profile of TAF allows a marked reduction in dosage (25 mg/day) thus reducing systemic exposure to tenofovir and improving the bone and renal safety, keeping however the same virological efficacy, compared to TDF 300 mg/day."( Tenofovir alafenamide (TAF) treatment of HBV, what are the unanswered questions?
Grossi, G; Lampertico, P; Loglio, A; Viganò, M, 2018
)
0.48
"Nondaily dosing of oral preexposure prophylaxis (PrEP) may provide equivalent coverage of sex events compared with daily dosing."( Daily and Nondaily Oral Preexposure Prophylaxis in Men and Transgender Women Who Have Sex With Men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study.
Amico, KR; Anderson, PL; Chitwarakorn, A; Curlin, ME; Dye, BJ; Elharrar, V; Eshleman, SH; Grant, RM; Hendrix, CW; Hirsch-Moverman, Y; Holtz, TH; Hughes, JP; Li, M; Loquere, A; Mannheimer, S; Marzinke, MA; McKinstry, L; McNicholl, JM; Piwowar-Manning, E; Rooney, JF; Stirratt, M; van Griensven, F, 2018
)
0.48
"At-risk men and transgender women who have sex with men were randomly assigned to 1 of 3 dosing regimens: 1 tablet daily, 1 tablet twice weekly with a postsex dose (time-driven), or 1 tablet before and after sex (event-driven), and were followed for coverage of sex events with pre- and postsex dosing measured by weekly self-report, drug concentrations, and electronic drug monitoring."( Daily and Nondaily Oral Preexposure Prophylaxis in Men and Transgender Women Who Have Sex With Men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study.
Amico, KR; Anderson, PL; Chitwarakorn, A; Curlin, ME; Dye, BJ; Elharrar, V; Eshleman, SH; Grant, RM; Hendrix, CW; Hirsch-Moverman, Y; Holtz, TH; Hughes, JP; Li, M; Loquere, A; Mannheimer, S; Marzinke, MA; McKinstry, L; McNicholl, JM; Piwowar-Manning, E; Rooney, JF; Stirratt, M; van Griensven, F, 2018
)
0.48
"Daily dosing recommendations increased coverage and protective drug concentrations in the Harlem cohort, while daily and nondaily regimens led to comparably favorable outcomes in Bangkok, where participants had higher levels of education and employment."( Daily and Nondaily Oral Preexposure Prophylaxis in Men and Transgender Women Who Have Sex With Men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study.
Amico, KR; Anderson, PL; Chitwarakorn, A; Curlin, ME; Dye, BJ; Elharrar, V; Eshleman, SH; Grant, RM; Hendrix, CW; Hirsch-Moverman, Y; Holtz, TH; Hughes, JP; Li, M; Loquere, A; Mannheimer, S; Marzinke, MA; McKinstry, L; McNicholl, JM; Piwowar-Manning, E; Rooney, JF; Stirratt, M; van Griensven, F, 2018
)
0.48
"We estimated the required number of tablets/person/week for dosing regimens used in the HPTN 067/ADAPT (daily/time-driven/event-driven) and IPERGAY (on-demand) trials for different patterns of sexual intercourse."( In what circumstances could nondaily preexposure prophylaxis for HIV substantially reduce program costs?
Amico, KR; Bekker, LG; Boily, MC; Bokoch, K; Chitwarakorn, A; Dimitrov, D; Donnell, D; Grant, RM; Holtz, TH; Hughes, JP; Mannheimer, S; Mitchell, KM; Xia, F, 2018
)
0.48
" Electrospun fibers (EFs), in particular, have recently been applied to FRT delivery, resulting in an alternative dosage form with the potential to provide protection and therapeutic effect against a variety of infection types."( Computational Modeling of Antiviral Drug Diffusion from Poly(lactic- co-glycolic-acid) Fibers and Multicompartment Pharmacokinetics for Application to the Female Reproductive Tract.
Frieboes, HB; Halwes, ME; Steinbach-Rankins, JM; Tyo, KM, 2018
)
0.48
" Geometric least squares means ratios (coadministration:alone) and 90% confidence intervals were constructed for area under the plasma concentration-time curve over the dosing interval, maximum concentration, and trough, for all analytes."( Drug-Drug Interaction Studies Between Hepatitis C Virus Antivirals Sofosbuvir/Velpatasvir and Boosted and Unboosted Human Immunodeficiency Virus Antiretroviral Regimens in Healthy Volunteers.
Brainard, DM; Ling, KHJ; Mathias, A; Mogalian, E; Osinusi, A; Shen, G; Stamm, LM, 2018
)
0.48
" In 4 macaques dosed subcutaneously, drug levels over 5 weeks in plasma, lymph node mononuclear cells (LNMCs), and peripheral blood mononuclear cells (PBMCs) were analyzed by liquid chromatography-tandem mass spectrometry."( Long-Acting Profile of 4 Drugs in 1 Anti-HIV Nanosuspension in Nonhuman Primates for 5 Weeks After a Single Subcutaneous Injection.
Collier, AC; Ho, RJY; Kinman, LM; Koehn, J; Kraft, JC; Lane, S; Lee, W; McConnachie, LA, 2018
)
0.48
" Four placebo-controlled randomized clinical trials have demonstrated that preexposure prophylaxis (PrEP) with daily dosing of TDF/emtricitabine significantly reduces HIV acquisition in men who have sex with men, high-risk heterosexuals, and injection drug users who share injection equipment."( HIV Preexposure Prophylaxis: A Review.
Amico, KR; Mayer, KH; Riddell, J, 2018
)
0.48
" Offering a choice of dosing regimen to PrEP users may enable further personalization of HIV prevention strategies and enhance up-take, adherence and cost-effectiveness."( Men who have sex with men more often chose daily than event-driven use of pre-exposure prophylaxis: baseline analysis of a demonstration study in Amsterdam.
Achterbergh, RC; Davidovich, U; de Vries, HJ; Hogewoning, A; Hoornenborg, E; Prins, M; Sonder, GJ; van der Helm, JJ; van der Loeff, MFS; van Duijnhoven, YT, 2018
)
0.48
"MTN-014 was a phase 1, cross-over, randomized sequence trial comparing the cross-compartment pharmacokinetics and pharmacodynamics of daily TFV reduced-glycerin 1% gel after 14 days each of rectal and vaginal application, with directly observed dosing and a 6-week washout period between phases."( Pharmacokinetics and Pharmacodynamics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women: A Cross-Compartmental Study With Directly Observed Dosing.
Balar, B; Dai, JY; Dezzutti, CS; Galaska, B; Hendrix, CW; Justman, JE; Kunjara Na Ayudhya, RP; Levy, L; Marzinke, MA; McGowan, I; Mushamiri, I; Nair, GL; Pan, Z; Piper, JM; Schwartz, JL, 2018
)
0.48
" TFV and TFV diphosphate (TFV-DP) were detected in most samples collected from the dosing compartment."( Pharmacokinetics and Pharmacodynamics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women: A Cross-Compartmental Study With Directly Observed Dosing.
Balar, B; Dai, JY; Dezzutti, CS; Galaska, B; Hendrix, CW; Justman, JE; Kunjara Na Ayudhya, RP; Levy, L; Marzinke, MA; McGowan, I; Mushamiri, I; Nair, GL; Pan, Z; Piper, JM; Schwartz, JL, 2018
)
0.48
" Although high TFV concentrations in the dosing compartment may be protective, low cross-compartment tissue concentrations are not likely to be protective."( Pharmacokinetics and Pharmacodynamics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women: A Cross-Compartmental Study With Directly Observed Dosing.
Balar, B; Dai, JY; Dezzutti, CS; Galaska, B; Hendrix, CW; Justman, JE; Kunjara Na Ayudhya, RP; Levy, L; Marzinke, MA; McGowan, I; Mushamiri, I; Nair, GL; Pan, Z; Piper, JM; Schwartz, JL, 2018
)
0.48
" Intravaginal dosing with ARVs has shown to result in drug exposures in rectal tissues, thus raising the possibility of dual compartment protection."( Efficacy of Vaginally Administered Gel Containing Emtricitabine and Tenofovir Against Repeated Rectal Simian Human Immunodeficiency Virus Exposures in Macaques.
Dinh, C; Dobard, CW; Garcia-Lerma, G; Heneine, W; Khalil, G; Lipscomb, J; Makarova, N; Martin, A; Mitchell, J; Taylor, A; West-Deadwyler, R, 2018
)
0.48
" Using a murine model, we compared the plasma and tissue pharmacokinetics of TFV and various TFV prodrugs, including tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), and hexadecyloxypropyl tenofovir (CMX157), after dosing as enema formulations with varying osmolality and ion content."( Development of rectal enema as microbicide (DREAM): Preclinical progressive selection of a tenofovir prodrug enema.
Bensouda, S; Cone, RA; Date, AA; Ensign, LM; Fuchs, EJ; Gumber, S; Hanes, J; Hendrix, C; Hoang, T; Marzinke, M; Ortiz, JO; Rohan, L; Villinger, F; Xiao, P; Young, TW, 2019
)
0.51
" Tenofovir intravenous daily dosing in monkeys for 2 or 4 weeks at 30 mg/kg/day resulted in minimal to moderate tubular degeneration and regeneration, and tenofovir disoproxil fumarate oral dosing in dogs for 10 days at 45 mg/kg/day resulted in mild to marked tubular degeneration, necrosis, and regeneration."( Performance Assessment of New Urinary Translational Safety Biomarkers of Drug-induced Renal Tubular Injury in Tenofovir-treated Cynomolgus Monkeys and Beagle Dogs.
Glaab, WE; Gu, YZ; Pasello Dos Santos, FR; Peiffer, RL; Sistare, FD; Tournade, H; Troth, SP; Vlasakova, K, 2018
)
0.48
" This made adherence to the dosing strategy challenging."( "It Was Not My Aim to Sleep There": The Impact of Timing and Location of Sex on Adherence to Coitally-Dependent HIV Pre-exposure Prophylaxis.
Baron, D; Delany-Moretlwe, S; Gray, G; Ikaneng, T; Ju, S; Mabude, Z; Makgopa, S; Malefo, MA; Manenzhe, KN; Mazibuko, T; Nkala, B; Ntjana, H; Palanee-Phillips, T; Rees, H; Scorgie, F; Stadler, J, 2018
)
0.48
" Assessing adherence to recommended enema dosing regimens is essential in evaluating the utility of this strategy."( Fecal Coliform Bacterial Detection to Assess Enema Adherence in HIV Prevention Clinical Studies.
Aung, WS; Bakshi, RP; Breakey, J; Fuchs, EJ; Hendrix, CW; Johnson, JE; Marzinke, MA; Weld, E, 2019
)
0.51
"The goal of this work was to evaluate dosing strategies for tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), and emtricitabine (FTC) for pre-exposure prophylaxis (PrEP) with injection drug use with a pharmacokinetic/pharmacodynamics analysis of concentration data generated from two single-dose clinical studies conducted in healthy women."( A Pharmacokinetic/Pharmacodynamic Model to Predict Effective HIV Prophylaxis Dosing Strategies for People Who Inject Drugs.
Chen, J; Cottrell, ML; Dumond, JB; Garrett, KL; Maas, BM; Prince, HA; Schauer, AP; Sykes, C; White, N, 2018
)
0.48
"We assessed tenofovir hair concentrations in HIV-uninfected volunteers randomized to receive 100%, 67%, or 33% of daily dosing of TDF/FTC for 12 weeks (DOT-DBS, NCT02022657)."( Similar tenofovir hair concentrations in men and women after directly observed dosing of tenofovir disoproxil fumarate/emtricitabine: implications for preexposure prophylaxis adherence monitoring.
Anderson, PL; Bacchetti, P; Castillo-Mancilla, J; Gandhi, M; Koss, CA; Kuncze, K; Liu, AY; Louie, A; MaWhinney, S; McHugh, C; Morrow, M; Okochi, H; Seifert, S, 2018
)
0.48
" Data collected included demographic data, laboratory tests, antiretroviral treatment history, methadone dosing and drug abstinence."( Risk factors for kidney disease among HIV-1 positive persons in the methadone program.
Firląg-Burkacka, E; Grycner, E; Horban, A; Kowalska, JD; Matłosz, B; Pietraszkiewicz, E, 2019
)
0.51
"Intravaginal rings (IVRs) for HIV pre-exposure prophylaxis (PrEP) theoretically overcome some adherence concerns associated with frequent dosing that can occur with oral or vaginal film/gel regimens."( Safety and pharmacokinetics of single, dual, and triple antiretroviral drug formulations delivered by pod-intravaginal rings designed for HIV-1 prevention: A Phase I trial.
Anton, PA; Baum, MM; Butkyavichene, I; Churchman, SA; Cortez, JM; Dawson, L; Fanter, R; Gunawardana, M; Guthrie, KM; Hendrix, CW; Marzinke, MA; Miller, CS; Moss, JA; Olive, TJ; Pyles, RB; Rosen, RK; Vargas, SE; Vincent, KL; Yang, F, 2018
)
0.48
" IM SMC concentrations were low relative to PBMC, as were EN concentrations, suggesting differences in cell phenotype and lineage in the MGT; these differences in phenotype and pharmacology may have an impact on selecting and dosing ARVs used in cure strategies."( Differential extracellular, but similar intracellular, disposition of two tenofovir formulations in the male genital tract.
Blake, KH; Chen, J; Cohen, MS; Dumond, JB; Gay, CL; Greene, SA; Kashuba, ADM; Maas, BM; Nelson, JAE; Prince, HMA; Schauer, AP; Sykes, C, 2019
)
0.51
" At baseline (pre-switch) and at 12 weeks post-switch, we measured HIV-1 RNA in seminal plasma (SP) and blood plasma (BP), tenofovir (TFV) in SP and BP, and TFV-diphosphate (dp) in peripheral blood mononuclear cells (PBMCs) and seminal mononuclear cells (SMCs) at the end of the dosing interval (C24h)."( Seminal Tenofovir Concentrations, Viral Suppression, and Semen Quality With Tenofovir Alafenamide, Compared With Tenofovir Disoproxil Fumarate (Spanish HIV/AIDS Research Network, PreEC/RIS 40).
Cottrell, ML; Garcia, B; Imaz, A; Kashuba, ADM; Morenilla, S; Niubó, J; Perez, E; Podzamczer, D; Tiraboschi, JM, 2019
)
0.51
" We examined rank correlations between levels of TFV and emtricitabine in urine, dried blood spots (DBS), and hair and determined the sensitivity and specificity of undetectable urine TFV for predicting dosing cut-offs in DBS."( Low tenofovir level in urine by a novel immunoassay is associated with seroconversion in a preexposure prophylaxis demonstration project.
Buchbinder, SP; Defechereux, P; Gandhi, M; Glidden, DV; Grant, RM; Kuncze, K; Mehrotra, M; Okochi, H; Rodrigues, WC; Spinelli, MA; Vincent, M; Wang, G, 2019
)
0.51
" Cisgender men who have sex with men and transwomen in the optional dual-energy X-ray absorptiometry (DXA) substudy of a large, international, open-label PrEP demonstration project, the iPrEx-open-label extension (OLE) study underwent DXA scans and DBS collection every 24 weeks, with average weekly dosing adherence patterns (2, 4, and 7 doses/week) estimated from validated TFV-DP cut-offs."( Impact of Estimated Pre-Exposure Prophylaxis (PrEP) Adherence Patterns on Bone Mineral Density in a Large PrEP Demonstration Project.
Anderson, PL; Bekker, LG; Buchbinder, SP; Chariyalertsak, S; Defechereux, P; Gandhi, M; Glidden, DV; Grant, RM; Guanira, JV; McMahan, VM; Schechter, M; Spinelli, MA; Veloso, VG, 2019
)
0.51
"The USPSTF reviewed the evidence on the benefits of PrEP for the prevention of HIV infection with oral tenofovir disoproxil fumarate monotherapy or combined tenofovir disoproxil fumarate and emtricitabine and whether the benefits vary by risk group, population subgroup, or regimen or dosing strategy; the diagnostic accuracy of risk assessment tools to identify persons at high risk of HIV acquisition; the rates of adherence to PrEP in primary care settings; the association between adherence and effectiveness of PrEP; and the harms of PrEP when used for HIV prevention."( Preexposure Prophylaxis for the Prevention of HIV Infection: US Preventive Services Task Force Recommendation Statement.
Barry, MJ; Cabana, M; Caughey, AB; Curry, SJ; Davidson, KW; Doubeni, CA; Epling, JW; Krist, AH; Kubik, M; Landefeld, CS; Mangione, CM; Owens, DK; Pbert, L; Silverstein, M; Simon, MA; Tseng, CW; Wong, JB, 2019
)
0.51
" On-demand (2-1-1 dosing strategy for MSM) and injectable PrEP appear to be acceptable among participants in clinical trials."( Current and Future PrEP Medications and Modalities: On-demand, Injectables, and Topicals.
Beymer, MR; Holloway, IW; Landovitz, RJ; Pulsipher, C, 2019
)
0.51
" The pericoital, before-and-after sex, dosing regimen used in the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 tenofovir gel trial meant that women who were infected with hepatitis B virus (HBV) were exposed intermittently to tenofovir during their participation."( Frequency of Hepatitis B Virus Resistance Mutations in Women Using Tenofovir Gel as Pre-Exposure Prophylaxis.
Abdool Karim, SS; Baxter, C; Blackard, JT; Ngcapu, S; Penton, PK; Powell, EA, 2019
)
0.51
" Participants were randomized to receive controlled TDF/FTC dosing as (1) "perfect" adherence (daily); (2) "moderate" adherence (4 doses/week); or (3) "low" adherence (2 doses/week)."( Urine Tenofovir Concentrations Correlate With Plasma and Relate to Tenofovir Disoproxil Fumarate Adherence: A Randomized, Directly Observed Pharmacokinetic Trial (TARGET Study).
Bacchetti, P; Baeten, JM; Cressey, R; Cressey, TR; Drain, PK; Gandhi, M; Klinbuayaem, V; Kubiak, RW; Okochi, H; Punyati, P; Quame-Amaglo, J; Siriprakaisil, O; Sirirungsi, W; Sukrakanchana, PO; Tanasri, S, 2020
)
0.56
"High urine FTC and TFV concentrations could provide an indication of adherence to daily oral dosing with TDF or TAF-based regimens used for treatment and prevention."( Brief Report: Urine Emtricitabine and Tenofovir Concentrations Provide Markers of Recent Antiretroviral Drug Exposure Among HIV-Negative Men Who Have Sex With Men.
Conway-Washington, C; Dinh, C; Fountain, J; Haaland, RE; Hall, L; Holder, A; Kelley, CF; Livermont, T; Lupo, LD; Martin, A, 2019
)
0.51
" In this paper, we compared the dosage levels of tenofovir exposure in fetuses, breastfed infants, and children receiving tenofovir treatment."( Guides concerning tenofovir exposure via breastfeeding: A comparison of drug dosages by developmental stage.
Hu, X; Wang, L; Xu, F, 2019
)
0.51
"The CROPrEP project, a real-world study of PrEP use, will recruit 1000 high-risk HIV-negative MSM participants from four cities in China, who will be able to choose between daily or event-driven dosing regimens, according to their preference."( Protocol for a multicenter, real-world study of HIV pre-exposure prophylaxis among men who have sex with men in China (CROPrEP).
Chu, Z; Ding, H; Geng, W; Jia, Y; Jiang, Y; Leuba, SI; Mei, Z; Shang, H; Wang, H; Xu, J; Zhang, J; Zhang, Y, 2019
)
0.51
" The latest strategies for the prevention of the sexual transmission of HIV have moved towards sustained-release dosage forms, so films may be an effective strategy that could also improve the patient's comfort."( Development of mucoadhesive vaginal films based on HPMC and zein as novel formulations to prevent sexual transmission of HIV.
Bedoya, LM; Cazorla-Luna, R; Martín-Illana, A; Notario-Pérez, F; Peña, J; Ruiz-Caro, R; Veiga, MD, 2019
)
0.51
"Participants were randomly assigned to one of three self-administered dosing regimens for 24 weeks: daily, time-driven, or event-driven."( HPTN 067/ADAPT: Correlates of Sex-Related Pre-exposure Prophylaxis Adherence, Thai Men Who Have Sex With Men, and Transgender Women, 2012-2013.
Amico, KR; Chitwarakorn, A; Curlin, ME; Grant, RM; Holtz, TH; Hughes, JP; Li, M; Mock, PA; Varangrat, A, 2019
)
0.51
" Regardless of these factors, Thai MSM and TGW maintained high adherence levels to oral PrEP dosing regimens and coverage of sexual exposures."( HPTN 067/ADAPT: Correlates of Sex-Related Pre-exposure Prophylaxis Adherence, Thai Men Who Have Sex With Men, and Transgender Women, 2012-2013.
Amico, KR; Chitwarakorn, A; Curlin, ME; Grant, RM; Holtz, TH; Hughes, JP; Li, M; Mock, PA; Varangrat, A, 2019
)
0.51
" This study predicted the pharmacokinetics (PK) of three renally excreted antiretroviral drugs in the elderly population and compared them with known exposures in renal impairment, to evaluate the need for dosing adjustments."( Are Standard Doses of Renally-Excreted Antiretrovirals in Older Patients Appropriate: A PBPK Study Comparing Exposures in the Elderly Population With Those in Renal Impairment.
Chetty, M; De Sousa Mendes, M, 2019
)
0.51
" The majority of virtual patients had exposures that did not require dosage adjustments."( Are Standard Doses of Renally-Excreted Antiretrovirals in Older Patients Appropriate: A PBPK Study Comparing Exposures in the Elderly Population With Those in Renal Impairment.
Chetty, M; De Sousa Mendes, M, 2019
)
0.51
"Comparison of the exposure in the elderly with exposure observed in patients with different levels of renal impairment, indicated that a dosage adjustment may not be required in elderly patients on lamivudine, emtricitabine and the majority of the patients on tenofovir."( Are Standard Doses of Renally-Excreted Antiretrovirals in Older Patients Appropriate: A PBPK Study Comparing Exposures in the Elderly Population With Those in Renal Impairment.
Chetty, M; De Sousa Mendes, M, 2019
)
0.51
" We found that standard dosing strategies in preclinical species closely mimicked tissue concentrations in humans for some, but not all, ARVs."( Antiretroviral Penetration across Three Preclinical Animal Models and Humans in Eight Putative HIV Viral Reservoirs.
Adamson, L; Akkina, R; Blake, K; Burgunder, EM; Devanathan, AS; Garcia, JV; Kashuba, ADM; Kovarova, M; Luciw, P; Pirone, JR; Remling-Mulder, L; Rosen, EP; Schauer, AP; Srinivas, N; Sykes, C; White, NR, 2019
)
0.51
" Pericoital PrEP dosing seems to be effective in preventing HIV transmission among men who have sex with men, but has not been evaluated in women."( PrEP 1.0 and Beyond: Optimizing a Biobehavioral Intervention.
Allan-Blitz, LT; Mayer, KH, 2019
)
0.51
"PrEP has been shown to be safe and effective when used consistently, but new approaches to enhance uptake, adherence, and convenience with less-frequent dosing are under study, suggesting that new models and modalities will evolve to optimize impact."( PrEP 1.0 and Beyond: Optimizing a Biobehavioral Intervention.
Allan-Blitz, LT; Mayer, KH, 2019
)
0.51
" With the assistance of therapeutic drug monitoring, dolutegravir dosing was increased to 150 mg daily."( Successful use of once-daily high-dose darunavir and dolutegravir in multidrug-resistant HIV.
Fulco, PP; Gomes, D; Leibrand Kaczmar, CR; Smith, T, 2020
)
0.56
" In this perspective, we summarize data related to on-demand PrEP, describe advantages and disadvantages for this alternative dosing strategy, and provide clinical counseling points."( On-Demand Oral Pre-exposure Prophylaxis with Tenofovir/Emtricitabine: What Every Clinician Needs to Know.
Saberi, P; Scott, HM, 2020
)
0.56
" Recent dosing measures include antiretroviral levels in plasma or urine, as well as emtricitabine-triphosphate in dried blood spots (DBS) for those on tenofovir-emtricitabine-based therapy."( Approaches to Objectively Measure Antiretroviral Medication Adherence and Drive Adherence Interventions.
Anderson, PL; Castillo-Mancilla, J; Chai, PR; Gandhi, M; Haberer, JE; Spinelli, MA, 2020
)
0.56
"\ Conclusions: The patients were generally satisfied with the change in medication and well nformed about the dosage and advantages of TAF over TDF, but less well informed about the possible adverse effects of TAF."( Satisfaction and knowledge among patients with HIV after switching from tenofovir to tenofovir alafenamide in regimens containing emtricitabine and rilpivirine
Bermejo-Vicedo, T; Gramage-Caro, T; Montero-Llorente, B; Rodríguez-Sagrado, MÁ; Vélez-Díaz-Pallarés, M, 2020
)
0.56
"TAF-DBS was a randomized, crossover clinical study of TFV-DP in DBS, following directly observed dosing of 33%, 67%, or 100% of daily TAF (25 mg)/FTC (200 mg)."( Intracellular Tenofovir-Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots Following Tenofovir Alafenamide: The TAF-DBS Study.
Anderson, PL; Brooks, KM; Bushman, LR; Castillo-Mancilla, J; Ibrahim, ME; Kiser, JJ; MaWhinney, S; McCallister, S; McHugh, C; Morrow, M; Yager, J, 2020
)
0.56
" Together, these moieties provide complementary measures of cumulative adherence and recent dosing for TAF/FTC."( Intracellular Tenofovir-Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots Following Tenofovir Alafenamide: The TAF-DBS Study.
Anderson, PL; Brooks, KM; Bushman, LR; Castillo-Mancilla, J; Ibrahim, ME; Kiser, JJ; MaWhinney, S; McCallister, S; McHugh, C; Morrow, M; Yager, J, 2020
)
0.56
" Plasma and urine samples were collected regularly during the 6-week dosing phase and for 4 weeks following drug cessation."( Plasma pharmacokinetics and urinary excretion of tenofovir following cessation in adults with controlled levels of adherence to tenofovir disoproxil fumarate.
Baeten, JM; Cressey, R; Cressey, TR; Drain, PK; Gandhi, M; Klinbuayaem, V; Kubiak, RW; Okochi, H; Quame-Amaglo, J; Siriprakaisil, O; Sukrakanchana, PO; Tawon, Y, 2020
)
0.56
" Participants in the intervention arm will be provided with remote real-time monitoring equipment that triggers twice just-in-time SMS (Short Messaging Service) medication reminders to PrEP users every half an hour when a scheduled dosage is missed, and followed with just-in-time SMS medication reminders to clinicians half an hour when there is no supplement after the second just-in-time SMS reminder to PrEP users."( Real-time monitoring and just-in-time intervention for adherence to pre-exposure prophylaxis among men who have sex with men in China: a multicentre RCT study protocol.
Bao, R; Chen, Y; Chu, Z; Ding, H; Geng, W; He, X; Hu, Q; Hu, Z; Huang, X; Jiang, Y; Jin, X; Li, H; Li, S; Lv, W; Shang, H; Wang, H; Xu, J; Zhang, J; Zhang, L, 2020
)
0.56
" The agents were vaginally dosed individually and in combination, and the efficacy of HIV-1 prevention was analyzed using the established, rigorous median-effect model."( Highly synergistic drug combination prevents vaginal HIV infection in humanized mice.
Baum, MM; Bobardt, M; Gallay, PA; Gunawardana, M; Moss, JA; Ramirez, CM, 2020
)
0.56
"Diverging physicochemical properties of HIV drug combinations are challenging to formulate as a single dosage form."( Controlled Solvent Removal from Antiviral Drugs and Excipients in Solution Enables the Formation of Novel Combination Multi-Drug-Motifs in Pharmaceutical Powders Composed of Lopinavir, Ritonavir and Tenofovir.
Ho, RJY; Lane, S; McConnachie, L; Yu, D; Yu, J, 2020
)
0.56
"Findings will provide timely information on the safety, efficacy, and optimal dosing of t-PA to treat moderate/severe COVID-19-induced ARDS, which can be rapidly adapted to a phase III trial (NCT04357730; FDA IND 149634)."(
Abbasi, S; Abd El-Wahab, A; Abdallah, M; Abebe, G; Aca-Aca, G; Adama, S; Adefegha, SA; Adidigue-Ndiome, R; Adiseshaiah, P; Adrario, E; Aghajanian, C; Agnese, W; Ahmad, A; Ahmad, I; Ahmed, MFE; Akcay, OF; Akinmoladun, AC; Akutagawa, T; Alakavuklar, MA; Álava-Rabasa, S; Albaladejo-Florín, MJ; Alexandra, AJE; Alfawares, R; Alferiev, IS; Alghamdi, HS; Ali, I; Allard, B; Allen, JD; Almada, E; Alobaid, A; Alonso, GL; Alqahtani, YS; Alqarawi, W; Alsaleh, H; Alyami, BA; Amaral, BPD; Amaro, JT; Amin, SAW; Amodio, E; Amoo, ZA; Andia Biraro, I; Angiolella, L; Anheyer, D; Anlay, DZ; Annex, BH; Antonio-Aguirre, B; Apple, S; Arbuznikov, AV; Arinsoy, T; Armstrong, DK; Ash, S; Aslam, M; Asrie, F; Astur, DC; Atzrodt, J; Au, DW; Aucoin, M; Auerbach, EJ; Azarian, S; Ba, D; Bai, Z; Baisch, PRM; Balkissou, AD; Baltzopoulos, V; Banaszewski, M; Banerjee, S; Bao, Y; Baradwan, A; Barandika, JF; Barger, PM; Barion, MRL; Barrett, CD; Basudan, AM; Baur, LE; Baz-Rodríguez, SA; Beamer, P; Beaulant, A; Becker, DF; Beckers, C; Bedel, J; Bedlack, R; Bermúdez de Castro, JM; Berry, JD; Berthier, C; Bhattacharya, D; Biadgo, B; Bianco, G; Bianco, M; Bibi, S; Bigliardi, AP; Billheimer, D; Birnie, DH; Biswas, K; Blair, HC; Bognetti, P; Bolan, PJ; Bolla, JR; Bolze, A; Bonnaillie, P; Borlimi, R; Bórquez, J; Bottari, NB; Boulleys-Nana, JR; Brighetti, G; Brodeur, GM; Budnyak, T; Budnyk, S; Bukirwa, VD; Bulman, DM; Burm, R; Busman-Sahay, K; Butcher, TW; Cai, C; Cai, H; Cai, L; Cairati, M; Calvano, CD; Camacho-Ordóñez, A; Camela, E; Cameron, T; Campbell, BS; Cansian, RL; Cao, Y; Caporale, AS; Carciofi, AC; Cardozo, V; Carè, J; Carlos, AF; Carozza, R; Carroll, CJW; Carsetti, A; Carubelli, V; Casarotta, E; Casas, M; Caselli, G; Castillo-Lora, J; Cataldi, TRI; Cavalcante, ELB; Cavaleiro, A; Cayci, Z; Cebrián-Tarancón, C; Cedrone, E; Cella, D; Cereda, C; Ceretti, A; Ceroni, M; Cha, YH; Chai, X; Chang, EF; Chang, TS; Chanteux, H; Chao, M; Chaplin, BP; Chaturvedi, S; Chaturvedi, V; Chaudhary, DK; Chen, A; Chen, C; Chen, HY; Chen, J; 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Langaro, MC; Langham, MC; Lao, X; Larocca, MC; Lassus, J; Lattimer, TA; Lazar, S; Le, MH; Leal, DB; Leal, M; Leary, A; Ledermann, JA; Lee, JF; Lee, MV; Lee, NH; Leeds, CM; Leeds, JS; Lefrandt, JD; Leicht, AS; Leonard, M; Lev, S; Levy, K; Li, B; Li, C; Li, CM; Li, DH; Li, H; Li, J; Li, L; Li, LJ; Li, N; Li, P; Li, T; Li, X; Li, XH; Li, XQ; Li, XX; Li, Y; Li, Z; Li, ZY; Liao, YF; Lin, CC; Lin, MH; Lin, Y; Ling, Y; Links, TP; Lira-Romero, E; Liu, C; Liu, D; Liu, H; Liu, J; Liu, L; Liu, LP; Liu, M; Liu, T; Liu, W; Liu, X; Liu, XH; Liu, Y; Liuwantara, D; Ljumanovic, N; Lobo, L; Lokhande, K; Lopes, A; Lopes, RMRM; López-Gutiérrez, JC; López-Muñoz, MJ; López-Santamaría, M; Lorenzo, C; Lorusso, D; Losito, I; Lu, C; Lu, H; Lu, HZ; Lu, SH; Lu, SN; Lu, Y; Lu, ZY; Luboga, F; Luo, JJ; Luo, KL; Luo, Y; Lutomski, CA; Lv, W; M Piedade, MF; Ma, J; Ma, JQ; Ma, JX; Ma, N; Ma, P; Ma, S; Maciel, M; Madureira, M; Maganaris, C; Maginn, EJ; Mahnashi, MH; Maierhofer, M; Majetschak, M; Malla, TR; Maloney, L; Mann, DL; 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Mustafa, B; Nair, GM; Nakanishi, I; Nakanjako, D; Naraparaju, K; Nawani, N; Neffati, R; Neil, EC; Neilipovitz, D; Neira-Borrajo, I; Nelson, MT; Nery, PB; Nese, M; Nguyen, F; Nguyen, MH; Niazy, AA; Nicolaï, J; Nogueira, F; Norbäck, D; Novaretti, JV; O'Donnell, T; O'Dowd, A; O'Malley, DM; Oaknin, A; Ogata, K; Ohkubo, K; Ojha, M; Olaleye, MT; Olawande, B; Olomo, EJ; Ong, EWY; Ono, A; Onwumere, J; Ortiz Bibriesca, DM; Ou, X; Oza, AM; Ozturk, K; Özütemiz, C; Palacio-Pastrana, C; Palaparthi, A; Palevsky, PM; Pan, K; Pantanetti, S; Papachristou, DJ; Pariani, A; Parikh, CR; Parissis, J; Paroul, N; Parry, S; Patel, N; Patel, SM; Patel, VC; Pawar, S; Pefura-Yone, EW; Peixoto Andrade, BCO; Pelepenko, LE; Peña-Lora, D; Peng, S; Pérez-Moro, OS; Perez-Ortiz, AC; Perry, LM; Peter, CM; Phillips, NJ; Phillips, P; Pia Tek, J; Piner, LW; Pinto, EA; Pinto, SN; Piyachaturawat, P; Poka-Mayap, V; Polledri, E; Poloni, TE; Ponessa, G; Poole, ST; Post, AK; Potter, TM; Pressly, BB; Prouty, MG; Prudêncio, M; Pulkki, K; 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Tung, SY; Turpault, S; Tuynman, JB; Uemoto, AT; Ugurlu, M; Ullah, S; Underwood, RS; Ungell, AL; Usandizaga-Elio, I; Vakonakis, I; van Boxel, GI; van den Beucken, JJJP; van der Boom, T; van Slegtenhorst, MA; Vanni, JR; Vaquera, A; Vasconcellos, RS; Velayos, M; Vena, R; Ventura, G; Verso, MG; Vincent, RP; Vitale, F; Vitali, S; Vlek, SL; Vleugels, MPH; Volkmann, N; Vukelic, M; Wagner Mackenzie, B; Wairagala, P; Waller, SB; Wan, J; Wan, MT; Wan, Y; Wang, CC; Wang, H; Wang, J; Wang, JF; Wang, K; Wang, L; Wang, M; Wang, S; Wang, WM; Wang, X; Wang, Y; Wang, YD; Wang, YF; Wang, Z; Wang, ZG; Warriner, K; Weberpals, JI; Weerachayaphorn, J; Wehrli, FW; Wei, J; Wei, KL; Weinheimer, CJ; Weisbord, SD; Wen, S; Wendel Garcia, PD; Williams, JW; Williams, R; Winkler, C; Wirman, AP; Wong, S; Woods, CM; Wu, B; Wu, C; Wu, F; Wu, P; Wu, S; Wu, Y; Wu, YN; Wu, ZH; Wurtzel, JGT; Xia, L; Xia, Z; Xia, ZZ; Xiao, H; Xie, C; Xin, ZM; Xing, Y; Xing, Z; Xu, S; Xu, SB; Xu, T; Xu, X; Xu, Y; Xue, L; Xun, J; Yaffe, MB; Yalew, A; Yamamoto, S; Yan, D; Yan, H; Yan, S; Yan, X; Yang, AD; Yang, E; Yang, H; Yang, J; Yang, JL; Yang, K; Yang, M; Yang, P; Yang, Q; Yang, S; Yang, W; Yang, X; Yang, Y; Yao, JC; Yao, WL; Yao, Y; Yaqub, TB; Ye, J; Ye, W; Yen, CW; Yeter, HH; Yin, C; Yip, V; Yong-Yi, J; Yu, HJ; Yu, MF; Yu, S; Yu, W; Yu, WW; Yu, X; Yuan, P; Yuan, Q; Yue, XY; Zaia, AA; Zakhary, SY; Zalwango, F; Zamalloa, A; Zamparo, P; Zampini, IC; Zani, JL; Zeitoun, R; Zeng, N; Zenteno, JC; Zepeda-Palacio, C; Zhai, C; Zhang, B; Zhang, G; Zhang, J; Zhang, K; Zhang, Q; Zhang, R; Zhang, T; Zhang, X; Zhang, Y; Zhang, YY; Zhao, B; Zhao, D; Zhao, G; Zhao, H; Zhao, Q; Zhao, R; Zhao, S; Zhao, T; Zhao, X; Zhao, XA; Zhao, Y; Zhao, Z; Zheng, Z; Zhi-Min, G; Zhou, CL; Zhou, HD; Zhou, J; Zhou, W; Zhou, XQ; Zhou, Z; Zhu, C; Zhu, H; Zhu, L; Zhu, Y; Zitzmann, N; Zou, L; Zou, Y, 2022
)
0.72
" However, this change was modest, not warranting a change in TFV dosing at this time."( Methotrexate Decreases Tenofovir Exposure in Antiretroviral-Suppressed Individuals Living With HIV.
Aweeka, FT; Currier, JS; Deitchman, AN; Gingrich, D; Hsue, PY; Huang, L; Kantor, A; Ribaudo, HJ; Stein, JH, 2020
)
0.56
"02) times as likely to engage in optimal PrEP dosing compared to controls."( The Impact of a Mobile Gaming Intervention to Increase Adherence to Pre-exposure Prophylaxis.
Arnold, T; Brown, LK; Craker, L; Haubrick, KK; Mena, L; Olsen, E; Whiteley, L, 2021
)
0.62
"In this study, a green stability indicating chromatographic methods were developed and validated for the quantitative determination of tenofovir alafenamide in the presence of its degradation products in bulk powder as well as in dosage forms."( Assessment of the greenness of new stability indicating micellar UPLC and HPTLC methods for determination of tenofovir alafenamide in dosage forms.
Abdel-Razeq, SA; Nasr, ZA; Said, NS, 2021
)
0.62
"A novel method was developed for the simultaneous estimation of the doravirine, lamivudine, and tenofovir disoproxil fumarate in the pharmaceutical dosage form."( A simple alternative and improved HPLC method for the estimation of doravirine, lamivudine, and tenofovir disoproxil fumarate in solid oral dosage form.
Alegete, P; Kancherla, P; Kokkirala, TK; Suryakala, D, 2021
)
0.62
" TAF was well tolerated and only 4 patients discontinued therapy due to adverse event during a median duration of TAF dosing of 74 weeks."( Safety and Effectiveness of Tenofovir Alafenamide in Usual Clinical Practice Confirms Results of Clinical Trials: TARGET-HBV.
Bernstein, DE; Fried, MW; Lok, AS; Mospan, AR; Schiff, ER; Smith, CI; Trinh, HN; Zink, RC, 2022
)
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" Several studies have shown short but potent intermittent PrEP could provide comparable protection to daily PrEP in men, suggesting such dosing strategy might be useful in Chinese as well."( Impact of dosing strategies on plasma concentrations of tenofovir: Implications in HIV pre-exposure prophylaxis in China.
Alnajebi, B; Huang, A; Ma, Q; Shang, J; Tan, R; Yan, B; Yang, J; Zhang, Y; Zhong, X, 2021
)
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"An open label study in 40 Chinese healthy volunteers, randomized to receive the WHO-recommended dose of tenofovir (300mg) at four different dosing intervals: twice weekly for 4 weeks; once daily for 4 weeks with one missing dose in weeks 2-4; once daily for 4 weeks with two missing doses in weeks 2-4; and once every other day for 12 days."( Impact of dosing strategies on plasma concentrations of tenofovir: Implications in HIV pre-exposure prophylaxis in China.
Alnajebi, B; Huang, A; Ma, Q; Shang, J; Tan, R; Yan, B; Yang, J; Zhang, Y; Zhong, X, 2021
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0.62
" The trough concentrations (24h dosing interval) at the steady state were 51."( Impact of dosing strategies on plasma concentrations of tenofovir: Implications in HIV pre-exposure prophylaxis in China.
Alnajebi, B; Huang, A; Ma, Q; Shang, J; Tan, R; Yan, B; Yang, J; Zhang, Y; Zhong, X, 2021
)
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" No studies have yet compared TFV-DP in PBMC from lower than daily dosing between prodrugs, which has potential implications for event-driven preexposure prophylaxis and pharmacologic forgiveness."( Tenofovir-diphosphate in peripheral blood mononuclear cells during low, medium and high adherence to emtricitabine/ tenofovir alafenamide vs. emtricitabine/ tenofovir disoproxil fumarate.
Anderson, PL; Brooks, KM; Bushman, L; Castillo-Mancilla, JR; Ibrahim, M; Kiser, JJ; MaWhinney, S; Morrow, M; Nemkov, C; Peterson, S; Yager, JL, 2021
)
0.62
"HIV-negative adults were randomized to two 12-week DOT regimens of 33, 67 or 100% of daily dosing with emtricitabine (F)/TAF 200 mg/25 mg (TAF-DBS) or F/TDF 200 mg/300 mg (DOT-DBS), separated by a 12-week washout."( Tenofovir-diphosphate in peripheral blood mononuclear cells during low, medium and high adherence to emtricitabine/ tenofovir alafenamide vs. emtricitabine/ tenofovir disoproxil fumarate.
Anderson, PL; Brooks, KM; Bushman, L; Castillo-Mancilla, JR; Ibrahim, M; Kiser, JJ; MaWhinney, S; Morrow, M; Nemkov, C; Peterson, S; Yager, JL, 2021
)
0.62
"This is an open-label, randomized, fixed sequence single intravenous dosing study to assess pharmacokinetic interactions between remdesivir and TDF/3TC (Study A, crossover design) or TDF/3TC plus ATV/r (Study B)."( An open-label, randomized, single intravenous dosing study to investigate the effect of fixed-dose combinations of tenofovir/lamivudine or atazanavir/ritonavir on the pharmacokinetics of remdesivir in Ugandan healthy volunteers (RemTLAR).
Byakika-Kibwika, P; D'Avolio, A; Kaboggoza, JP; Lamorde, M; Waitt, C; Walimbwa, SI, 2021
)
0.62
"A simple, selective and rapid ultra performance liquid chromatography-tandem mass spectrometry method was developed and validated for the simultaneous estimation of dolutegravir, lamivudine and tenofovir in bulk and tablet dosage form."( Development and validation of ultra performance liquid chromatography-tandem mass spectrometry method for the simultaneous estimation of dolutegravir, lamivudine and tenofovir in bulk and tablet dosage form.
Dodda, S; Gangarapu, K; Veerareddy, V, 2021
)
0.62
" Different dosage forms - including films - for vaginal administration of antiretroviral drugs have been developed for this purpose."( Eudragit® L100/chitosan composite thin bilayer films for intravaginal pH-responsive release of Tenofovir.
Cazorla-Luna, R; Martín-Illana, A; Notario-Pérez, F; Rubio, J; Ruiz-Caro, R; Tamayo, A; Veiga, MD, 2022
)
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" Tenofovir is an important component of management, but the associated risk of nephrotoxicity makes dosing a challenge in patients with impaired kidney function."( Tenofovir alafenamide: An initial experience at Groote Schuur Hospital, Cape Town, South Africa.
Barday, Z; Geragotellis, A; Naicker, V; Patel, S; Sanglay, L; Sonderup, M; Spearman, CW; Wearne, N, 2022
)
0.72
" Final models were subjected to Monte Carlo simulations to compare drug exposure following once daily and on-demand (IPERGAY 2 + 1 + 1) dosing of F/TDF."( Population pharmacokinetics of tenofovir, emtricitabine and intracellular metabolites in transgender women.
Bakshi, RP; Chaturvedula, A; Fuchs, EJ; Hendrix, CW; Marzinke, MA; Shieh, E; Tanaudommongkon, A, 2022
)
0.72
" Simulations demonstrated that at least 2, weekly 2 + 1 + 1 cycles of on-demand dosing in TGW on GAHT is necessary for TFV-diphosphate to reach similar exposure after the initial week of on-demand dosing in CGM not on GAHT."( Population pharmacokinetics of tenofovir, emtricitabine and intracellular metabolites in transgender women.
Bakshi, RP; Chaturvedula, A; Fuchs, EJ; Hendrix, CW; Marzinke, MA; Shieh, E; Tanaudommongkon, A, 2022
)
0.72
"Daily dosing of tenofovir disoproxil fumarate, with or without emtricitabine, has high efficacy in preventing human immunodeficiency virus (HIV) infection when individuals are adherent."( Characterizing HIV-Preventive, Plasma Tenofovir Concentrations-A Pooled Participant-level Data Analysis From Human Immunodeficiency Virus Preexposure Prophylaxis Clinical Trials.
Anderson, P; Baeten, JM; Celum, CL; Choopanya, K; Garcia-Cremades, M; Glidden, DV; Grant, R; Hendrix, CW; Jarlsberg, L; Jayachandran, P; Marrazzo, J; Martin, M; Savic, RM; Vanichseni, S; Vučićević, K, 2022
)
0.72
" Dosing simulations indicated that high-risk women require full adherence to maintain protective levels."( Characterizing HIV-Preventive, Plasma Tenofovir Concentrations-A Pooled Participant-level Data Analysis From Human Immunodeficiency Virus Preexposure Prophylaxis Clinical Trials.
Anderson, P; Baeten, JM; Celum, CL; Choopanya, K; Garcia-Cremades, M; Glidden, DV; Grant, R; Hendrix, CW; Jarlsberg, L; Jayachandran, P; Marrazzo, J; Martin, M; Savic, RM; Vanichseni, S; Vučićević, K, 2022
)
0.72
" Systemic drug disposition during TAF implant dosing was explained by a multi-compartment pharmacokinetic (PK) model."( Fundamental aspects of long-acting tenofovir alafenamide delivery from subdermal implants for HIV prophylaxis.
Baum, MM; Beliveau, M; Buser, C; Caprioli, RM; Castonguay, AE; Gallay, PA; Gunawardana, M; Hendrix, CW; Kuo, J; Marzinke, MA; Moss, JA; Remedios-Chan, M; Reyzer, ML; Sanchez, D; Trinh, M; Tuck, M; Webster, P; Webster, S, 2022
)
0.72
" PrEP could be prescribed as a daily regimen with one pill per day or, in men who have sex with men (MSM) or in transgender women who have sex with men, as an on-demand regimen following the IPERGAY dosing recommendation."( Daily and on-demand HIV pre-exposure prophylaxis with emtricitabine and tenofovir disoproxil (ANRS PREVENIR): a prospective observational cohort study.
Algarte-Genin, M; Assoumou, L; Ben-Mechlia, M; Beniguel, L; Costagliola, D; Delaugerre, C; Ghosn, J; Goldwirt, L; Katlama, C; Le Mestre, S; Liegeon, G; Lourenco, J; Loze, B; Molina, JM; Mouhim, H; Ohayon, M; Pavie, J; Pialoux, G; Rojas-Castro, D; Slama, L; Spire, B; Surgers, L, 2022
)
0.72
" At enrolment, 1540 (50·5%) of 3049 participants opted for daily PrEP dosing and 1509 (49·5%) opted for on-demand PrEP dosing; these proportions remained stable during follow-up."( Daily and on-demand HIV pre-exposure prophylaxis with emtricitabine and tenofovir disoproxil (ANRS PREVENIR): a prospective observational cohort study.
Algarte-Genin, M; Assoumou, L; Ben-Mechlia, M; Beniguel, L; Costagliola, D; Delaugerre, C; Ghosn, J; Goldwirt, L; Katlama, C; Le Mestre, S; Liegeon, G; Lourenco, J; Loze, B; Molina, JM; Mouhim, H; Ohayon, M; Pavie, J; Pialoux, G; Rojas-Castro, D; Slama, L; Spire, B; Surgers, L, 2022
)
0.72
" We observed significant dose-response relationships between number of HIV risk factors and PrEP drug concentrations."( Alignment of PrEP adherence with periods of HIV risk among adolescent girls and young women in South Africa and Zimbabwe: a secondary analysis of the HPTN 082 randomised controlled trial.
Anderson, PL; Bekker, LG; Celum, C; Chirenje, ZM; Delany-Moretlwe, S; Donnell, D; Hosek, S; Marzinke, MA; Mgodi, N; Velloza, J, 2022
)
0.72
" TDF toxicity is more likely among African patients, it is reversible and TDF may be renal dosed in patients with dysfunction."( Proximal tubular renal dysfunction among HIV infected patients on Tenofovir versus Tenofovir sparing regimen in western Kenya.
Karoney, MJ; Koech, MK; Njiru, EW; Owino Ong'or, WD, 2022
)
0.72
" Our existing PK model, supported by an intravenous (IV) dosing dog study, was adapted to analyze mechanistic aspects underlying implant TAF delivery."( Preclinical Considerations for Long-acting Delivery of Tenofovir Alafenamide from Subdermal Implants for HIV Pre-exposure Prophylaxis.
Baum, MM; Beliveau, M; Fanter, R; Gallay, PA; Gunawardana, M; Kuo, J; Marzinke, MA; Moss, JA; Ramirez, CM; Remedios-Chan, M; Sanchez, D; Trinh, M; Webster, P; Webster, S, 2023
)
0.91
"Antiretroviral agents with novel mechanisms and dosing intervals could expand treatment options for people with HIV."( Lenacapavir administered every 26 weeks or daily in combination with oral daily antiretroviral therapy for initial treatment of HIV: a randomised, open-label, active-controlled, phase 2 trial.
Baeten, JM; Benson, P; Berhe, M; Crofoot, G; Dvory-Sobol, H; Gupta, SK; Koenig, E; Liu, SY; McDonald, C; Ramgopal, M; Rhee, MS; Ruane, P; Sanchez, WE; Scribner, A; Sims, J; VanderVeen, LA, 2023
)
0.91
"  Methods: In this randomized, open label, controlled pilot trial, we evaluated RBV (n=4) dosed for the initial 24 weeks of treatment versus no RBV (n=4) in tenofovir recipients dosed over 48 weeks."( Ribavirin Does Not Enhance Hepatitis B Virus Nucleotide Antiviral Activity: A Pilot Study.
Coffin, C; Cooper, C; Crawley, A; Fung, S; Keeshan, A; Ma, M; Mortimer, L; Osiowy, C; Patel, N; Vachon, A, 2022
)
0.72
" We characterized DBS TFVdp and FTCtp concentrations across many dosing scenarios."( A Novel Algorithm to Improve PrEP Adherence Monitoring Using Dried Blood Spots.
Anderson, DJC; Cottrell, ML; Devanathan, AS; Dumond, JB; Gay, CL; Kashuba, ADM; Moody, K; Poliseno, AJ; Rosen, EP; Schauer, AP; Sykes, C, 2023
)
0.91
"Dolutegravir concentrations are reduced by efavirenz induction effect necessitating twice-daily dolutegravir dosing when coadministered."( Initial Supplementary Dose of Dolutegravir in Second-Line Antiretroviral Therapy: A Noncomparative, Double-Blind, Randomized Placebo-Controlled Trial.
Griesel, R; Hill, A; Keene, C; Maartens, G; Meintjes, G; Omar, Z; Simmons, B; van Zyl, G; Zhao, Y, 2023
)
0.91
"7 ng/mL within 24 h after dosing in the third month postpartum."( Low levels of tenofovir in breast milk support breastfeeding in HBV-infected mothers treated with tenofovir disoproxil fumarate.
Jiang, X; Jiang, Y; Jin, J; Li, S; Lin, N; Ma, Z; Shi, J, 2023
)
0.91
" New non-vaccine biomedical products aimed at overcoming this global health challenge need to provide a range of safe, effective, and discreet dosage forms based on the delivery of one or more antiviral compounds."( Acute antagonism in three-drug combinations for vaginal HIV prevention in humanized mice.
Baum, MM; Gallay, PA; Ramirez, CM, 2023
)
0.91
" This semimechanistic model describes the population pharmacokinetics of tenofovir when dosed as either TDF or TAF in an African population living with HIV and can be used as a tool for exposure prediction in patients, and to simulate alternative regimes to inform further clinical trials."( Population pharmacokinetics of tenofovir given as either tenofovir disoproxil fumarate or tenofovir alafenamide in an African population.
Chandiwana, N; Denti, P; Kawuma, AN; Maartens, G; Sinxadi, P; Sokhela, SM; Venter, WDF; Wasmann, RE; Wiesner, L, 2023
)
0.91
" However, considering its rapid uptake into target cells, we suggest only a cautious increase of tenofovir alafenamide dosage intervals to 2 or 3 days only in case of moderate or severe CKD, respectively."( Population pharmacokinetic modelling to characterize the effect of chronic kidney disease on tenofovir exposure after tenofovir alafenamide administration.
Alves Saldanha, S; Andre, P; Buclin, T; Cavassini, M; Courlet, P; Decosterd, LA; Desfontaine, V; Guidi, M; Kusejko, K; Thoueille, P, 2023
)
0.91
" Due to the long dosing interval (8 weeks), long-acting cabotegravir has low compliance requirements for people at high risk of HIV infection."( Efficacy and safety of long-acting cabotegravir versus oral tenofovir disoproxil fumarate-emtricitabine as HIV pre-exposure prophylaxis: A systematic review and meta-analysis.
Chen, X; Kou, L; Li, J; Li, Y; Wei, D; Xie, X, 2023
)
0.91
" Daily emtricitabine/TAF was dosed according to World Health Organization (WHO)-recommended weight bands: 120/15 mg in children weighing 14 to <25 kg and 200/25 mg in those weighing ≥25 kg."( First Pharmacokinetic Data of Tenofovir Alafenamide Fumarate and Tenofovir With Dolutegravir or Boosted Protease Inhibitors in African Children: A Substudy of the CHAPAS-4 Trial.
Bamford, A; Burger, DM; Bwakura-Dangarembizi, M; Chabala, C; Colbers, A; Denti, P; Doerholt, K; Gibb, DM; Griffiths, AL; Makumbi, S; McIlleron, HM; Monkiewicz, LN; Mulenga, V; Mumbiro, V; Musiime, V; Nangiya, J; Szubert, AJ; Waalewijn, H; Wasmann, RE; Wiesner, L, 2023
)
0.91
"In children, TAF combined with boosted PIs or dolutegravir and dosed according to WHO-recommended weight bands provides TAF and tenofovir concentrations previously demonstrated to be well tolerated and effective in adults."( First Pharmacokinetic Data of Tenofovir Alafenamide Fumarate and Tenofovir With Dolutegravir or Boosted Protease Inhibitors in African Children: A Substudy of the CHAPAS-4 Trial.
Bamford, A; Burger, DM; Bwakura-Dangarembizi, M; Chabala, C; Colbers, A; Denti, P; Doerholt, K; Gibb, DM; Griffiths, AL; Makumbi, S; McIlleron, HM; Monkiewicz, LN; Mulenga, V; Mumbiro, V; Musiime, V; Nangiya, J; Szubert, AJ; Waalewijn, H; Wasmann, RE; Wiesner, L, 2023
)
0.91
" Although no dosage adjustment is needed for Oral Nirmatrelvir/Ritonavir in patients with mild renal impairment and coronavirus disease 2019, the dosage is reduced to twice daily in those with moderate renal impairment."( Medication safety in chronic kidney disease.
Singh, S, 2023
)
0.91
"Cabotegravir plus rilpivirine is the only approved complete long-acting regimen for the maintenance of HIV-1 virological suppression dosed every 2 months."( Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a random
Berni, A; Castagna, A; Cazanave, C; Chounta, V; D'Amico, R; Di Perri, G; Diaz-Brito, V; Dretler, R; Garges, HP; Latham, CL; Oka, S; Osiyemi, O; Pascual Bernáldez, M; Patel, P; Ramgopal, MN; Sims, J; Smith, K; Spreen, WR; Sutherland-Phillips, D; Sutton, K; Van Eygen, V; Van Solingen-Ristea, R; van Wyk, J; Walmsley, S; Zhang, F, 2023
)
0.91
" Participants with HIV-1 RNA less than 50 copies per mL were randomly assigned (2:1), stratified by sex at birth and BMI, to either long-acting cabotegravir (600 mg) plus rilpivirine (900 mg) dosed intramuscularly every 2 months or to continue daily oral bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg)."( Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a random
Berni, A; Castagna, A; Cazanave, C; Chounta, V; D'Amico, R; Di Perri, G; Diaz-Brito, V; Dretler, R; Garges, HP; Latham, CL; Oka, S; Osiyemi, O; Pascual Bernáldez, M; Patel, P; Ramgopal, MN; Sims, J; Smith, K; Spreen, WR; Sutherland-Phillips, D; Sutton, K; Van Eygen, V; Van Solingen-Ristea, R; van Wyk, J; Walmsley, S; Zhang, F, 2023
)
0.91
"These data support the use of long-acting cabotegravir plus rilpivirine dosed every 2 months as a complete antiretroviral regimen that has similar efficacy to a commonly used integrase strand transfer inhibitor-based first-line regimen, while addressing unmet psychosocial issues associated with daily oral treatment."( Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a random
Berni, A; Castagna, A; Cazanave, C; Chounta, V; D'Amico, R; Di Perri, G; Diaz-Brito, V; Dretler, R; Garges, HP; Latham, CL; Oka, S; Osiyemi, O; Pascual Bernáldez, M; Patel, P; Ramgopal, MN; Sims, J; Smith, K; Spreen, WR; Sutherland-Phillips, D; Sutton, K; Van Eygen, V; Van Solingen-Ristea, R; van Wyk, J; Walmsley, S; Zhang, F, 2023
)
0.91
"To develop an injectable dosage form of the daily oral HIV drugs, tenofovir (T), lamivudine (L), and dolutegravir (D), creating a single, complete, all-in-one TLD 3-drug-combination that demonstrates long-acting pharmacokinetics."( A novel formulation enabled transformation of 3-HIV drugs tenofovir-lamivudine-dolutegravir from short-acting to long-acting all-in-one injectable.
Collier, AC; Delle Fratte, R; Eguchi, M; Ho, RJY; Melvin, AJ; Perazzolo, S; Stephen, ZR; Xu, X, 2023
)
0.91
" Studies in macaques found that shorter courses of PEP with INSTIs were effective, particularly if dosing occurred close to the time of retroviral exposure."( Post-exposure prophylaxis to prevent HIV: new drugs, new approaches, and more questions.
Allan-Blitz, LT; Mayer, KH, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
HIV-1 reverse transcriptase inhibitorAn entity which inhibits the activity of HIV-1 reverse transcriptase.
antiviral drugA substance used in the prophylaxis or therapy of virus diseases.
drug metabolitenull
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (2)

ClassDescription
phosphonic acidsHP(=O)(OH)2 (phosphonic acid) and its P-substituted derivatives.
nucleoside analogueAn analogue of a nucleoside, being an N-glycosyl compound in which the nitrogen-containing moiety is a modified nucleotide base. They are commonly used as antiviral products to prevent viral replication in infected cells.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (1)

PathwayProteinsCompounds
Tenofovir Metabolism Pathway45

Protein Targets (11)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
EWS/FLI fusion proteinHomo sapiens (human)Potency0.46860.001310.157742.8575AID1259255
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Cytochrome P450 3A4Homo sapiens (human)IC50 (µMol)45.80000.00011.753610.0000AID1832362
Replicase polyprotein 1abSevere acute respiratory syndrome-related coronavirusIC50 (µMol)12.98500.00402.92669.9600AID1805801
Replicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2IC50 (µMol)12.98500.00022.45859.9600AID1805801
Cytochrome P450 2D6Homo sapiens (human)IC50 (µMol)50.00000.00002.015110.0000AID1832361
Reverse transcriptase/RNaseH Human immunodeficiency virus 1IC50 (µMol)0.38000.00011.076810.0000AID289142; AID320326; AID393069
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Capsid protein Hepatitis B virusEC50 (µMol)0.24150.00020.26030.8194AID1363957
Reverse transcriptase/RNaseH Human immunodeficiency virus 1Kd3.20000.00062.40599.8000AID341978
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Solute carrier family 22 member 6Homo sapiens (human)Km33.80000.42004.61839.3000AID544648
Reverse transcriptase/RNaseH Human immunodeficiency virus 1Activity1.35000.00091.30738.0000AID341976; AID341977; AID341991; AID341992
Reverse transcriptase/RNaseH Human immunodeficiency virus 1Km1,112.50000.07001.91446.9000AID341979; AID341980; AID341981; AID341982
Solute carrier family 22 member 8Homo sapiens (human)Km770.00000.34501.32173.1000AID544649
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (46)

Processvia Protein(s)Taxonomy
ADP biosynthetic processAdenylate kinase isoenzyme 1Homo sapiens (human)
nucleoside triphosphate biosynthetic processAdenylate kinase isoenzyme 1Homo sapiens (human)
nucleobase-containing small molecule interconversionAdenylate kinase isoenzyme 1Homo sapiens (human)
AMP metabolic processAdenylate kinase isoenzyme 1Homo sapiens (human)
ATP metabolic processAdenylate kinase isoenzyme 1Homo sapiens (human)
nucleoside monophosphate phosphorylationAdenylate kinase isoenzyme 1Homo sapiens (human)
lipid hydroxylationCytochrome P450 3A4Homo sapiens (human)
lipid metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid catabolic processCytochrome P450 3A4Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid metabolic processCytochrome P450 3A4Homo sapiens (human)
cholesterol metabolic processCytochrome P450 3A4Homo sapiens (human)
androgen metabolic processCytochrome P450 3A4Homo sapiens (human)
estrogen metabolic processCytochrome P450 3A4Homo sapiens (human)
alkaloid catabolic processCytochrome P450 3A4Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 3A4Homo sapiens (human)
calcitriol biosynthetic process from calciolCytochrome P450 3A4Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D metabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D catabolic processCytochrome P450 3A4Homo sapiens (human)
retinol metabolic processCytochrome P450 3A4Homo sapiens (human)
retinoic acid metabolic processCytochrome P450 3A4Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 3A4Homo sapiens (human)
aflatoxin metabolic processCytochrome P450 3A4Homo sapiens (human)
oxidative demethylationCytochrome P450 3A4Homo sapiens (human)
symbiont-mediated perturbation of host ubiquitin-like protein modificationReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
xenobiotic metabolic processCytochrome P450 2D6Homo sapiens (human)
steroid metabolic processCytochrome P450 2D6Homo sapiens (human)
cholesterol metabolic processCytochrome P450 2D6Homo sapiens (human)
estrogen metabolic processCytochrome P450 2D6Homo sapiens (human)
coumarin metabolic processCytochrome P450 2D6Homo sapiens (human)
alkaloid metabolic processCytochrome P450 2D6Homo sapiens (human)
alkaloid catabolic processCytochrome P450 2D6Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2D6Homo sapiens (human)
isoquinoline alkaloid metabolic processCytochrome P450 2D6Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2D6Homo sapiens (human)
retinol metabolic processCytochrome P450 2D6Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 2D6Homo sapiens (human)
negative regulation of bindingCytochrome P450 2D6Homo sapiens (human)
oxidative demethylationCytochrome P450 2D6Homo sapiens (human)
negative regulation of cellular organofluorine metabolic processCytochrome P450 2D6Homo sapiens (human)
arachidonic acid metabolic processCytochrome P450 2D6Homo sapiens (human)
ADP biosynthetic processAdenylate kinase 2, mitochondrialHomo sapiens (human)
nucleobase-containing small molecule interconversionAdenylate kinase 2, mitochondrialHomo sapiens (human)
AMP metabolic processAdenylate kinase 2, mitochondrialHomo sapiens (human)
ATP metabolic processAdenylate kinase 2, mitochondrialHomo sapiens (human)
nucleoside monophosphate phosphorylationAdenylate kinase 2, mitochondrialHomo sapiens (human)
monoatomic anion transportSolute carrier family 22 member 6Homo sapiens (human)
response to organic cyclic compoundSolute carrier family 22 member 6Homo sapiens (human)
inorganic anion transportSolute carrier family 22 member 6Homo sapiens (human)
organic anion transportSolute carrier family 22 member 6Homo sapiens (human)
prostaglandin transportSolute carrier family 22 member 6Homo sapiens (human)
alpha-ketoglutarate transportSolute carrier family 22 member 6Homo sapiens (human)
xenobiotic transportSolute carrier family 22 member 6Homo sapiens (human)
sodium-independent organic anion transportSolute carrier family 22 member 6Homo sapiens (human)
transmembrane transportSolute carrier family 22 member 6Homo sapiens (human)
metanephric proximal tubule developmentSolute carrier family 22 member 6Homo sapiens (human)
renal tubular secretionSolute carrier family 22 member 6Homo sapiens (human)
monoatomic ion transportSolute carrier family 22 member 8Homo sapiens (human)
response to toxic substanceSolute carrier family 22 member 8Homo sapiens (human)
inorganic anion transportSolute carrier family 22 member 8Homo sapiens (human)
prostaglandin transportSolute carrier family 22 member 8Homo sapiens (human)
xenobiotic transportSolute carrier family 22 member 8Homo sapiens (human)
transmembrane transportSolute carrier family 22 member 8Homo sapiens (human)
transport across blood-brain barrierSolute carrier family 22 member 8Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (50)

Processvia Protein(s)Taxonomy
adenylate kinase activityAdenylate kinase isoenzyme 1Homo sapiens (human)
nucleoside diphosphate kinase activityAdenylate kinase isoenzyme 1Homo sapiens (human)
ATP bindingAdenylate kinase isoenzyme 1Homo sapiens (human)
nucleoside triphosphate adenylate kinase activityAdenylate kinase isoenzyme 1Homo sapiens (human)
monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
steroid bindingCytochrome P450 3A4Homo sapiens (human)
iron ion bindingCytochrome P450 3A4Homo sapiens (human)
protein bindingCytochrome P450 3A4Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
retinoic acid 4-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
oxidoreductase activityCytochrome P450 3A4Homo sapiens (human)
oxygen bindingCytochrome P450 3A4Homo sapiens (human)
enzyme bindingCytochrome P450 3A4Homo sapiens (human)
heme bindingCytochrome P450 3A4Homo sapiens (human)
vitamin D3 25-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
caffeine oxidase activityCytochrome P450 3A4Homo sapiens (human)
quinine 3-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
testosterone 6-beta-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1-alpha,25-dihydroxyvitamin D3 23-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
aromatase activityCytochrome P450 3A4Homo sapiens (human)
vitamin D 24-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1,8-cineole 2-exo-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
3'-5'-RNA exonuclease activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
RNA-dependent RNA polymerase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
cysteine-type endopeptidase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
mRNA 5'-cap (guanine-N7-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
mRNA (nucleoside-2'-O-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
5'-3' RNA helicase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
K63-linked deubiquitinase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
K48-linked deubiquitinase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
3'-5'-RNA exonuclease activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
RNA-dependent RNA polymerase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
cysteine-type endopeptidase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA 5'-cap (guanine-N7-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA (nucleoside-2'-O-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA guanylyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
RNA endonuclease activity, producing 3'-phosphomonoestersReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
ISG15-specific peptidase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
5'-3' RNA helicase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
protein guanylyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
monooxygenase activityCytochrome P450 2D6Homo sapiens (human)
iron ion bindingCytochrome P450 2D6Homo sapiens (human)
oxidoreductase activityCytochrome P450 2D6Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2D6Homo sapiens (human)
heme bindingCytochrome P450 2D6Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
adenylate kinase activityAdenylate kinase 2, mitochondrialHomo sapiens (human)
protein bindingAdenylate kinase 2, mitochondrialHomo sapiens (human)
ATP bindingAdenylate kinase 2, mitochondrialHomo sapiens (human)
solute:inorganic anion antiporter activitySolute carrier family 22 member 6Homo sapiens (human)
protein bindingSolute carrier family 22 member 6Homo sapiens (human)
organic anion transmembrane transporter activitySolute carrier family 22 member 6Homo sapiens (human)
prostaglandin transmembrane transporter activitySolute carrier family 22 member 6Homo sapiens (human)
alpha-ketoglutarate transmembrane transporter activitySolute carrier family 22 member 6Homo sapiens (human)
antiporter activitySolute carrier family 22 member 6Homo sapiens (human)
transmembrane transporter activitySolute carrier family 22 member 6Homo sapiens (human)
chloride ion bindingSolute carrier family 22 member 6Homo sapiens (human)
identical protein bindingSolute carrier family 22 member 6Homo sapiens (human)
xenobiotic transmembrane transporter activitySolute carrier family 22 member 6Homo sapiens (human)
sodium-independent organic anion transmembrane transporter activitySolute carrier family 22 member 6Homo sapiens (human)
solute:inorganic anion antiporter activitySolute carrier family 22 member 8Homo sapiens (human)
organic anion transmembrane transporter activitySolute carrier family 22 member 8Homo sapiens (human)
prostaglandin transmembrane transporter activitySolute carrier family 22 member 8Homo sapiens (human)
xenobiotic transmembrane transporter activitySolute carrier family 22 member 8Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (17)

Processvia Protein(s)Taxonomy
outer dense fiberAdenylate kinase isoenzyme 1Homo sapiens (human)
cytosolAdenylate kinase isoenzyme 1Homo sapiens (human)
extracellular exosomeAdenylate kinase isoenzyme 1Homo sapiens (human)
cytoplasmAdenylate kinase isoenzyme 1Homo sapiens (human)
cytosolAdenylate kinase isoenzyme 1Homo sapiens (human)
cytoplasmCytochrome P450 3A4Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 3A4Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 3A4Homo sapiens (human)
double membrane vesicle viral factory outer membraneReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
double membrane vesicle viral factory outer membraneReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mitochondrionCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulumCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2D6Homo sapiens (human)
cytoplasmCytochrome P450 2D6Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2D6Homo sapiens (human)
mitochondrial intermembrane spaceAdenylate kinase 2, mitochondrialHomo sapiens (human)
extracellular exosomeAdenylate kinase 2, mitochondrialHomo sapiens (human)
sperm mitochondrial sheathAdenylate kinase 2, mitochondrialHomo sapiens (human)
cytoplasmAdenylate kinase 2, mitochondrialHomo sapiens (human)
mitochondrionAdenylate kinase 2, mitochondrialHomo sapiens (human)
plasma membraneSolute carrier family 22 member 6Homo sapiens (human)
caveolaSolute carrier family 22 member 6Homo sapiens (human)
basal plasma membraneSolute carrier family 22 member 6Homo sapiens (human)
basolateral plasma membraneSolute carrier family 22 member 6Homo sapiens (human)
extracellular exosomeSolute carrier family 22 member 6Homo sapiens (human)
protein-containing complexSolute carrier family 22 member 6Homo sapiens (human)
plasma membraneSolute carrier family 22 member 8Homo sapiens (human)
basolateral plasma membraneSolute carrier family 22 member 8Homo sapiens (human)
apical plasma membraneSolute carrier family 22 member 8Homo sapiens (human)
extracellular exosomeSolute carrier family 22 member 8Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (576)

Assay IDTitleYearJournalArticle
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID548820Antiviral activity against HIV1 isolate 071 harboring reverse transcriptase 65R/S68N/184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID549069Cellular uptake in PHA/IL-2-stimulated human PBMC at 1 uM assessed as TFV-diphosphate level after 24 hrs by MS/MS analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548847Cellular uptake in human PBMC at 10 uM assessed as TFV-diphosphate after 24 hrs by MS/MS analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID558382Drug level in HIV-infected pregnant woman amniotic fluid at 300 mg, po QD by LC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genital tract, cord blood, and amniotic fluid exposures of seven antiretroviral drugs during and after pregnancy in human immunodeficiency virus type 1-infected women.
AID289144Antiviral activity against HIV1 with reverse transcriptase 6TAM mutation assessed as reduction of potency relative to wild type2007Bioorganic & medicinal chemistry, Aug-15, Volume: 15, Issue:16
Synthesis, anti-HIV activity, and resistance profile of thymidine phosphonomethoxy nucleosides and their bis-isopropyloxymethylcarbonyl (bisPOC) prodrugs.
AID544649Activity of human OAT3 transfected in BHK-21 cells2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Novel nucleotide human immunodeficiency virus reverse transcriptase inhibitor GS-9148 with a low nephrotoxic potential: characterization of renal transport and accumulation.
AID1636525Cytotoxicity against human PBMC assessed as reduction in cell viability by XTT assay2016Journal of medicinal chemistry, 08-11, Volume: 59, Issue:15
Reduction Sensitive Lipid Conjugates of Tenofovir: Synthesis, Stability, and Antiviral Activity.
AID618320Cytotoxicity against PAP-activated human H9 cells on day 7 by MTT assay2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID548833Antiviral activity against HIV1 isolate 201 harboring reverse transcriptase M41L/L210W/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID394461Cmax in Sprague-Dawley rat assessed as tenofovir level at 100 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID341184Cytotoxicity against human MT4 cells by MTT assay2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Activity against human immunodeficiency virus type 1, intracellular metabolism, and effects on human DNA polymerases of 4'-ethynyl-2-fluoro-2'-deoxyadenosine.
AID322847Fold resistance, ratio of Lamivudine -adenofir-resistant HBV with reverse transcriptase V173L/L180M/A181V mutant to wildtype HBV genotype E2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID394468AUC (0 to 24 hrs) in Sprague-Dawley rat assessed as tenofovir level at 10 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID1140531Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of hepatitis B surface antigen secretion by ELISA2014Bioorganic & medicinal chemistry letters, May-15, Volume: 24, Issue:10
Synthesis, structure-activity relationships and biological evaluation of dehydroandrographolide and andrographolide derivatives as novel anti-hepatitis B virus agents.
AID1457750Cytotoxicity against human TZM-bl cells assessed as cell viability by tetrazolium dye assay2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID548803Antiviral activity against HIV1 isolate 201 harboring reverse transcriptase M41L/L210W/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548584Antiviral activity against HIV1 isolate 160 harboring reverse transcriptase S68G/V75(I/T)/F77L/Y115F/F116Y /Q151M mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID341979Activity of HIV1 reverse transcriptase assessed as nucleotide excision activity in presence of 0.5 uM dCTP2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID588964Substrates of transporters of clinical importance in the absorption and disposition of drugs, OAT12010Nature reviews. Drug discovery, Mar, Volume: 9, Issue:3
Membrane transporters in drug development.
AID618434Antiviral activity against Hepatitis B virus infected in human HuH7 cells assessed as reduction in viral DNA level treated day 3 to day 8 post transfection by real time quantitative PCR analysis2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID548804Antiviral activity against HIV1 isolate 203 harboring reverse transcriptase M41L/L210W/T215Y/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID548817Antiviral activity against HIV1 isolate 067 harboring reverse transcriptase A62V/D67G/T69SVG/V75I/T215I mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID289146Antiviral activity against HIV with reverse transcriptase M184V mutation assessed as reduction of potency relative to wild type2007Bioorganic & medicinal chemistry, Aug-15, Volume: 15, Issue:16
Synthesis, anti-HIV activity, and resistance profile of thymidine phosphonomethoxy nucleosides and their bis-isopropyloxymethylcarbonyl (bisPOC) prodrugs.
AID394464Tmax in Sprague-Dawley rat assessed as tenofovir level at 30 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID10054Antiviral activity against AD169 strain of cytomegalovirus (CMV) in HEL (human erythroleukemia) cells.2003Journal of medicinal chemistry, Nov-06, Volume: 46, Issue:23
5-Substituted-2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]pyrimidines-acyclic nucleoside phosphonate analogues with antiviral activity.
AID392504Antiviral activity against Cowpox virus2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
AID548816Antiviral activity against HIV1 isolate 066 harboring reverse transcriptase 184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1186716Activity of recombinant AK2 (unknown origin) assessed as ADP formation by spectroscopic pyruvate kinase/lactate dehydrogenase coupled assay2014Bioorganic & medicinal chemistry letters, Sep-01, Volume: 24, Issue:17
Synthesis of {[5-(adenin-9-yl)-2-furyl]methoxy}methyl phosphonic acid and evaluations against human adenylate kinases.
AID1832365Metabolic stability in human liver microsomes assessed as half life at 3 uM measured up to 30 min in presence of NADPH by LC-MS/MS analysis2021Journal of medicinal chemistry, 09-09, Volume: 64, Issue:17
ω-Functionalized Lipid Prodrugs of HIV NtRTI Tenofovir with Enhanced Pharmacokinetic Properties.
AID548835Antiviral activity against HIV1 isolate 204 harboring reverse transcriptase M41L/L210W/T215Y/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1457752Antiviral activity against CCR5 tropic HIV1 BaL infected in human PHA-stimulated PBMC assessed as inhibition of viral replication by measuring reduction in p24 antigen production preincubated with cells for 30 mins followed by viral infection measured on 2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID1686654Therapeutic index, ratio of CC50 for uninfected human PBMC to EC50 for HIV1 infected in human PBMC2016Journal of medicinal chemistry, 11-23, Volume: 59, Issue:22
Next-Generation Reduction Sensitive Lipid Conjugates of Tenofovir: Antiviral Activity and Mechanism of Release.
AID729827Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of viral surface antigen production2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis of hemslecin A derivatives: a new class of hepatitis B virus inhibitors.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID275090Cytotoxicity against MAGI-CCR5 cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID618313Antiviral activity against 100 TCID50 wild-type Human immunodeficiency virus 1 3B infected in CEM cells assessed as inhibition of syncytia formation after 4 days by microscopic analysis2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID548805Antiviral activity against HIV1 isolate 204 harboring reverse transcriptase M41L/L210W/T215Y/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1192287Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for inhibition of HBV HBeAg secretion in HepG2(2.2.15) cells2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Synthesis of erythrocentaurin derivatives as a new class of hepatitis B virus inhibitors.
AID1599865Cmax in Sprague-Dawley rat at 20 mg/kg, po administered as single dose and measured after 0.25 to 24 hrs by HPLC analysis2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID341180Antiviral activity against R5-HIV1MDR/MM assessed as inhibition of p24 Gag protein production in human PHA-PBMC by ELISA2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Activity against human immunodeficiency virus type 1, intracellular metabolism, and effects on human DNA polymerases of 4'-ethynyl-2-fluoro-2'-deoxyadenosine.
AID618322Antiviral activity against HIV1 clade B isolate 2101 infected in human H9 cells assessed as inhibition of viral replication2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID557023Antiviral activity against HIV1 clade A harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID568380Antiviral activity against HBV infected in human HepG 2.215 cells assessed as inhibition of DNA replication by RT-PCR analysis2011Bioorganic & medicinal chemistry, Feb-15, Volume: 19, Issue:4
Synthesis and biological assay of 4-aryl-6-chloro-quinoline derivatives as novel non-nucleoside anti-HBV agents.
AID1636522Oral bioavailability in mouse2016Journal of medicinal chemistry, 08-11, Volume: 59, Issue:15
Reduction Sensitive Lipid Conjugates of Tenofovir: Synthesis, Stability, and Antiviral Activity.
AID394447Selectivity index, ratio of CC50 for human HepG2 cells to EC50 for HBV2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID125503Antiproliferative activity was determined against human T-lymphocyte cells -Molt4/C82003Journal of medicinal chemistry, Jun-19, Volume: 46, Issue:13
Deoxyribonucleoside 2'- or 3'-mixed disulfides: prodrugs to target ribonucleotide reductase and/or to inhibit HIV reverse transcription.
AID1192289Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for inhibition of HBV DNA replication in HepG2(2.2.15) cells2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Synthesis of erythrocentaurin derivatives as a new class of hepatitis B virus inhibitors.
AID548837Antiviral activity against HIV1 isolate 211 harboring reverse transcriptase D67N/K70R/T215F/K219E/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID341977Inhibition of HIV1 reverse transcriptase assessed as dCTP level required to form 80% of binary enzyme complex formation with drug-terminated primer in posttranslocation state by site-specific foot printing assay2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID659695Selectivity ratio of CC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral replication2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis, structure-activity relationships and biological evaluation of caudatin derivatives as novel anti-hepatitis B virus agents.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID548561Antiviral activity against HIV1 52534-2 harboring reverse transcriptase 41L//74V/210W/215Y/184V/69SSS mutant gene infected in human PBMC by ELISA2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID423157Antiviral activity against wild type HIV1 NL4-3 produced from full length pR9deltaApa infected in human MAGIC-5A cells assessed as inhibition of Lac+ foci expression after 40 hrs2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Human immunodeficiency virus types 1 and 2 exhibit comparable sensitivities to Zidovudine and other nucleoside analog inhibitors in vitro.
AID394465Tmax in Sprague-Dawley rat assessed as tenofovir level at 30 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID548838Antiviral activity against HIV1 isolate 212 harboring reverse transcriptase L210W/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID548557Antiviral activity against HIV1 7324-1 harboring reverse transcriptase 41L/67N/69N/70R/215F/219E mutant gene infected in human PBMC by ELISA2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1140533Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of hepatitis B e antigen secretion by ELISA2014Bioorganic & medicinal chemistry letters, May-15, Volume: 24, Issue:10
Synthesis, structure-activity relationships and biological evaluation of dehydroandrographolide and andrographolide derivatives as novel anti-hepatitis B virus agents.
AID394457Antiviral activity against HIV1 LAI in human MT2 cells assessed as inhibition of p24 antigen production by ELISA2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID1186715Activity of recombinant AK1 (unknown origin) assessed as ADP formation by spectroscopic pyruvate kinase/lactate dehydrogenase coupled assay2014Bioorganic & medicinal chemistry letters, Sep-01, Volume: 24, Issue:17
Synthesis of {[5-(adenin-9-yl)-2-furyl]methoxy}methyl phosphonic acid and evaluations against human adenylate kinases.
AID548819Antiviral activity against HIV1 isolate 070 harboring reverse transcriptase 65R/S68G mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548809Antiviral activity against HIV1 isolate 215 harboring reverse transcriptase D67N/K70E mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID394477AUC (0 to infinity) in Sprague-Dawley rat assessed as tenofovir level at 30 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID289141Inhibition of virus-induced cytopathic effect in wild type HIV 3a infected MT2 cells after 5 days2007Bioorganic & medicinal chemistry, Aug-15, Volume: 15, Issue:16
Synthesis, anti-HIV activity, and resistance profile of thymidine phosphonomethoxy nucleosides and their bis-isopropyloxymethylcarbonyl (bisPOC) prodrugs.
AID1600830Antiviral activity against hepatitis B virus infected in human HepG2.2.15 cells assessed as reduction in HBeAg secretion at 5 uM incubated for 9 days by ELISA (Rvb = 25.13 +/- 1.93 ng/ml)2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
Design, synthesis and biological evaluation of benzamide derivatives as novel NTCP inhibitors that induce apoptosis in HepG2 cells.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID394470AUC (0 to 24 hrs) in Sprague-Dawley rat assessed as tenofovir level at 30 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID322848Fold resistance, ratio of Lamivudine -adenofir-resistant with HBV reverse transcriptase V173L/L180M/A181V/M204V mutant to wildtype HBV genotype E2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID392513Antiviral activity against HIV12009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
AID328845Inhibition of human MRP3 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence at 10 uM by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID105555In vitro antiviral activity against HIV-1 in MT-4 cells2001Bioorganic & medicinal chemistry letters, Apr-23, Volume: 11, Issue:8
Synthesis and evaluation of novel amidate prodrugs of PMEA and PMPA.
AID1649794Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as reduction in viral DNA levels incubated for 6 days by PCR analysis2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
Discovery of (1
AID1186718Ratio of Kcat to Km for recombinant AK2 (unknown origin)2014Bioorganic & medicinal chemistry letters, Sep-01, Volume: 24, Issue:17
Synthesis of {[5-(adenin-9-yl)-2-furyl]methoxy}methyl phosphonic acid and evaluations against human adenylate kinases.
AID1561719Antiviral activity against HIV1 3B infected in human MT4 cells grown under 30 passages in presence of 4-[[4-[[4-[4-[2-cyanovinyl]-2,6-dimethylphenoxy]thieno[3,2-d]pyrimidin-2-yl]amino]-1-piperidyl]methyl]benzenesulfonamide assessed as protection against v
AID548798Antiviral activity against HIV1 isolate 185 harboring reverse transcriptase T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID659571Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral DNA replication by RT-PCR analysis2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis, structure-activity relationships and biological evaluation of caudatin derivatives as novel anti-hepatitis B virus agents.
AID618509Cytotoxicity against human HEL cells assessed as alteration in cellular morphology by microscopic analysis2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID1599864Tmax in Sprague-Dawley rat at 20 mg/kg, po administered as single dose and measured after 0.25 to 24 hrs by HPLC analysis2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID322828Antiviral activity against adenofir-resistant HBV with reverse transcriptase N236T mutant assessed as inhibition of replication2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID328846Inhibition of human MRP1 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence at 10 uM by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID394466Tmax in Sprague-Dawley rat assessed as tenofovir level at 100 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID548564Selectivity ratio of EC50 for HIV1 7324-1 harboring reverse transcriptase 41L/67N/69N/70R/215F/219E mutant gene infected in human PBMC to EC50 for HIV1 NL 4-3 expressing wild type reverse transcriptase infected in human PBMC2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID98126Antiproliferative activity was determined against murine leukemia cells (L1210)2003Journal of medicinal chemistry, Jun-19, Volume: 46, Issue:13
Deoxyribonucleoside 2'- or 3'-mixed disulfides: prodrugs to target ribonucleotide reductase and/or to inhibit HIV reverse transcription.
AID1599863Half-life in Sprague-Dawley rat at 20 mg/kg, po administered as single dose and measured after 0.25 to 24 hrs by HPLC analysis2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1457749Antiviral activity against CCR5 tropic HIV1 BaL infected in human TZM-bl cells assessed as inhibition of virus-induced cytopathic effect preincubated with cells for 30 mins followed by viral infection measured after 48 hrs in presence of p-24 HIV-1 Ag by 2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID322833Fold resistance, ratio of EC50 for lamivudine-adefovir-resistant HBV with reverse transcriptase L180M/M204V/N236T mutant to EC50 for wild-type HBV2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID341368Antiviral activity against HIV1 NL4-3 replication in human MT4 cells at 0.01 uM pretreated 24 hrs before infection assessed as protection at 1 uM by MTT assay2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Activity against human immunodeficiency virus type 1, intracellular metabolism, and effects on human DNA polymerases of 4'-ethynyl-2-fluoro-2'-deoxyadenosine.
AID1686646Retention time in PBS buffer at pH 7.4 using compound 6 by LC-MS analysis2016Journal of medicinal chemistry, 11-23, Volume: 59, Issue:22
Next-Generation Reduction Sensitive Lipid Conjugates of Tenofovir: Antiviral Activity and Mechanism of Release.
AID394459Cmax in Sprague-Dawley rat assessed as tenofovir level at 30 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID1192285Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for inhibition of HBV HBsAg secretion in HepG2(2.2.15) cells2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Synthesis of erythrocentaurin derivatives as a new class of hepatitis B virus inhibitors.
AID341983Ratio of Kcat to Km for HIV1 reverse transcriptase assessed as nucleotide excision activity in presence of 0.5 uM dCTP2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID478937Cytotoxicity against human HepG2 cells assessed as inhibition of cellular DNA replication after 14 days2010Bioorganic & medicinal chemistry, May-15, Volume: 18, Issue:10
Discovery of GS-9131: Design, synthesis and optimization of amidate prodrugs of the novel nucleoside phosphonate HIV reverse transcriptase (RT) inhibitor GS-9148.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1457748Antiviral activity against CXCR4-tropic HIV-1 NL4-3 infected in human TZM-bl cells assessed as inhibition of virus-induced cytopathic effect preincubated with cells for 30 mins followed by viral infection measured after 48 hrs in presence of p-24 HIV-1 Ag2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID341982Activity of HIV1 reverse transcriptase M41L/D67N/L210W/T215Y mutant assessed as nucleotide excision activity in presence of 10 uM dCTP2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID82134Antiviral activity against HIV-1 (IIIB) in CEM (human leukemia) cells.2003Journal of medicinal chemistry, Nov-06, Volume: 46, Issue:23
5-Substituted-2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]pyrimidines-acyclic nucleoside phosphonate analogues with antiviral activity.
AID341986Ratio of Kcat to Km for HIV1 reverse transcriptase M41L/D67N/L210W/T215Y mutant assessed as nucleotide excision activity in presence of 10 uM dCTP2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID310043Antiviral activity against Hepatitis B virus infected human HepG2 cells after 9 days by MTT assay2007Bioorganic & medicinal chemistry letters, Nov-15, Volume: 17, Issue:22
Some new acyclic nucleotide analogues as antiviral prodrugs: synthesis and bioactivities in vitro.
AID557049Antiviral activity against HIV1 clade G harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID548559Antiviral activity against HIV1 7303-3 harboring reverse transcriptase 41L/44D/67N/69D/118I/210W/215Y mutant gene infected in human PBMC by ELISA2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID422693Antiviral activity against HIV1 with reverse transcriptase K70E M184V and K70G M184V mutation by antivirogram biological cutoffs assay relative to wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID618328Antiviral activity against HIV1 clade A/E isolate 2165 infected in human H9 cells assessed as inhibition of viral replication2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID1561717Antiviral activity against HIV1 3B infected in human MT4 cells grown under 30 passages in presence of (E)-4-((4-((4-(4-(2-Cyanovinyl)-2,6-dimethylphenoxy)thieno[2,3- d]pyrimidin-2-yl)amino)piperidin-1-yl)methyl)benzenesulfonamide assessed as protection ag
AID211497In vitro cytotoxic concentration against MT-4 cells2001Bioorganic & medicinal chemistry letters, Apr-23, Volume: 11, Issue:8
Synthesis and evaluation of novel amidate prodrugs of PMEA and PMPA.
AID1686656Cytotoxicity in uninfected human hepG2 assessed as reduction in cell viability by XTT assay2016Journal of medicinal chemistry, 11-23, Volume: 59, Issue:22
Next-Generation Reduction Sensitive Lipid Conjugates of Tenofovir: Antiviral Activity and Mechanism of Release.
AID618316Antiviral activity against 125 TCID50 wild type HIV1 LAI infected in human H9 cells assessed as reduction in viral replication measured on day 7 post infection by reverse transcriptase activity2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID548843Cellular uptake in human PBMC at 1 uM assessed as TFV-monophosphate level after 24 hrs by MS/MS analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID142453Antiviral activity against murine sarcoma virus2003Journal of medicinal chemistry, Nov-06, Volume: 46, Issue:23
5-Substituted-2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]pyrimidines-acyclic nucleoside phosphonate analogues with antiviral activity.
AID618518Cytotoxicity against human HepAD38 cells2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID341988Ratio of Kcat/Km for HIV1 reverse transcriptase M41L/D67N/L210W/T215Y mutant to Kcat/Km for wild-type reverse transcriptase assessed as nucleotide excision activity in presence of 10 uM dCTP2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID549089Cytotoxicity against human bone marrow cells after 24 hrs by BFU-E assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID341981Activity of HIV1 reverse transcriptase M41L/D67N/L210W/T215Y mutant assessed as nucleotide excision activity in presence of 0.5 uM dCTP2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID548583Antiviral activity against HIV1 isolate 157 harboring reverse transcriptase L74V/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID568376Antiviral activity against HBV infected in human HepG 2.215 cells assessed as inhibition of HBsAg secretion by ELISA2011Bioorganic & medicinal chemistry, Feb-15, Volume: 19, Issue:4
Synthesis and biological assay of 4-aryl-6-chloro-quinoline derivatives as novel non-nucleoside anti-HBV agents.
AID341369Antiviral activity against HIV1 NL4-3 replication in human MT4 cells at 0.01 uM pretreated 48 hrs before infection assessed as protection at 1 uM by MTT assay2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Activity against human immunodeficiency virus type 1, intracellular metabolism, and effects on human DNA polymerases of 4'-ethynyl-2-fluoro-2'-deoxyadenosine.
AID557022Antiviral activity against HIV1 CRF01_AE harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID592796Cytotoxicity against human CEM cells assessed as inhibition of cell proliferation after 72 hrs by coulter counter analysis2011Bioorganic & medicinal chemistry, Apr-01, Volume: 19, Issue:7
Synthesis and antiviral activity of N9-[3-fluoro-2-(phosphonomethoxy)propyl] analogues derived from N6-substituted adenines and 2,6-diaminopurines.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID548574Antiviral activity against HIV1 isolate 060 harboring reverse transcriptase M41L/D67N/K70R/L210W/T215Y/K219E mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID341181Antiviral activity against X4-HIV1 NL4-3 assessed as inhibition of p24 Gag protein production in human MT4 cells by MTT assay2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Activity against human immunodeficiency virus type 1, intracellular metabolism, and effects on human DNA polymerases of 4'-ethynyl-2-fluoro-2'-deoxyadenosine.
AID670453Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral DNA replication2012European journal of medicinal chemistry, Aug, Volume: 54Design, synthesis, and molecular hybrids of caudatin and cinnamic acids as novel anti-hepatitis B virus agents.
AID1649770Antiviral activity against HBV infected in human HepAD38 cells assessed as reduction in viral DNA levels incubated for 6 days by PCR analysis2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
Discovery of (1
AID581817Cytotoxicity against human TZM-bl cells by MTT assay2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Reverse transcriptase inhibitors as potential colorectal microbicides.
AID1457759Selectivity ratio of EC50 for tenofovir-resistant CXCR4-tropic HIV-1 NL4-3 harboring reverse transcriptase K65R mutant infected in human MT4 cells to EC50 for CXCR4-tropic HIV-1 NL4-3 infected in human MT4 cells2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID1363962Cytotoxicity in human HepG2.215 cells assessed as reduction in cell viability after 5 days by CCK8 assay2017Bioorganic & medicinal chemistry, 02-01, Volume: 25, Issue:3
Discovery of hepatitis B virus capsid assembly inhibitors leading to a heteroaryldihydropyrimidine based clinical candidate (GLS4).
AID322834Antiviral activity against wild type HBV genotype H assessed as inhibition of replication2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID548566Selectivity ratio of EC50 for HIV1 7303-3 harboring reverse transcriptase 41L/44D/67N/69D/118I/210W/215Y mutant gene infected in human PBMC to EC50 for HIV1 NL 4-3 expressing wild type reverse transcriptase infected in human PBMC2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID394453Cytotoxicity against human PBMC by XTT assay2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID422695Ratio of IC50 for HIV1 with reverse transcriptase K70G mutation to IC50 for wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID618314Antiviral activity against 100 TCID50 wild-type Human immunodeficiency virus type 2 ROD infected in C8166 cells assessed as inhibition of syncytia formation after 4 days by microscopic analysis2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID1599867Oral bioavailability in Sprague-Dawley rat at 20 mg/kg administered as single dose and measured after 0.25 to 24 hrs by HPLC analysis2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID1649795Cytotoxicity in human HepG2 cells assessed as induction of cell killing2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
Discovery of (1
AID3059Antiviral activity against 07/1 strain of VZV in HEL (human erythroleukemia) cells.2003Journal of medicinal chemistry, Nov-06, Volume: 46, Issue:23
5-Substituted-2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]pyrimidines-acyclic nucleoside phosphonate analogues with antiviral activity.
AID548576Antiviral activity against HIV1 isolate 063 harboring reverse transcriptase M41L/D67N/K70R/M184V/L210W/T215Y/K219E mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID394475AUC (0 to infinity) in Sprague-Dawley rat assessed as tenofovir level at 10 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID549087Cytotoxicity against human HepG2 cells after 24 hrs by XTT assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1363957Inhibition of hepatitis B virus capsid assembly infected in human HepG2.215 cells assessed as reduction in viral DNA replication measured on day 7 by real time PCR analysis2017Bioorganic & medicinal chemistry, 02-01, Volume: 25, Issue:3
Discovery of hepatitis B virus capsid assembly inhibitors leading to a heteroaryldihydropyrimidine based clinical candidate (GLS4).
AID1126831Antiviral activity against Human immunodeficiency virus type 2 ROD infected in human CEM cells assessed as inhibition of virus-induced giant cell formation after 4 to 5 days by microscopic analysis2014European journal of medicinal chemistry, May-06, Volume: 78PMPA and PMEA prodrugs for the treatment of HIV infections and human papillomavirus (HPV) associated neoplasia and cancer.
AID548842Cellular uptake in human PBMC at 1 uM after 24 hrs by MS/MS analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID659369Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for HBV by viral DNA replication detection assay2012Bioorganic & medicinal chemistry letters, May-15, Volume: 22, Issue:10
Synthesis, biological evaluation and structure-activity relationships of glycyrrhetinic acid derivatives as novel anti-hepatitis B virus agents.
AID341975Ratio of Ki/Km for HIV1 reverse transcriptase M41L/D67N/L210W/T215Y mutant to Ki/Km for wild-type reverse transcriptase2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID394472AUC (0 to 24 hrs) in Sprague-Dawley rat assessed as tenofovir level at 100 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID553332Displacement of Mant-ATP from human recombinant UCK by fluorescence competition assay2011Journal of medicinal chemistry, Jan-13, Volume: 54, Issue:1
Novel antiviral C5-substituted pyrimidine acyclic nucleoside phosphonates selected as human thymidylate kinase substrates.
AID581811Antiviral activity against X4 tropic HIV1 3B infected in human TZM-b1 cells after 2 hrs by luciferase assay2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Reverse transcriptase inhibitors as potential colorectal microbicides.
AID275078Stability in pH 5.2 buffer at 37 degC after 72 hrs2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID394471AUC (0 to 24 hrs) in Sprague-Dawley rat assessed as tenofovir level at 30 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID729826Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for HBV infected in human HepG2.2.15 cells assessed as inhibition of viral surface antigen production2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis of hemslecin A derivatives: a new class of hepatitis B virus inhibitors.
AID549085Cytotoxicity against human ME180 cells after 24 hrs by XTT assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID105556In vitro antiviral activity against HIV-2 in MT-4 cells2001Bioorganic & medicinal chemistry letters, Apr-23, Volume: 11, Issue:8
Synthesis and evaluation of novel amidate prodrugs of PMEA and PMPA.
AID548569Selectivity ratio of EC50 for HIV1 71361-1 harboring reverse transcriptase 65R mutant gene infected in human PBMC to EC50 for HIV1 NL 4-3 expressing wild type reverse transcriptase infected in human PBMC2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548821Antiviral activity against HIV1 isolate 153 harboring reverse transcriptase L74V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID618517Cytotoxicity against human HuH7 cells2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID618448Antiviral activity against TK-deficient and ACR-resistant Herpes simplex virus type 1 KOS infected in HEL cells assessed as inhibition of virus-induced cytopathic effect2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID275081Stability in pH 9.0 buffer at 37 degC after 72 hrs2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID1186717Ratio of Kcat to Km for recombinant AK1 (unknown origin)2014Bioorganic & medicinal chemistry letters, Sep-01, Volume: 24, Issue:17
Synthesis of {[5-(adenin-9-yl)-2-furyl]methoxy}methyl phosphonic acid and evaluations against human adenylate kinases.
AID322830Antiviral activity against lamivudine-adefovir-resistant HBV with reverse transcriptase L180M/M204V/N236T mutant assessed as inhibition of replication2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID581821Antiviral activity against X4 tropic HIV1 NL4.3 infected in human PBMC assessed as inhibition of p24 antigen production after 2 hrs by ELISA2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Reverse transcriptase inhibitors as potential colorectal microbicides.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID568377Selectivity index, CC50 for human HepG 2.215 cells to IC50 for HBV infected in human HepG 2.215 cells assessed as inhibition of HBsAg secretion2011Bioorganic & medicinal chemistry, Feb-15, Volume: 19, Issue:4
Synthesis and biological assay of 4-aryl-6-chloro-quinoline derivatives as novel non-nucleoside anti-HBV agents.
AID670447Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral surface antigen secretion by ELISA2012European journal of medicinal chemistry, Aug, Volume: 54Design, synthesis, and molecular hybrids of caudatin and cinnamic acids as novel anti-hepatitis B virus agents.
AID320329Antiviral activity against HIV with reverse transcriptase 6TAMs mutation assessed as fold resistance relative to wild type2008Bioorganic & medicinal chemistry letters, Feb-01, Volume: 18, Issue:3
Synthesis and anti-HIV activity of GS-9148 (2'-Fd4AP), a novel nucleoside phosphonate HIV reverse transcriptase inhibitor.
AID95008Antiviral activity against KOS strain of HSV-1 in E6SM cells.2003Journal of medicinal chemistry, Nov-06, Volume: 46, Issue:23
5-Substituted-2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]pyrimidines-acyclic nucleoside phosphonate analogues with antiviral activity.
AID1832362Inhibition of human recombinant CYP3A4 expressed in insect microsome using 7-benzyloxy-4-trifluoromethylcoumarin as a substrate incubated for 30 mins followed by addition of NADPH regenerating system measured immediately by fluorescence based analysis2021Journal of medicinal chemistry, 09-09, Volume: 64, Issue:17
ω-Functionalized Lipid Prodrugs of HIV NtRTI Tenofovir with Enhanced Pharmacokinetic Properties.
AID393070Antiviral activity against HIV1 3a infected human MT2 cells assessed as inhibition of viral-induced cytopathic effect after 3 days by XTT assay2009Bioorganic & medicinal chemistry, Feb-15, Volume: 17, Issue:4
Design, synthesis, and anti-HIV activity of 4'-modified carbocyclic nucleoside phosphonate reverse transcriptase inhibitors.
AID1140532Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for HBV infected in human HepG2.2.15 cells assessed as inhibition of hepatitis B surface antigen secretion2014Bioorganic & medicinal chemistry letters, May-15, Volume: 24, Issue:10
Synthesis, structure-activity relationships and biological evaluation of dehydroandrographolide and andrographolide derivatives as novel anti-hepatitis B virus agents.
AID544652Ratio of CC50 for CHO cells to CC50 for CHO cells expressing hOAT1 after 120 hrs by Cell-Titer Glo assay2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Novel nucleotide human immunodeficiency virus reverse transcriptase inhibitor GS-9148 with a low nephrotoxic potential: characterization of renal transport and accumulation.
AID289143Cytotoxicity against MT2 cells2007Bioorganic & medicinal chemistry, Aug-15, Volume: 15, Issue:16
Synthesis, anti-HIV activity, and resistance profile of thymidine phosphonomethoxy nucleosides and their bis-isopropyloxymethylcarbonyl (bisPOC) prodrugs.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID557021Antiviral activity against HIV1 CRF02_AG harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID394485Elimination half life in Sprague-Dawley rat assessed as tenofovir level at 100 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID729824Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for HBV infected in human HepG2.2.15 cells assessed as inhibition of viral e antigen production2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis of hemslecin A derivatives: a new class of hepatitis B virus inhibitors.
AID1140530Cytotoxicity against human HepG2.2.15 cells by MTT assay2014Bioorganic & medicinal chemistry letters, May-15, Volume: 24, Issue:10
Synthesis, structure-activity relationships and biological evaluation of dehydroandrographolide and andrographolide derivatives as novel anti-hepatitis B virus agents.
AID670452Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral DNA replication by PCR analysis2012European journal of medicinal chemistry, Aug, Volume: 54Design, synthesis, and molecular hybrids of caudatin and cinnamic acids as novel anti-hepatitis B virus agents.
AID1126841Cytostatic activity against human HeLa cells after 72 hrs by coulter counting analysis2014European journal of medicinal chemistry, May-06, Volume: 78PMPA and PMEA prodrugs for the treatment of HIV infections and human papillomavirus (HPV) associated neoplasia and cancer.
AID1126838Cytotoxicity against HEL cells assessed as change in cellular morphology by microscopic analysis2014European journal of medicinal chemistry, May-06, Volume: 78PMPA and PMEA prodrugs for the treatment of HIV infections and human papillomavirus (HPV) associated neoplasia and cancer.
AID1832358Antiviral activity against human immunodeficiency virus expressed in HEK293T cells coexpressing firefly luciferase gene incubated for 48 hrs in absence of HSA by Bright-Glo luciferase assay2021Journal of medicinal chemistry, 09-09, Volume: 64, Issue:17
ω-Functionalized Lipid Prodrugs of HIV NtRTI Tenofovir with Enhanced Pharmacokinetic Properties.
AID557047Antiviral activity against HIV1 clade D harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID670448Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral e antigen secretion by ELISA2012European journal of medicinal chemistry, Aug, Volume: 54Design, synthesis, and molecular hybrids of caudatin and cinnamic acids as novel anti-hepatitis B virus agents.
AID1916051Antiviral activity against HIV-1 IIIb infected in human MT2 cells assessed as reduction in virus induced cytopathic effect and measured after 5 days by XTT assay2021European journal of medicinal chemistry, Aug-05, Volume: 220Tailor-made amino acids in the design of small-molecule blockbuster drugs.
AID1457757Selectivity index, ratio of CC50 for human PHA-stimulated PBMCs to IC50 for CCR5 tropic HIV1 BaL infected in human PHA-stimulated PBMC2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID548568Selectivity ratio of EC50 for HIV1 52534-2 harboring reverse transcriptase 41L//74V/210W/215Y/184V/69SSS mutant gene infected in human PBMC to EC50 for HIV1 NL 4-3 expressing wild type reverse transcriptase infected in human PBMC2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID618319Cytotoxicity against PAP-activated human PBMC on day 7 by MTT assay2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID548810Antiviral activity against HIV1 isolate 217 harboring reverse transcriptase D67N/K70E/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1561721Resistance index, ratio of EC50 for antiviral activity against HIV1 3B infected in human MT4 cells grown under 30 passages in presence of 4-[[4-[[4-(4-cyano-2,6-dimethylphenoxy)thieno[3,2-d]pyrimidin-2-yl]amino]-1-piperidyl]methyl]benzenesulfonamide to EC
AID320328Antiviral activity against HIV with reverse transcriptase K65R mutation assessed as fold resistance relative to wild type2008Bioorganic & medicinal chemistry letters, Feb-01, Volume: 18, Issue:3
Synthesis and anti-HIV activity of GS-9148 (2'-Fd4AP), a novel nucleoside phosphonate HIV reverse transcriptase inhibitor.
AID568379Selectivity index, CC50 for human HepG 2.215 cells to IC50 for HBV infected in human HepG 2.215 cells assessed as inhibition of HBeAg secretion2011Bioorganic & medicinal chemistry, Feb-15, Volume: 19, Issue:4
Synthesis and biological assay of 4-aryl-6-chloro-quinoline derivatives as novel non-nucleoside anti-HBV agents.
AID549072Cellular uptake in PHA/IL-2-stimulated human PBMC at 10 uM assessed as TFV-diphosphate after 24 hrs by MS/MS analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1192286Inhibition of HBV HBeAg secretion in HepG2(2.2.15) cells after 72 hrs by ELISA method2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Synthesis of erythrocentaurin derivatives as a new class of hepatitis B virus inhibitors.
AID1599856Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as reduction in cytoplasmic DNA synthesis by reed and munch method2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID581825Antiviral activity against HIV1 isolate 8415-2 harboring reverse transcriptase K65R mutant co-expressing M184V mutant infected in human TZM-b1 cells after 2 hrs by luciferase assays2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Reverse transcriptase inhibitors as potential colorectal microbicides.
AID392536Antiviral activity against Vaccinia virus2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
AID548556Antiviral activity against HIV1 NL 4-3 expressing wild type reverse transcriptase infected in human PBMC by ELISA2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548562Antiviral activity against HIV1 71361-1 harboring reverse transcriptase 65R mutant gene infected in human PBMC by ELISA2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID557020Antiviral activity against HIV1 clade B harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID341371Ratio of EC50 for X4-HIV1MDR/C in human PHA-PBMC to EC50 for X4-HIV1NL4-3 in human MT4 cells2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Activity against human immunodeficiency virus type 1, intracellular metabolism, and effects on human DNA polymerases of 4'-ethynyl-2-fluoro-2'-deoxyadenosine.
AID317371Inhibition of wild type HIV reverse transcriptase2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Synthesis, anti-HIV activity, and resistance profiles of ribose modified nucleoside phosphonates.
AID548839Antiviral activity against HIV1 isolate 215 harboring reverse transcriptase D67N/K70E mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1126836Antiviral activity against thymidine kinase-deficient acyclovir-resistant Herpes simplex virus KOS infected in HEL cells assessed as inhibition of virus-induced cytopathicity2014European journal of medicinal chemistry, May-06, Volume: 78PMPA and PMEA prodrugs for the treatment of HIV infections and human papillomavirus (HPV) associated neoplasia and cancer.
AID1193398Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for decrease in hepatitis B viral DNA replication in human HepG2(2.2.15) cells2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Isolation, synthesis and anti-hepatitis B virus evaluation of p-hydroxyacetophenone derivatives from Artemisia capillaris.
AID1193393Antiviral activity against hepatitis B viral in human HepG2.2.15 cells assessed as surface antigen HBsAg secretion after 72 hrs by ELISA2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Isolation, synthesis and anti-hepatitis B virus evaluation of p-hydroxyacetophenone derivatives from Artemisia capillaris.
AID394476AUC (0 to infinity) in Sprague-Dawley rat assessed as tenofovir level at 30 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID81263Effective concentration against cytopathicity of HIV-1 strain (HTLV IIIB) in CEM cell line2003Journal of medicinal chemistry, Jun-19, Volume: 46, Issue:13
Deoxyribonucleoside 2'- or 3'-mixed disulfides: prodrugs to target ribonucleotide reductase and/or to inhibit HIV reverse transcription.
AID549082Cytotoxicity against PHA/IL-2-stimulated human PBMC after 24 hrs by XTT assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548834Antiviral activity against HIV1 isolate 203 harboring reverse transcriptase M41L/L210W/T215Y/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID322849Fold resistance, ratio of lamivudine -adenofir-resistant with HBV reverse transcriptase V173L/L180M/A181V/M204V/N236T mutant to wild-type HBV genotype E2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID659569Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as suppression of HBsAg secretion by ELISA2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis, structure-activity relationships and biological evaluation of caudatin derivatives as novel anti-hepatitis B virus agents.
AID72410Antiviral activity against vaccinia virus in HEL (human erythroleukemia) cells.2003Journal of medicinal chemistry, Nov-06, Volume: 46, Issue:23
5-Substituted-2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]pyrimidines-acyclic nucleoside phosphonate analogues with antiviral activity.
AID659366Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as reduction in hepatitis B e-antigen release2012Bioorganic & medicinal chemistry letters, May-15, Volume: 22, Issue:10
Synthesis, biological evaluation and structure-activity relationships of glycyrrhetinic acid derivatives as novel anti-hepatitis B virus agents.
AID344319Antiviral activity against HIV1 3B in CEM/0 cells assessed as inhibition of virus-induced cytopathogenicity2008Bioorganic & medicinal chemistry, Jul-15, Volume: 16, Issue:14
Anti-retroviral and cytostatic activity of 2',3'-dideoxyribonucleoside 3'-disulfides.
AID341984Ratio of Kcat to Km for HIV1 reverse transcriptase assessed as nucleotide excision activity in presence of 10 uM dCTP2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID548573Antiviral activity against HIV1 isolate 058 harboring reverse transcriptase M41L/D67N/K70R/L210W/T215F/K219Q mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1686657Therapeutic index, ratio of CC50 for uninfected human HepG2 cells to EC50 for HBV infected in human HepG2 cells2016Journal of medicinal chemistry, 11-23, Volume: 59, Issue:22
Next-Generation Reduction Sensitive Lipid Conjugates of Tenofovir: Antiviral Activity and Mechanism of Release.
AID548826Antiviral activity against HIV1 isolate 174 harboring reverse transcriptase M184V mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID618317Antiviral activity against 6250 TCID50 wild type HIV1 LAI infected in human H9 cells assessed as reduction in viral replication measured on day 7 post infection by reverse transcriptase activity2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID394478AUC (0 to infinity) in Sprague-Dawley rat assessed as tenofovir level at 100 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID341978Binding affinity to ternary complex of HIV1 reverse transcriptase with primer/template in presence of dCTP substrate2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID1394856Cytotoxicity against human PBMC assessed as reduction in cell growth after 7 days by MTT assay2018European journal of medicinal chemistry, Apr-25, Volume: 150Synthesis of 3'-halo-5'-norcarbocyclic nucleoside phosphonates as potent anti-HIV agents.
AID618325Antiviral activity against HIV1 clade C isolate 2914 infected in human H9 cells assessed as inhibition of viral replication2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID341182Antiviral activity against R5-HIV1MDR/C assessed as inhibition of p24 Gag protein production in human PHA-PBMC by ELISA2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Activity against human immunodeficiency virus type 1, intracellular metabolism, and effects on human DNA polymerases of 4'-ethynyl-2-fluoro-2'-deoxyadenosine.
AID393069Inhibition on HIV1 reverse transcriptase p66/p512009Bioorganic & medicinal chemistry, Feb-15, Volume: 17, Issue:4
Design, synthesis, and anti-HIV activity of 4'-modified carbocyclic nucleoside phosphonate reverse transcriptase inhibitors.
AID322843Antiviral activity against entecavir-resistant HBV with reverse transcriptase L180M/S202G/M204V mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID405582Cytotoxicity against human 293T cells assessed as inhibition of cell proliferation by tetrazolium dye method2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
Selective inhibition of porcine endogenous retrovirus replication in human cells by acyclic nucleoside phosphonates.
AID558396Ratio of drug level in HIV-infected pregnant woman amniotic fluid to maternal blood plasma at 300 mg, po QD by LC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genital tract, cord blood, and amniotic fluid exposures of seven antiretroviral drugs during and after pregnancy in human immunodeficiency virus type 1-infected women.
AID618315Cytotoxicity against human CEM cells2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID1599862AUC(0 to infinity) in Sprague-Dawley rat at 5 mg/kg, iv2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID1264923Antiviral activity against HIV1 3B infected in human CEM cells assessed as inhibition of virus-induced giant cell formation after 4 to 5 days by microscopic analysis2015European journal of medicinal chemistry, Dec-01, Volume: 106Tryptophan dendrimers that inhibit HIV replication, prevent virus entry and bind to the HIV envelope glycoproteins gp120 and gp41.
AID322836Antiviral activity against lamivudine-resistant HBV with reverse transcriptase L180M/M204V mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID47278Antiproliferative activity was determined against human T-lymphocyte cells-CEM2003Journal of medicinal chemistry, Jun-19, Volume: 46, Issue:13
Deoxyribonucleoside 2'- or 3'-mixed disulfides: prodrugs to target ribonucleotide reductase and/or to inhibit HIV reverse transcription.
AID1774088Anti-HIV activity against HIV infected in human MT2 cells using infectious supernatant from NL4.3 transfected 293T cells assessed as luminescence measured after 48 hrs by recombinant virus assay2021Journal of natural products, 10-22, Volume: 84, Issue:10
Withanolide-Type Steroids from
AID548581Antiviral activity against HIV1 isolate 071 harboring reverse transcriptase 65R/S68N/184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID394456Cytotoxicity against human MT2 cells2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID394249Cmax in Sprague-Dawley rat assessed as tenofovir level at 10 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID548587Antiviral activity against HIV1 isolate 174 harboring reverse transcriptase M184V mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548829Antiviral activity against HIV1 isolate 188 harboring reverse transcriptase T215Y/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID341991Inhibition of HIV1 reverse transcriptase M41L/D67N/L210W/T215Y mutant assessed as dCTP level required to form 50% of binary enzyme complex formation with drug-terminated primer in posttranslocation state by site-specific foot printing assay2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID544650Cytotoxicity against CHO cells after 120 hrs by Cell-Titer Glo assay2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Novel nucleotide human immunodeficiency virus reverse transcriptase inhibitor GS-9148 with a low nephrotoxic potential: characterization of renal transport and accumulation.
AID659363Cytotoxicity against human HepG2(2.2.15) cells2012Bioorganic & medicinal chemistry letters, May-15, Volume: 22, Issue:10
Synthesis, biological evaluation and structure-activity relationships of glycyrrhetinic acid derivatives as novel anti-hepatitis B virus agents.
AID581812Antiviral activity against R5 tropic HIV1 BaL infected in human TZM-b1 cells after 2 hrs by luciferase assay2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Reverse transcriptase inhibitors as potential colorectal microbicides.
AID1774089Cytotoxicity against human MT2 cells assessed as cell viability by CellTiter Glo assay2021Journal of natural products, 10-22, Volume: 84, Issue:10
Withanolide-Type Steroids from
AID394484Elimination half life in Sprague-Dawley rat assessed as tenofovir level at 100 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID548801Antiviral activity against HIV1 isolate 194 harboring reverse transcriptase M41L/T215Y/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1695188Antiviral activity against HIV1 LAI infected in human HeLa-P4 cells harboring a stably integrated LTR-linked LacZ reporter gene assessed as inhibition of viral replication preincubated with cells for 2 hrs followed by viral infection and measured after 482020RSC medicinal chemistry, May-01, Volume: 11, Issue:5
Discovery, SAR study and ADME properties of methyl 4-amino-3-cyano-1-(2-benzyloxyphenyl)-1
AID478935Cytotoxicity against human MT2 cells after 5 days by XTT assay2010Bioorganic & medicinal chemistry, May-15, Volume: 18, Issue:10
Discovery of GS-9131: Design, synthesis and optimization of amidate prodrugs of the novel nucleoside phosphonate HIV reverse transcriptase (RT) inhibitor GS-9148.
AID394450Cytotoxicity against human HepG2(2.2.15) cells after 24 hrs by neutral red uptake assay2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID394482Elimination half life in Sprague-Dawley rat assessed as tenofovir level at 30 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID699541Inhibition of human liver OATP2B1 expressed in HEK293 Flp-In cells assessed as reduction in [3H]E3S uptake at 20 uM incubated for 5 mins by scintillation counting2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Classification of inhibitors of hepatic organic anion transporting polypeptides (OATPs): influence of protein expression on drug-drug interactions.
AID592797Cytotoxicity against human CEM cells assessed as minimum concentration required for morphological alteration by microscopic analysis2011Bioorganic & medicinal chemistry, Apr-01, Volume: 19, Issue:7
Synthesis and antiviral activity of N9-[3-fluoro-2-(phosphonomethoxy)propyl] analogues derived from N6-substituted adenines and 2,6-diaminopurines.
AID1197621Antiviral activity against HIV2 ROD infected in human CEM cells assessed as reduction in virus-induced cytopathicity after 4 to 5 days by microscopy based syncytium cell formation assay2015European journal of medicinal chemistry, Mar-06, Volume: 92Linear and branched alkyl-esters and amides of gallic acid and other (mono-, di- and tri-) hydroxy benzoyl derivatives as promising anti-HCV inhibitors.
AID581816Antiviral activity against X4 tropic HIV1 RF infected in human PBMC assessed as inhibition of p24 antigen production after 2 hrs by ELISA2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Reverse transcriptase inhibitors as potential colorectal microbicides.
AID322851Fold resistance, ratio of entecavir-resistant HBV with reverse transcriptase L180M/S202G/M204V mutant to wild-type HBV genotype H2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1290411Antiviral activity against HIV1 NL4.3 infected in human TZM-bl cells using compound gel formulation incubated for 72 hrs by luciferase based transwell assay2016Journal of medicinal chemistry, Mar-24, Volume: 59, Issue:6
Development and in Vitro Evaluation of a Microbicide Gel Formulation for a Novel Non-Nucleoside Reverse Transcriptase Inhibitor Belonging to the N-Dihydroalkyloxybenzyloxopyrimidines (N-DABOs) Family.
AID548822Antiviral activity against HIV1 isolate 157 harboring reverse transcriptase L74V/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1832361Inhibition of human recombinant CYP2D6 expressed in insect microsome using (3-[2-(N,N-dimethyl-N-methylammonium)-ethyl]-7-methoxy-4-methylcoumarin iodide as a substrate incubated for 30 mins followed by addition of NADPH regenerating system measured immed2021Journal of medicinal chemistry, 09-09, Volume: 64, Issue:17
ω-Functionalized Lipid Prodrugs of HIV NtRTI Tenofovir with Enhanced Pharmacokinetic Properties.
AID612651Activity of recombinant human ADAL1 expressed in Escherichia coli by UV-spectrophotometry2011Journal of medicinal chemistry, Aug-25, Volume: 54, Issue:16
Adenosine deaminase-like protein 1 (ADAL1): characterization and substrate specificity in the hydrolysis of N(6)- or O(6)-substituted purine or 2-aminopurine nucleoside monophosphates.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID548571Antiviral activity against HIV1 isolate 056 expressing wild type reverse transcriptase gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1774090Selectivity index, ratio of CC50 for human MT2 cells to IC50 for Anti-HIV activity against HIV2021Journal of natural products, 10-22, Volume: 84, Issue:10
Withanolide-Type Steroids from
AID322846Fold resistance, ratio of lamivudine-resistant HBV with reverse transcriptase V173L/L180/M204V mutant to wild-type HBV genotype H2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID557048Antiviral activity against HIV1 clade F1 harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID394469AUC (0 to 24 hrs) in Sprague-Dawley rat assessed as tenofovir level at 10 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID275082Stability in pH 11.5 buffer at 37 degC after 72 hrs2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID618447Antiviral activity against Herpes simplex virus type 1 KOS infected in HEL cells assessed as inhibition of virus-induced cytopathic effect2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID1636524Antiviral activity against HIV1 infected in human PBMC assessed as inhibition of viral replication by measuring reverse transcriptase activity in cell supernatant preincubated with cells followed by viral infection measured after 7 days by radioactive inc2016Journal of medicinal chemistry, 08-11, Volume: 59, Issue:15
Reduction Sensitive Lipid Conjugates of Tenofovir: Synthesis, Stability, and Antiviral Activity.
AID548585Antiviral activity against HIV1 isolate 162 harboring reverse transcriptase A62V/V75I/F77L/Y115F/F116Y/Q151M/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID328843Inhibition of human MRP3 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID1457788Antiviral activity against CXCR4-tropic HIV-1 NL4-3 infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 6 days by XTT dye based assay2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID659570Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as suppression of HbeAg secretion by ELISA2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis, structure-activity relationships and biological evaluation of caudatin derivatives as novel anti-hepatitis B virus agents.
AID1320780Antiviral activity against HIV1 3B infected in human MT2 cells assessed as protection against virus-induced cytopathic effect after 5 days by XTT assay2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Amidate Prodrugs of Deoxythreosyl Nucleoside Phosphonates as Dual Inhibitors of HIV and HBV Replication.
AID1686653Cytotoxicity in uninfected human PBMC assessed as reduction in cell viability by XTT assay2016Journal of medicinal chemistry, 11-23, Volume: 59, Issue:22
Next-Generation Reduction Sensitive Lipid Conjugates of Tenofovir: Antiviral Activity and Mechanism of Release.
AID548563Antiviral activity against HIV1 8415-2 harboring reverse transcriptase 65R/184V mutant gene infected in human PBMC by ELISA2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID581823Cytotoxicity against human PBMC by MTT assay2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Reverse transcriptase inhibitors as potential colorectal microbicides.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1126837Antiviral activity against Vaccinia virus Lederle infected in HEL cells assessed as inhibition of virus-induced cytopathicity2014European journal of medicinal chemistry, May-06, Volume: 78PMPA and PMEA prodrugs for the treatment of HIV infections and human papillomavirus (HPV) associated neoplasia and cancer.
AID322850Fold resistance, ratio of Lamivudine -adenofir-resistant with HBV reverse transcriptase V173L/L180M/A181V/N236T mutant to wildtype HBV genotype E2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1832359Therapeutic index, ratio of CC50 for cytotoxicity against HEK293T cells to IC50 for antiviral activity against human immunodeficiency virus expressed in HEK293T cells2021Journal of medicinal chemistry, 09-09, Volume: 64, Issue:17
ω-Functionalized Lipid Prodrugs of HIV NtRTI Tenofovir with Enhanced Pharmacokinetic Properties.
AID322825Inhibition of wild type HBV replication in Huh7 cells2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID548807Antiviral activity against HIV1 isolate 211 harboring reverse transcriptase D67N/K70R/T215F/K219E/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1193397Antiviral activity against hepatitis B viral in human HepG2.2.15 cells assessed as decrease in viral DNA replication treated for 7 days by real time PCR analysis2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Isolation, synthesis and anti-hepatitis B virus evaluation of p-hydroxyacetophenone derivatives from Artemisia capillaris.
AID478949Antiviral activity against HIV1 3B infected in human MT2 cells assessed as inhibition of virus-induced cytopathic effect after 5 days by XTT assay2010Bioorganic & medicinal chemistry, May-15, Volume: 18, Issue:10
Discovery of GS-9131: Design, synthesis and optimization of amidate prodrugs of the novel nucleoside phosphonate HIV reverse transcriptase (RT) inhibitor GS-9148.
AID1457755Selectivity index, ratio of CC50 for human TZM-bl cells to EC50 for CCR5 tropic HIV1 BaL infected in human TZM-bl cells2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID548579Antiviral activity against HIV1 isolate 069 harboring reverse transcriptase D67E/T69SSG/V75M/M184V/L210W/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1192284Inhibition of HBV HBsAg secretion in HepG2(2.2.15) cells after 72 hrs by ELISA method2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Synthesis of erythrocentaurin derivatives as a new class of hepatitis B virus inhibitors.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1140536Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for HBV infected in human HepG2.2.15 cells assessed as inhibition of DNA replication2014Bioorganic & medicinal chemistry letters, May-15, Volume: 24, Issue:10
Synthesis, structure-activity relationships and biological evaluation of dehydroandrographolide and andrographolide derivatives as novel anti-hepatitis B virus agents.
AID341980Activity of HIV1 reverse transcriptase assessed as nucleotide excision activity in presence of 10 uM dCTP2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID422694Antiviral activity against HIV1 with reverse transcriptase K70E M184V and K70G M184V mutation by vircotype clinical cutoffs assay relative to wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID729825Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of viral e antigen production2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis of hemslecin A derivatives: a new class of hepatitis B virus inhibitors.
AID1599861Half-life in Sprague-Dawley rat at 5 mg/kg, iv2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID328844Inhibition of human MRP2 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence at 10 uM by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID548812Antiviral activity against HIV1 isolate 058 harboring reverse transcriptase M41L/D67N/K70R/L210W/T215F/K219Q mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID394467Tmax in Sprague-Dawley rat assessed as tenofovir level at 100 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID322827Antiviral activity against wild type HBV assessed as inhibition of replication2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID581815Antiviral activity against R5 tropic HIV1 R8.BaL infected in human TZM-b1 cells after 2 hrs by luciferase assay2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Reverse transcriptase inhibitors as potential colorectal microbicides.
AID548567Selectivity ratio of EC50 for HIV1 1617-1 harboring reverse transcriptase 69K/70G/75I/77L/116Y/151M/184V mutant gene infected in human PBMC to EC50 for HIV1 NL 4-3 expressing wild type reverse transcriptase infected in human PBMC2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548846Cellular uptake in human PBMC at 10 uM assessed as TFV-monophosphate after 24 hrs by MS/MS analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID289145Antiviral activity against HIV1 with reverse transcriptase K65R mutation assessed as reduction of potency relative to wild type2007Bioorganic & medicinal chemistry, Aug-15, Volume: 15, Issue:16
Synthesis, anti-HIV activity, and resistance profile of thymidine phosphonomethoxy nucleosides and their bis-isopropyloxymethylcarbonyl (bisPOC) prodrugs.
AID328841Inhibition of human MRP1 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID544651Cytotoxicity against CHO cells expressing hOAT1 after 120 hrs by Cell-Titer Glo assay2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Novel nucleotide human immunodeficiency virus reverse transcriptase inhibitor GS-9148 with a low nephrotoxic potential: characterization of renal transport and accumulation.
AID83255Antiviral activity against HIV-2 (ROD) in CEM (human leukemia) cells.2003Journal of medicinal chemistry, Nov-06, Volume: 46, Issue:23
5-Substituted-2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]pyrimidines-acyclic nucleoside phosphonate analogues with antiviral activity.
AID618449Antiviral activity against Herpes simplex virus type 2 G infected in HEL cells assessed as inhibition of virus-induced cytopathic effect2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID394463Tmax in Sprague-Dawley rat assessed as tenofovir level at 10 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID549088Cytotoxicity against human bone marrow cells after 24 hrs by GM-CFU assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID659692Cytotoxicity against human HepG2(2.2.15) cells by MTT assay2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis, structure-activity relationships and biological evaluation of caudatin derivatives as novel anti-hepatitis B virus agents.
AID1600828Antiproliferative activity against human HepG2 cells assessed as inhibition of cell growth incubated for 24 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
Design, synthesis and biological evaluation of benzamide derivatives as novel NTCP inhibitors that induce apoptosis in HepG2 cells.
AID47263In vitro antiviral activity against HIV-2 in CEM cells2001Bioorganic & medicinal chemistry letters, Apr-23, Volume: 11, Issue:8
Synthesis and evaluation of novel amidate prodrugs of PMEA and PMPA.
AID659364Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as reduction in hepatitis B surface antigen release2012Bioorganic & medicinal chemistry letters, May-15, Volume: 22, Issue:10
Synthesis, biological evaluation and structure-activity relationships of glycyrrhetinic acid derivatives as novel anti-hepatitis B virus agents.
AID1600829Antiviral activity against hepatitis B virus infected in human HepG2.2.15 cells assessed as HBsAg secretion at 5 uM incubated for 9 days by ELISA (Rvb = 8.41+/- 0.54 ng/ml)2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
Design, synthesis and biological evaluation of benzamide derivatives as novel NTCP inhibitors that induce apoptosis in HepG2 cells.
AID1192288Inhibition of HBV DNA replication in HepG2(2.2.15) cells exposed to fresh medium supplemented with compound every other day for additional 5 days by real-time PCR-fluorescent probing method2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Synthesis of erythrocentaurin derivatives as a new class of hepatitis B virus inhibitors.
AID393072Antiviral activity against HIV1 3a with reverse transcriptase K65R mutation in human MT2 cells assessed as inhibition of viral-induced cytopathic effect by XTT assay relative to wild type2009Bioorganic & medicinal chemistry, Feb-15, Volume: 17, Issue:4
Design, synthesis, and anti-HIV activity of 4'-modified carbocyclic nucleoside phosphonate reverse transcriptase inhibitors.
AID1599855Cytotoxicity against human HepG2.2.15 cells infected with HBV2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID618431Antiviral activity against HIV1 clade G isolate 3187 infected in human H9 cells assessed as inhibition of viral replication2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID618318Antiviral activity against 100 TCID50 wild type HIV1 LAI infected in human PBMC assessed as reduction in viral replication measured on day 7 post infection by reverse transcriptase activity2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID322842Antiviral activity against lamivudine-adenofir-resistant HBV with reverse transcriptase V173L/L180M/A181V/N236T mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID394462Tmax in Sprague-Dawley rat assessed as tenofovir level at 10 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID670451Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral e antigen secretion2012European journal of medicinal chemistry, Aug, Volume: 54Design, synthesis, and molecular hybrids of caudatin and cinnamic acids as novel anti-hepatitis B virus agents.
AID618450Antiviral activity against Vaccinia virus infected in HEL cells assessed as inhibition of virus-induced cytopathic effect2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID548578Antiviral activity against HIV1 isolate 067 harboring reverse transcriptase A62V/D67G/T69SVG/V75I/T215I mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID557052Antiviral activity against NRTI-resistant HIV1 harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID322844Fold resistance, ratio of lamivudine-resistant HBV with reverse transcriptase L180M/M204V mutant to wild-type HBV genotype E2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID317369Antiviral activity against wild type HIV2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Synthesis, anti-HIV activity, and resistance profiles of ribose modified nucleoside phosphonates.
AID625276FDA Liver Toxicity Knowledge Base Benchmark Dataset (LTKB-BD) drugs of most concern for DILI2011Drug discovery today, Aug, Volume: 16, Issue:15-16
FDA-approved drug labeling for the study of drug-induced liver injury.
AID1140534Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for HBV infected in human HepG2.2.15 cells assessed as inhibition of hepatitis B e antigen secretion2014Bioorganic & medicinal chemistry letters, May-15, Volume: 24, Issue:10
Synthesis, structure-activity relationships and biological evaluation of dehydroandrographolide and andrographolide derivatives as novel anti-hepatitis B virus agents.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID592792Antiviral activity against HIV2 ROD infected in human CEM cells assessed as inhibition of virus-induced syncytium formation after 4 to 5 days by microscopic analysis2011Bioorganic & medicinal chemistry, Apr-01, Volume: 19, Issue:7
Synthesis and antiviral activity of N9-[3-fluoro-2-(phosphonomethoxy)propyl] analogues derived from N6-substituted adenines and 2,6-diaminopurines.
AID557053Antiviral activity against NRTI-, PI-resistant HIV1 harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID394481Elimination half life in Sprague-Dawley rat assessed as tenofovir level at 10 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID548582Antiviral activity against HIV1 isolate 153 harboring reverse transcriptase L74V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID72409Antiviral activity against G strain of HSV-2 in E6SM cells.2003Journal of medicinal chemistry, Nov-06, Volume: 46, Issue:23
5-Substituted-2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]pyrimidines-acyclic nucleoside phosphonate analogues with antiviral activity.
AID313874Antiviral activity against HIV1 3B in MT2 cells2008Bioorganic & medicinal chemistry letters, Feb-01, Volume: 18, Issue:3
Synthesis and anti-HIV activity of 2'-fluorine modified nucleoside phosphonates: analogs of GS-9148.
AID322831Fold resistance, ratio of EC50 for adenofir-resistant HBV with reverse transcriptase N236T mutant to EC50 for wild-type HBV2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID618323Antiviral activity against HIV1 clade B isolate 2056 infected in human H9 cells assessed as inhibition of viral replication2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID394479AUC (0 to infinity) in Sprague-Dawley rat assessed as tenofovir level at 100 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID729822Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for HBV infected in human HepG2.2.15 cells assessed as inhibition of viral DNA replication2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis of hemslecin A derivatives: a new class of hepatitis B virus inhibitors.
AID275079Stability in pH 7.4 buffer at 37 degC after 72 hrs2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID659365Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for HBV by hepatitis B surface antigen release detection assay2012Bioorganic & medicinal chemistry letters, May-15, Volume: 22, Issue:10
Synthesis, biological evaluation and structure-activity relationships of glycyrrhetinic acid derivatives as novel anti-hepatitis B virus agents.
AID544648Activity of human OAT1 transfected in CHO cells2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Novel nucleotide human immunodeficiency virus reverse transcriptase inhibitor GS-9148 with a low nephrotoxic potential: characterization of renal transport and accumulation.
AID1561718Antiviral activity against HIV1 3B infected in human MT4 cells grown under 30 passages in presence of 4-[[4-[[4-(4-cyano-2,6-dimethylphenoxy)thieno[3,2-d]pyrimidin-2-yl]amino]-1-piperidyl]methyl]benzenesulfonamide assessed as protection against virus-indu
AID341372Antiviral activity against R5-HIV1MDR/G assessed as inhibition of p24 Gag protein in human PHA-PBMC by ELISA relative to X4-HIV1NL4-32007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Activity against human immunodeficiency virus type 1, intracellular metabolism, and effects on human DNA polymerases of 4'-ethynyl-2-fluoro-2'-deoxyadenosine.
AID548832Antiviral activity against HIV1 isolate 200 harboring reverse transcriptase M41L/L210W/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1649793Antiviral activity against multidrug-resistant HBV infected in human HepG2.1403F cells assessed as reduction in viral replication incubated for 6 days by PCR analysis2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
Discovery of (1
AID1197622Cytotoxicity against human CEM cells assessed as inhibition of cell proliferation2015European journal of medicinal chemistry, Mar-06, Volume: 92Linear and branched alkyl-esters and amides of gallic acid and other (mono-, di- and tri-) hydroxy benzoyl derivatives as promising anti-HCV inhibitors.
AID317374Antiviral activity against HIV with reverse transcriptase K65R mutation in MT4 cells assessed as fold resistance relative to wild type2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Synthesis, anti-HIV activity, and resistance profiles of ribose modified nucleoside phosphonates.
AID394452Selectivity index, ratio of CC50 for human PBMC to EC50 for HIV1 clade B HT/92/599 isolate2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID548823Antiviral activity against HIV1 isolate 160 harboring reverse transcriptase S68G/V75(I/T)/F77L/Y115F/F116Y /Q151M mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID317373Antiviral activity against HIV with reverse transcriptase 6TAMs mutation in MT4 cells assessed as fold resistance relative to wild type2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Synthesis, anti-HIV activity, and resistance profiles of ribose modified nucleoside phosphonates.
AID548814Antiviral activity against HIV1 isolate 061 harboring reverse transcriptase M41L/D67N/K70R/M184V/L210W/T215Y/K219E mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID322841Antiviral activity against Lamivudine -adenofir-resistant HBV with reverse transcriptase V173L/L180M/A181V/M204V/N236T mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID310044Antiviral activity against HIV1 3B in MT4 cells after 4 days by MTT assay2007Bioorganic & medicinal chemistry letters, Nov-15, Volume: 17, Issue:22
Some new acyclic nucleotide analogues as antiviral prodrugs: synthesis and bioactivities in vitro.
AID549090Cmax in PHA/IL-2-stimulated human PBMC2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548825Antiviral activity against HIV1 isolate 166 harboring reverse transcriptase L74V mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID341179Antiviral activity against R5-HIV1Ba-L assessed as inhibition of p24 Gag protein production in human PHA-PBMC by ELISA2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Activity against human immunodeficiency virus type 1, intracellular metabolism, and effects on human DNA polymerases of 4'-ethynyl-2-fluoro-2'-deoxyadenosine.
AID548836Antiviral activity against HIV1 isolate 206 harboring reverse transcriptase D67N/K70R mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1126834Antiviral activity against Herpes simplex virus KOS infected in HEL cells assessed as inhibition of virus-induced cytopathicity2014European journal of medicinal chemistry, May-06, Volume: 78PMPA and PMEA prodrugs for the treatment of HIV infections and human papillomavirus (HPV) associated neoplasia and cancer.
AID322837Antiviral activity against lamivudine-resistant HBV with reverse transcriptase L180M/A181V mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID548828Antiviral activity against HIV1 isolate 185 harboring reverse transcriptase T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID549068Cellular uptake in PHA/IL-2-stimulated human PBMC at 1 uM assessed as TFV-monophosphate level after 24 hrs by MS/MS analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1126835Antiviral activity against Herpes simplex virus G infected in HEL cells assessed as inhibition of virus-induced cytopathicity2014European journal of medicinal chemistry, May-06, Volume: 78PMPA and PMEA prodrugs for the treatment of HIV infections and human papillomavirus (HPV) associated neoplasia and cancer.
AID310047Therapeutic index, Ratio of TC50 for human HepG2 cells to IC50 for HBV-infected human HepG2 cells2007Bioorganic & medicinal chemistry letters, Nov-15, Volume: 17, Issue:22
Some new acyclic nucleotide analogues as antiviral prodrugs: synthesis and bioactivities in vitro.
AID423281Selectivity ratio of EC50 for multinucleoside-resistant HIV1 NL4-3 harboring A62V, V75I, F77L, F116Y, Q151M mutation in viral reverse transcriptase to EC50 for wild type HIV1 NL4-32008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Human immunodeficiency virus types 1 and 2 exhibit comparable sensitivities to Zidovudine and other nucleoside analog inhibitors in vitro.
AID1599860Clearance in Sprague-Dawley rat at 5 mg/kg, iv2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID322838Antiviral activity against lamivudine-resistant HBV with reverse transcriptase V173L/L180/M204V mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID394474AUC (0 to infinity) in Sprague-Dawley rat assessed as tenofovir level at 10 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID557045Antiviral activity against HIV1 CRF17_BF harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID548588Antiviral activity against HIV1 isolate 180 harboring reverse transcriptase K65R mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID618327Antiviral activity against HIV1 clade D isolate 1649 infected in human H9 cells assessed as inhibition of viral replication2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID1457756Selectivity index, ratio of CC50 for human PHA-stimulated PBMC to IC50 for CXCR4-tropic HIV-1 NL4-3 infected in human PHA-stimulated PBMC2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID729823Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of viral DNA replication2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis of hemslecin A derivatives: a new class of hepatitis B virus inhibitors.
AID1832350Therapeutic index, ratio of CC50 for cytotoxicity against HEK293T cells in absence of HSA to IC50 for antiviral activity against human immunodeficiency virus expressed in HEK293T cells in absence of HSA2021Journal of medicinal chemistry, 09-09, Volume: 64, Issue:17
ω-Functionalized Lipid Prodrugs of HIV NtRTI Tenofovir with Enhanced Pharmacokinetic Properties.
AID317372Antiviral activity against HIV with reverse transcriptase M184V mutation in MT4 cells assessed as fold resistance relative to wild type2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Synthesis, anti-HIV activity, and resistance profiles of ribose modified nucleoside phosphonates.
AID1832357Cytotoxicity against HEK293T cells assessed as reduction in cell viability in absence of HSA measured after 48 hrs by CellTiter 96 Aqueous One Solution reagent based cell proliferation assay2021Journal of medicinal chemistry, 09-09, Volume: 64, Issue:17
ω-Functionalized Lipid Prodrugs of HIV NtRTI Tenofovir with Enhanced Pharmacokinetic Properties.
AID393071Cytotoxicity against human MT2 cells after 5 days2009Bioorganic & medicinal chemistry, Feb-15, Volume: 17, Issue:4
Design, synthesis, and anti-HIV activity of 4'-modified carbocyclic nucleoside phosphonate reverse transcriptase inhibitors.
AID320327Cytotoxicity against human MT2 cells2008Bioorganic & medicinal chemistry letters, Feb-01, Volume: 18, Issue:3
Synthesis and anti-HIV activity of GS-9148 (2'-Fd4AP), a novel nucleoside phosphonate HIV reverse transcriptase inhibitor.
AID548802Antiviral activity against HIV1 isolate 200 harboring reverse transcriptase M41L/L210W/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1743971Substrate activity at HIV1 reverse transcriptase assessed as incorporation of compound into growing DNA strand at 500 uM incubated for 1 hr using primer and template in presence of MgCl2 by gel based nucleotide incorporation assay2021Journal of medicinal chemistry, 01-14, Volume: 64, Issue:1
Tenofovir-Amino Acid Conjugates Act as Polymerase Substrates-Implications for Avoiding Cellular Phosphorylation in the Discovery of Nucleotide Analogues.
AID322826Effect on cell viability in human Huh7 cells2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID341989Ratio of Kcat/Km for HIV1 reverse transcriptase in presence of 0.5 uM dCTP to Kcat/Km for reverse transcriptase in presence of 10 uM dCTP by nucleotide excision activity assay2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID322835Antiviral activity against wild type HBV genotype E assessed as inhibition of replication2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1599857Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for HBV infected in human HepG2.2.15 cells2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID548815Antiviral activity against HIV1 isolate 063 harboring reverse transcriptase M41L/D67N/K70R/M184V/L210W/T215Y/K219E mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID549081Cytotoxicity against human dendritic cells after 24 hrs by XTT assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID558375Drug level in HIV-infected pregnant woman cord blood plasma at 300 mg, po QD by LC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genital tract, cord blood, and amniotic fluid exposures of seven antiretroviral drugs during and after pregnancy in human immunodeficiency virus type 1-infected women.
AID581813Antiviral activity against R5 tropic HIV1 YU.2 infected in human TZM-b1 cells after 2 hrs by luciferase assay2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Reverse transcriptase inhibitors as potential colorectal microbicides.
AID1832363Antiviral activity against human immunodeficiency virus expressed in HEK293T cells coexpressing firefly luciferase gene incubated for 48 hrs by Bright-Glo luciferase assay2021Journal of medicinal chemistry, 09-09, Volume: 64, Issue:17
ω-Functionalized Lipid Prodrugs of HIV NtRTI Tenofovir with Enhanced Pharmacokinetic Properties.
AID592791Antiviral activity against HIV1 3B infected in human CEM cells assessed as inhibition of virus-induced syncytium formation after 4 to 5 days by microscopic analysis2011Bioorganic & medicinal chemistry, Apr-01, Volume: 19, Issue:7
Synthesis and antiviral activity of N9-[3-fluoro-2-(phosphonomethoxy)propyl] analogues derived from N6-substituted adenines and 2,6-diaminopurines.
AID341990Ratio of Kcat/Km for HIV1 reverse transcriptase M41L/D67N/L210W/T215Y mutant in presence of 0.5 uM dCTP to Kcat/Km for reverse transcriptase M41L/D67N/L210W/T215Y mutant in presence of 10 uM dCTP by nucleotide excision activity assay2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID568375Cytotoxicity against human HepG2(2.2.15) cells2011Bioorganic & medicinal chemistry, Feb-15, Volume: 19, Issue:4
Synthesis and biological assay of 4-aryl-6-chloro-quinoline derivatives as novel non-nucleoside anti-HBV agents.
AID1264924Antiviral activity against HIV2 ROD infected in human CEM cells assessed as inhibition of virus-induced giant cell formation after 4 to 5 days by microscopic analysis2015European journal of medicinal chemistry, Dec-01, Volume: 106Tryptophan dendrimers that inhibit HIV replication, prevent virus entry and bind to the HIV envelope glycoproteins gp120 and gp41.
AID659367Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for HBV by hepatitis B e-antigen release detection assay2012Bioorganic & medicinal chemistry letters, May-15, Volume: 22, Issue:10
Synthesis, biological evaluation and structure-activity relationships of glycyrrhetinic acid derivatives as novel anti-hepatitis B virus agents.
AID1782276Selectivity index, ratio of CC50 for human MT-4 cells to EC50 for HIV-1 infected in MT-4 cells2021Journal of medicinal chemistry, 11-25, Volume: 64, Issue:22
Discovery of Modified Amidate (ProTide) Prodrugs of Tenofovir with Enhanced Antiviral Properties.
AID1561720Resistance index, ratio of EC50 for antiviral activity against HIV1 3B infected in human MT4 cells grown under 30 passages in presence of (E)-4-((4-((4-(4-(2-Cyanovinyl)-2,6-dimethylphenoxy)thieno[2,3- d]pyrimidin-2-yl)amino)piperidin-1-yl)methyl)benzenes
AID394460Cmax in Sprague-Dawley rat assessed as tenofovir level at 100 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID1126832Cytotoxicity against human CEM cells2014European journal of medicinal chemistry, May-06, Volume: 78PMPA and PMEA prodrugs for the treatment of HIV infections and human papillomavirus (HPV) associated neoplasia and cancer.
AID659368Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as reduction in viral DNA replication2012Bioorganic & medicinal chemistry letters, May-15, Volume: 22, Issue:10
Synthesis, biological evaluation and structure-activity relationships of glycyrrhetinic acid derivatives as novel anti-hepatitis B virus agents.
AID1457753Cytotoxicity against human PHA-stimulated PBMC assessed as cell viability by tetrazolium dye assay2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID556525Antiviral activity against Human immunodeficiency virus 1 clone 38086 harboring K49R, V60I, I135V, Q145M, Q174H, G196E, Q207E, R211K, V245K mutation in reverse transcriptase by phenosense assay relative to wild type2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Human immunodeficiency virus type 1 isolates with the reverse transcriptase (RT) mutation Q145M retain nucleoside and nonnucleoside RT inhibitor susceptibility.
AID548565Selectivity ratio of EC50 for HIV1 4755-5 harboring reverse transcriptase 41L/44D/67N/69D/118I/210W/215Y/184V mutant gene infected in human PBMC to EC50 for HIV1 NL 4-3 expressing wild type reverse transcriptase infected in human PBMC2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1264925Cytotoxicity against human CEM cells assessed as cell count after 3 days2015European journal of medicinal chemistry, Dec-01, Volume: 106Tryptophan dendrimers that inhibit HIV replication, prevent virus entry and bind to the HIV envelope glycoproteins gp120 and gp41.
AID83112Effective concentration against cytopathicity of HIV-2 strain (ROD) in CEM cell line2003Journal of medicinal chemistry, Jun-19, Volume: 46, Issue:13
Deoxyribonucleoside 2'- or 3'-mixed disulfides: prodrugs to target ribonucleotide reductase and/or to inhibit HIV reverse transcription.
AID394458Cmax in Sprague-Dawley rat assessed as tenofovir level at 30 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID1197620Antiviral activity against HIV1 3B infected in human CEM cells assessed as reduction in virus-induced cytopathicity after 4 to 5 days by microscopy based syncytium cell formation assay2015European journal of medicinal chemistry, Mar-06, Volume: 92Linear and branched alkyl-esters and amides of gallic acid and other (mono-, di- and tri-) hydroxy benzoyl derivatives as promising anti-HCV inhibitors.
AID317370Cytotoxicity against human MT2 cells2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Synthesis, anti-HIV activity, and resistance profiles of ribose modified nucleoside phosphonates.
AID341992Inhibition of HIV1 reverse transcriptase M41L/D67N/L210W/T215Y mutant assessed as dCTP level required to form 80% of binary enzyme complex formation with drug-terminated primer in posttranslocation state by site-specific foot printing assay2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID548808Antiviral activity against HIV1 isolate 212 harboring reverse transcriptase L210W/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID618321Antiviral activity against HIV1 clade A isolate 4113 infected in human H9 cells assessed as inhibition of viral replication2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID1561716Antiviral activity against HIV1 3B infected in human MT4 cells grown under 30 passages in absence of test compound assessed as protection against virus-induced cytopathic effect incubated for 5 days by MTT assay
AID581824Antiviral activity against HIV1 isolate 71361-1 harboring reverse transcriptase K65R mutant infected in human TZM-b1 cells after 2 hrs by luciferase assays2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Reverse transcriptase inhibitors as potential colorectal microbicides.
AID394473AUC (0 to 24 hrs) in Sprague-Dawley rat assessed as tenofovir level at 100 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID1636526Therapeutic index, ratio of CC50 for human PBMC to EC50 for HIV1 infected in human PBMC2016Journal of medicinal chemistry, 08-11, Volume: 59, Issue:15
Reduction Sensitive Lipid Conjugates of Tenofovir: Synthesis, Stability, and Antiviral Activity.
AID275084Stability in culture medium (RPMI+FBS)2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID320326Inhibition of wild type HIV 3B reverse transcriptase in MT2 cells2008Bioorganic & medicinal chemistry letters, Feb-01, Volume: 18, Issue:3
Synthesis and anti-HIV activity of GS-9148 (2'-Fd4AP), a novel nucleoside phosphonate HIV reverse transcriptase inhibitor.
AID328842Inhibition of human MRP2 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID618324Antiviral activity against HIV1 clade B isolate 1722 infected in human H9 cells assessed as inhibition of viral replication2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID322845Fold resistance, ratio of lamivudine-resistant HBV with reverse transcriptase L180M/A181V mutant to wild-type HBV genotype E2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID275083Stability in RPMI-1640 medium2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID1126840Cytostatic activity against human CEM cells after 72 hrs by coulter counting analysis2014European journal of medicinal chemistry, May-06, Volume: 78PMPA and PMEA prodrugs for the treatment of HIV infections and human papillomavirus (HPV) associated neoplasia and cancer.
AID394446Cytotoxicity against human HepG2 cells by MTS assay2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID548841Antiviral activity against HIV1 isolate 220 harboring reverse transcriptase K70E/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548845Cellular uptake in human PBMC at 10 uM after 24 hrs by MS/MS analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID423158Antiviral activity against wild type HIV2 ROD produced from full length pROD9 infected in human MAGIC-5A cells assessed as inhibition of Lac+ foci expression after 40 hrs2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Human immunodeficiency virus types 1 and 2 exhibit comparable sensitivities to Zidovudine and other nucleoside analog inhibitors in vitro.
AID549083Cytotoxicity against human HeLa cells after 24 hrs by XTT assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID322839Antiviral activity against lamivudine-adenofir-resistant HBV with reverse transcriptase V173L/L180M/A181V mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID548586Antiviral activity against HIV1 isolate 166 harboring reverse transcriptase L74V mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1140535Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of DNA replication2014Bioorganic & medicinal chemistry letters, May-15, Volume: 24, Issue:10
Synthesis, structure-activity relationships and biological evaluation of dehydroandrographolide and andrographolide derivatives as novel anti-hepatitis B virus agents.
AID1192283Cytotoxicity against human HepG2(2.2.15) cells after 72 hrs by MTT assay2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Synthesis of erythrocentaurin derivatives as a new class of hepatitis B virus inhibitors.
AID423280Antiviral activity against multinucleoside-resistant HIV1 NL4-3 harboring A62V, V75I, F77L, F116Y, Q151M mutation in viral reverse transcriptase infected in human MAGIC-5A cells assessed as inhibition of Lac+ foci expression after 40 hrs2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Human immunodeficiency virus types 1 and 2 exhibit comparable sensitivities to Zidovudine and other nucleoside analog inhibitors in vitro.
AID1394855Antiviral activity against HIV1 LAI infected in PHA-P activated human PBMC assessed as reduction in viral replication preincubated with cells for 30 mins followed by viral infection and measured at day 7 post infection by reverse transcriptase activity-ba2018European journal of medicinal chemistry, Apr-25, Volume: 150Synthesis of 3'-halo-5'-norcarbocyclic nucleoside phosphonates as potent anti-HIV agents.
AID548560Antiviral activity against HIV1 1617-1 harboring reverse transcriptase 69K/70G/75I/77L/116Y/151M/184V mutant gene infected in human PBMC by ELISA2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID394455Antiviral activity against HIV1 clade B HT/92/599 isolate in human PBMC assessed as reduction in reverse transcriptase2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID670449Cytotoxicity against human HepG2(2.2.15) cells by modified-MTT assay2012European journal of medicinal chemistry, Aug, Volume: 54Design, synthesis, and molecular hybrids of caudatin and cinnamic acids as novel anti-hepatitis B virus agents.
AID1686655Antiviral activity against HBV infected in human HepG2 assessed as reduction in viral replication incubated for 6 days by real time Q-PCR analysis2016Journal of medicinal chemistry, 11-23, Volume: 59, Issue:22
Next-Generation Reduction Sensitive Lipid Conjugates of Tenofovir: Antiviral Activity and Mechanism of Release.
AID422692Ratio of IC50 for HIV1 with reverse transcriptase K70G/M184V mutation to IC50 for wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID394454Selectivity index, ratio of CC50 for human MT2 cells to EC50 for HIV1 LAI2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID548575Antiviral activity against HIV1 isolate 061 harboring reverse transcriptase M41L/D67N/K70R/M184V/L210W/T215Y/K219E mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548800Antiviral activity against HIV1 isolate 192 harboring reverse transcriptase M41L/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID618430Antiviral activity against HIV1 clade F isolate 2338 infected in human H9 cells assessed as inhibition of viral replication2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID549084Cytotoxicity against human CEM-SS cells after 24 hrs by XTT assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID313875Cytotoxicity against human MT2 cells2008Bioorganic & medicinal chemistry letters, Feb-01, Volume: 18, Issue:3
Synthesis and anti-HIV activity of 2'-fluorine modified nucleoside phosphonates: analogs of GS-9148.
AID422691Ratio of IC50 for HIV1 with reverse transcriptase K70E/M184V mutation to IC50 for wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID341985Ratio of Kcat to Km for HIV1 reverse transcriptase M41L/D67N/L210W/T215Y mutant assessed as nucleotide excision activity in presence of 0.5 uM dCTP2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID55965Antiviral activity against Davis strain of cytomegalovirus (CMV) in HEL (human erythroleukemia) cells.2003Journal of medicinal chemistry, Nov-06, Volume: 46, Issue:23
5-Substituted-2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]pyrimidines-acyclic nucleoside phosphonate analogues with antiviral activity.
AID341185Cytotoxicity against human PHA-PBMC cells by MTT assay2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Activity against human immunodeficiency virus type 1, intracellular metabolism, and effects on human DNA polymerases of 4'-ethynyl-2-fluoro-2'-deoxyadenosine.
AID699539Inhibition of human liver OATP1B1 expressed in HEK293 Flp-In cells assessed as reduction in E17-betaG uptake at 20 uM by scintillation counting2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Classification of inhibitors of hepatic organic anion transporting polypeptides (OATPs): influence of protein expression on drug-drug interactions.
AID1457758Antiviral activity against tenofovir-resistant CXCR4-tropic HIV-1 NL4-3 harboring reverse transcriptase K65R mutant infected in human MT4 cells assessed as inhibition of viral replication inhibition of virus-induced cytopathic effect after 6 days by XTT d2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID72026Antiproliferative activity was determined against murine mammary carcinoma cells (FM3A)2003Journal of medicinal chemistry, Jun-19, Volume: 46, Issue:13
Deoxyribonucleoside 2'- or 3'-mixed disulfides: prodrugs to target ribonucleotide reductase and/or to inhibit HIV reverse transcription.
AID1599866AUC(0 to infinity) in Sprague-Dawley rat at 20 mg/kg, po administered as single dose and measured after 0.25 to 24 hrs by HPLC analysis2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID548831Antiviral activity against HIV1 isolate 194 harboring reverse transcriptase M41L/T215Y/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID405412Antiviral activity against PERV infected in human 293T cells assessed as inhibition of proximal DNA synthesis after 24 hrs by RT-PCR2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
Selective inhibition of porcine endogenous retrovirus replication in human cells by acyclic nucleoside phosphonates.
AID394480Elimination half life in Sprague-Dawley rat assessed as tenofovir level at 10 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID548577Antiviral activity against HIV1 isolate 066 harboring reverse transcriptase 184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1193392Cytotoxicity against human HepG 2.2.15 cells by MTT assay2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Isolation, synthesis and anti-hepatitis B virus evaluation of p-hydroxyacetophenone derivatives from Artemisia capillaris.
AID275065Antiviral activity against HIV1 in MAGI-CCR5 cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID341370Ratio of EC50 for R5-HIV1MDR/MM in human PHA-PBMC to EC50 for R5-HIV1Ba-L in human PHA-PBMC2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Activity against human immunodeficiency virus type 1, intracellular metabolism, and effects on human DNA polymerases of 4'-ethynyl-2-fluoro-2'-deoxyadenosine.
AID147626Antiviral activity against OKA strain of VZV in HEL (human erythroleukemia) cells.2003Journal of medicinal chemistry, Nov-06, Volume: 46, Issue:23
5-Substituted-2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]pyrimidines-acyclic nucleoside phosphonate analogues with antiviral activity.
AID45994Cytotoxicity against CEM (human lymphoblastic leukemia) cells in vitro.2003Journal of medicinal chemistry, Nov-06, Volume: 46, Issue:23
5-Substituted-2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]pyrimidines-acyclic nucleoside phosphonate analogues with antiviral activity.
AID548806Antiviral activity against HIV1 isolate 206 harboring reverse transcriptase D67N/K70R mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1686652Antiviral activity against HIV1 infected in human PBMC assessed as reduction in viral replication incubated for 7 days by radioactive incorporation polymerization assay based reverse transcriptase activity detection method2016Journal of medicinal chemistry, 11-23, Volume: 59, Issue:22
Next-Generation Reduction Sensitive Lipid Conjugates of Tenofovir: Antiviral Activity and Mechanism of Release.
AID1457751Antiviral activity against CXCR4-tropic HIV-1 NL4-3 infected in human PHA-stimulated PBMC assessed as inhibition of viral replication by measuring reduction in p24 antigen production preincubated with cells for 30 mins followed by viral infection measured2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID393073Antiviral activity against HIV1 3a with reverse transcriptase M184V mutation in human MT2 cells assessed as inhibition of viral-induced cytopathic effect by XTT assay relative to wild type2009Bioorganic & medicinal chemistry, Feb-15, Volume: 17, Issue:4
Design, synthesis, and anti-HIV activity of 4'-modified carbocyclic nucleoside phosphonate reverse transcriptase inhibitors.
AID211496In vitro cytotoxic concentration against CEM cells2001Bioorganic & medicinal chemistry letters, Apr-23, Volume: 11, Issue:8
Synthesis and evaluation of novel amidate prodrugs of PMEA and PMPA.
AID320325Antiviral activity against wild type HIV1 3B in MT2 cells2008Bioorganic & medicinal chemistry letters, Feb-01, Volume: 18, Issue:3
Synthesis and anti-HIV activity of GS-9148 (2'-Fd4AP), a novel nucleoside phosphonate HIV reverse transcriptase inhibitor.
AID618433Antiviral activity against Hepatitis B virus infected in human HepAD38 cells assessed as reduction in viral DNA level after 6 days by real time quantitative PCR analysis2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID699540Inhibition of human liver OATP1B3 expressed in HEK293 Flp-In cells assessed as reduction in [3H]E17-betaG uptake at 20 uM incubated for 5 mins by scintillation counting2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Classification of inhibitors of hepatic organic anion transporting polypeptides (OATPs): influence of protein expression on drug-drug interactions.
AID275080Stability in pH 8.1 buffer at 37 degC after 72 hrs2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID341976Inhibition of HIV1 reverse transcriptase assessed as dCTP level required to form 50% of binary enzyme complex formation with drug-terminated primer in posttranslocation state by site-specific foot printing assay2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID548580Antiviral activity against HIV1 isolate 070 harboring reverse transcriptase 65R/S68G mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548818Antiviral activity against HIV1 isolate 069 harboring reverse transcriptase D67E/T69SSG/V75M/M184V/L210W/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1561722Resistance index, ratio of EC50 for antiviral activity against HIV1 3B infected in human MT4 cells grown under 30 passages in presence of 4-[[4-[[4-[4-[2-cyanovinyl]-2,6-dimethylphenoxy]thieno[3,2-d]pyrimidin-2-yl]amino]-1-piperidyl]methyl]benzenesulfonam
AID581814Antiviral activity against X4 tropic HIV1 NL4.3 infected in human TZM-b1 cells after 2 hrs by luciferase assay2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Reverse transcriptase inhibitors as potential colorectal microbicides.
AID670450Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral surface antigen secretion2012European journal of medicinal chemistry, Aug, Volume: 54Design, synthesis, and molecular hybrids of caudatin and cinnamic acids as novel anti-hepatitis B virus agents.
AID581820Antiviral activity against R5 tropic HIV1 YU.2 infected in human PBMC assessed as inhibition of p24 antigen production after 2 hrs by ELISA2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Reverse transcriptase inhibitors as potential colorectal microbicides.
AID1832360Cytotoxicity against HEK293T cells assessed as reduction in cell viability measured after 48 hrs by CellTiter 96 Aqueous One Solution reagent based cell proliferation assay2021Journal of medicinal chemistry, 09-09, Volume: 64, Issue:17
ω-Functionalized Lipid Prodrugs of HIV NtRTI Tenofovir with Enhanced Pharmacokinetic Properties.
AID544666Activity of human OAT1 transfected in CHO cells measured per 10'6 cells2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Novel nucleotide human immunodeficiency virus reverse transcriptase inhibitor GS-9148 with a low nephrotoxic potential: characterization of renal transport and accumulation.
AID1457754Selectivity index, ratio of CC50 for human TZM-bl cells to EC50 for CXCR4-tropic HIV-1 NL4-3 infected in human TZM-bl cells2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID581810Antiviral activity against X4 tropic HIV1 RF infected in human TZM-b1 cells after 2 hrs by luciferase assay2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Reverse transcriptase inhibitors as potential colorectal microbicides.
AID568381Selectivity index, CC50 for human HepG 2.215 cells to IC50 for HBV infected in human HepG 2.215 cells assessed as inhibition of DNA replication2011Bioorganic & medicinal chemistry, Feb-15, Volume: 19, Issue:4
Synthesis and biological assay of 4-aryl-6-chloro-quinoline derivatives as novel non-nucleoside anti-HBV agents.
AID344318Inhibition of murine sarcoma virus-induced transformation of mouse embryo fibroblast C3H/3T3 cells after 6 days2008Bioorganic & medicinal chemistry, Jul-15, Volume: 16, Issue:14
Anti-retroviral and cytostatic activity of 2',3'-dideoxyribonucleoside 3'-disulfides.
AID549086Cytotoxicity against human HuH7 cells after 24 hrs by XTT assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID289142Inhibition of HIV1 reverse transcriptase2007Bioorganic & medicinal chemistry, Aug-15, Volume: 15, Issue:16
Synthesis, anti-HIV activity, and resistance profile of thymidine phosphonomethoxy nucleosides and their bis-isopropyloxymethylcarbonyl (bisPOC) prodrugs.
AID568378Antiviral activity against HBV infected in human HepG 2.215 cells assessed as inhibition of HBeAg secretion by ELISA2011Bioorganic & medicinal chemistry, Feb-15, Volume: 19, Issue:4
Synthesis and biological assay of 4-aryl-6-chloro-quinoline derivatives as novel non-nucleoside anti-HBV agents.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID322832Fold resistance, ratio of EC50 for lamivudine-resistant HBV with reverse transcriptase L180M/M204V mutant to EC50 for wild-type HBV2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID275085Stability in CEM-SS cell extracts2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID659693Selectivity ratio of CC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus infected in human HepG2.2.15 cells assessed as suppression of HBsAg secretion2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis, structure-activity relationships and biological evaluation of caudatin derivatives as novel anti-hepatitis B virus agents.
AID558389Ratio of drug level in HIV-infected pregnant woman cord blood plasma to maternal blood plasma at 300 mg, po QD by LC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genital tract, cord blood, and amniotic fluid exposures of seven antiretroviral drugs during and after pregnancy in human immunodeficiency virus type 1-infected women.
AID558368Drug level in HIV-infected pregnant woman maternal blood plasma at 300 mg, po QD by LC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genital tract, cord blood, and amniotic fluid exposures of seven antiretroviral drugs during and after pregnancy in human immunodeficiency virus type 1-infected women.
AID394451Antiviral activity against HBV in human HepG2(2.2.15) cells assessed as viral DNA levels treated for 9 days measured after 24 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID1782294Antiviral activity against HIV-12021Journal of medicinal chemistry, 11-25, Volume: 64, Issue:22
Discovery of Modified Amidate (ProTide) Prodrugs of Tenofovir with Enhanced Antiviral Properties.
AID322829Antiviral activity against lamivudine-resistant HBV with reverse transcriptase L180M/M204V mutant assessed as inhibition of replication2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID320330Antiviral activity against HIV with reverse transcriptase M184V mutation assessed as fold resistance relative to wild type2008Bioorganic & medicinal chemistry letters, Feb-01, Volume: 18, Issue:3
Synthesis and anti-HIV activity of GS-9148 (2'-Fd4AP), a novel nucleoside phosphonate HIV reverse transcriptase inhibitor.
AID618326Antiviral activity against HIV1 clade C isolate 4110 infected in human H9 cells assessed as inhibition of viral replication2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Acyclic nucleoside thiophosphonates as potent inhibitors of HIV and HBV replication.
AID548830Antiviral activity against HIV1 isolate 192 harboring reverse transcriptase M41L/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548844Cellular uptake in human PBMC at 1 uM assessed as TFV-diphosphate level after 24 hrs by MS/MS analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID557050Antiviral activity against HIV1 clade H harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID557051Antiviral activity against PI-resistant HIV1 harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID548827Antiviral activity against HIV1 isolate 180 harboring reverse transcriptase K65R mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548840Antiviral activity against HIV1 isolate 217 harboring reverse transcriptase D67N/K70E/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548856Cellular uptake in PHA/IL-2-stimulated human PBMC at 1 uM after 24 hrs by MS/MS analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1457760Cytotoxicity against human MT4 cells assessed as reduction in cell viability after 6 days by XTT tetrazolium dye-based assay2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID341183Antiviral activity against R5-HIV1MDR/G assessed as inhibition of p24 Gag protein production in human PHA-PBMC by ELISA2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Activity against human immunodeficiency virus type 1, intracellular metabolism, and effects on human DNA polymerases of 4'-ethynyl-2-fluoro-2'-deoxyadenosine.
AID322840Antiviral activity against Lamivudine -adenofir-resistant HBV with reverse transcriptase V173L/L180M/A181V/M204V mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID556526Antiviral activity against Human immunodeficiency virus 1 clone Q9016 harboring K122E, Q145M, I202V, F214L mutation in reverse transcriptase by phenosense assay relative to wild type2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Human immunodeficiency virus type 1 isolates with the reverse transcriptase (RT) mutation Q145M retain nucleoside and nonnucleoside RT inhibitor susceptibility.
AID557046Antiviral activity against HIV1 clade C harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID548811Antiviral activity against HIV1 isolate 220 harboring reverse transcriptase K70E/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID394449Antiviral activity against HBV in human HepAD38 cells assessed as intracellular viral DNA levels treated for 3 days measured on day 6 postinfection by RT-PCR2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID1126839Cytostatic activity against mouse L1210 cells after 48 hrs by coulter counting analysis2014European journal of medicinal chemistry, May-06, Volume: 78PMPA and PMEA prodrugs for the treatment of HIV infections and human papillomavirus (HPV) associated neoplasia and cancer.
AID47262In vitro antiviral activity against HIV-1 in CEM cells2001Bioorganic & medicinal chemistry letters, Apr-23, Volume: 11, Issue:8
Synthesis and evaluation of novel amidate prodrugs of PMEA and PMPA.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID394448Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to EC50 for HBV2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID729828Cytotoxicity against human HepG2.2.15 cells2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis of hemslecin A derivatives: a new class of hepatitis B virus inhibitors.
AID581822Antiviral activity against R5 tropic HIV1 R8.BaL infected in human PBMC assessed as inhibition of p24 antigen production after 2 hrs by ELISA2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Reverse transcriptase inhibitors as potential colorectal microbicides.
AID556524Antiviral activity against Human immunodeficiency virus 1 clone pNL4-3-Q145M harboring K102Q, Q145M, S162C, K277R, I293V mutation in reverse transcriptase by phenosense assay relative to wild type2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Human immunodeficiency virus type 1 isolates with the reverse transcriptase (RT) mutation Q145M retain nucleoside and nonnucleoside RT inhibitor susceptibility.
AID549070Cellular uptake in PHA/IL-2-stimulated human PBMC at 10 uM after 24 hrs by MS/MS analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID549071Cellular uptake in PHA/IL-2-stimulated human PBMC at 10 uM assessed as TFV-monophosphate after 24 hrs by MS/MS analysis2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID394483Elimination half life in Sprague-Dawley rat assessed as tenofovir level at 30 mg/kg, po administered daily for 7 days measured on day 72007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID544667Activity of human OAT3 transfected in BHK-21 cells measured per 10'6 cells2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Novel nucleotide human immunodeficiency virus reverse transcriptase inhibitor GS-9148 with a low nephrotoxic potential: characterization of renal transport and accumulation.
AID548570Selectivity ratio of EC50 for HIV1 8415-2 harboring reverse transcriptase 65R/184V mutant gene infected in human PBMC to EC50 for HIV1 NL 4-3 expressing wild type reverse transcriptase infected in human PBMC2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1126829Antiviral activity against Human immunodeficiency virus 1 3B infected in human CEM cells assessed as inhibition of virus-induced giant cell formation after 4 to 5 days by microscopic analysis2014European journal of medicinal chemistry, May-06, Volume: 78PMPA and PMEA prodrugs for the treatment of HIV infections and human papillomavirus (HPV) associated neoplasia and cancer.
AID659694Selectivity ratio of CC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as suppression of HBeAg secretion2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis, structure-activity relationships and biological evaluation of caudatin derivatives as novel anti-hepatitis B virus agents.
AID341987Ratio of Kcat/Km for HIV1 reverse transcriptase M41L/D67N/L210W/T215Y mutant to Kcat/Km for wild-type reverse transcriptase assessed as nucleotide excision activity in presence of 0.5 uM dCTP2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effects of the translocation status of human immunodeficiency virus type 1 reverse transcriptase on the efficiency of excision of tenofovir.
AID394252Cmax in Sprague-Dawley rat assessed as tenofovir level at 10 mg/kg, po administered daily for 7 days measured on day 12007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Evaluation of hexadecyloxypropyl-9-R-[2-(Phosphonomethoxy)propyl]- adenine, CMX157, as a potential treatment for human immunodeficiency virus type 1 and hepatitis B virus infections.
AID548572Antiviral activity against HIV1 isolate 057 expressing wild type reverse transcriptase gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID275077Stability in pH 1.2 buffer at 37 degC after 72 hrs2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID588979Substrates of transporters of clinical importance in the absorption and disposition of drugs, MRP42010Nature reviews. Drug discovery, Mar, Volume: 9, Issue:3
Membrane transporters in drug development.
AID548813Antiviral activity against HIV1 isolate 060 harboring reverse transcriptase M41L/D67N/K70R/L210W/T215Y/K219E mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1649792Antiviral activity against HBV infected in human HepG2.A64 cells containing reverse transcriptase L180M/T184L/M204V mutant assessed as reduction in viral replication incubated for 6 days by PCR analysis2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
Discovery of (1
AID1193395Antiviral activity against hepatitis B viral in human HepG2.2.15 cells assessed as surface antigen HBeAg secretion after 72 hrs by ELISA2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Isolation, synthesis and anti-hepatitis B virus evaluation of p-hydroxyacetophenone derivatives from Artemisia capillaris.
AID548799Antiviral activity against HIV1 isolate 188 harboring reverse transcriptase T215Y/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID556527Antiviral activity against Human immunodeficiency virus 1 clone 14682 harboring 122E, 135V, Q145V, 200A mutation in reverse transcriptase by phenosense assay relative to wild type2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Human immunodeficiency virus type 1 isolates with the reverse transcriptase (RT) mutation Q145M retain nucleoside and nonnucleoside RT inhibitor susceptibility.
AID548824Antiviral activity against HIV1 isolate 162 harboring reverse transcriptase A62V/V75I/F77L/Y115F/F116Y/Q151M/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID548558Antiviral activity against HIV1 4755-5 harboring reverse transcriptase 41L/44D/67N/69D/118I/210W/215Y/184V mutant gene infected in human PBMC by ELISA2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1383902Antiviral activity against HSV2018European journal of medicinal chemistry, Apr-25, Volume: 150Polypharmacology in HIV inhibition: can a drug with simultaneous action against two relevant targets be an alternative to combination therapy?
AID1745854NCATS anti-infectives library activity on HEK293 viability as a counter-qHTS vs the C. elegans viability qHTS2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1745855NCATS anti-infectives library activity on the primary C. elegans qHTS viability assay2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1805801Various Assay from Article 10.1021/acs.jmedchem.1c00409: \\Perspectives on SARS-CoV-2 Main Protease Inhibitors.\\2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
Perspectives on SARS-CoV-2 Main Protease Inhibitors.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (4,957)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's40 (0.81)18.2507
2000's938 (18.92)29.6817
2010's2747 (55.42)24.3611
2020's1232 (24.85)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials940 (18.15%)5.53%
Reviews574 (11.09%)6.00%
Case Studies412 (7.96%)4.05%
Observational152 (2.94%)0.25%
Other3,100 (59.87%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (755)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized, Pilot Estimation Study to Compare the Safety and Efficacy of Raltegravir+TDF+3TC Versus TDF+3TC+EFV in HBV/HIV Co-infected Patients [NCT01318096]60 participants (Anticipated)Interventional2011-03-31Not yet recruiting
Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum [NCT05355467]Phase 440 participants (Actual)Interventional2019-08-21Completed
A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose [NCT01489046]Phase 2297 participants (Actual)Interventional2011-02-28Terminated
A Phase 1b/2a, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Patients With Chronic Hepatitis B [NCT03109730]Phase 1/Phase 238 participants (Actual)Interventional2017-06-15Completed
Changes in Coagulation and Platelet Reactivity in HIV-1 Infected Patients Switching Between Abacavir and Tenofovir Containing Antiretroviral Regimens [NCT02093585]Phase 443 participants (Actual)Interventional2014-01-31Completed
"A Prospective, Randomized, Multicenter, Open-label, Exploratory Study of Utilizing of Response-Guided-Therapy (RGT) Strategy on Optimal Nucleoside Analogue (NUC)-Experienced Patients" [NCT02560649]Phase 4324 participants (Anticipated)Interventional2015-05-31Active, not recruiting
Multicenter, Double-Blind, Randomized, Dose Ranging Study to Compare the Safety and Activity of MK0518 Plus Tenofovir and Lamivudine (3TC) Versus Efavirenz Plus Tenofovir and Lamivudine (3TC) in ART-Naive, HIV-Infected Patients [NCT00100048]Phase 2206 participants (Actual)Interventional2005-01-31Completed
Treatment Cohort of HIV-infected Children With Resistance or Intolerance to Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI) First Line and PI Second Line Antiretroviral Therapy [NCT01225406]56 participants (Actual)Observational2010-08-31Completed
Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure [NCT03920618]150 participants (Anticipated)Interventional2019-02-01Recruiting
A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™ [NCT00369941]Phase 3566 participants (Actual)Interventional2006-08-31Completed
[NCT01274780]Phase 4180 participants (Actual)Interventional2011-05-31Completed
Microbicide Safety and Acceptability in Young Men [NCT01283360]Phase 1249 participants (Actual)Interventional2010-10-31Completed
A Prospective, Multi-center, Cohort Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide (TAF) for Prevention of Mother-to-child Transmission of Hepatitis B Virus Among Pregnant Women With High Level HBV DNA [NCT05177926]Phase 4330 participants (Anticipated)Interventional2021-04-04Recruiting
Bictegravir in the Elderly Living With HIV: Impact of Polypharmacy and Multimorbidity (BICEP) [NCT05064020]162 participants (Anticipated)Observational2020-08-01Active, not recruiting
Clinical Trial of CNS Penetrating ART to Prevent NeuroAIDS in China [NCT01340950]Phase 4250 participants (Actual)Interventional2010-07-31Completed
Use of Immune Modulatory Properties of Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity: Proposal for Pilot Clinical Trial [NCT03759782]Phase 324 participants (Anticipated)Interventional2019-01-10Recruiting
UNCPM 22314 - Evaluating the Safety of Pregnancy, Infant and Maternal Health Outcomes Among PrEP Users in Malawi [NCT06158126]621 participants (Anticipated)Observational [Patient Registry]2024-01-01Not yet recruiting
A Phase 2 Open-label Trial to Evaluate Safety, Efficacy, Tolerability, and Pharmacodynamics of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs, and a PD-1 Inhibitor in Chronic Hepatitis B Patients [NCT05275023]Phase 237 participants (Actual)Interventional2022-06-30Active, not recruiting
A Phase 1b, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Treatment With JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, HBeAg-negative Participants With Chronic Hepatitis B Vi [NCT05123599]Phase 124 participants (Actual)Interventional2021-12-06Active, not recruiting
A Phase 2 Randomized, Open-label, Parallel-group, Multicenter Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Response to Combination Regimens Containing JNJ-73763989 and Nucleos(t)Ide Analog With or Without JNJ [NCT04585789]Phase 224 participants (Actual)Interventional2021-03-11Active, not recruiting
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled Study With Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hep [NCT04535544]Phase 252 participants (Actual)Interventional2020-09-17Active, not recruiting
A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate Efficacy, Pharmacokinetics, Safety, and Tolerability of Treatment With JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog With or Without JNJ-56136379 in Treatment-naive Patie [NCT04439539]Phase 254 participants (Actual)Interventional2020-09-14Active, not recruiting
Pharmacokinetics of Tenofovir and Tenofovir-diphosphate, Emtricitabine and Emtricitabine-triphosphate, and Efavirenz Once Daily Over 10 Days Following Drug Intake Cessation in Healthy Volunteers [NCT01108926]Phase 119 participants (Actual)Interventional2010-06-30Completed
Maternal Tenofovir-containing Combination Drug Regimen During the Second and Third Trimesters of Pregnancy for Prevention of Mother-to-child Transmission of HIV and HBV in HIV-HBV Co-infected Mothers [NCT01125696]Phase 245 participants (Actual)Interventional2012-05-31Completed
Phase 3B, Randomized, Open-Label, Safety, and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs [NCT04140266]Phase 3394 participants (Actual)Interventional2020-09-24Completed
A Prospective, Randomized, Open Label Study to Evaluate the Safety and Tolerability of Raltegravir + Truvada Versus Kaletra + Truvada, for Post-exposure Prophylaxis in Health Care Workers [NCT01234116]Phase 416 participants (Actual)Interventional2011-02-28Completed
Virtual PrEP: Rendering PrEP Delivery More Efficient Using an mHealth Intervention and TAF/FTC [NCT05159531]Phase 4142 participants (Anticipated)Interventional2023-05-01Recruiting
F/TAF Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis (TAF4TRANS) [NCT04616963]Phase 464 participants (Actual)Interventional2019-10-24Active, not recruiting
Immediate Initiation of Antiretroviral Therapy During Acute HIV Infection [NCT02656511]Phase 474 participants (Anticipated)Interventional2015-12-31Active, not recruiting
Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-negative Chronic Hepatitis B [NCT01369212]Phase 3201 participants (Actual)Interventional2012-11-30Completed
Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression [NCT01174914]Phase 2171 participants (Actual)Interventional2008-03-31Completed
Tenofovir Disoproxil Fumarat 300 mg - Phyllanthus Urinaria 300mg - Adenosma Glutinosum 150mg - Eclipta Prostrata 150mg, Ascorbic Acid 500 mg Daily is Effective in the Long-term Treatment of Chronic and Acute Hepatitis B. [NCT01198860]0 participants Expanded AccessApproved for marketing
A Real-world Clinical Study on Effectiveness and Safety of Long-term TAF Treatment in Chronic Hepatitis B Patients in China [NCT03752658]500 participants (Anticipated)Observational2019-01-25Recruiting
A Multicenter, Randomized, Double-Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir + Darunavir/Ritonavir For The Treatment Of Antiretroviral-Naive Hiv-Infected Patients With Ccr5-Tropic Hiv-1 [NCT01345630]Phase 3813 participants (Actual)Interventional2011-09-30Terminated(stopped due to See termination reason in detailed description.)
Optimal Combination Therapy After Nevirapine Exposure [NCT00089505]Phase 3745 participants (Actual)Interventional2006-11-30Completed
A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Patients With Chronic Hepatitis B [NCT03576066]Phase 273 participants (Actual)Interventional2018-06-11Completed
Randomized, Open-Label, Active Comparator, Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Hepatitis B Virus (HBV) Activity of NCO-48 Fumarate in Treatment-Naive Adults With Chronic HBV Infection [NCT04629976]Phase 121 participants (Actual)Interventional2021-01-12Completed
A Single Arm, Phase 3 Study, Exploring the Safety of Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV, a Pilot Switch Study Strategy in South Africa [NCT04433780]Phase 3133 participants (Actual)Interventional2021-01-04Completed
A Study of the Safety and Efficacy of Entecavir Plus Tenofovir in Adults With Chronic Hepatitis B Virus Infection With Previous Nucleoside/Nucleotide Treatment Failure [NCT01063036]Phase 3144 participants (Actual)Interventional2010-05-31Completed
A Multi-Center, Randomized, Open-label, Parallel, Active-controlled, Non-inferiority, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of Switching to Tenolid Tab From Viread Tab in Chronic Hepatitis B Patients on Treatment With Tenofovir Disop [NCT05282407]Phase 4118 participants (Actual)Interventional2017-11-20Completed
Bioequivalence of Tenofovir and Emtricitabine Following Overencapsulation [NCT02968576]25 participants (Actual)Interventional2016-12-31Completed
Pre-exposure Prophylaxis of HIV Infection Among Men Who Have Sex With Men (MSM) and Transgender Women (TG) in Suburban Yangon, Myanmar [NCT04781426]200 participants (Actual)Observational2020-10-28Completed
A Phase 4, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed-dose Combination (FDC) Regimen in Antiretroviral Treatment-experienced Human Immunodeficie [NCT04388904]Phase 475 participants (Actual)Interventional2021-09-01Active, not recruiting
An Open-Label Study to Investigate the Effect of Renal Impairment on the Pharmacokinectics of Tenofovir Exalidex [NCT03284164]Phase 116 participants (Actual)Interventional2017-09-28Completed
Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Lamivudine Plus Adefovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir Combination Therapy - Multicenter Randomiz [NCT03236584]Phase 376 participants (Actual)Interventional2015-09-01Active, not recruiting
The Study of Starting to Use Tenofovir Disoproxil Fumarate(TDF) Antiviral Treatment From the 32 Weeks of Gestation to Block Mother-to-child Transmission of Hepatitis B Virus(HBV MTCT) and Withdrawal Time [NCT03209908]380 participants (Anticipated)Observational2017-01-01Recruiting
A Randomized, Double-Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B [NCT00507507]Phase 2126 participants (Actual)Interventional2007-09-30Completed
I-BrEATHe - Interactions Between Antiretrovirals And Transgender Hormones [NCT04050371]Phase 448 participants (Actual)Interventional2017-08-03Completed
A Phase 2, Open-label, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection [NCT05005507]Phase 21 participants (Actual)Interventional2021-11-03Terminated(stopped due to A strategic decision was made to not further execute the study. This decision was not based on a safety concern.)
Simplified Model of Linkage and Retention to Healthcare System, Using a Mobil Unit and a Same-day Test and Treat Approach Among Excluded Population. [NCT05405751]Phase 4100 participants (Actual)Interventional2022-07-04Active, not recruiting
Two Randomized, Open-labeled, Parallel Designed Multiple-dose Clinical Trials to Evaluate Pharmacokinetics of Ritonavir-unboosted and Ritonavir-boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunte [NCT01368783]Phase 132 participants (Anticipated)Interventional2011-06-30Not yet recruiting
Dose Proportionality of TFV-DP in Mucosal Tissue, and Endogenous Nucleotide Quantification, After a Single Dose of GS-7340 in Women [NCT02357602]Phase 124 participants (Actual)Interventional2015-03-31Completed
A Phase IV, Open-label Three-arm Study Investigating the Impact of a Combination of Tenofovir Disoproxil Fumarate/Emtricitabine With Raltegravir or Dolutegravir or Elvitegravir/Cobicistat on Renal Tubular Function and Renal Transporters in HIV-1 Antiretro [NCT02351908]Phase 460 participants (Actual)Interventional2015-03-31Completed
Prevention of Hepatitis B Virus (HBV) Mother-to-Child (MTC) Transmission by Serovaccination of Newborns and Use of Tenofovir DF During the Last Trimester of Pregnancy in Mothers With HBV DNA Above 100, 000 I.U/mL [NCT02039362]Phase 437 participants (Actual)Interventional2012-07-31Completed
An Open Label Study Evaluating the Safety and Efficacy of Switching From Rilpivirine/Emtricitabine/Tenofovir Alafenamide in Combination With Dolutegravir, to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Combination With Doravirine, in Male HIV+ Subj [NCT04538040]Phase 420 participants (Actual)Interventional2019-12-19Completed
An Open-label, Randomized Study to Compare the Efficacy and Safety of P1101 Plus Tenofovir Alafenamide With or Without Ursodeoxycholic Acid in Patients With Chronic Hepatitis B and Hepatitis D Virus Co-Infection [NCT05467553]Phase 230 participants (Anticipated)Interventional2023-02-24Not yet recruiting
Assessing Virologic Success and Metabolic Changes in Patients Switching From a TDF to TAF Containing Antiretroviral Therapy Regimen [NCT03646370]110 participants (Actual)Observational2018-07-25Completed
Antiretroviral Activity and Tolerability of Once Daily Etravirine in Treatment-Naïve Adults With HIV-1 Infection [NCT00959894]Phase 280 participants (Actual)Interventional2009-09-30Completed
A Phase 1, Open-label, 2-cohort, Multiple Dose, Drug-drug Interaction, Safety and Tolerability, Fixed-sequence Study to Investigate the Potential Interaction Between ATI-2173 When Coadministered With Tenofovir Disoproxil Fumarate in Healthy Subjects [NCT05137548]Phase 132 participants (Actual)Interventional2021-10-27Completed
A Phase 2, Exploratory Study Evaluating the Safety and Antiviral Efficacy of Inarigivir Soproxil in Non-cirrhotic Treatment-Naive Subjects Infected With Chronic Hepatitis B Virus [NCT04059198]Phase 25 participants (Actual)Interventional2019-10-10Terminated(stopped due to Evidence of liver injury in a separate Inarigavir study)
A Open-label, Single Center Drug Interaction Study of Morphothiadine Mesilate/Ritonavir , Entecavir and Tenofovir Disoproxil Fumarate in Healthy Subjects [NCT03662568]Phase 156 participants (Actual)Interventional2018-06-26Completed
"Assessment of a New Boosting Strategy for HIV Pre-exposure Prophylaxis in Healthy Volunteers" [NCT03202511]Early Phase 115 participants (Actual)Interventional2017-06-23Completed
Pilot Study to Assess the Antiviral Activity and Safety of Besifovir Dipivoxil 150mg and L-carnitine 660mg Compared to Tenofovir Alafenamide 25mg in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver [NCT03604016]Phase 476 participants (Anticipated)Interventional2018-09-23Not yet recruiting
A Randomised Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis [NCT02238860]Phase 4100 participants (Anticipated)Interventional2014-09-30Recruiting
A Sequential Phase 1a/1b Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ARC-521 in Normal Adult Volunteers and Patients With Chronic Hepatitis B [NCT02797522]Phase 147 participants (Actual)Interventional2016-06-30Terminated(stopped due to Company decision to discontinue trial)
A Phase 3 Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir Once-Daily in HIV-1 Infected Treatment-Naïve Participants [NCT04233879]Phase 3599 participants (Actual)Interventional2020-02-28Active, not recruiting
Extracellular and Intracellular TFV/FTC Residues After a Single Dose in HIV-Negative Men and Women: Implications for Pre-exposure HIV Prophylaxis Dosing of Truvada® [NCT01326221]12 participants (Actual)Observational2008-10-31Completed
A Multi-centre, One-arm Prospective Study to Evaluate Efficacy and Safety of Switching From Entecavir (ETV) to Tenofovir Disoproxil Fumarate (TDF) in Japanese Chronic Hepatitis B HBeAg-positive and HBV-DNA Undetectable Subjects [NCT03258710]Phase 475 participants (Actual)Interventional2017-10-02Completed
A Rollover Protocol to Provide Subjects From Taiwan Continued Access to Tenofovir Disoproxil Fumarate After Completing Study GS-US-174-0108 [NCT01334567]Phase 230 participants (Actual)Interventional2010-08-31Completed
Real-life Data of Switching From Tenofovir Disoproxi Fumarate (TDF) to Tenofovir Alafenamide (TAF) in Virologically Suppressed Chronic Hepatitis B Patients With Antiviral Resistance [NCT03566030]300 participants (Anticipated)Observational2018-09-01Not yet recruiting
The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients [NCT03789968]411 participants (Actual)Observational2019-09-01Completed
Treatment Efficacy and Safety of Tenofovir Alafenamide (TAF) Switch Therapy in Patients Who Have Been Treated With Tenofovir Disoproxil Fumarate (TDF) in naïve Chronic Hepatitis B: a Real Life Multicenter Cohort Study in Korea [NCT03559790]400 participants (Anticipated)Observational2018-07-18Recruiting
Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy With Tenofovir in ACLF-HBV [NCT04431375]70 participants (Anticipated)Interventional2020-06-22Recruiting
Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel Using the Bat 24 Regimen Versus Daily and Pericoital Dosing [NCT01369303]Phase 1194 participants (Actual)Interventional2012-01-31Completed
"Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir in Virologically-suppressed HIV-infected Rwandans (Near-Rwanda)" [NCT02104700]Phase 2/Phase 3150 participants (Actual)Interventional2014-04-30Completed
Bioequivalence of Crushed and Whole Genvoya Tablets (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fumarate) [NCT03717129]Phase 412 participants (Actual)Interventional2019-04-15Completed
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of Oral FXR Modulator EYP001a Combined With Nucleos(t)Ide Analogues (NA) in Virologically Suppressed Chronic Hepatitis B Patients to Improve Functional Cure Rates [NCT04465916]Phase 226 participants (Actual)Interventional2020-05-12Terminated(stopped due to DSMC reviewed results of 26 subjects. New randomizations were stopped. Already randomized subjects were followed up to W40.)
Body Composition Sub-study of the D2EFT Trial [NCT03675815]Phase 4155 participants (Actual)Interventional2019-12-05Active, not recruiting
An Exploratory, Randomized, Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug Alone in HBeAg Negative Chronic Hepatitis B Patients [NCT01260610]0 participants (Actual)Interventional2011-06-30Withdrawn(stopped due to lack of funds)
Phase IIa, 90-Day Safety, Adherence, and Acceptability Study of Intravaginal Rings Releasing Tenofovir With and Without Levonorgestrel Among Women in Western Kenya [NCT03762382]Phase 250 participants (Anticipated)Interventional2018-12-12Active, not recruiting
Study of the Safety and Efficacy of Daily Tenofovir to Prevent HIV Infection Among Injection Drug Users in Bangkok, Thailand [NCT00119106]Phase 2/Phase 32,413 participants (Actual)Interventional2005-06-30Completed
A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects [NCT00118898]Phase 31,864 participants (Actual)Interventional2005-09-30Completed
Maintaining Options for Mothers Study (MOMS): A Phase II Randomized Comparison of Three Antiretroviral Strategies Administered for 7 or 21 Days to Reduce the Emergence of Nevirapine Resistant HIV-1 Following a Single Intrapartum Dose of Nevirapine [NCT00099632]Phase 2484 participants (Actual)Interventional2006-03-31Completed
Reversibility of Mitochondrial Toxicity in HIV Lipoatrophy [NCT00119379]Phase 250 participants (Actual)Interventional2005-04-30Completed
A Phase 3, Randomized, Multicenter Study of the Treatment of Antiretroviral-Naive HIV-1 Infected Subjects Comparing Tenofovir Disoproxil Fumarate and Emtricitabine in Combination With Efavirenz vs Combivir (Lamivudine/Zidovudine) and Efavirenz [NCT00112047]Phase 3517 participants (Actual)Interventional2003-07-31Completed
Arresting Vertical Transmission of Hepatitis B Virus in the Democratic Republic of the Congo: The AVERT-HBV Study [NCT03567382]Phase 4179 participants (Actual)Interventional2018-09-24Completed
An Evaluation of the Uptake and Safety of, and Adherence to Antiretroviral Treatment Among Individuals With CD4 ≥ 250 Cells/mm3 and HIV Virus Load ≥ 50,000 cp/mL [NCT01583439]11 participants (Actual)Interventional2012-09-30Terminated(stopped due to Low Accrual.)
Advanced HIV: Outcomes for Rapid ART [NCT05526118]50 participants (Anticipated)Observational2022-08-30Not yet recruiting
The Clinical Efficacy of Tenofovir Alafenamide-switching Therapy in Patients With Chronic Hepatitis B Experiencing Clinical Flare-up After Discontinuation of Nucleos[t]Ide Analogues Therapy [NCT04496882]Phase 4260 participants (Anticipated)Interventional2020-09-09Recruiting
Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part B [NCT03120494]Phase 475 participants (Actual)Interventional2016-11-30Enrolling by invitation
COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry [NCT00705419]180 participants (Actual)Observational2007-07-31Completed
DOR/TDF/3TC Maintenance Therapy Among Patients Harboring M184V/I Mutation: a Pilot Open-label Study [NCT06034938]Phase 232 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication - A Controlled, Mono Center, Three-arm, Randomized Phase I Study. [NCT02203461]Phase 130 participants (Actual)Interventional2014-07-31Completed
Bioequivalence Study of Efavirenz, Emtricitabine and Tenofovir in Healthy Volunteers, After Administering a Single Dose of a Fixed Dose Combination of the Test Formulation With Respect to the Reference Product, Atripla ® From Gador S.A [NCT03309566]Phase 424 participants (Actual)Interventional2016-09-04Completed
OPTIMA: A Randomized, Open-label, 156-week Treatment Study to Evaluate the Efficacy and Safety of Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept [NCT01379508]Phase 4241 participants (Actual)Interventional2011-03-21Completed
Multicenter Study of Options for Second-Line Effective Combination Therapy (SELECT) [NCT01352715]Phase 3515 participants (Actual)Interventional2012-03-13Completed
Switching Tenofovir/Emtricitabine/Efavirenz to Tenofovir/Emtricitabine/Rilpivirine Versus Continuing Tenofovir/Emtricitabine/Efavirenz in HIV1-infected Patients With Complete Virological Suppression [NCT03251690]246 participants (Actual)Interventional2016-10-27Completed
A Prospective, Randomized, Multicenter, Open-label, Exploratory Study of Utilizing of Peginterferon Alfa-2a on the Relapse Rate of the Subjects With Hepatocellular Carcinoma Who Have Been Treated by Resection [NCT03253250]Phase 4432 participants (Anticipated)Interventional2017-09-01Recruiting
To Study the Efficacy of 'Tenofovir Pulse and Peg Interferon Alpha 2b' Therapy in HBeAg-positive Patients With Normal ALT - A Randomized Control Trial [NCT02454764]0 participants (Actual)InterventionalWithdrawn(stopped due to lack of funds)
A Single-Dose, Open-Label, Randomized, Crossover Study to Assess the Bioequivalence of Darunavir 800 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg, in the Presence of Cobicistat 150 mg, Administered as Either a Fixed-Dose Combination Tablet or [NCT02578550]Phase 1126 participants (Actual)Interventional2015-11-30Completed
[NCT02287857]360 participants (Anticipated)Interventional2014-09-30Recruiting
Structural and Partnership Factors Affecting Adherence to Pre-exposure Prophylaxis (PREP)Among Young Men Who Have Sex With Men [NCT02411630]167 participants (Actual)Observational2013-06-30Completed
Prospective Cohort Study to Assess the Safety and Efficacy of Replacing Tenofovir Disoproxil Fumarate by Tenofovir Alafenamide in HIV/HBV-coinfected Patients With Mild or Moderate Renal Dysfunction [NCT03115736]Phase 224 participants (Actual)Interventional2017-05-23Completed
"Efficacy, Safety, and Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1 Infection." [NCT03502005]Phase 4100 participants (Actual)Interventional2018-03-01Completed
A Prospective, Randomized, Blank Control, Multicenter Study to Evaluate the Efficacy and Safety of Alanine Aminotransferase(TMF)in the Treatment of Chronic Hepatitis B Patients With Normal Alanine Aminotransferase. [NCT05797714]200 participants (Anticipated)Interventional2022-06-23Recruiting
A Maternal Short Course of Tenofovir Disoproxil Fumarate and Infant Vaccine to Prevent Mother-to-child Transmission of Hepatitis B Virus [NCT03343431]Phase 3504 participants (Actual)Interventional2018-08-02Active, not recruiting
The Cellular Pharmacology of F-TAF in Dried Blood Spots [NCT02962739]Phase 138 participants (Actual)Interventional2016-03-31Completed
Demonstration Project of Early Antiretroviral Therapy and Pre-exposure Prophylaxis for HIV Prevention Among Female Sex Workers in Cotonou, Benin [NCT02237027]Phase 4361 participants (Actual)Interventional2014-10-31Completed
Pre-exposure Option for Reducing HIV in the UK: an Open-label Randomisation to Immediate or Deferred Daily Truvada for HIV Negative Gay Men.(PROUD) [NCT02065986]Phase 4544 participants (Actual)Interventional2012-10-31Completed
Phase I One-Month Safety, Pharmacokinetic, Pharmacodynamic, and Acceptability Study of Intravaginal Rings Releasing Tenofovir and Levonorgestrel or Tenofovir Alone [NCT02235662]Phase 186 participants (Actual)Interventional2014-10-31Completed
Efficacy of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in HIV-1-infected Treatment-naïve Adults Without Baseline Genotyping Test (D2ARLING Study) [NCT04549467]Phase 4244 participants (Actual)Interventional2020-11-17Active, not recruiting
Evaluating Inflammatory and Immunological Changes of HIV-positive Patients Switching to DTG Dual Regimen Compared to Those Switching to a Triple Drugs Regimen (B/F/TAF) [NCT04054089]Phase 466 participants (Anticipated)Interventional2019-09-30Not yet recruiting
Intensive Pharmacokinetic Studies of Antiretroviral Drug Combinations in Children [NCT00260078]Phase 1/Phase 275 participants (Actual)Interventional2006-02-28Completed
A Randomized Phase 2a, Multicenter, Open-Label, Multiple-Cohort Study Evaluating Regimens Containing Vebicorvir in Subjects With Chronic Hepatitis B Virus Infection [NCT04820686]Phase 265 participants (Actual)Interventional2021-05-07Terminated(stopped due to Sponsor decision)
Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Switch Followed by Sofosbuvir/Velpatasvir (SOF/VEL) Antiviral HCV Therapy Followed by Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Simplification in HIV-HCV [NCT03549312]Phase 425 participants (Anticipated)Interventional2018-02-01Recruiting
Phase III Multicenter Randomized Trial Evaluating in Patients at the Time of the Primary HIV-1 Infection, the Impact on the Viral Reservoir of a Combination Including Tenofovir/Emtricitabine and Dolutegravir or Tenofovir/Emtricitabine and Darunavir/Cobici [NCT02987530]Phase 3101 participants (Actual)Interventional2017-04-11Completed
The Effect of Anti-viral Drugs Used in Late Pregnancy in Mothers With Hepatitis B Virus Infection on Long-term Development of Children [NCT02301650]400 participants (Anticipated)Observational2014-10-31Enrolling by invitation
Stop Hep B @ Birth: Community-Oriented Care Model for the Prevention of Mother-To-Child Transmission of Hepatitis B in Peri-Urban Yangon [NCT04998838]110 participants (Anticipated)Interventional2018-07-01Recruiting
DOT Diary Longitudinal Pilot: A Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men [NCT03771638]Phase 4100 participants (Actual)Interventional2019-02-01Completed
A Phase III, Randomised, Double-blind, Multicentre, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in HIV-1-infected Treatment-n [NCT02831764]Phase 3722 participants (Actual)Interventional2016-07-18Completed
A Multi-centre Phase III Study to Evaluate Pre-emptive Tenofovir for Prevention of Hepatitis B Virus Reactivation in HBsAg Negative/Anti-HBc Positive Individuals Undergoing Anti-CD20-based Chemotherapy for Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leu [NCT02186574]Phase 3184 participants (Anticipated)Interventional2015-05-31Recruiting
A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects With Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations [NCT02629822]Phase 210 participants (Actual)Interventional2016-01-14Completed
Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus [NCT03695029]Phase 4120 participants (Anticipated)Interventional2010-12-29Recruiting
A Prospective, Cohort Study of Renal and Bone Outcome After Changing Tenofovir in Patients With Renal Toxicity According to Antiretroviral Strategy [NCT02209740]245 participants (Actual)Observational2014-07-31Completed
A Phase III, Randomised, Double Blind, Multicentre, Parallel Group, Non Inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in Human Immunodeficiency Vir [NCT02831673]Phase 3719 participants (Actual)Interventional2016-07-21Completed
TAF (Tenofovir Alafenamide) for Preventing Progression of Liver Disease in Non-cirrhotic Chronic HBV Infection With Normal ALT and Low Viral Load - a Randomized Controlled Trial [NCT05195450]200 participants (Anticipated)Interventional2022-02-23Recruiting
A Phase 1, Open-label Study in Healthy Participants to Investigate the Effect of Multiple-dose JNJ-56136379 on the Single-dose Pharmacokinetics of Bictegravir, Emtricitabine, and Tenofovir Alafenamide [NCT04853524]Phase 10 participants (Actual)Interventional2021-05-06Withdrawn(stopped due to Sponsor Decision)
Safety and Efficacy of Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B (TAF-PPT): A Multicentre, Prospective, Open-label, Randomized Controlled Trial [NCT04850950]Phase 4240 participants (Anticipated)Interventional2021-04-26Not yet recruiting
A Multinational, Multicenter, Open-label, Randomized Controlled Trial to Investigate the Effectiveness of Tenofovir Alafenamide in Reducing Clinical Events in Chronic Hepatitis B Patients Beyond Treatment Indications by Current Guidelines [NCT03753074]Phase 4780 participants (Anticipated)Interventional2019-02-18Recruiting
A Prosp., Multic., Randomized, Open-label Trial to Assess the Safety, Tolerability and Efficacy of Dual Therapy With Boosted Darunavir + Dolutegravir When Switching From SOC ART in HIV-patients With Sustained Virological Suppr. [NCT02486133]Phase 3269 participants (Actual)Interventional2015-07-31Completed
HIV Drug Resistance Profiles Among Individuals Failing Tenofovir/Lamivudine and Dolutegravir First Line Regimen in Brazil [NCT04453436]2,500 participants (Anticipated)Observational [Patient Registry]2020-09-01Not yet recruiting
A Phase I, Open Label, Single Sequence,Drug Interaction Study Evaluating Plasma GSK1349572 and Tenofovir Pharmacokinetics in Healthy Adult Subjects (ING111604) [NCT00726336]Phase 116 participants (Anticipated)Interventional2008-08-31Completed
A Phase III, Multi-center, Randomized, Double-blinded, Parallel Study to Assess the Antiviral Activity and Safety Endpoints for the Treatment of Besifovir 150mg Compared to Tenofovir 300mg in Chronic Hepatitis B Patients Who Have Resistance to Nucleoside [NCT02792088]Phase 3146 participants (Actual)Interventional2015-07-31Completed
Change in Sleep Architecture and Neuropsychological Performance Following Switch From Atripla to Stribild. [NCT02283060]Phase 430 participants (Anticipated)Interventional2014-09-30Recruiting
HIV Infection and Gut Mucosal Immune Function: Longitudinal Analyses of Intestinal CD4+ and Th17 T Cells in HIV-infected Individuals on Short-term Antiretroviral Therapy [NCT02097381]10 participants (Actual)Interventional2010-04-30Active, not recruiting
Implementation and Evaluation of an HIV-2 Viral Load and ARV Resistance Informed Algorithm for 2nd-line ART in HIV-2 Infected Patients in the Initiative Sénégalaise d'Accès Aux Antirétroviraux (ISAARV) Program [NCT03394196]152 participants (Actual)Interventional2018-07-04Terminated(stopped due to COVID-19 and Funding)
ANRS HB 05 : A Randomized, Double Blind, Multicenter Study Evaluating Efficacy and Safety of Clevudine Monotherapy Versus Tenofovir Monotherapy Versus Combination Therapy of Clevudine and Tenofovir for 96 Weeks in HBeAg Negative Patients With Chronic Hepa [NCT00823342]Phase 3150 participants (Anticipated)Interventional2008-12-14Terminated(stopped due to safety aspects)
Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability and Pharmacokinetics Study of Birinapant in Subjects With Chronic Hepatitis B [NCT02288208]Phase 17 participants (Actual)Interventional2014-11-30Terminated(stopped due to Due to cranial nerve palsies observed)
Prevention of Liver Fibrosis and Cancer in Africa. Observational Study of Screening, Assessment and Treatment for Chronic Hepatitis B Virus Infection [NCT02129829]1,079 participants (Actual)Observational2011-10-31Completed
Effect of SwitChing AtriPla to Eviplera on Neurocognitive and Emotional Functioning, ESCAPE Study [NCT02308332]Phase 458 participants (Actual)Interventional2015-02-28Completed
A Phase 2, Open-label, Randomized, Two-part, Multiple Dose Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic Hepatitis B Virus [NCT02751996]Phase 280 participants (Actual)Interventional2016-05-31Completed
The SETPOINT Study - A Randomized Study of the Effect of Immediate Treatment With Potent Antiretroviral Therapy Versus Observation With Treatment as Indicated in Newly Infected HIV-1 Infected Subjects: Does Early Therapy After the Virologic Setpoint? [NCT00090779]Phase 2130 participants (Actual)Interventional2005-01-31Terminated(stopped due to The DSMB concluded that the findings regarding the primary analysis would persist and that no additional study goals would be achieved by continuing the study.)
A Prospective, Multi-center, Cohort Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) Therapy in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis [NCT02224456]Phase 4197 participants (Actual)Interventional2015-03-25Completed
An Open, Multi-center Clinical Study of Combination Therapy With Tenofovir Disoproxil Fumarate and Peginterferon Alpha 2a in Nucleos(t)Ide Analogs Experienced Patients With HBV Related Hepatic Fibrosis. [NCT03957629]186 participants (Anticipated)Interventional2019-11-06Recruiting
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum [NCT00042289]1,578 participants (Actual)Observational2003-06-09Completed
A Phase IV, Open-label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-daily for 48 Weeks in HIV-infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensifi [NCT00038506]Phase 4100 participants Interventional2002-03-31Completed
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine With or Without Tenofovir on the Pharmacokinetics of Atazanavir When Given With Ritonavir in HIV-Infected Subjects [NCT00384904]Phase 440 participants (Actual)Interventional2006-12-31Completed
Initiation of a Once Daily Regimen of Tenofovir, Lamivudine and Efavirenz After 4 Weeks Versus 12 Weeks of Tuberculosis Treatment in HIV-1 Infected Patients (Time Study) [NCT01014481]Phase 4156 participants (Actual)Interventional2009-10-31Terminated(stopped due to this study was ended prematurely by ethical committees with a reason of the final outcome was achieved with no longer recruitment was needed.)
A Phase III, Randomized, 2x2 Factorial Trial to Assess the Efficacy of Antiviral Therapy in Women and Infants in Reducing Vertical Transmission of Hepatitis B in Africa [NCT04704024]Phase 3450 participants (Anticipated)Interventional2021-09-03Recruiting
An Open Label, Comparative, Randomized , Phase IV Pilot Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load [NCT05898841]Phase 475 participants (Anticipated)Interventional2023-05-26Recruiting
A Phase IV Open-label, Multi-centre, Randomised, Dual-arm, Pilot Study to Assess the Feasibility of Switching Individuals Receiving Efavirenz With Continuing Central Nervous System (CNS) Toxicity, to Dolutegravir [NCT02285374]Phase 440 participants (Anticipated)Interventional2014-11-30Not yet recruiting
A Phase 2B, Randomized, Double-Blind, Active-Comparator-Controlled, Dose-Ranging Clinical Trial to Evaluate the Safety, Tolerability, Antiretroviral Activity, and Pharmacokinetics of MK-8591 Given in Combination With Doravirine (DOR) and Lamivudine (3TC) [NCT03272347]Phase 2123 participants (Actual)Interventional2017-11-27Completed
Study on Optimized Treatment of Peginterferon Alfa 2a or 2b in Anti-virus Treatment Experienced Patients With Hepatitis b Virus Related Liver Fibrosis [NCT03920605]100 participants (Anticipated)Interventional2019-02-01Recruiting
A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Rectal Safety and Acceptability Study of Tenofovir 1% Gel [NCT01232803]Phase 165 participants (Actual)Interventional2010-10-31Completed
Induction of HBsAg Decline Using an add-on Treatment of Peginterferon Alfa-2a in HBeAg-negative Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogous (PAS) [NCT01373684]Phase 490 participants (Actual)Interventional2012-05-25Completed
A Randomized, Open-label, Controlled, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine 600 mg and Tenofovir Disproxil Fumarate 300 mg in Combination or Telbivudine 600 mg or Tenofovir Disproxil Fumarate 300 mg Mono [NCT00804622]Phase 215 participants (Actual)Interventional2008-12-31Completed
DOT Diary (D2): Developing a Mobile App With Combined Automated DOT and Daily Sexual Diary for Monitoring and Improving PrEP Adherence: DOT Diary Optimization Pilot [NCT03387462]Phase 420 participants (Actual)Interventional2018-02-28Completed
Decreasing Risk of Recurrence by TAF in HCC Patients After Curative Treatment With Low HBV Viral Load [NCT04290936]Phase 4402 participants (Anticipated)Interventional2020-10-16Recruiting
Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population [NCT01180075]85 participants (Actual)Observational2010-05-31Completed
Phase II Pilot Study of Simplification to Maraviroc - Raltegravir Dual Therapy After 6 Months of Maraviroc - Raltegravir - Tenofovir - Emtricitabine Quadruple Therapy in ARV Treatment-naive, HIV-1-infected Patients With CCR5- Virus [NCT01291459]Phase 240 participants (Anticipated)Interventional2011-09-30Active, not recruiting
A Multicenter, Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Combination With Entecavir or Tenofovir in Patients With Chronic Hepatitis B Virus (HBV) Infection [NCT02738008]Phase 212 participants (Actual)Interventional2016-03-31Terminated(stopped due to Company decision to discontinue trial)
Safety, PK/PD, Acceptability, and Desirability of a Novel HIV Prevention Douche Among Adolescent Men (DREAM) [NCT04686279]Phase 18 participants (Actual)Interventional2021-04-01Completed
A Phase IV, Open-label, Multi Centre Pilot Study to Assess Changes in Cerebral Function Parameters in Patients Without Perceived Central Nervous System (CNS) Symptoms When Switched From a Fixed Dose Combination of Tenofovir/Emtricitabine/Efavirenz (Atripl [NCT02529059]Phase 440 participants (Anticipated)Interventional2015-11-30Completed
Study on Optimized Treatment of Peginterferon Alfa 2a or 2b in Anti-virus Treatment Naive Patients With Hepatitis b Virus Related Liver Fibrosis [NCT03919565]120 participants (Anticipated)Interventional2019-02-01Recruiting
A Phase 2a Randomized, Double-blinded, Placebo-controlled, Multi Center, Dose Ranging Study of the Safety and Efficacy of ATI-2173 and Vebicorvir in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection [NCT05238844]Phase 22 participants (Actual)Interventional2022-04-11Terminated(stopped due to Sponsor stopped due to partner collaboration ending)
Expanded Safety Investigation of Tenofovir 1% Gel in Pregnancy and Lactation [NCT01136759]Phase 1232 participants (Actual)Interventional2011-03-31Completed
"Prevention of HIV in Île-de-France" [NCT03113123]3,257 participants (Anticipated)Interventional2017-05-03Recruiting
A Phase III, Multi-Centre, Randomized Controlled Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel in the Prevention of Human Immunodeficiency Virus Type 1 Infection in Women, and to Examine Effects of the Microbicid [NCT01386294]Phase 32,059 participants (Actual)Interventional2011-10-31Completed
A Multicenter, Open-label, Randomised, Comparative, Parallel-Arm, Phase II Study to Assess Efficacy and Safety of Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delt [NCT02888106]Phase 290 participants (Actual)Interventional2016-04-30Completed
Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir-boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)-Naive Adults or Adults Recommencing ART. [NCT01258439]Phase 425 participants (Actual)Interventional2010-11-30Completed
MULTICENTRE STUDY TO ASSESS CHANGES IN BONE MINERAL DENSITY OF THE SWITCH FROM TENOFOVIR TO ABACAVIR IN HIV-1-INFECTED SUBJECTS WITH LOSS OF BONE MINERAL DENSITY [NCT01153217]Phase 354 participants (Actual)Interventional2010-07-31Completed
Modifiers of Tenofovir Exposure in the Female Genital Tract of African Women on Depo-provera [NCT03377608]50 participants (Actual)Observational2017-11-17Completed
Pilot Single-Arm Clinical Trial to Evaluate the Efficacy, PK Interactions and Safety of Dolutegravir Plus 2 NRTIs in HIV-1-Infected Solid Organ Transplant Patients [NCT03360682]Phase 420 participants (Anticipated)Interventional2018-04-12Active, not recruiting
Pharmacokinetics of EFV 400mg Once Daily During Pregnancy in HIV+ Women [NCT02499874]Phase 126 participants (Actual)Interventional2015-08-31Completed
Efficacy and Safety of Switching to Tenofovir Alafenamide for Chronic Hepatitis B Patients With Advanced Fibrosis and Partial Virologic Responses to Oral Nucleos(t)Ide Analogues [NCT03798119]Phase 480 participants (Anticipated)Interventional2019-02-25Recruiting
Single Observed Dose Administration of Truvada® to Establish Single Dose Pharmacokinetic Standards in Healthy Individuals [NCT03719053]Phase 144 participants (Actual)Interventional2018-10-25Completed
Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants [NCT03048422]Phase 3643 participants (Actual)Interventional2018-01-19Completed
Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals [NCT01293123]2 participants (Actual)Interventional2011-12-31Terminated(stopped due to Did not meet enrollment goals)
Acceptability and Feasibility of a Pre-Exposure Prophylaxis (PrEP) Trial With Young Men Who Have Sex With Men (YMSM) [NCT01033942]Phase 268 participants (Actual)Interventional2009-08-31Completed
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine on the Pharmacokinetics of Atazanavir in HIV-Infected Subjects Receiving Atazanavir With Ritonavir and Tenofovir [NCT01232127]Phase 425 participants (Actual)Interventional2011-02-28Completed
Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study [NCT01003990]Phase 3710 participants (Actual)Interventional2002-10-31Completed
Real World Study of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate to Prevent Vertical Transmission of Hepatitis B in Mothers With High Viral Load [NCT04211805]450 participants (Anticipated)Observational2020-01-27Recruiting
A Pilot Study--randomized, Prospective, Single Site Trial Evaluating Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients [NCT00762892]Phase 433 participants (Actual)Interventional2009-01-31Completed
Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women [NCT00705679]Phase 25,029 participants (Actual)Interventional2009-08-31Completed
The Use of Tenofovir Disoproxil Fumarate (TDF) in the Management of Patients With Inactive Chronic Hepatitis B (CHB) Infection [NCT02600117]Phase 350 participants (Actual)Interventional2016-01-26Completed
Efficacy and Safety of Tenofovir Alafenamide in Chronic Hepatitis B Patients With Suboptimal Response Following Nucleos(t)Ide Therapy [NCT04201808]Phase 4100 participants (Anticipated)Interventional2021-05-01Recruiting
A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet and Viread® Tablet in Chronic Hepatitis B Patients [NCT02805738]Phase 3158 participants (Anticipated)Interventional2016-04-30Recruiting
A Randomized, Open-label Trial to Compare the Efficacy and Safety of Early Initiation of cART With or Without Autologous HIV-1 Specific Cytotoxic T Lymphocyte (CTL) Infusion in Treatment-Naïve Acute HIV-1 Infected Adults [NCT02231281]Phase 365 participants (Anticipated)Interventional2014-08-31Active, not recruiting
A Randomized, Non-comparative, Phase IIb, Unblinded Trial, Evaluating the Efficacy and Safety of Tenofovir-emtricitabine or Lamivudine Plus Zidovudine, Lopinavir/Ritonavir, or Raltegravir, Among ARV-naïve HIV-2 Infected Adult Patients, in West Africa [NCT02150993]Phase 2/Phase 3210 participants (Actual)Interventional2016-01-26Completed
A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects With Chronic Hepatitis B Infection [NCT02258581]241 participants (Actual)Observational2014-12-09Terminated
Evaluation of the Capacity of a Weekly Strategy of 4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV-1 Infected Patients With Undetectable Viral Load for at Least 12 Months, to Maintain a Virological Success With This Intermittent M [NCT02157311]Phase 3100 participants (Actual)Interventional2014-07-31Completed
Comparison of the Pharmacokinetics and Pharmacodynamics of Single Dose Tenofovir Vaginal Gel and Film Formulation [NCT02280109]Early Phase 110 participants (Actual)Interventional2014-11-30Completed
Cellular Pharmacology and Platelet Effects of Abacavir and Lamivudine Anabolites [NCT04301661]25 participants (Actual)Observational2020-03-06Completed
Effectiveness of the Use of Personal Protective Equipment in Addition to Tenofovir/Emtricitabine for the Prevention of the Transmission of SARS-COV-2 to Health Care Personnel. Randomized Clinical Trial [NCT04519125]Phase 2/Phase 3950 participants (Anticipated)Interventional2020-08-30Not yet recruiting
Efficacy of HBV Therapeutic Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy: a Pilot Study [NCT02505009]Phase 4116 participants (Actual)Interventional2015-05-01Completed
Phase IIb, Double-Blinded, Multicenter, Randomized Study to Assess the Effect on Central Nervous System (CNS) Toxicity of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppre [NCT02652260]Phase 286 participants (Actual)Interventional2016-03-04Active, not recruiting
A Randomized Study to Compare the Efficacy of Vorinostat/Hydroxychloroquine/Maraviroc (VHM) in Controlling HIV After Treatment Interruption in Subjects Who Initiated ART During Acute HIV Infection [NCT02475915]Phase 1/Phase 215 participants (Actual)Interventional2015-01-31Completed
Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF) in Treatment-Naive CHB Related Fibrosis/Cirrhosis: a 96w Open-label Multicenter Study [NCT04939441]Phase 4100 participants (Anticipated)Interventional2021-04-20Active, not recruiting
A Single-dose, Open-label, Randomized, Crossover Study to Assess the Impact of Food on the Pharmacokinetics of Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Administered as a Fixed-dose Combination Tablet, and the Relative Bioavailabilit [NCT02475135]Phase 172 participants (Actual)Interventional2015-06-01Completed
Prevention of Mother-to-child Transmission of Hepatitis B Virus: a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy [NCT02995005]Phase 1/Phase 298 participants (Actual)Interventional2018-05-24Completed
Sustainable Healthcenter Implementation PrEP Pilot Study [NCT02074891]1,200 participants (Anticipated)Observational2014-10-31Recruiting
Effect of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide and Bictegravir/Emtricitabine/Tenofovir Alafenamide on the Circulatory microRNA Profile in Treatment naïve HIV Patients, and Its Correlation With Change in Body Weight [NCT05463783]Phase 430 participants (Anticipated)Interventional2023-03-14Recruiting
The Efficacy and Safety of 12-week SOF/VEL Regimen Combined With Prophylactic Use of TAF for Treatment-naïve Genotype 1-6 HCV/HBV Co-infection Adult Patients With or Without Compensated Cirrhosis in China : a Mutil-center,Prospective,Single-arm,Open-label [NCT04997564]Phase 4120 participants (Anticipated)Interventional2021-08-31Recruiting
A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population [NCT03074786]Phase 20 participants (Actual)Interventional2017-11-30Withdrawn(stopped due to Study was transferred to partner who will conduct under its own IND)
The Role of Home Packs of HIV Post-Exposure Prophylaxis for Sexual Exposure (PEPSE) to Improve the Speed and Appropriate Uptake of PEPSE in High Risk Individuals [NCT04965662]Phase 4139 participants (Actual)Interventional2018-01-01Completed
Switching From Tenofovir Disoproxil Fumarate(TDF) to Tenofovir AlaFenamide(TAF) vs. Maintaining TDF Monotherapy in Chronic Hepatitis B Patients With Genotypic Resistance to Adefovir or Entecavir [NCT03241641]Phase 4174 participants (Actual)Interventional2017-10-26Completed
The Pharmacokinetic and Pharmacodynamic Impacts of Depot Medroxyprogesterone Acetate on HIV Pre-exposure Prophylaxis (PrEP) [NCT03197961]Early Phase 115 participants (Actual)Interventional2017-11-17Completed
A 48-week, Randomized, Open-label, 2-arm Study to Compare the Efficacy of Saquinavir/Ritonavir Twice Daily (BID) Plus Emtricitabine/Tenofovir Once Daily (QD) Versus Lopinavir/Ritonavir BID Plus Emtricitabine/Tenofovir QD in Treatment-naïve Human Immunodef [NCT00105079]Phase 3337 participants (Actual)Interventional2005-04-30Completed
Randomized Clinical Trial to Evaluate the Efficacy of Different Treatments in Patients With COVID-19 [NCT04890626]Phase 32,193 participants (Anticipated)Interventional2020-04-04Recruiting
An Open Label Randomized Clinical Trial, to Evaluate the Treatment With Darunavir/Ritonavir + Lamivudine Once Daily Versus Continuing With Darunavir/Ritonavir Once Daily + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject With Suppres [NCT02159599]Phase 4249 participants (Actual)Interventional2014-07-31Completed
Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers [NCT03510468]Phase 151 participants (Actual)Interventional2018-06-12Completed
A Single Centre, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effects of Tipranavir 500 mg and Ritonavir 100 mg or Tipranavir 750 mg and Ritonavir 200 mg Twice a Day for 11.5 Days on the Pharmacokinetic Characteristics of Tenofovir Di [NCT02251145]Phase 149 participants (Actual)Interventional2002-05-31Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled Multi-dose Study to Determine the Depth of Hepatitis B Surface Antigen (HBsAg) Reduction Following Intravenous ARC-520 in Combination With Entecavir or Tenofovir in Patients With HBeAg Positive, [NCT02604212]Phase 232 participants (Actual)Interventional2015-11-30Terminated(stopped due to Company decision to discontinue trial)
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologica [NCT02603120]Phase 3567 participants (Actual)Interventional2015-11-11Completed
An Open-label, Randomized, Single Administration, Full Replicated Crossover Phase 1 Clinical Trial to Compare Pharmacokinetics and Safety Between JLP-1901 and JC-001 in Healthy Subjects [NCT06171880]Phase 148 participants (Actual)Interventional2022-02-15Completed
A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infe [NCT02016924]Phase 2/Phase 3130 participants (Anticipated)Interventional2014-01-16Recruiting
Effect of Reducing Nucleotide Exposure on Bone Health (ReNew) [NCT03549689]Phase 20 participants (Actual)Interventional2019-08-01Withdrawn(stopped due to Withdrawn by drug manufacturer)
Tenofovir Pharmacokinetics in HIV-infected Thai Adults With Moderate Renal Function Impairment Receiving Either a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Based or Lopinavir/Ritonavir-based Antiretroviral Therapy [NCT01671982]Phase 140 participants (Actual)Interventional2012-08-31Completed
Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open. [NCT02198443]Phase 4160 participants (Actual)Interventional2015-06-06Completed
Implementation of HIV Preexposure Prophylaxis With Antiretroviral Medications Among People at High Risk for HIV Infection: A Demonstration Project [NCT02206555]Phase 4327 participants (Actual)Interventional2014-11-14Completed
Study of Once-Daily Abacavir/Lamivudine Versus Tenofovir/Emtricitabine, Administered With Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects [NCT00549198]Phase 4392 participants (Actual)Interventional2007-06-30Completed
Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples [NCT02572505]0 participants (Actual)Interventional2015-11-30Withdrawn
An Open-label, Randomized, Active Controlled, Parallel Comparison Study of the Safety and Efficacy of REP 2139-Mg in Combination With Pegasys® and Viread® and REP 2165-Mg in Combination With Pegasys® and Viread® in Patients With HBeAg Negative Chronic Hep [NCT02565719]Phase 240 participants (Actual)Interventional2016-03-31Completed
The Efficacy and Safety of TAF as a Prophylactic Antiviral Agent for HBsAg-positive Cancer Patients Receiving Chemotherapy [NCT04619082]Phase 4150 participants (Anticipated)Interventional2021-07-01Recruiting
Phase IIb Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Tenofovir+Emtricitabine+Raltegravir or to Lamivudine+Abacavir+Raltegravir in Patients With Optimal Virological Control and Toxicity to the Current Co [NCT00958100]Phase 240 participants (Actual)Interventional2009-08-31Completed
A Randomized, Prospective, Multicenter, Open-label Study to Evaluate the Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir in HBeAg-positive Chronic Hepatitis B Patients [NCT01588912]Phase 4104 participants (Anticipated)Interventional2012-04-30Recruiting
Doravirine for Persons With Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study) [NCT04636437]Phase 4222 participants (Anticipated)Interventional2021-05-20Recruiting
Adherence to a One Pill, Once-a-day Antiretroviral Regimen [NCT00990600]Phase 3212 participants (Actual)Interventional2008-04-30Completed
IMPAACT P1058A: Intensive Pharmacokinetic Studies of New Classes of Antiretroviral Drug Combinations in Children, Adolescents and Young Adults [NCT00977756]168 participants (Actual)Observational2002-08-31Completed
A Multicenter Randomised Study Comparing the Antiviral Efficacy of Pegylated Interferon-alfa-2a Plus Placebo vs. Pegylated Interferon-alfa-2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis [NCT01088659]Phase 350 participants (Actual)Interventional2010-02-16Completed
A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples [NCT00074581]Phase 33,526 participants (Actual)Interventional2005-02-28Completed
The Effect of Rifampicin on the Pharmacokinetics of Intracellular Tenofovir-diphosphate and Tenofovir When Coadministered With Tenofovir Alafenamide Fumarate During the Maintenance Phase of Tuberculosis Treatment in TB/HIV-1 Coinfected Participants [NCT04424264]Phase 118 participants (Actual)Interventional2019-12-05Completed
Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir [NCT02588287]14 participants (Actual)Interventional2015-11-30Completed
"A Phase Randomized Open Labelled Controlled Dose Escalation Study of Repeated Administration of CYT107 (Glyco-r-hIL-7) Added on Antiviral Treatment and Vaccination in HBeAg-negative Chronic Hepatitis B-infected Patients" [NCT01027065]Phase 1/Phase 224 participants (Anticipated)Interventional2009-12-31Active, not recruiting
ADORE: A Single-arm, Phase 3, Pilot Study Investigating the Efficacy of Doravirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With Non-nucleoside Reverse Transcriptase Inhibitor Resistan [NCT04429152]Phase 325 participants (Anticipated)Interventional2021-02-09Recruiting
Phase III Open Label Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV [NCT00035932]Phase 3571 participants (Actual)Interventional2001-11-30Completed
An Open-Label One-way Interaction Clinical Trial to Evaluate the Pharmacokinetic Interactions Between GSK3640254 and Tenofovir Alafenamide/Emtricitabine in Healthy Subjects [NCT03836729]Phase 116 participants (Actual)Interventional2019-02-11Completed
Safety, Tolerability, and Adherence to a Raltegravir-based Antiretroviral Regimen for HIV Non-occupational Postexposure Prophylaxis [NCT01087840]Phase 4120 participants (Actual)Interventional2010-07-31Completed
An Open-Label Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration of a Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine Fixed-Dose Combination Tablet in Healthy Japanese Adult Male Subjec [NCT02530060]Phase 48 participants (Actual)Interventional2015-08-31Completed
Pre-Exposure Prophylaxis With TDF/FTC to Prevent HIV-1 Acquisition in Young Men and Transgender Women of Color Who Have Sex With Men [NCT02367807]50 participants (Actual)Observational2015-02-28Completed
International Trial of Modified Directly Observed Therapy Versus Self-Administered Therapy for Participants With First Virologic Failure on a Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Antiretroviral Regimen [NCT00608569]529 participants (Actual)Interventional2009-03-31Completed
Chronic HBV Infection in Pregnant Women Taking TAF to Prevent Mother-to-child Transmission in the Third Trimester: a Multicenter, Prospective Study [NCT04237376]600 participants (Anticipated)Observational2019-04-09Recruiting
A Multicenter Randomised Study Comparing the Efficacy of PegIFN-alfa2a Plus Placebo vs. PegIFN-alfa2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis-The Hep-Net International Delta Hepatitis Interventional Trial II (HIDIT-II) [NCT00932971]Phase 270 participants (Actual)Interventional2009-06-30Completed
A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women [NCT03164564]Phase 33,224 participants (Actual)Interventional2017-11-07Active, not recruiting
Multicentric, Non-inferiority, Randomized, Non-blinded Phase 3 Trial Comparing Virological Response at 48 Weeks of 3 Antiretroviral Treatment Regimens in HIV-1-infected Patients With Treatment Failure After 1st Line Antiretroviral Therapy (Cameroon, Burki [NCT00928187]Phase 3454 participants (Actual)Interventional2009-11-30Completed
A Phase 4, Randomized, Open Label, Controlled Study of Boosted Darunavir and Lamivudine Versus Boosted Darunavir and Emtricitabine/Tenofovir or Lamivudine/Tenofovir in Naïve HIV-1 Infected Subjects [NCT02770508]Phase 4145 participants (Actual)Interventional2015-11-30Completed
A Cohort Study of Tenofovir on Blocking HBV Intrauterine Infection [NCT02719808]500 participants (Anticipated)Observational2015-03-31Recruiting
A Phase 2, Randomized, Open-label, Ascending, Sequential Dose Group, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of CMX157 in HBV-infected Subjects [NCT02710604]Phase 262 participants (Actual)Interventional2016-05-31Completed
APT-POCT-01: An Open Label, Pharmacokinetic Study of Plasma/Urine/Salivary Drug Concentrations Over Fourteen Days Following Drug Intake Cessation, In HIV-Uninfected Healthy Volunteers Dosing to Steady-state to Further Development of Point of Care Diagnost [NCT04302896]Early Phase 130 participants (Actual)Interventional2020-08-31Completed
Institute of HIV Research and Innovation (IHRI) [NCT04593680]40 participants (Anticipated)Interventional2020-10-01Recruiting
Change of Renal Function and Bone Mineral Density Marker in Chronic Hepatitis B Patients Switching From TDF to TAF vs. Maintaining TDF [NCT03356834]Phase 41,000 participants (Anticipated)Interventional2017-12-01Recruiting
TMC125-TiDP2-C238: A Randomized, Exploratory, Open-label 48-week Trial to Investigate the Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Etravirine (ETR) in Combination With Ritonavir-boosted Atazanavir (ATV/Rtv) and 1 NRTI in Treatment- [NCT00896051]Phase 250 participants (Actual)Interventional2009-08-31Completed
Efficacy and Safety of Switching From AZT to Tenofovir [NCT00647244]Phase 440 participants (Actual)Interventional2008-06-30Completed
A Phase II, Open-Label, Multicentre, Randomised, Comparator Study of Substitution With Tenofovir or Abacavir in HIV-1 Infected Individuals, With a Viral Load < 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of Their Highly [NCT00647946]Phase 2100 participants (Actual)Interventional2003-02-28Completed
First-Phase Viral Decay Rates in Treatment-Naive Subjects Initiating Treatment With Raltegravir (RAL) and Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF): A Pilot Study [NCT00660972]Phase 140 participants (Actual)Interventional2008-05-31Completed
An Exploratory Study to Evaluate The Efficacy And Safety of HLX10, A Humanized Monoclonal Antibody Targeting Programmed Death-1 (PD-1) Protein In Chronic Hepatitis B Patients [NCT04133259]Phase 244 participants (Anticipated)Interventional2019-12-31Recruiting
A Randomized Prospective Open-label Trial for Comparing Combination Therapy Peg-Interferon Alfa-2a/Adefovir Dipivoxil and Peg-Interferon Alfa-2a/Tenofovir Disoproxil Fumarate Versus no Treatment in HBeAg Negative Chronic Hepatitis B Patients With Low Vira [NCT00973219]151 participants (Actual)Interventional2009-09-30Completed
Open Label Study of Nucleus(t)Ide Treated Patients Randomised to Tenofovir, or Tenofovir + Telbivudine [NCT02774837]Phase 4146 participants (Actual)Interventional2016-04-30Active, not recruiting
The Different Effects of Nucleotide and Nucleoside Analogues on the Prognosis of Hepatitis B Virus-Related Hepatocellular Carcinoma Patients After Curative Resection:a Randomized Controlled Trial [NCT04032860]Phase 4104 participants (Actual)Interventional2017-07-01Active, not recruiting
A Study to Evaluate Clinical Benefits and Drawbacks of Antiretroviral Drugs as Pre-exposure Prophylaxis to Prevent HIV Infection Under Real-life Conditions Among Persons Who Pursue High-risk Sexual Practices: The Seville HIV PrEP Cohort [NCT05492565]500 participants (Anticipated)Observational [Patient Registry]2020-01-01Enrolling by invitation
A Study Comparing Efficacy and Tolerance of Two Maintenance Strategies : a Monotherapy With Lopinavir/Ritonavir or a Single-tablet Triple Therapy by Efavirenz/Emtricitabin/Tenofovir in HIV-1 Infected Patients With HIV RNA Below 50 cp/mL [NCT00946595]Phase 2/Phase 3420 participants (Anticipated)Interventional2009-11-30Completed
Cellular Pharmacology of Tenofovir and Emtricitabine for HIV Prophylaxis (Cell Prep) [NCT01040091]Phase 134 participants (Actual)Interventional2009-12-31Completed
"The Effect of Prior Short Course Combination Antiretroviral Therapy Administered for the Prevention of Mother-to-Child Transmission (pMTCT) of HIV-1 on Subsequent Treatment Efficacy in Treatment-Nearly Naive Participants" [NCT00442962]Phase 454 participants (Actual)Interventional2007-05-31Completed
A Two-site, Phase 1, Partially-blinded, Placebo-controlled Safety, Acceptability and Pharmacokinetic Trial of Topical, Vaginally-formulated Tenofovir 1% Gel Applied Rectally Compared With Oral 300 mg Tenofovir Disoproxil Fumarate in HIV-1 Seronegative Adu [NCT00984971]Phase 118 participants (Actual)Interventional2009-09-30Completed
Closing a Critical HIV Prevention Gap: Demonstrating Safety and Effective Delivery of Daily Oral Pre-exposure Prophylaxis (PrEP) as Part of an HIV Combination Preventive Intervention for Sex Workers in Kolkata and Mysore-Mandya, India [NCT02148094]Early Phase 11,325 participants (Actual)Interventional2016-01-31Completed
A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM:The PREPARATORY-5 Study [NCT02149888]Phase 452 participants (Actual)Interventional2014-10-31Completed
A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D [NCT03546621]Phase 2120 participants (Actual)Interventional2016-02-16Completed
A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB) [NCT04891770]Phase 2103 participants (Actual)Interventional2021-08-14Active, not recruiting
Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention During Pregnancy and Postpartum in Adolescents and Young Women and Their Infants [NCT03386578]Phase 2390 participants (Actual)Interventional2018-07-03Active, not recruiting
The Stability and Bioequivalence of Tenofovir, Emtricitabine and Efavirenz (Atripla) in an Extemporaneously Prepared Oral Liquid Formulation Compared With the Commercially Available Tablet Formulation [NCT00862823]Phase 414 participants (Actual)Interventional2009-02-28Completed
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women [NCT00869960]Phase 424 participants (Actual)Interventional2009-03-31Completed
Nucleoside-Sparing Combination Therapy With Lopinavir/Ritonavir (LPV/r) + Raltegravir (RAL) vs. Efavirenz (EFV) + Tenofovir Disoproxil Fumarate + Emtricitabine (TDF/FTC) in Antiretroviral-Naïve Patients [NCT00752856]Phase 251 participants (Actual)Interventional2008-08-26Completed
A Single-arm, Multinational, Two Year Study Evaluating the Efficacy and Safety of lead-in Telbivudine for 24 Weeks With or Without Tenofovir Treatment Intensification in Adult Patients With HBeAg-positive Chronic Hepatitis B. [NCT00651209]Phase 4105 participants (Actual)Interventional2008-02-29Completed
Pilot Study Of Novel Combination Of Maraviroc + Atazanavir/Ritonavir vs. Atazanavir/Ritonavir + Emtricitabine/Tenofovir For The Treatment Of Naïve HIV-Infected Patients With R5 HIV-1 [NCT00827112]Phase 2129 participants (Actual)Interventional2009-03-31Completed
A Phase 2, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Patients [NCT04667104]Phase 248 participants (Actual)Interventional2021-02-01Completed
An Open-Label Phase 2 Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Tenofovir in Naive Patients With Chronic Hepatitis b: a Multicenter, Randomized, Positive Controlled Clinical Trial [NCT04157699]Phase 2100 participants (Anticipated)Interventional2019-07-26Recruiting
CID 0706 - Safety, Tolerability, Pharmacokinetic, and Metabolic Features of Raltegravir Among African-American Men and Women With HIV Infection [NCT00667433]Phase 138 participants (Actual)Interventional2008-06-30Completed
Effects of Antiviral Therapies on Epstein-Barr Virus Replication [NCT05957913]Phase 250 participants (Anticipated)Interventional2023-06-05Enrolling by invitation
Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects [NCT00759070]Phase 450 participants (Anticipated)Interventional2008-09-30Active, not recruiting
Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis: A Multicenter, Real-world and Respective Study [NCT04160897]4,000 participants (Anticipated)Observational2019-10-22Enrolling by invitation
A Randomized, Open-label, Two-way Crossover Study to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg After a Single Oral Dose in Healthy Male Volunteers [NCT02557594]Phase 136 participants (Actual)Interventional2015-10-06Completed
[NCT02920931]Phase 150 participants (Actual)Interventional2016-02-29Completed
Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure. [NCT02689245]64 participants (Actual)Interventional2016-02-26Completed
Evaluation of Intrahepatic Immune and Virological Response to Tenofovir Alafenamide With Fine Needle Aspiration Biopsy in Chronic Hepatitis B: an Investigator-Initiated, Cohort Study [NCT04070079]Phase 415 participants (Anticipated)Interventional2019-01-29Recruiting
Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana [NCT00448669]Phase 2/Phase 31,219 participants (Actual)Interventional2007-03-31Completed
A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Adolescents With Chronic Hepatitis B Infection [NCT00734162]Phase 3106 participants (Actual)Interventional2008-12-31Completed
A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily [NCT00711009]Phase 3206 participants (Actual)Interventional2008-07-31Completed
A Phase IV Study to Evaluate the Efficacy, Safety and Tolerability of Tenofovir DF in Asian-American Adults With Chronic Hepatitis B Infection [NCT00736190]Phase 490 participants (Actual)Interventional2008-08-31Completed
Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg. [NCT02583464]Phase 124 participants (Actual)Interventional2014-09-30Completed
Phase 2a Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV - An Extended Safety Evaluation [NCT00122512]Phase 2500 participants InterventionalTerminated
Direct Antiviral Agents for the Treatment of Chronic HCV/HBV Co-infection Patients [NCT02555943]Phase 2/Phase 323 participants (Actual)Interventional2015-02-28Completed
CID 0805 - Treatment of Acute HIV Infection With a Once Daily Regimen of Emtricitabine, Tenofovir and Efavirenz - A Pilot Study of Response to Therapy and HIV Pathogenesis [NCT00924898]Phase 492 participants (Actual)Interventional2005-01-31Completed
A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Two-Phase Crossover Study of the Metabolic Impact of Tenofovir Disoproxil Fumarate on HIV-1 Seronegative Healthy Adult Males [NCT00648817]Phase 48 participants (Actual)Interventional2006-07-31Completed
Open Randomized Study to Assess the Evolution of Plasma Lipid Profile by Lipidomic in Patients Infected With Human Immunodeficiency Virus (HIV-1) With Viral Suppression That Change Atripla® to Eviplera® Compared to Continue With Atripla® [NCT02547844]Phase 430 participants (Actual)Interventional2015-09-30Completed
Quantification of Estradiol's Impact on Nucleotides in Different Cellular Populations of the Lower Gastrointestinal Tract [NCT03917420]Phase 110 participants (Actual)Interventional2019-03-26Completed
A Prospective,Multi-center,Cohort Trial: the Efficacy and Safety of Tenofovir Alafenamide Fumarate Tablets (TAF) in Blocking Mother-to-child Transmission of Hepatitis B Virus(HBV) [NCT04065230]330 participants (Anticipated)Observational [Patient Registry]2019-08-31Recruiting
Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in HBV Negative Recipients Received Orthotopic Liver Transplant With HBcAb+ Donors [NCT04703465]30 participants (Anticipated)Interventional2021-04-01Not yet recruiting
Pharmacokinetics and Safety of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants [NCT04862975]200 participants (Anticipated)Observational2024-01-08Not yet recruiting
A Randomized, Open-Label, Parallel, Multi-Center, Non-inferiority, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Switching to Besifovir Dipivoxil Maleate From Tenofovir Disoproxil Fumarate (TDF) in Chronic Hepatitis B Patients Who Pretrea [NCT04202536]Phase 4152 participants (Anticipated)Interventional2019-05-29Recruiting
Decay Kinetics of HIV With the Integrase Inhibitor Raltegravir [NCT00863668]0 participants (Actual)Interventional2009-03-31Withdrawn
CID 0708 - Sex, Aging and Antiretroviral Pharmacokinetics [NCT00666055]11 participants (Actual)Observational2008-03-31Completed
Steady-state Pharmacokinetics of Efavirenz (Sustiva/Stocrin) 400 mg Once Daily in the Presence of Rifampicin and Isoniazid (Rifinah or the Local Generics) [NCT02832778]Phase 135 participants (Anticipated)Interventional2016-11-21Recruiting
An Open-Label Phase 2 Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Entecavir or Tenofovir in Patients With Chronic Hepatitis b Who Have Received Nucleoside (Acid) Therapy : a Multicenter, Randomized, Positive Controlled Clin [NCT04157257]Phase 260 participants (Anticipated)Interventional2019-07-26Recruiting
Clinical Investigation About Therapeutic Effects and Long-term Follow-up After Ending Anti-hepatitis B Virus Therapy With Nucleos(t)Ide Analogs in Patients With Chronic Hepatitis b [NCT02883647]100 participants (Anticipated)Observational2014-01-31Recruiting
A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) or Intolerant to Entecavir [NCT04034368]Phase 48 participants (Anticipated)Interventional2019-08-31Not yet recruiting
Exploratory Study on Antiviral Therapy for Patients With Chronic Hepatitis B Virus Infection (Immune Tolerance Period) [NCT05382351]Phase 2238 participants (Anticipated)Interventional2022-05-10Recruiting
A Phase I, Open-label, Randomized, Crossover Trial in 20 Healthy Subjects to Investigate the Pharmacokinetic Interactions Between the Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir. [NCT00828789]Phase 120 participants (Actual)Interventional2009-02-28Completed
Antiretroviral Therapy and the Hepatitis C Virus [NCT00545558]Phase 118 participants (Actual)Interventional2006-04-30Completed
Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects [NCT00551018]Phase 2218 participants (Actual)Interventional2007-12-31Completed
Safety and Efficacy of Tenofovir Alafenamide for Chronic Hepatitis B Patients With Decompensated Liver Disease [NCT04683341]Phase 4100 participants (Anticipated)Interventional2020-09-01Recruiting
TDF Combined With LDT for the Treatment of HBeAg-positive Hepatitis B Patients With Poor Response to TDF for Twelve Months [NCT04650828]200 participants (Anticipated)Observational [Patient Registry]2020-12-01Recruiting
An Omnibus Protocol to Characterize Patients With Hepatitis B and C (the HOPE Study) With Hepatitis B Treatment Sub-study [NCT02995252]550 participants (Anticipated)Observational2014-12-31Recruiting
Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa [NCT06138600]Phase 3200 participants (Anticipated)Interventional2023-11-01Active, not recruiting
Randomized Trial of Tenofovir Disoproxil Fumerate Dose Adjustment VS. Switching to Tenofovir Alafenamide in Tenofovir Disoproxil Fumarate-experienced Chronic Hepatitis B Patients With Renal Impairment [NCT04391608]Phase 480 participants (Anticipated)Interventional2019-11-09Recruiting
Safety and Efficacy of Emtricitabine/Tenofovir Alafenamide as Part of Salvage Antiretroviral Regimens in Patients With Uncontrolled Viremia and Drug-Resistant HIV Infection [NCT02556333]Phase 21 participants (Actual)Interventional2015-09-16Terminated
A Pilot Trial of Simvastatin Alone and Added to Tenofovir or Entecavir for the Treatment of Chronic Hepatitis B [NCT00994773]Phase 132 participants (Actual)Interventional2009-12-31Completed
A Phase III, Randomized, Open-Label Study Comparing the Safety and Efficacy of Switching Stavudine or Zidovudine to Tenofovir Disoproxil Fumarate Versus Continuing Stavudine or Zidovudine in Virologically Suppressed HIV-Infected Children Taking Highly Act [NCT00528957]Phase 397 participants (Actual)Interventional2006-12-28Completed
The Optimization of HAART for Chinese--a RCT Study [NCT02945163]Phase 4184 participants (Actual)Interventional2018-03-05Completed
A Phase 3, Randomized, Active-Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Women at High Risk for HIV-1 Infection [NCT04644029]Phase 3730 participants (Actual)Interventional2021-02-24Active, not recruiting
Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine [NCT03218085]50 participants (Anticipated)Observational2017-07-14Recruiting
Cell Cycle Independent Antiretroviral Therapy: Combination of Nevirapine, FTC, and Tenofovir [NCT00344461]Phase 454 participants (Actual)Interventional2004-03-31Completed
A Multicenter, Open-label, Randomized Study to Assess the Metabolics, Efficacy, and Safety of Once-daily Darunavir Versus Atazanavir in HIV-infected Treatment-naive Adult Patients [NCT00757783]Phase 468 participants (Actual)Interventional2008-10-31Completed
Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment-naïve Patients and Treated Patients With Chronic He [NCT06150014]Phase 1/Phase 264 participants (Anticipated)Interventional2023-12-07Recruiting
A Phase 2, Randomized, Double-Blind Study Exploring the Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine Plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects Currently Being Treated With Adef [NCT00307489]Phase 2106 participants (Actual)Interventional2006-03-31Completed
A Multicenter, Randomized, Open-Label, Active-Controlled Pilot Study to Evaluate the Safety and Antiretroviral Activity of Unboosted Atazanavir BID Plus Raltegravir BID and Boosted Atazanavir QD in Combination With Tenofovir/Emtricitabine QD in Treatment [NCT00768989]Phase 2167 participants (Actual)Interventional2008-11-30Terminated(stopped due to Efficacy endpoint met, but overall experimental dosing regimen not considered optimal to support further clinical development in this population.)
The ARDENT Study: Atazanavir, Raltegravir, or Darunavir With Emtricitabine/Tenofovir for Naive Treatment [NCT00811954]Phase 31,814 participants (Actual)Interventional2009-05-31Completed
A Phase III Randomized, Open Label Trial to Evaluate Dolutegravir Versus Efavirenz 400 mg, Both Combined With Tenofovir Disoproxil Fumarate + Lamivudine for the Initial Management of HIV Infected Adults in Resource-limited Settings [NCT02777229]Phase 3616 participants (Actual)Interventional2016-07-31Completed
A Prospective, Randomized, Open Label Phase IV Study to Evaluate the Rationale of Switching From Fixed Dose Abacavir (ABC)/Lamivudine (3TC) to Fixed Dose Tenofovir DF (TDF)/Emtricitabine (FTC) in Virologically Suppressed, HIV-1 Infected Patients Maintaine [NCT00724711]Phase 4312 participants (Actual)Interventional2008-07-31Completed
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers [NCT02589457]Phase 140 participants (Actual)Interventional2015-10-31Completed
A Multicenter Study to Compare the Efficacy of a Prophylactic Use of Tenofovir by Duration for the Non-Hodgkin's Lymphoma Patients With Isolated Anti-HBc-positivity Who Will be Treated With Rituximab Based Chemotherapy [NCT02585947]Phase 490 participants (Anticipated)Interventional2015-11-30Recruiting
A Phase 2, Double-Blind, Multi-center, Randomized Study Comparing Tenofovir Disoproxil Fumarate, Emtricitabine Plus Tenofovir Disoproxil Fumarate, and Entecavir in the Treatment of Chronic Hepatitis B Subjects With Decompensated Liver Disease and in the P [NCT00298363]Phase 2112 participants (Actual)Interventional2006-04-30Completed
Severe Impairment of Solute-Free Water Clearance in Patients With HIV Infection [NCT01869010]30 participants (Actual)Observational2010-01-31Completed
Study to Evaluate the Pharmacokinetic, Safety, and Efficacy of TAF in HBV-Infected Pregnant Women [NCT05853718]Phase 450 participants (Anticipated)Interventional2021-05-06Recruiting
A Randomized, Phase II, Open Label Study to Compare Twice Daily and Once Daily Potent Antiretroviral Therapy and to Compare Self-Administered Therapy and Therapy Administered Under Direct Observation [NCT00036452]Phase 2402 participants (Actual)InterventionalCompleted
A Prospective Study to Investigate the Relationship Between Hepatitis B Surface Antigen (HBsAg) Loss and the Dynamics in Host and Viral Markers After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment in Chronic Hepatitis B E-antigen Negative Patients [NCT05550519]Early Phase 10 participants (Actual)Interventional2022-10-31Withdrawn(stopped due to Sponsor decision after reevaluation of strategy in the context of recruitment timelines projection)
Correcting Pre-Exposure Prophylaxis (PrEP) Dosing and Adherence Benchmarks in Pregnancy to Optimize HIV Prevention (PrEP-P): A Randomized Comparative Pharmacokinetic Trial [NCT03834909]Phase 10 participants (Actual)Interventional2022-04-30Withdrawn(stopped due to Study was not funded)
US Expanded Access Program of Tenofovir Disoproxil Fumarate in the Treatment of HIV-1 Infected Patients Who Have Limited Treatment Options [NCT00011089]0 participants Interventional2001-02-28Active, not recruiting
Switching to Tenofovir Alafenamide Fumarate or Abacavir in Patients With Tenofovir Disoproxil Fumarate Associated eGFR Decline. A Randomized Trial. [NCT02957864]Phase 480 participants (Anticipated)Interventional2016-10-31Recruiting
IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project [NCT03058835]Phase 4125 participants (Actual)Interventional2016-09-30Active, not recruiting
Randomized Controlled Trail (RCT) of Emtricitabine, Tenofovir Disoproxil and Raltegravir for Patients With Primary Biliary Cholangitis Unresponsive to Ursodeoxycholic Acid (UDCA) [NCT03954327]Phase 237 participants (Actual)Interventional2021-03-01Active, not recruiting
Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl. A Prospective, Randomized, Multicentre, Open Clinical Study. [NCT00532168]Phase 4108 participants (Actual)Interventional2007-09-30Completed
Optimization of Antiretroviral Therapy [NCT02935075]Phase 4184 participants (Actual)Interventional2018-03-05Completed
A Phase 1 Pharmacokinetic Study of Varying Dosing Patterns on Tenofovir Concentrations in Hair [NCT00903084]Phase 124 participants (Actual)Interventional2009-06-30Completed
A Randomized Evaluation of Antiretroviral Therapy Alone or With Delayed Chemotherapy Versus Antiretroviral Therapy With Immediate Adjunctive Chemotherapy for Treatment of Limited Stage AIDS-KS in Resource-Limited Settings (REACT-KS) AMC 067 [NCT01352117]Phase 3192 participants (Actual)Interventional2011-11-18Completed
Effect of Tenofovir/Emtricitabine Short Course on Viral Clearance in Patients Recently Infected With SARS-COV2 (Covid-19) Not Requiring Hospitalization: a Phase IIB/III Multicenter Open-label Randomized Controlled Trial [NCT04685512]Phase 2/Phase 360 participants (Actual)Interventional2020-11-18Completed
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Tenofovir DF as Part of an Optimized Antiretroviral Regimen in HIV-1-Infected Adolescents [NCT00352053]Phase 387 participants (Actual)Interventional2006-06-30Completed
A Comparative Study of Entecavir vs. Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-resistant Chronic Hepatitis B Subjects: The DEFINE Study [NCT00410202]Phase 3629 participants (Actual)Interventional2008-03-31Completed
Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM) [NCT01033760]Phase 390 participants (Actual)Interventional2010-04-30Completed
A Comparative Study of Chronic Hepatitis B Subjects Treated With Entecavir Plus Tenofovir Combination Therapy vs. Entecavir Monotherapy in Adults Who Are Treatment-Naive to Nucleosides and Nucleotides: The BE-LOW Study [NCT00410072]Phase 3669 participants (Actual)Interventional2007-04-30Completed
A Pilot Study of Lopinavir/Ritonavir in Participants Experiencing Virologic Relapse on NNRTI-Containing Regimens [NCT00357552]123 participants (Actual)Interventional2008-01-31Completed
Nucleosides And Darunavir/Dolutegravir In Africa (NADIA): a Randomised Controlled Trial of Darunavir Versus Dolutegravir and Tenofovir Versus Zidovudine in Second-line Antiretroviral Therapy Regimens for the Public Health Approach in Sub-Saharan Africa [NCT03988452]Phase 3465 participants (Actual)Interventional2019-07-30Active, not recruiting
A Randomised, Open-label, 96-week Study Comparing the Safety and Efficacy of Three Different Combination Antiretroviral Regimens as Initial Therapy for HIV Infection. [NCT00335322]Phase 4329 participants (Actual)Interventional2007-02-28Completed
A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Patients With Chronic Hepatitis B Infection [NCT01651403]Phase 390 participants (Actual)Interventional2012-12-06Active, not recruiting
Tenofovir Reduces Morbidity and Mortality in Patients With Spontaneous Reactivation of Hepatitis B Presenting as Acute-on-chronic Liver Failure (ACLF): A Randomized Placebo Controlled Trial [NCT01074645]Phase 427 participants (Actual)Interventional2007-11-30Completed
Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Marginalized Populations Who Are Virologically Suppressed [NCT04132674]Phase 440 participants (Anticipated)Interventional2018-11-26Recruiting
Treatment Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in naïve Chronic Hepatitis B : a Real Life Multicenter Cohort Study in Korea [NCT02533544]572 participants (Actual)Observational2015-10-31Completed
An Open-label Randomised Two-year Trial Comparing Two First-line Regimens in HIV-infected Antiretroviral naïve Subjects: Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir (ANRS 143/NEAT 001) [NCT01066962]Phase 3800 participants (Actual)Interventional2010-08-31Completed
Randomized, Open-Label Evaluation of Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Persons From Resource-Limited Settings (PE [NCT00084136]Phase 41,571 participants (Actual)Interventional2005-05-31Completed
A Phase 1, Randomized Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir [NCT03670355]Phase 149 participants (Actual)Interventional2018-12-07Completed
Switching HIV-positive Women on Tenofovir/Emtricitabine Plus Boosted Atazanavir to RALtegravir Plus Boosted ATazanavir: A Pilot Randomized Clinical Trial Investigating 48-weeks Changes in Bone Mineral Density [NCT01902186]Phase 44 participants (Actual)Interventional2014-09-30Terminated(stopped due to Low enrollment)
Safety, Tolerability, and Adherence to Co-formulated Emtricitabine-rilpivirine-tenofovir Used as HIV Nonoccupational Post Exposure Prophylaxis in Men Who Have Sex With Men (EPEP) [NCT01715636]Phase 4100 participants (Actual)Interventional2012-12-31Completed
[NCT01918631]36 participants (Actual)Interventional2013-08-31Completed
A Phase Ⅲ, Multi-center, Randomized, Double-blinded, Parallel Study to Assess the Antiviral Activity and Safety of Besifovir 150 mg Compared to Tenofovir 300 mg in Chronic Hepatitis B Patients for 48 Weeks [NCT01937806]Phase 3197 participants (Actual)Interventional2013-10-31Active, not recruiting
Addition of Single-dose, Maternal Tenofovir and Emtricitabine to Reduce Non-nucleoside Reverse Transcriptase Inhibitor Resistance Mutations in the Setting of Zidovudine and Nevirapine for Prevention of Mother-to-child HIV Transmission [NCT00204308]Phase 2400 participants (Actual)Interventional2005-03-31Completed
Evaluate the Efficacy and Safety of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients Who Pretreated With Tenofovir Disoproxil Fumarate [NCT03485534]Phase 4189 participants (Actual)Interventional2018-01-23Completed
Tenofovir, Emtricitabine, and Nevirapine for Recently HIV-Infected Subjects: Can Short-Course, Once Daily Therapy Reduce the Viral Load at 12 Months From Estimated Date of Infection? [NCT00087464]0 participants (Actual)InterventionalWithdrawn(stopped due to study was withdrawn before any participants were recruited and enrolled)
Single Dose and 14-Day Once or Twice-Daily Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel [NCT00561496]Phase 149 participants (Actual)Interventional2007-03-31Completed
Phase 2 Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV [NCT00122486]Phase 21,200 participants Interventional2004-07-31Completed
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project. [NCT01989611]400 participants (Anticipated)Interventional2014-06-30Active, not recruiting
A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04 [NCT01989663]Phase 178 participants (Actual)Interventional2013-11-30Completed
Phase 3 Randomized Trial Evaluating the Virological Efficacy and the Tolerance of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Dakar and Yaounde [NCT00573001]Phase 3120 participants (Actual)Interventional2008-07-31Completed
A Prospective, Randomized, Three-period Crossover, Interaction Study to Evaluate the Pharmacokinetics of Doravirine and Tenofovir Disoproxil Fumarate Co-administered With Cross-sex Hormonal Therapy in Adult HIV-negative Transgender Women [NCT04283656]Phase 17 participants (Actual)Interventional2022-02-14Completed
CHAMPS: Choices For Adolescent Prevention Methods For South Africa. Pilot Study B: 'PlusPills' [NCT02213328]Phase 2148 participants (Actual)Interventional2015-04-30Completed
HPTN 091: Integrating HIV Prevention, Gender-Affirmative Medical Care, and Peer Health Navigation for Transgender Women in the Americas: A Vanguard Study [NCT04742491]Phase 2/Phase 3307 participants (Actual)Interventional2021-03-26Active, not recruiting
Randomized, Double-blinded, Controlled Trial of Intensive HAART Including Raltegravir, and Maraviroc, on HIV-1 Pro-viral DNA and Reservoir Decay in HIV-1-infected Individuals During the Acute/Early Infection [NCT01154673]Phase 2/Phase 332 participants (Actual)Interventional2011-11-30Completed
A Randomized, Pilot Study on the Antiviral Activity and Immunological Effects of Lopinavir/Ritonavir vs. Efavirenz in Treatment-naïve HIV-Infected Patients With CD4 Cell Counts Below 100 Cells/mm3 [NCT00386659]Phase 460 participants InterventionalTerminated
A Phase 2 Randomized Cross-Over Design Study of the Early Metabolic Effects of Dolutegravir or Tenofovir Alafenamide in Healthy Volunteers [NCT05652478]Phase 2120 participants (Anticipated)Interventional2024-01-03Recruiting
Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals [NCT02251236]14 participants (Actual)Interventional2016-01-31Completed
HIV Pre-exposure Prophylaxis Implementation Study in South Korea [NCT04583267]200 participants (Anticipated)Interventional2018-08-28Recruiting
Optimizing Access to Non-occupational Post Exposure Prophylaxis for HIV Using Contingency Management in Stimulant-Using Men Who Have Sex With Men [NCT01140880]Phase 2170 participants (Actual)Interventional2010-05-31Completed
A Randomized, Single-Dose, Parallel-Group Study to Evaluate thePharmacokinetic Profiles of Two Formulations of Tenofovir Disoproxil Fumarate After Oral Administration in Healthy Volunteers Under Fasting Conditions [NCT04671563]Phase 428 participants (Actual)Interventional2019-04-22Completed
A Phase IV Open-label Evaluation of Safety, Tolerability and Acceptability of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Disoproxil Fumarate Single-tablet Regimen for Non-occupational Prophylaxis Following Potential Exposure to HIV-1 [NCT01855867]Phase 4100 participants (Actual)Interventional2013-05-31Completed
The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis [NCT02211690]Phase 4100 participants (Actual)Interventional2014-08-31Completed
Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Multi-center, Double-Blind, Randomized, Positive Control, Phase3 Study [NCT04543565]Phase 3900 participants (Anticipated)Interventional2020-09-30Recruiting
A Comparative Study of the Efficacy and Safety of Entecavir and Tenofovir Versus Entecavir Alone in the Treatment of Hepatitis B DNA-positive Patients With Lymphomas [NCT04539119]Phase 3120 participants (Anticipated)Interventional2020-07-03Recruiting
Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir of Chinese HIV/AIDS Patients In Acute HIV-1 Infection [NCT02219672]Phase 318 participants (Anticipated)Interventional2014-07-31Recruiting
Transgender Men and HIV in Uganda: PrEP Uptake and Persistence [NCT04867798]75 participants (Actual)Observational2021-09-16Completed
DREAM-01: Optimization of a Tenofovir Enema for HIV Prevention [NCT02750540]Phase 121 participants (Actual)Interventional2016-10-31Completed
A Phase IV Open-label Evaluation of Safety, Tolerability and Patient Acceptance of Atazanavir Boosted With Ritonavir Combined With a Fixed-dose Formulation of Tenofovir DF and Emtricitabine for Non-occupational Prophylaxis Following Potential Exposure to [NCT01602822]Phase 411 participants (Actual)Interventional2012-02-29Terminated(stopped due to Grade 3 elevation in liver function tests)
Phase 1 Evaluation of the Impact of Coitus on Pharmacokinetics and Pharmacodynamics of Tenofovir 1% Gel Following Pericoital or Daily Gel Dosing [NCT01687205]Phase 131 participants (Actual)Interventional2012-11-30Completed
Effect of Multiple Dosing With 240 mg BID BI 201335 on the Steady State Pharmacokinetics of 300mg QD Tenofovir and Effect of Multiple Dosing With 300mg QD Tenofovir on Steady State BI 201335 Pharmacokinetics in Healthy Male and Female Volunteers [NCT01340196]Phase 116 participants (Actual)Interventional2011-04-30Completed
Phase III Open-label Randomized Multicenter Trial to Assess the Non-inferiority of Raltegravir Compared With EFavirenz, Both in Combination With LAmivudine and TEnofovir, in ART-naïve HIV-1-infected Patients Receiving Rifampin for Active TuBerculosis [NCT02273765]Phase 3460 participants (Actual)Interventional2015-09-11Completed
An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazan [NCT01332227]Phase 4132 participants (Actual)Interventional2011-10-31Completed
Safety and Efficacy of the Universal Use of EFV-TDF-FTC and AZT-3TC-LPV/r Combinations in Pregnant and Breastfeeding Women to Prevent mother-to Child Transmission of HIV-1 o, Resource-limited Settings: A Multicentre Randomized Phase 3 Clinical Trial [NCT00936195]Phase 30 participants (Actual)Interventional2010-01-31Withdrawn(stopped due to faillure to obtain insurance because of refusal from insurance companies)
Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine. [NCT00808002]Phase 330 participants (Actual)Interventional2009-02-28Completed
The Impact of in Utero and Breastfeeding Exposure to Tenofovir on Renal Function in HIV-exposed Uninfected Children in Cameroon: The PREVENT-IT Study [NCT04070482]400 participants (Anticipated)Observational2017-10-01Active, not recruiting
Phase I Exploratory Pharmacodynamic Study of Tenofovir-Based Products [NCT02722343]Phase 125 participants (Actual)Interventional2016-04-30Completed
Biobehavioral Interventions for HIV-negative Methamphetamine-using MSM [NCT00856323]Phase 253 participants (Actual)Interventional2009-01-31Completed
Open Label Extension (OLE) of the Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana [NCT04318210]229 participants (Actual)Interventional2012-10-31Completed
Cardiovascular, Anthropometric, and Skeletal Effects of Antiretroviral Therapy (ART) Initiation With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Plus Atazanavir/Ritonavir (ATV/r), Darunavir/Ritonavir (DRV/r), or Raltegravir (RAL): Metabolic Subs [NCT00851799]334 participants (Actual)Observational2009-06-30Completed
Tenofovir Disoproxil Fumarate Alone Versus Its Combination With Emtricitabine for Treatment of Chronic Hepatitis B [NCT00524173]Phase 235 participants (Actual)Interventional2007-08-29Terminated
The Effects of Switching From Dolutegravir/Lamivudine/Abacavir (d/l/a) to Bictegravir/Emtricitabine/Tenofovir Alafenamide (b/f/Taf) in Patients With Suppressed Viral Load on Neuropsychiatric Side Effects and Neurocognitive Function [NCT04155554]Phase 3100 participants (Anticipated)Interventional2020-01-29Recruiting
Evaluation of Safety and Efficacy of Raltegravir/Darunavir Combination in Antiretroviral-Naive Patients [NCT00677300]Phase 485 participants (Actual)Interventional2009-01-31Completed
A Phase II of Randomized, Double-blind, Placebo-controlled, Multi-center Study of Hepalatide for Injection Combined With Pegylated Interferon and TAF as Finite Treatment in Chronic Hepatitis B Patients [NCT05244057]Phase 230 participants (Anticipated)Interventional2022-08-23Recruiting
Phase 1 Safety and Pharmacokinetic Study of a Polyurethane Tenofovir Disoproxil Fumarate Vaginal Ring in Sexually Active Women (TDF IVR-002) [NCT02762617]Phase 117 participants (Actual)Interventional2017-02-24Terminated(stopped due to Safety-related)
Adjunctive Therapy With Telmisartan Instituted With ART During Acute HIV Infection to Reduce the Establishment of CNS Reservoirs of HIV and Lymph Node Fibrosis [NCT02750059]Phase 221 participants (Actual)Interventional2015-01-31Completed
Simplifying Treatment and Monitoring for HIV (STREAM HIV): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa [NCT04341779]540 participants (Anticipated)Interventional2021-02-04Recruiting
A Phase I, Open-label Multiple Dose Safety, Pharmacokinetic, Pharmacodynamic, and Acceptability Study of Tenofovir Rectal Douche [NCT04016233]Phase 19 participants (Actual)Interventional2020-01-10Completed
Point of Care PrEP Delivery for Young Black/African American Men Who Have Sex With Men and Young Transgender Women at High Risk for HIV Infection [NCT04329442]0 participants (Actual)Interventional2020-04-01Withdrawn(stopped due to COVID-19 caused substantial barriers to recruitment.)
Use of Tenofovir/Emtricitabine With Immediate or Deferred Doxycycline 100mg PO Daily for Combination HIV and Syphilis Pre-exposure Prophylaxis in HIV-negative Men Who Have Sex With Men: a Pilot Study of Dual Daily HIV and Syphilis PrEP. (The DuDHS Trial). [NCT02844634]Phase 452 participants (Actual)Interventional2018-05-15Active, not recruiting
A Randomised, Double-Blind, Multi-Centre, Parallel-Group Phase 3b Study to Demonstrate Non-inferiority of Stavudine (20 mg Twice Daily) Compared With Tenofovir Disoproxil Fumarate (300 mg Once Daily) When Administered in Combination With Lamivudine and Ef [NCT02670772]Phase 31,077 participants (Actual)Interventional2012-07-31Completed
ART Drug Dosage Adjustment Using FSCII in Chinese HIV-infected Population [NCT02632474]Phase 410 participants (Actual)Interventional2015-04-30Completed
Defining the PrEP Care Continuum Among Recently Incarcerated Men at High-Risk for HIV Infection [NCT04240509]Phase 4100 participants (Anticipated)Interventional2019-11-01Enrolling by invitation
A Randomized, Open-label, Controlled, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine 600 mg and Tenofovir Disproxil Fumarate 300 mg in Combination or Telbivudine 600 mg or Tenofovir Disproxil Fumarate 300 mg Mono [NCT00805675]Phase 383 participants (Actual)Interventional2008-11-30Completed
A Phase IV Open-Label Evaluation of Safety, Tolerability and Patient Acceptance of Raltegravir (MK-0518) Combined With a Fixed-Dose Formulation of Tenofovir Following Potential Exposure to HIV-1 [NCT00594646]Phase 4100 participants (Actual)Interventional2008-02-29Completed
Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere) [NCT01061151]Phase 33,747 participants (Actual)Interventional2011-03-01Completed
Phase I Study of the Maternal Single-Dose Pharmacokinetics and Placental Transfer of Tenofovir 1% Vaginal Gel Among Healthy Term Gravidas [NCT00540605]Phase 121 participants (Actual)InterventionalCompleted
A Randomized, Phase II, Controlled Trial Comparing the Efficacy of Adefovir Dipivoxil and Tenofovir Disoproxil Fumarate for the Treatment of Lamivudine-Resistant Hepatitis B Virus in Subjects Who Are Co-Infected With HIV [NCT00033163]Phase 290 participants InterventionalCompleted
[NCT02902523]Phase 150 participants (Actual)Interventional2016-09-30Completed
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women [NCT01394133]0 participants (Actual)Observational2011-07-31Withdrawn(stopped due to Lack of enrollment)
Determination of Plasma and Intracellular Levels of Nucleoside Reverse Transcriptase Inhibitors (NRTI) and of Nucleotide Analog Tenofovir Disoproxil Fumarate (TDF) in Patients Treated With Abacavir and/or Lamivudine Given With or Without TDF. [NCT00335192]Phase 432 participants (Actual)Interventional2005-01-31Completed
Assessing the Effect of Contraception and the Menstrual Cycle on Pharmacokinetics, Pharmacodynamics, and Vaginal Safety in Tenofovir Vaginal Gel Users [NCT01421368]Phase 172 participants (Actual)Interventional2012-03-31Completed
An Open-label, Randomized, Controlled Clinical Trial to Determine the Optimal Time for Tenofovir of Anti-HBV Treatment During the Pregnancy Among Chronic HBV-infected Pregnant Women With Normal Liver Function [NCT02510963]300 participants (Anticipated)Interventional2015-11-30Recruiting
Analysis of Lipodystrophy in HIV-Infected Individuals A Prospective, Non-randomised, 48 Week Study of the Effect of PI Containing and Non-PI Containing Antiretroviral Regimens on the Expression of Adipocyte Specific Genes, Protein Levels and Cellular Stru [NCT00192660]Phase 480 participants (Actual)Interventional2003-02-28Completed
Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naïve Patients With HIV/HBV co-Infection [NCT00127959]Phase 424 participants Interventional2004-03-31Completed
Clinical, Control, Double-blind, Randomized Experimentation With Tenofovir Disoproxyl Fumarate and Emtricitabine for COVID-19 [NCT04712357]219 participants (Anticipated)Interventional2020-11-09Recruiting
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males - A Sub-study of HPTN 083 [NCT04692077]Phase 29 participants (Actual)Interventional2020-02-19Completed
A Phase II, Open Label, Single Arm Trial to Evaluate the Pharmacokinetics,Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Antiretroviral Naive HIV-1 Infected Adolescents and Children Aged >= 6 to <18 Years [NCT00799864]Phase 254 participants (Actual)Interventional2011-01-07Completed
A Randomized, Double-blind, Double-simulated, Active-controlled,Phase III Clinical Study Evaluating the Efficacy and Safety of Azvudine Combined With Tenofovir Fumarate and Efavirenz in Hiv-infected Treatment Naive Patients [NCT04303598]Phase 3720 participants (Anticipated)Interventional2020-04-01Not yet recruiting
A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg When A [NCT04236453]Phase 116 participants (Actual)Interventional2020-01-23Terminated(stopped due to COVID-19 pandemic impacted the BE assessment of the trial. The clinical team decided to terminate the trial in order to start a new pivotal BE trial)
A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics and Safety of Twice Yearly Long-Acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in People Who Inject Drugs [NCT06101342]Phase 2250 participants (Anticipated)Interventional2023-12-13Recruiting
Pilot Trial to Evaluate the Efficacy and Tolerance of a Simple Once Daily Combined Regimen Including Tenofovir (TDF), Emtricitabine (FTC) and Efavirenz (EFV) in HIV-1 Infected Patients Naive to Prior Antiretroviral Treatment in Senegal [NCT00158457]Phase 340 participants (Actual)Interventional2004-06-30Completed
Study on Screening, Verification and Intervention of High-risk Patients With Liver Cancer [NCT05721300]2,215 participants (Anticipated)Interventional2023-02-10Recruiting
A Prospective, Randomized, Trial to Investigate the Effect of Continued Adefovir Versus Combination Regimens of Telbivudine Plus Adefovir, and Telbivudine Plus Tenofovir in Patients With Chronic Hepatitis B and Suboptimal Viral Suppression (PROACTIV Study [NCT00409019]Phase 40 participants (Actual)InterventionalWithdrawn(stopped due to Study cancelled: Withdrawn before enrollment of any participants)
Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine in Virologically-suppressed Adults Living With HIV on Bictegravir/Tenofovir Alafenamide/emtricitabine-the DYAD Study [NCT04585737]Phase 4222 participants (Actual)Interventional2020-09-22Completed
Efficacy, Safety, and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-HBV Coinfection [NCT03797014]Phase 428 participants (Actual)Interventional2019-04-30Completed
Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation [NCT01848743]Phase 3120 participants (Anticipated)Interventional2013-04-30Recruiting
A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study. [NCT00192634]Phase 4357 participants (Actual)Interventional2005-12-31Completed
Pegylated Interferon Alfa-2a Versus Emtricitabine / Tenofovir +/- Pegylated Interferon Alfa-2a for the Treatment of Chronic HBe-Ag Positive Hepatitis B Infection in HIV-Coinfected Patients - the PEGPLUS Trial [NCT00221286]Phase 32 participants (Actual)Interventional2004-09-30Terminated(stopped due to Lack of accrual)
Tenofovir Disoproxil Fumarate Improves Outcomes Following Palliative Transarterial Chemoembolization for Hepatitis B Virus Related Hepatocellular Carcinoma [NCT01872988]Phase 3320 participants (Anticipated)Interventional2012-09-30Terminated(stopped due to Difficult in patient enrollment)
Optimizing the Delivery of HIV Post-exposure Prophylaxis: A Randomized Controlled Trial of Text Messaging Support and Physician to Nurse Task-shifting [NCT03259698]Phase 2434 participants (Anticipated)Interventional2021-11-04Recruiting
Reverse Transcriptase Inhibitors in Aicardi Goutières Syndrome [NCT03304717]Phase 1/Phase 234 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Randomized, Double-blind, Placebo-controlled Trial of TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study) [NCT04405271]Phase 31,378 participants (Anticipated)Interventional2020-07-31Not yet recruiting
An Open-label, Randomized Study to Evaluate the Acute Immunologic Responses in Asian Subjects With E Antigen Positive Chronic Hepatitis B Following Initiation of Therapy for Hepatitis B With Pegasys, Nucleoside Analogues, or Both. [NCT00962871]Phase 130 participants (Actual)Interventional2009-08-31Completed
ENLIGHTEN: Establishing Novel Antiretroviral (ARV) Imaging for Hair to Elucidate Non-Adherence [NCT03218592]Phase 436 participants (Actual)Interventional2017-06-28Completed
Tenofovir Disoproxil Fumarate in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus in Highly Viremic Mothers [NCT01488526]Phase 4200 participants (Actual)Interventional2012-03-01Completed
Body Compartment Pharmacokinetics of Anti-retroviral Agents That May be Considered for Future On-demand Peri-exposure HIV Prophylaxis Regimens [NCT03976752]Phase 141 participants (Actual)Interventional2019-03-13Completed
Open Label Randomized Controlled Trial to Assess the Impact of Prophylactic Exposure to Tenofovir Gel on the Efficacy of Subsequent Tenofovir-containing Antiretroviral Therapy on Viral Suppression [NCT01387022]59 participants (Actual)Interventional2011-06-30Completed
Phase 2 Expanded Safety Study of Tenofovir Gel in Pregnancy [NCT01490671]Phase 20 participants (Actual)InterventionalWithdrawn
Randomized Trial of Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients Who Have Undergone Lamivudine/Adefovir Add-on Treatment [NCT01491295]Phase 4160 participants (Anticipated)Interventional2012-09-30Recruiting
The Pharmacokinetics of Co-formulated Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Smear-positive Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania [NCT00474435]Phase 230 participants (Anticipated)Interventional2008-11-30Recruiting
Open-Label, Part-Randomized Study Designed to Evaluate the PK Profile of Tenofovir Exalidex (TXL) Following Single Dose of Oral Formulations in Comparison to a Reference IR TXL Tablet in Healthy Subjects [NCT03279146]Phase 129 participants (Actual)Interventional2017-09-06Completed
Phase I, 90-Day Safety, Pharmacokinetic, And Pharmacodynamic Study Of Intravaginal Rings Releasing Tenofovir And Levonorgestrel [NCT03279120]Phase 166 participants (Actual)Interventional2017-09-28Completed
The ADAPT Study: A Phase II, Randomized, Open-Label, Pharmacokinetic and Behavioral Study of the Use of Intermittent Oral Emtricitabine/Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis (PrEP) Pre-Exposure Prophylaxis (PrEP) [NCT01327651]Phase 2622 participants (Actual)Interventional2011-08-31Completed
A Randomized, Multicenter, Prospective Study to Compare Antiviral Efficacy and Safety of Switching to ETV Plus TDF Versus Maintaining LAM/LDT Plus ADF Combination in CHC With PVR to LAM/LDF Plus ADF Combination Rescue Therapy for YMDD Mutation [NCT01597934]Phase 4104 participants (Anticipated)Interventional2012-08-31Active, not recruiting
Pilot Study to Measure Exposure to Atazanavir, as a Component of Pharmacokinetic Parameters and Adherence Measured With MEMS in Naive HIV-infected Patients Treated Once Daily With Atazanavir Combined to Ritonavir and to Tenofovir/Emtricitabine. ANRS 134 C [NCT00528060]Phase 235 participants (Actual)Interventional2008-01-31Completed
Randomized, Non-inferiority Trial Comparing a Dual Maintenance Therapy Strategy With Dolutegravir + Lamivudine (DTG/3TC) or Atazanavir/Ritonavir + Lamivudine (ATV/r+3TC) Versus the Standard WHO First Line Triple Therapy Tenofovir + Lamivudine + Efavirenz [NCT04022967]Phase 3480 participants (Actual)Interventional2020-09-21Active, not recruiting
Tenofovir As Prevention Of Hepatitis b Mother-to-child Transmission [NCT02937779]Phase 4933 participants (Anticipated)Interventional2017-10-04Active, not recruiting
Pharmacokinetics of Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Pre-exposure Prophylaxis in Transgender Women Receiving Feminizing Hormone Therapy [NCT03270969]Phase 115 participants (Actual)Interventional2018-01-05Completed
Effect of Repeated Applications of Tenofovir Gel on Mucosal Mediators of Immunity and Intrinsic Antimicrobial Activity of Cervicovaginal Secretions in Women at Low Risk for HIV-1 Infection [NCT00594373]Phase 130 participants (Actual)InterventionalCompleted
Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study [NCT00537966]2,017 participants (Anticipated)Interventional2002-01-31Recruiting
A Randomized, Open Label, Multicenter Study Comparing the Safety and Efficacy of Once Daily Regimen Containing Epzicom or Truvada Combined With Ritonavir Boosted Atazanavir as Initial Therapy for HIV-1 Infection (ET Study) [NCT00544128]Phase 4109 participants (Actual)Interventional2007-10-31Completed
A Phase 1a/1b, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Healthy Volunteers and Patients With Chronic Hepatitis B [NCT02908191]Phase 186 participants (Actual)Interventional2016-11-30Completed
A Multicentre, Randomized Controlled Trial in HBsAg Seroclearance After Receiving Combined Therapy of Peginterferon and Tenofovir in Nucleos(t)Ide Analogue-treated Patients With HBV Related Liver Fibrosis. [NCT04640129]Phase 4272 participants (Anticipated)Interventional2020-11-30Not yet recruiting
Exploratory Pharmacokinetic and Pharmacodynamic Study of Oral F/TAF for the Prevention of HIV Acquisition [NCT02904369]Phase 173 participants (Actual)Interventional2016-10-06Completed
The Effectiveness and Safety of Tenofovir Alafenamide in the Treatment of Chronic Hepatitis B Patients With Mildly Elevated Alanine Aminotransferase and Significant Liver Injury [NCT04674423]Phase 440 participants (Anticipated)Interventional2020-05-14Recruiting
A Pilot Study of Rapid HIV Treatment Initiation, Access and Engagement in Care (RHAE) [NCT03512964]32 participants (Actual)Interventional2016-11-29Completed
Treating HIV-infected Elite Controllers as a Model of HIV Remission [NCT01025427]Phase 416 participants (Actual)Interventional2009-12-31Completed
Effect of Tenofovir on Genital HSV Shedding: a Randomized, Double-blind, Placebo-controlled Clinical Trial [NCT01448616]Phase 473 participants (Actual)Interventional2012-02-29Completed
An Open-Label, Pilot, Randomized, Multi-Center Study to Compare Efficacy and Safety of Tenofovir Monotherapy Alone With Tenofovir Monotherapy Followed by Concurrent Combination of Pegylated Interferon-Alpha-2b and Tenofovir or Tenofovir Monotherapy Follow [NCT01727271]Phase 40 participants (Actual)Interventional2013-08-31Withdrawn
The Efficacy of TAF as a Prophylactic Antiviral Agent for HBsAg-positive Patients Receiving Biological DMARDs (bDMARDs) [NCT05001672]Phase 4108 participants (Anticipated)Interventional2021-08-15Not yet recruiting
Switching to Tenofovir Disoproxil Fumarate vs. Continuing Entecavir in Chronic Hepatitis B Patients With Partial Virologic Response During Entecavir Therapy: STEEP Study [NCT01711567]Phase 460 participants (Actual)Interventional2013-04-30Completed
A Prospective, Randomized, Multicenter, Open-label Study of Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients [NCT03013556]Phase 4180 participants (Anticipated)Interventional2016-11-30Recruiting
A Phase 4, Open-Label Study to Investigate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (Viread(R)) in Preventing Hepatocellular Carcinoma Recurrence in Chronic Hepatitis B Virus Infected Patients With Low Viral Load at Baseline Treated With R [NCT02308319]Phase 4124 participants (Anticipated)Interventional2015-01-31Not yet recruiting
Open-Label, Single-Centre, Randomised Pilot Study to Evaluate Immunovirological and Clinical Evolution of a Combination With Nucleoside Analogues/Nucleotides (Trizivir +Tenofovir) in Multiresistant Patients With Virological Failure [NCT00356616]Phase 424 participants (Actual)Interventional2005-09-30Terminated(stopped due to terminated)
Prospective Study on the Incidence of Hepatitis B Virus Reactivation in Untreated Patients With Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide [NCT03804372]Phase 2180 participants (Anticipated)Interventional2020-07-07Recruiting
Comparison Atazanavir/Ritonavir (ATV/r) vs Nevirapine (NVP) Twice a Day (Bid) on Truvada Backbone [NCT00552240]Phase 4154 participants (Actual)Interventional2007-09-30Completed
An Open Label Trial of STRIBILD™ (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate) for ARV-naïve HIV-2 Infected Adults in Dakar, Senegal [NCT02180438]Phase 430 participants (Actual)Interventional2014-09-30Completed
A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects [NCT02403674]Phase 3734 participants (Actual)Interventional2015-06-05Completed
On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men [NCT01473472]Phase 3400 participants (Actual)Interventional2012-01-31Completed
A Phase III, Open Label, Randomized, Comparative Study of the Antiviral Efficacy of ARV Therapy With Lopinavir/Ritonavir (LPV/r-Kaletra) in Combination With Tenofovir (TDF) Versus Standard of Care (Kaletra in Combination With 2 Nucleoside RTIs) in naïve-H [NCT00234910]Phase 3152 participants (Actual)Interventional2005-01-31Completed
A Phase I Study of the Safety, Tolerance, and Pharmacokinetics of Tenofovir Disoproxil Fumarate (TDF) and the Combination of TDF Plus Emtricitabine in HIV-1 Infected Pregnant Women and Their Infants [NCT00076791]Phase 166 participants (Actual)Interventional2004-03-31Completed
An Open-Label, Randomized Study to Determine the Impact of Antiretroviral Treatment in HCV/HIV-Coinfected Subjects With High CD4+ Cell Count on the Efficacy of Hepatitis C Treatment With Pegylated Interferon Alfa-2A and Ribavirin [NCT00100581]2 participants (Actual)InterventionalCompleted
A Multicenter Randomized Controlled Open-label Trial of Tenofovir Plus Entecavir Combination vs. Tenofovir Monotherapy in Chronic Hepatitis B Patients With Genotypic Resistance to Adefovir and Partial Virologic Response to Ongoing Treatment [NCT01639066]Phase 4102 participants (Actual)Interventional2012-09-25Completed
Phase II, Open-Label,Randomised, Comparator Study of Substitution w/Tenofovir or Abacavir in HIV-1 Infected Individuals, w/Viral Load Less 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of HAART. [NCT00270556]Phase 2100 participants Interventional2003-01-31Completed
Open-Label Study With Rilpivirine in Treatment-naïve Indian Subjects With HIV-1 Infection to Determine Safety and Efficacy [NCT03563742]Phase 358 participants (Actual)Interventional2018-09-24Terminated(stopped due to High SF rate (less treatment-naïve subjects & subjects with viral load <100000). Reevaluation in scientific position in India after internal discussion.)
Study of the Safety and Efficacy of Daily Tenofovir Disoproxil Fumarate for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana [NCT00111150]Phase 2/Phase 31,200 participants Interventional2005-09-30Terminated(stopped due to Consenting participants entered tenofovir/emtricitabine oral prophylaxis trial)
Study of Daily Oral Tenofovir (Tenofovir Disoproxil Fumarate) to Prevent HIV-1 Infection Among Sex Workers in Cambodia [NCT00078182]Phase 2/Phase 30 participants (Actual)InterventionalWithdrawn
A Phase I Clinical Trial Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Disintegration Time of Vaginal Tablets Containing Tenofovir and/or Emtricitabine [NCT01694407]Phase 148 participants (Actual)Interventional2013-02-28Completed
A Phase I Open Label Trial of the Safety and Pharmacokinetics of Tenofovir Disoproxil Fumarate in HIV-1 Infected Pregnant Women and Their Infants [NCT00120471]Phase 1122 participants (Actual)Interventional2006-11-30Completed
A Randomized, Open-Label Study Assessing Safety, Tolerability and Efficacy of an Induction-Maintenance Treatment Strategy Including Lopinavir/Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine Versus Efavirenz Plus Tenofovir Disoproxil Fumarat [NCT00121017]Phase 2200 participants InterventionalWithdrawn
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Men and Transgender Women Who Have Sex With Men, and Are at High Risk for HIV [NCT04652700]Phase 3494 participants (Actual)Interventional2021-03-15Completed
Randomized Open Label Study Assessing the Antiviral Activity, Toxicity and Pharmacologic Interaction of Tenofovir DF/Atazanavir Enhanced With Low Dose of Ritonavir as Part of a Salvage Regimen in HIV Infected Patients With Multiple Treatment Failures (ANR [NCT00122577]Phase 250 participants Interventional2002-03-31Terminated
Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department [NCT03711253]Phase 440 participants (Anticipated)Interventional2019-10-14Active, not recruiting
Clinical Trial: Backup With Combivir (AZT/3TC) or Single Dose (sd) Truvada (FTC/TDF) in Order to Avoid NNRTI Resistance After sd Nevirapine for the Prevention of Mother-to-child Transmission (MTCT) [NCT00346567]566 participants (Actual)Interventional2006-06-30Completed
"Analysis of Proximal Renal Tubular Function of Real World Chronic Hepatitis B (CHB) Patients Who Are Suppressed on TDF and Switched to TAF" [NCT02957994]Phase 482 participants (Actual)Interventional2016-12-22Active, not recruiting
A Phase II, Randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Two Antiretroviral Therapeutic Strategies: A Dual PI-Based HAART Regimen Versus a Multi-NRTI ART Regimen, in ART-Experienced Children and Youth Who Have Experienced Virol [NCT00102206]Phase 26 participants (Actual)InterventionalCompleted
A Phase 4, Single-Arm Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Tenofovir Disoproxil Fumarate in Combination With Emtricitabine in HIV-1 Infected Patients Experiencing Various Degrees of Renal Impairment [NCT00106379]Phase 452 participants Interventional2004-10-31Completed
Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women in South Africa [NCT00441298]Phase 2889 participants (Actual)Interventional2007-05-31Completed
A Randomized Comparison of Protease Inhibitor-based Versus Non-nucleoside Reverse Transcriptase Inhibitor-based Antiretroviral Therapy for Initial Treatment of Individuals With AIDS-related Kaposi's Sarcoma in Sub-Saharan Africa [NCT00444379]Phase 4224 participants (Actual)Interventional2007-04-30Completed
A Phase 3b, Multi-center, Randomized, Parallel-group, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Compared to Oral Bictegravir/Emtricitabine/Tenofov [NCT05979311]Phase 3412 participants (Anticipated)Interventional2023-12-29Not yet recruiting
A Phase I Trial for the Evaluation of the Two-way Pharmacokinetic-pharmacodynamic (PD) Interaction of Gender Affirming Exogenous Estrogen (With Testosterone Suppression) on TDF/FTC PrEP in Transgender Women (TGW) [NCT04760691]Phase 120 participants (Anticipated)Interventional2021-03-01Recruiting
Prevention of SARS-CoV-2 (COVID-19) Through Pre-Exposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine and Hydroxychloroquine in Healthcare Personnel: Randomized Clinical Trial Controlled With Placebo [NCT04334928]Phase 31,002 participants (Actual)Interventional2020-04-15Completed
Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Effectiveness and Safety Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women [NCT00625404]Phase 32,120 participants (Actual)Interventional2009-05-31Completed
A Multi-Center Comparison of Raltegravir to Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV-Infected Individuals Naive to Antiretroviral Therapy [NCT00632970]Phase 46 participants (Actual)Interventional2008-02-29Terminated(stopped due to no patients completed)
An Open Label Study to Investigate the Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age [NCT01335620]Phase 419 participants (Actual)Interventional2011-04-30Completed
Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy [NCT01285050]Phase 420 participants (Actual)Interventional2011-01-31Completed
An Open-Label Study to Assess the Anti-HIV-1 Activity of Tenofovir Disoproxil Fumarate (TDF) in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1 [NCT00016588]0 participants Interventional2001-05-31Completed
Contribution of the Integrase Inhibitor Dolutegravir to Obesity and Cardiovascular Disease in Persons Living With HIV [NCT04340388]Phase 410 participants (Actual)Interventional2020-09-17Completed
Open-label Multicenter Study to Assess the Efficacy, the Tolerability and the Adherence of a Once Daily (QD) Taken Antiretroviral Therapy (ART) Containing the NtRTI Tenofovir DF 300 mg in Combination With the Best Suitable Once a Day Regimen Being 1 NRTI [NCT00324688]Phase 460 participants Interventional2003-03-31Completed
Randomized Order, Controlled, Double Blind, Crossover Early Phase 1 Pilot Study to Assess Safety and Pharmacokinetics of a Tenofovir Disoproxil Fumarate and Emtricitabine (TDF-FTC) Releasing IVR Over 28 Days Compared to Placebo [NCT03255915]Early Phase 115 participants (Actual)Interventional2018-09-20Active, not recruiting
A Pilot Study of the Novel Antiretroviral Combination of Atazanavir and Raltegravir in HIV-1 Infected Subjects With Virologic Suppression on a Standard Regimen of Boosted Atazanavir, Tenofovir and Emtricitabine [NCT00931801]Phase 443 participants (Actual)Interventional2009-12-31Completed
Phase II Trial, Multicentre, Opened Label Evaluating the Pharmacokinetics and the Safety and Toxicity of the Tenofovir-Emtricitabine Combination in Pregnant Women and Infants in Africa and Asia [NCT00334256]Phase 272 participants (Actual)Interventional2006-10-31Completed
A Study to Probe The Safety And Durability of Tenofovir And a Cell Cycle Agent to Maintain Viral Suppression [NCT00344981]9 participants (Actual)Interventional2003-06-30Completed
A Multi-centre, Double Blind, Double Dummy, Randomised, Controlled Study to Evaluate the Efficacy and Safety of TDF 300mg Once Daily (QD) Versus Adefovir Dipivoxil (ADV) 10mg QD in Chinese Subjects With CHB [NCT01300234]Phase 3512 participants (Actual)Interventional2011-03-30Completed
A Randomized Controlled Trial to Compare the Effects of Highly Active Antiretroviral Therapy (HAART) Versus Statin Therapy on Endothelial Function and Markers of Inflammation/Coagulation In HIV-Infected Individuals With High CD4 Cell Counts [NCT01515813]Phase 20 participants (Actual)Interventional2011-11-30Withdrawn(stopped due to On 05/08/12, team working on revising protocol and re-open study under version 2.0)
Efficacy of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients With High Viral Load But Slight Aminotransferase Elevation [NCT01522625]Phase 4160 participants (Actual)Interventional2012-01-31Completed
A Phase I/II Study of Safety and Efficacy of Lamivudine (EPIVIR®) and Tenofovir Disoproxil Fumarate (VIREAD®) Used to Lower the Plasma Level of Viral RNA of HERV-K(HML2) in Patients With Lymphoma [NCT01528865]Phase 1/Phase 20 participants (Actual)Interventional2015-12-31Withdrawn(stopped due to Funding was removed.)
A Pilot Study to Determine the Impact on Dyslipidemia of the Addition of Tenofovir to Stable Background Antiretroviral Therapy in HIV-Infected Subjects [NCT00109603]17 participants (Actual)Interventional2005-05-31Completed
Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel [NCT00111943]Phase 2200 participants (Actual)InterventionalCompleted
A Phase 3, Open-Label, Multicenter Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients [NCT00007436]Phase 30 participants InterventionalActive, not recruiting
Pilot Trial Evaluating Once Daily Triple Combination Antiretroviral Therapy With Tenofovir-Emtricitabine and Efavirenz in HIV-1 Infected Patients With Mycobacterium Tuberculosis Infection ANRS129 BKVIR [NCT00115609]Phase 370 participants (Actual)Interventional2006-01-31Completed
Phase II Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men [NCT00131677]Phase 2400 participants (Actual)Interventional2005-02-28Completed
Early Intensification of Combination Antiretroviral Therapy Including FUZEON® in the Treatment of Progressive Multifocal Leucoencephalopathy During HIV-1 Infection ANRS 125 Trial [NCT00120367]Phase 230 participants Interventional2005-04-30Completed
Phase I Safety and Acceptability Study of the Vaginal Microbicide Agent PMPA Gel [NCT00028132]Phase 1120 participants InterventionalCompleted
A Randomized, Comparative Study of Lopinavir/Ritonavir Versus GW433908 and Ritonavir Versus Lopinavir/Ritonavir and GW433908 (In Combination With Tenofovir Disoproxil Fumarate and One or Two Nucleoside Reverse Transcriptase Inhibitors) in HIV-1-Infected S [NCT00028366]56 participants InterventionalCompleted
Safety and Efficacy of Finite Versus Continuous Nucleos(t)Ide Analogues Therapy in Patients With Chronic Hepatitis B: A Multicenter Randomized Controlled Trial [NCT05793268]360 participants (Anticipated)Interventional2022-12-20Active, not recruiting
Pilot Study on Efficacy and Tolerance of Peg-interferon Alpha-2a (Pegasys) Added to Tenofovir DF and Emtricitabine (Truvada) in AGHBe Positive HBV-HIV Co-infected Patients. ANRS HB 01 EMVIPEG. [NCT00391638]Phase 2/Phase 356 participants (Actual)Interventional2007-01-31Completed
A Phase 1/2, Randomized, Double-Blind, Active Controlled, Dose Escalation Study of the Safety, Tolerance, Pharmacokinetic,, and Antiviral Activity of GS-7340-02 in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1 [NCT00036634]Phase 1/Phase 230 participants (Actual)Interventional2002-03-31Completed
A Randomized, Open-Label Study of 800 Mg Lopinavir/200 Mg Ritonavir QD in Combination With Tenofovir and Emtricitabine Vs. 400 Mg Lopinavir /100 Mg Ritonavir BID in Combination With Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects [NCT00043966]Phase 3200 participants Interventional2002-07-31Completed
A Phase II, Randomized, Open-Label Study Comparing Fixed-Dose Versus Concentration-Adjusted Lopinavir/Ritonavir Therapy in HIV-Infected Subjects on Salvage Therapy [NCT00046033]Phase 2118 participants InterventionalCompleted
Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: TENOFOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC [NCT01533272]Phase 4240 participants (Actual)Interventional2012-02-29Completed
A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV [NCT00053638]Phase 3345 participants Interventional2003-02-28Completed
A Phase IV Study of Antiretroviral Therapy for HIV Infected Adults Presenting With Acute Opportunistic Infections: Immediate Versus Deferred Initiation of Antiretroviral Therapy [NCT00055120]Phase 4283 participants (Actual)Interventional2003-03-31Completed
A Phase II Study of the Predictive Value of Pharmacokinetic-Adjusted Phenotypic Susceptibility (C12h/IC50) on Antiretroviral Response to Ritonavir-Enhanced Protease Inhibitors in Subjects With Failure of Previous Protease Inhibitor-Based Regimens [NCT00027339]Phase 253 participants (Actual)InterventionalCompleted
A Multicenter Clinical Trial to Evaluate the Feasibility and Outcome of Same-day Antiretroviral Therapy With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) Among Patients Testing Positive by HIV Confirmatory Tests [NCT04712058]200 participants (Anticipated)Interventional2021-01-20Recruiting
Immunologic Consequences of Antiretroviral Therapy Intensification in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315/375 [NCT00034086]22 participants InterventionalCompleted
A Phase I/II, Open Label Study to Evaluate the Ability of Combination Therapy With ABT-378/Ritonavir (Kaletra), Lamivudine (Epivir), Efavirenz (Sustiva)and Tenofovir DF to Completely Suppress Viral Replication in Subjects Infected With HIV-1 [NCT00038220]Phase 240 participants Interventional2000-07-31Completed
Efficacy and Safety of TAF for 48 Weeks in HBeAg Positive CHB Patients [NCT04864366]150 participants (Actual)Observational2021-04-30Active, not recruiting
A Multicenter, Open-label, Prospective Study to Evaluate Antiviral Efficacy and Safety of Entecavir Plus Tenofovir Combination in Subjects With Multi-drug Resistant Chronic Hepatitis B Virus Infection [NCT01594905]Phase 490 participants (Anticipated)Interventional2012-08-31Active, not recruiting
A Single-dose, Open-label, Randomized, Crossover Study to Assess the Relative Bioavailability of the Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Administered Orally as a Whole Tablet, as a Split Table [NCT02984852]Phase 130 participants (Actual)Interventional2016-12-31Completed
A Phase III, Randomized, Open-Label Comparison of Lopinavir/Ritonavir Plus Efavirenz Versus Lopinavir/Ritonavir Plus 2 NRTIs Versus Efavirenz Plus 2 NRTIs as Initial Therapy for HIV-1 Infection [NCT00050895]Phase 3775 participants InterventionalCompleted
A Pilot Study to Measure the Clearance of Replication-Competent HIV-1 in Resting Memory CD4+ Cells in HIV-1-Infected Subjects Who Receive Enfuvirtide Plus Oral Combination Antiretroviral Therapy [NCT00051831]19 participants (Actual)Interventional2003-10-31Completed
A Phase I Study of Tenofovir Disoproxil Fumarate (PMPA Prodrug), A Novel Nucleotide Analog Reverse Transcriptase Inhibitor in Children With HIV Infection [NCT00024986]Phase 130 participants Interventional2001-10-31Completed
Phase III Clinical Trial to Evaluate the Antiviral Activity and Safety of DA-2802(Tenofovir Disoproxil Orotate) and Viread®(Tenofovir Disoproxil Fumarate) in Chronic Hepatitis B Patients [NCT02967939]Phase 3123 participants (Actual)Interventional2017-03-28Completed
A Multi-centre, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate(TDF) Treatment in Chinese Chronic Hepatitis B (CHB) Subjects Following Failure of Multiple Nucleos(t)Ide Analogues(NAs) [NCT02195518]Phase 4213 participants (Actual)Interventional2015-03-18Completed
A Phase 3, Randomized, Double-Blind, Multicenter Study of the Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavir [NCT00158821]Phase 3180 participants (Anticipated)Interventional2000-03-31Completed
See Detailed Description [NCT00044577]Phase 3166 participants Interventional2002-07-16Completed
Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection [NCT00192595]Phase 436 participants (Actual)Interventional2004-01-31Completed
Adjuvant Entecavir or Tenofovir for Hepatitis B Virus Related Hepatocellular Carcinoma After Curative Hepatic Resection [NCT02650271]Phase 3240 participants (Anticipated)Interventional2021-02-02Recruiting
Optimizing Pediatric HIV-1 Treatment in Infants With Prophylactic Exposure to Nevirapine, Nairobi, Kenya (6-12 Month RCT) [NCT00427297]Phase 334 participants (Actual)Interventional2007-09-30Terminated(stopped due to There is no longer equipoise. DSMB recommended termination.)
Phase I/II Study of the Pharmacokinetics, Safety and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents [NCT03332095]Phase 1/Phase 255 participants (Actual)Interventional2018-07-02Completed
Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women Infected With Hepatitis B Virus (HBeAg Positive or With a High Viral Load) and Whose Newborns Had Been Vaccinated at Birth [NCT05403047]Phase 4150 participants (Anticipated)Interventional2022-07-31Not yet recruiting
IPrEP, Study #2: Evaluating the Effectiveness, Feasibility and Acceptability of Enhanced Pre-exposure Prophylaxis (PrEP) Packages for Young Female Sex Workers in Kisumu, Kenya [NCT03988387]200 participants (Actual)Interventional2019-10-31Completed
Entecavir Intensification for Persistent Hepatitis B Virus (HBV) Viremia in HIV-HBV Infection [NCT00662545]Phase 410 participants (Actual)Interventional2008-04-30Completed
A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population [NCT03593655]Phase 2247 participants (Actual)Interventional2019-01-14Completed
A Phase 4, Single-Arm Study of the Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Patients With Active Illicit Substance Use [NCT03998176]Phase 443 participants (Actual)Interventional2019-10-09Completed
Acute HIV Infection - A Key Link for Transmission Prevention: A Randomized Pilot Study [NCT01450189]46 participants (Actual)Interventional2011-10-31Completed
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum [NCT04518228]325 participants (Anticipated)Observational2021-06-08Recruiting
Compassionate Use Access to REP 2139-Mg for the Treatment of Chronic HBV Infection or Chronic HBV / HDV Co-infection [NCT05683548]0 participants Expanded AccessAvailable
An Open Label Study to Examine the Characteristics of HIV Decay Following Introduction of Combination Antiretroviral Therapy Including Raltegravir During Primary and Chronic HIV Infection [NCT00641641]16 participants (Actual)Interventional2008-03-31Completed
A Multicenter Controlled Open-label Trial of Evaluating Tenofovir Alafenamide, Tenofovir Disoproxil Fumarate and Entecavir in Acute-on-chronic Liver Failure of Chronic Hepatitis B Patients [NCT03640728]200 participants (Anticipated)Observational2019-01-25Recruiting
WRHI 060 (ADVANCE): A Randomised, Phase 3 Non-inferiority Study of DTG + TAF + FTC Compared With DTG + TDF + FTC and EFV + TDF + FTC in Patients Infected With HIV-1 Starting First-line Antiretroviral Therapy - Extension to 192 Weeks [NCT03122262]Phase 31,110 participants (Actual)Interventional2017-01-16Completed
Higher Risk of Kidney Function Decline With Entecavir Than Tenofovir Alafenamide in Patients With HBV Related Acute-on-chronic Liver Failure: Real-World Study [NCT05453448]272 participants (Actual)Interventional2022-05-01Completed
Advanced Neuroimaging Evaluation of the Central Nervous System Biological Changes Associated With Efavirenz Therapy and Switch to an Elvitegravir-based Regimen [NCT01929759]10 participants (Actual)Interventional2014-01-31Completed
Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa: a Phase 3b, Open-label, Hybrid Type 2 Implementation and Effectiveness Trial [NCT06133686]Phase 3400 participants (Anticipated)Interventional2024-04-01Not yet recruiting
A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors [NCT03887702]Phase 3444 participants (Anticipated)Interventional2020-01-17Active, not recruiting
Molecular, Biochemical and Clinical Differences Between Stavudine and Tenofovir, Each Combined With Lamivudine and Efavirenz in South African HIV-infected Patients [NCT01601899]Phase 460 participants (Actual)Interventional2008-10-31Terminated(stopped due to DSMB decision to begin closeout process in view of April 2010 SA HAART guideline)
A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine Once Daily Compared to Atazanavir and Ritonavir Plus Tenofovir/Emtricitabine Once Daily in HIV-1 Infected Antiretroviral Therapy Naïve Women [NCT01910402]Phase 3499 participants (Actual)Interventional2013-08-22Completed
Defining the Rectal Mucosa in Men Who Have Sex With Men at Risk of HIV Infection [NCT02401230]Phase 486 participants (Actual)Interventional2015-03-31Completed
Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF) [NCT03471624]Phase 4270 participants (Actual)Interventional2018-05-01Completed
A Phase 3, Open Label, Randomised, Parallel Group Study to Compare the Effect on Prevention and Resolution of Treatment Related Adverse Events of a Simplified, Once Daily Regimen of a Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus [NCT00323544]Phase 3220 participants Interventional2004-10-31Completed
Enfuvirtide for the Initial Phase of Antiretroviral Therapy in HIV-infected Patients With High Risk of Clinical Progression : ANRS 130 APOLLO [NCT00302822]Phase 3195 participants (Actual)Interventional2006-04-30Completed
Viral Decay Kinetics During Induction Therapy With or Without the Use of Enfuvirtide in HAART-naÃ-ve Patients With Advanced HIV [NCT00344760]Phase 42 participants (Anticipated)Interventional2005-01-31Completed
Evaluation of Pre-Exposure Prophylaxis (PrEP) Initiation, Retention, and Adherence in Pregnant and Breastfeeding Women [NCT03902418]1,200 participants (Actual)Observational2019-08-01Active, not recruiting
A 48-Week, Randomized, Open-Label Phase 3B Study Comparing the Antiviral Efficacy and Safety of ATV/RTV 3TC With ATV/RTV Plus TDF/FTC In HIV-1-Infected, Treatment-Naïve Subjects, Followed By a 48-Week Period on ATV/RTV Plus 3TC [NCT01620944]Phase 33 participants (Actual)Interventional2012-07-31Terminated(stopped due to Business objectives have changed)
Maraviroc Switch Central Nervous System (CNS) Substudy: a Substudy of MARCH, a Randomised, Open-label Study to Evaluate the Efficacy and Safety of Maraviroc (MVC) as a Switch for Either Nucleoside or Nucleotide Analogue Reverse Transcriptase Inhibitors (N [NCT01637233]28 participants (Actual)Observational2012-06-30Completed
Maraviroc Switch Collaborative Study Renal Substudy [NCT01637259]Phase 476 participants (Actual)Interventional2012-06-30Completed
A Multicenter Randomized Controlled Open-label Trial of Tenofovir vs. Tenofovir Plus Entecavir in Chronic Hepatitis B Patients With Genotypic Resistance to Entecavir and Partial Virologic Response to Ongoing Treatment [NCT01639092]Phase 488 participants (Actual)Interventional2012-09-28Completed
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Tenofovir Disoproxil Fumarate in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients [NCT00002450]Phase 3600 participants InterventionalCompleted
Changes in Weight After Switch to Dolutegravir/Lamivudine or Doravirine/Tenofovir/Lamivudine Compared to Continued Treatment With Dolutegravir/Tenofovir/Lamivudine for Virologically Suppressed HIV Infection. AVERTAS-2 [NCT04903847]Phase 4126 participants (Anticipated)Interventional2021-02-02Recruiting
A Randomized, Double Blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Viro [NCT04129554]Phase 2130 participants (Actual)Interventional2019-11-06Completed
Economic Evaluation of Treatment of HIV With Zidovudine/Stavudine and Tenofovir Regimen: A Cost Effectiveness Study [NCT01694017]Phase 468 participants (Actual)Interventional2012-11-30Completed
Phase 2 Adherence and Pharmacokinetics Study of Oral and Vaginal Preparations of Tenofovir [NCT00592124]Phase 2168 participants (Actual)Interventional2008-06-30Completed
The Pharmacokinetic Parameters of Tenofovir (TFV) in Maternal Blood and Breast Milk in Women Treated With Daily Tenofovir Disoproxil Fumarate (TDF; 300mg) for Prevention of Mother to Child Transmission (PMTCT) of Hepatitis B Virus (HBV) Mono-infection [NCT04114890]Phase 227 participants (Actual)Interventional2021-01-08Active, not recruiting
What is the Impact of Current HIV Medication Regimens on Endothelial Dysfunction? [NCT03782142]22 participants (Actual)Observational2018-11-01Completed
A Pilot Study to Assess the Feasibility of Switching, Individuals Receiving Atripla With Continuing Central Nervous System (CNS) Toxicity, to a Fixed Dose Combination of Tenofovir/Emtricitabine/Rilpivirine [NCT01701882]Phase 340 participants (Actual)Interventional2012-09-30Completed
A Prospective and Open-Label Study of the Effect on Proximal Tubular Function in Asian-American Patients Receiving Tenofovir Disoproxil Fumarate (TDF) or Entecavir (ETV) for HBV Treatment [NCT01715987]48 participants (Actual)Observational2012-10-31Terminated
A Prospective Randomized Controlled Study to Compare the Efficacy of Combined Tenofovir Plus Telbuvidine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B. [NCT01732224]69 participants (Actual)Interventional2012-11-30Completed
Randomized Trial of Tenofovir Versus Lamivudine Plus Adefovir in Lamivudine Plus Adefovir Treated Lamivudine-resistant Chronic Hepatitis B Patients With Undetectable Hepatitis B Virus DNA. [NCT01732367]Phase 4171 participants (Actual)Interventional2012-11-30Completed
A Phase IIa, Randomized, Double-blind, Active-controlled, 12-week Study of Amdoxovir (Two Doses) Versus Tenofovir DF, in Combination With Zidovudine in HIV-1 Treatment-experienced Subjects With M184I/V Mutation in Addition to 0-2 Confirmed Thymidine Analo [NCT01737359]Phase 22 participants (Actual)Interventional2012-12-31Terminated
Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B [NCT03489239]Phase 327 participants (Actual)Interventional2017-11-16Active, not recruiting
Nevirapine vs Ritonavir-boosted Lopinavir in ART HIV-infected Adults in a Resource-limited Setting; a Randomized, Multicenter, Parallel Group Study [NCT01772940]Phase 4425 participants (Actual)Interventional2008-12-31Completed
Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine [NCT01778413]Phase 460 participants (Actual)Interventional2013-05-31Completed
In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products [NCT01813162]Phase 1101 participants (Actual)Interventional2013-12-31Completed
Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine With the Omission of Immune Globulin to Prevent Hepatitis B Transmission in Mother With High Viral Load: A Multi-Center, Prospective, Randomized and Open-Label Study [NCT03476083]Phase 4280 participants (Anticipated)Interventional2018-06-10Recruiting
Efficacy and Safety Evaluation of TDF-based Regimen in Thai HIV-infected Children [NCT01815255]36 participants (Actual)Observational2010-12-31Completed
A Pilot Demonstration Project to Operationalize Pre-exposure Prophylaxis as Part of Combination HIV Prevention Among Men Who Have Sex With Men (MSM) and Transgender Women in Los Angeles County [NCT01781806]Phase 4328 participants (Actual)Interventional2013-05-31Completed
A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) [NCT02397096]Phase 3673 participants (Actual)Interventional2015-06-09Completed
ANRS 159 VIH-2 : Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients [NCT01605890]Phase 230 participants (Actual)Interventional2012-07-31Completed
Phase 3, Randomized Clinical Trial to Assess the Efficacy and Safety of Tenofovir in Hepatitis B Virus Infected, s and e Antigen Positive, Pregnant Women to Prevent Perinatal Transmission Despite Infant Passive-active HBV Immunization. [NCT01745822]Phase 3654 participants (Actual)Interventional2013-01-31Completed
Effects of Biectegravir-Emtricitabine-Tenofovir Alafenamide on Coronary Flow Reserve in Stable HIV Patients (B/F/TAF-CFR) - Pilot Study [NCT03656783]Phase 325 participants (Actual)Interventional2018-09-14Completed
The Efficacy and Safety of Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection [NCT04296695]Phase 4250 participants (Anticipated)Interventional2021-07-14Active, not recruiting
Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of BMS-955176 (Double-Blinded) and BMS-955176 With Atazanavir +/- Ritonavir (Open-Labeled) in HIV-1 Infected Subjects [NCT01803074]Phase 2107 participants (Actual)Interventional2013-04-04Completed
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Antiviral Activity of the Addition of PMPA Prodrug to Combination Antiretroviral Regimens in Treatment-Experienced HIV-Infected Patients [NCT00002415]Phase 2175 participants InterventionalCompleted
A Phase 2b, Double-Blind, Placebo-Controlled, Exploratory Randomized Trial to Determine the Bone, Immunologic, Virologic, and Neurocognitive Effects of a Novel Maraviroc-Containing Antiretroviral Regimen in Treatment-Naïve Patients Infected With R5-Tropic [NCT01400412]Phase 2262 participants (Actual)Interventional2012-01-17Completed
Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Chronic Hepatitis b [NCT04195074]300 participants (Anticipated)Interventional2019-01-01Recruiting
Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women An Open-Label Randomised Control Study [NCT03227731]Phase 2/Phase 3540 participants (Actual)Interventional2017-09-28Completed
A Prospective Cohort Study of Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic Hepatitis B Virus Infection [NCT05410496]Phase 450 participants (Anticipated)Interventional2021-06-22Recruiting
Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia: A Pragmatic Randomized Controlled Trial [NCT04359095]Phase 2/Phase 3650 participants (Actual)Interventional2020-08-18Completed
Effects of Ledipasvir/Sofosbuvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF) in Patients With HIV. [NCT03126370]Phase 410 participants (Actual)Interventional2018-01-08Completed
Investigation on Antiviral Therapy of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B Patients Based on Detection of Interferon Gene Mutation and Interferon Receptor [NCT02973646]Phase 4100 participants (Anticipated)Interventional2016-01-31Recruiting
Efficacy Comparison Between Two Kind of Chinese Herbal Formulas on Traditional Chinese Medicine Syndromes Among Chronic Hepatitis Patients [NCT03018821]250 participants (Anticipated)Interventional2017-01-31Recruiting
A Randomized Comparison of Three Regimens of Chemotherapy With Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings [NCT01435018]Phase 3334 participants (Actual)Interventional2013-10-01Completed
A Phase II Acceptability Study of Oral Emtricitabine/Tenofovir Alafenamide (F/TAF) vs Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for the Prevention of HIV Acquisition in Adolescent Girls and Young Women (AGYW) [NCT05458765]Phase 2330 participants (Actual)Interventional2022-06-21Active, not recruiting
A Pilot Study to Evaluate the Effectiveness of a Tenofovir Raltegravir Switch in Resolving Tenofovir Induced Proteinuria in HIV Infected Individuals With Undetectable HIV Viral Loads [NCT01044771]20 participants (Actual)Interventional2010-01-31Completed
A Phase III, Open-label, Single Centre, Single-arm, Pilot Study to Assess the Feasibility of Switching, Individuals Receiving Efavirenz With Continuing Central Nervous System (CNS) Toxicity, to Raltegravir [NCT01195467]Phase 340 participants (Actual)Interventional2010-10-31Completed
Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (ECF/TAF) Switch Followed by Ledipasvir-Sofosbuvir HCV Therapy in HIV-HCV Co-Infection: A CIHR Canadian HIV Trials Network-Gilead Pilot Trial Proposal [NCT02660905]Phase 325 participants (Actual)Interventional2016-04-30Completed
Clinical Efficacy and Safety of Tenofovir Disoproxil Fumarate and Entcavir in Treatment of Chronic Hepatitis B Patients in Upper Egypt [NCT05874440]100 participants (Anticipated)Observational2023-04-15Recruiting
The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples [NCT03049176]46 participants (Actual)Observational2017-03-13Completed
Prospective, Randomised, Crossover, Double-Blind, Placebo-Controlled Trial To Assess The Lipid-Lowering Effect Of Adding Tenofovir/Emtricitabine Co-Formulation Vs Placebo To Hiv-1-Infected Subjects With Dyslipidemia And Sustained Viral Load Suppression Un [NCT01458977]Phase 448 participants (Actual)Interventional2012-01-31Completed
Demonstration Project on the Feasibility to Implement a Pre-Exposure Oral Prophylaxis Program in Men Who Have Sex With Other Men and Transgender Women at Risk of Acquiring HIV [NCT03043326]1,000 participants (Anticipated)Observational2017-01-23Recruiting
A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in Cisgender Women in the United States [NCT06101329]Phase 2250 participants (Anticipated)Interventional2023-11-17Recruiting
TEN Switch - An Observational Phase IV Study to Evaluate the Safety and Efficacy of Substituting Tenofovir for Didanosine in Virologically Controlled HIV-infected Patients Co-infected With Hepatitis C Virus. [NCT00358696]Phase 430 participants (Anticipated)Interventional2006-07-31Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled, Multi-dose Study to Determine the Depth of Hepatitis B Surface Antigen (HBsAg) Reduction Following Intravenous ARC-520 in Combination With Entecavir or Tenofovir in Patients With HBeAg Positive, [NCT02452528]Phase 24 participants (Actual)Interventional2015-08-31Terminated(stopped due to Company decision to discontinue trial)
The Efficacy and Safety of Tenofovir Alafenamide Fumarate Compared With Other Nucleoside Analogues (Acid) to Treat Patients With Low-level Viremia of HBV [NCT04501224]200 participants (Anticipated)Interventional2020-08-03Recruiting
A Phase 2b Study to Evaluate the Efficacy, Safety and PK of a Combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate for Treatment of HIV-1 Infection in Patients With Drug-susceptible Tuberculosis on a Rifampicin-based Regimen [NCT04734652]Phase 2120 participants (Anticipated)Interventional2022-02-18Recruiting
A Multicenter, Open-Label Study to Evaluate ARC-520 Administered Alone and in Combination With Other Therapeutics in Patients With Chronic Hepatitis B Virus (HBV) Infection (MONARCH) [NCT02577029]Phase 279 participants (Actual)Interventional2015-12-31Terminated(stopped due to Company decision to discontinue trial)
A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects [NCT05526911]Phase 128 participants (Actual)Interventional2022-07-20Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled, Multi-dose Study to Determine the Depth of Hepatitis B Surface Antigen (HBsAg) Reduction Following Intravenous ARC-520 in Combination With Entecavir or Tenofovir in Patients With HBeAg Negative, [NCT02604199]Phase 258 participants (Actual)Interventional2015-09-30Terminated(stopped due to Company decision to discontinue trial)
Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women [NCT00729573]518 participants (Actual)Observational2009-11-30Completed
A Randomized, Double Blind Phase 1 Safety, Acceptability, and Pharmacokinetic Study Comparing Three Formulations of Tenofovir 1% Gel Administered Rectally to HIV-1 Seronegative Adults [NCT01575405]Phase 113 participants (Actual)Interventional2013-03-31Completed
An Exploratory, Double-Blinded, Randomized, Pharmacokinetic and Safety Study of Three Rectally-Applied Tenofovir 1% Microbicide Gel Formulations [NCT01575418]Phase 19 participants (Actual)Interventional2013-03-31Completed
Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir [NCT01576731]Phase 4240 participants (Actual)Interventional2012-07-31Completed
Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection [NCT04507607]Early Phase 150 participants (Anticipated)Interventional2020-08-01Recruiting
A Study to Evaluate the Potential Drug-Drug Interaction Between Danoprevir When Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir in Healthy Adult Volunteers [NCT01592305]Phase 140 participants (Actual)Interventional2012-05-31Completed
Randomized Study Comparing Nucleoside Analogues Plus Tenofovir and Nucleoside Analogues Plus Adefovir in Chronic Hepatitis B Patients With Suboptimal Response to Adefovir-based Combination Therapy Due to Nucleoside Analogues Resistance [NCT01595633]Phase 4124 participants (Anticipated)Interventional2012-03-31Recruiting
Bone Health in Aging HIV Infected Women: Improvement or Prevention of Changes in Bone Mineral Density by Switching Antiretroviral Agents. Is There an Optimal Time to Intervene? [NCT02815566]Phase 434 participants (Actual)Interventional2017-09-12Completed
Randomized Controlled Pilot Study of Highly Active Anti-Retroviral Therapy for Patients With Primary Biliary Cirrhosis [NCT01614405]13 participants (Actual)Interventional2012-06-30Completed
A Phase 1 Open Label Study Evaluating the Distribution of a Tenofovir Douche in Combination With Tap Water Douching and Simulated Receptive Anal Intercourse (DREAM-02) [NCT04195776]Phase 16 participants (Actual)Interventional2021-06-01Completed
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV in Brazilian Transgender Women [NCT03220152]Phase 4120 participants (Anticipated)Interventional2017-07-10Recruiting
CCTG584: Viral Dynamics and Pharmacokinetics of Tenofovir and Abacavir Monotherapy Versus the Combination Therapy of TDF-ABC in HIV-Infected Treatment Naive Patients [NCT00214890]Phase 221 participants (Actual)Interventional2004-12-07Completed
Serologic and Virologic Outcomes of Tenofovir in Asian Chronic Hepatitis B Patients With Prior Nucleoside Analogue Exposure [NCT01728935]141 participants (Actual)Interventional2008-04-30Completed
A Phase I/II Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerance, and Pharmacokinetics, and Antiviral Activity of 9-[(R)-2-(Phosphonomethoxy)Propyl] Adenine (PMPA) in HIV-Infected Patients [NCT00002180]Phase 10 participants InterventionalCompleted
PrEP Adherence Monitoring Using Dried Blood Spots [NCT02022657]Phase 1/Phase 252 participants (Actual)Interventional2014-04-30Completed
A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicis [NCT02431247]Phase 3725 participants (Actual)Interventional2015-07-06Completed
SWITCH OR ADD PEGYLATED-INTERFERON IN CHRONIC HEPATITIS B PATIENTS ON LONG TERM NUCLEOS(T)IDE THERAPY (SWAP TRIAL) [NCT01928511]Phase 4254 participants (Actual)Interventional2014-01-31Completed
Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure (MULTI-OCTAVE) [NCT01641367]Phase 4545 participants (Actual)Interventional2013-02-22Completed
A Switch Clinical Trial of Antiretrovirals to Compare the Impact of Doravirine Versus Integrase Inhibitors With Backbone of Emtricitabine and Tenofovir Alafenamide on Instigators of Atherosclerosis in Persons With Chronic Treated HIV. [NCT04820933]Early Phase 120 participants (Anticipated)Interventional2024-02-01Not yet recruiting
Phase 3b, Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy [NCT03965923]Phase 3859 participants (Actual)Interventional2020-01-09Active, not recruiting
A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Adult Participants to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 [NCT04661397]Phase 137 participants (Actual)Interventional2021-01-05Completed
A Phase IV Open-label Evaluation of Safety, Tolerability, and Acceptability of a Fixed-dose Formulation of Bictegravir, Emtricitabine/Tenofovir Alafenamide (B/F/TAF) for Non-occupational Prophylaxis Following Potential Exposure to HIV-1 [NCT03499483]Phase 452 participants (Actual)Interventional2019-01-24Completed
Express Testing and Same-day Initiation of PrEP [NCT05690815]816 participants (Anticipated)Observational2023-01-24Recruiting
Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples [NCT00557245]Phase 34,758 participants (Actual)Interventional2008-05-31Completed
Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects [NCT00365339]Phase 140 participants Interventional2006-04-30Completed
Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir [NCT05423834]1,800 participants (Anticipated)Observational [Patient Registry]2022-09-01Active, not recruiting
Pharmacokinetic Study of an Optimized Dose Ratio of Dolutegravir/Emtricitabine/Tenofovir Alafenamide Fumarate: Expediting a UNIVERSAL First Line Regimen for All Children Living With HIV in Africa [NCT05993767]Phase 250 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women [NCT03060785]Phase 116 participants (Actual)Interventional2016-03-08Completed
Phase IV, Open-Label, Randomized, Multicenter Study Evaluating Efficacy and Tolerability of Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HIV-1 Infected Subjects Who Have Achieved Virological Suppression on [NCT00365612]Phase 4300 participants (Anticipated)Interventional2006-07-31Completed
Feasibility of Short-Term PrEP Uptake for MSM With Episodic High-Risk for HIV [NCT02495779]54 participants (Actual)Interventional2015-07-31Completed
Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth) [NCT01571128]1,215 participants (Actual)Interventional2014-11-30Completed
A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs [NCT03537404]Phase 136 participants (Actual)Interventional2017-04-24Completed
A Phase 3b, Randomized, Open-label Clinical Study to Demonstrate Non-inferiority in Virologic Response Rates of HIV-1 RNA Suppression <400 Copies/mL of TDF/FTC/RPV Versus TDF/FTC/EFV in First-line Antiretroviral NNRTI-based Suppressed Patients. Switching [NCT01709084]Phase 3426 participants (Actual)Interventional2013-10-02Completed
HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS) [NCT02437110]Phase 1122 participants (Actual)Interventional2019-04-01Active, not recruiting
Combination Therapy of Tenofovir and Telbivudine in Immune-tolerant Patients With Chronic Hepatitis B Awaiting Assisted Reproduction [NCT02338674]Phase 1/Phase 2121 participants (Actual)Interventional2014-10-31Completed
Open-Label Randomized Controlled Trial to Assess the Implementation Effectiveness and Safety of 1% Tenofovir Gel Provision Through Family Planning Services in KwaZulu-Natal, South Africa [NCT01691768]Phase 2/Phase 3372 participants (Actual)Interventional2012-10-31Completed
Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial [NCT03327155]Phase 3900 participants (Actual)Interventional2017-11-16Completed
Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis [NCT04880577]Phase 20 participants (Actual)Interventional2022-09-15Withdrawn(stopped due to Funding)
Investigating Influence of Pregnancy-induced Changes in Antiretroviral Pharmacokinetics, Together With Polymorphisms in Drug Disposition Genes, on Viral Decay Dynamics in HIV Positive Women Starting Therapy Late in Pregnancy and Postpartum [NCT03284645]194 participants (Actual)Observational2017-12-22Completed
A Phase I/II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerance, Pharmacokinetics, and Antiviral Activity of 9-[2-(R)-[[Bis[[(Isopropoxycarbonyl)- Oxy]Methoxy]Phosphinoyl]Methoxy]Propyl]Adenine Fumarate (PMPA Prodrug) in HIV-Infe [NCT00002396]Phase 160 participants InterventionalActive, not recruiting
Study of the Feasibility and Acceptability of an Adherence Promotion Package for Postpartum Women on Pre-exposure Prophylaxis (PrEP) [NCT04897737]106 participants (Actual)Interventional2020-11-05Completed
Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor for Determining Adherence Using Different Dosing Regimens of Disoproxil Fumarate/Emtricitabine (TDF/FTC) [NCT04870671]Early Phase 114 participants (Actual)Interventional2021-03-08Completed
Switching From Regimens Consisting of a RTV-Boosted Protease Inhibitor Plus TDF/FTC to a Combination of Raltegravir Plus Nevirapine and Lamivudine in HIV Patients With Suppressed Viremia and Impaired Renal Function (RANIA Study) (Pilot Study) Protocol MK- [NCT02116660]Phase 211 participants (Actual)Interventional2014-09-03Terminated(stopped due to This study was terminated early due to poor recruitment.)
Pharmacokinetics Study of Tenofovir in HIV-infected Thai Children Using Tenofovir-based Regimen [NCT02404259]32 participants (Actual)Interventional2010-06-30Completed
Comprehensive HIV Prevention Package for MSM in Port Elizabeth [NCT02449733]101 participants (Actual)Interventional2015-05-31Completed
An Open-Label, Multicenter, Compassionate Access Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients [NCT00002453]300 participants Interventional1999-12-31Completed
A Prospective Cohort Study of Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B Patients Who Are Unsatisfied to Entecavir Therapy [NCT05583006]60 participants (Anticipated)Observational2023-11-06Recruiting
A Multiple-Center, Randomized, Partially Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Effects of 12-Week Treatment With RO6864018 in Virologically Suppressed Patients Wit [NCT02391805]Phase 231 participants (Actual)Interventional2015-05-17Completed
Baseline Characteristics and Long Term Clinical Outcomes of Patients Using Malawi's New First Line Antiretroviral Regimen at Lighthouse: The Lighthouse Tenofovir Cohort [NCT02381275]1,500 participants (Actual)Observational2014-08-14Active, not recruiting
Efficacy and Safety of Albuvirtide for Injection Combined With LPV/r for Treatment of HIV-1-Infected Patients Failed First-line Antiretroviral Therapy [NCT02369965]Phase 3418 participants (Actual)Interventional2014-02-19Completed
Study on Therapeutic Effects and Safety of Nucleoside (Acid) Analogues Treatment in Patients With Chronic Hepatitis B With Normal Alanine Aminotransferase and Positive Hepatitis B Virus DNA: a Randomized Controlled Trial [NCT04231565]100 participants (Anticipated)Interventional2021-01-31Recruiting
A Feasibility Study to Assess Protection of Vaginal and Cervical Tissues From Ex-Vivo HIV-1 Challenge Following Oral Administration of Maraviroc and Tenofovir [NCT02039323]Phase 16 participants (Actual)Interventional2014-02-28Completed
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females - A Sub-study of HPTN 084 [NCT04824131]Phase 250 participants (Actual)Interventional2020-11-04Completed
A Pilot Study to Assess Virologic Suppression and Immune Recovery With Raltegravir and Lopinavir/Ritonavir and Raltegravir and Emtricitabine/Tenofovir in HIV-1 Infected Treatment-naïve Subjects [NCT00654147]Phase 244 participants (Actual)Interventional2008-04-30Completed
A Multi-centre, Open Label, Parallel Group Trial to Evaluate the Pharmacokinetic Interactions Between BI 207127 (600 mg t.i.d. or 600 mg b.i.d.) and BI 201335 (120 mg q.d.) Given in Combination With Ribavirin for 24 Weeks, and Their Combined Effect on the [NCT01525628]Phase 172 participants (Actual)Interventional2012-04-30Completed
A Single-center, Randomized, Open-label, Active-controlled Phase Ic/IIb Study to Evaluate the Efficacy,Safety and Pharmacokinetics of Hepenofovir Fumarate Tablets in Patients With CHB [NCT06122454]Phase 1/Phase 248 participants (Anticipated)Interventional2022-11-10Recruiting
A 96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of EPZICOM Versus TRUVADA Administered in Combination With KALETRA in Antiretroviral-Naive HIV-1 Infected Subjects [NCT00244712]Phase 4688 participants (Actual)Interventional2005-07-31Completed
Comparative Safety Study of Pre-Filled Plastic and User-Filled Paper Vaginal Applicators With Candidate Microbicide, Tenofovir [NCT01283555]25 participants (Actual)Interventional2011-01-31Completed
Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study [NCT02245022]Phase 2/Phase 360 participants (Actual)Interventional2017-03-14Completed
Artery Elasticity After Switch From Epzicom to Truvada [NCT00998582]Phase 427 participants (Actual)Interventional2009-10-31Terminated(stopped due to Low enrollment)
A Phase 2b Randomized, Active-Controlled, Staged, Open-Label Trial to Investigate Safety and Efficacy of BMS-955176/GSK3532795 in Combination With Dolutegravir and Atazanavir (With or Without Ritonavir) in Treatment-Experienced HIV-1 Infected Adults [NCT02386098]Phase 286 participants (Actual)Interventional2015-07-08Terminated(stopped due to GI Intolerability)
Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Hepatitis b Virus Related Compensated Cirrhosis [NCT04196998]150 participants (Anticipated)Interventional2019-01-01Recruiting
Parrying the Pitfalls of PrEP: Preventing Premature PrEP Discontinuation and STIs Among MSM [NCT05072093]Phase 4200 participants (Anticipated)Interventional2021-11-20Recruiting
A Prospective, Randomized, Open-label Study of the Investigation of Peginterferon Alfa-2a on Optimal in Chronic Hepatitis B Patients Who Have a High Risk of HCC [NCT03084250]Phase 4150 participants (Anticipated)Interventional2017-03-10Active, not recruiting
Pharmacoepidemiology Study to Define the Long-term Safety Profile of Tenofovir Disoproxil Fumarate (Tenofovir DF, Viread®) and Describe the Management of Tenofovir DF-associated Renal and Bone Toxicity in Chronic Hepatitis B (CHB)-Infected Adolescents Age [NCT02479880]Phase 430 participants (Actual)Interventional2015-07-03Terminated
Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM) in the United States [NCT01769456]Phase 278 participants (Actual)Interventional2013-03-31Completed
Hellenic Multicenter Real-life Clinical Study for Bulevirtide Therapy in Chronic Hepatitis D: HERACLIS-BLV [NCT05928000]80 participants (Anticipated)Observational [Patient Registry]2023-05-01Recruiting
A Prospective Randomized Controlled Trial of Tenofovir and Entecavir in the Treatment of Long-term Prognosis in Patients With Hepatitis B-related Hepatocellular Carcinoma After Curative Resection [NCT04392700]Phase 3706 participants (Anticipated)Interventional2019-07-25Recruiting
Dose-Proportionality and Intra-Individual Variability of Intracellular Tenofovir Diphosphate and Emtricitabine Triphosphate In Healthy Volunteers [NCT01276600]Phase 132 participants (Actual)Interventional2011-01-31Completed
Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMISE Protocol (Promoting Maternal and Infant Survival Everywhere) [NCT01066858]1,765 participants (Actual)Observational2011-03-22Completed
Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection [NCT00885664]Phase 460 participants (Actual)Interventional2005-10-31Completed
A Multicenter, Open-label, Single Arm Trial for the Effectiveness of Antiviral Treatment in Cirrhotic Patients With Low-level Hepatitis B Virus DNA Levels With a Comparison to Matched Historical Controls (ATTACH) [NCT04780204]Phase 4200 participants (Anticipated)Interventional2021-08-23Recruiting
A Multi-center, Open-label, Long-term Extension Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients [NCT03780543]Phase 292 participants (Actual)Interventional2018-12-20Terminated(stopped due to Sponsor decision)
Delivery of Pre-exposure Prophylaxis to Individuals With High Sexual Risk of HIV Infection in Hong Kong - an Implementation Study [NCT04367688]400 participants (Anticipated)Observational2020-03-01Recruiting
A Randomized, Blinded, 12-week Comparison of Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in HIV-1 Infected Treatment-naive Participants. There is a 36 Week, Open-label, Extension Phase for Eligible Participants. [NCT00350272]Phase 276 participants (Actual)Interventional2006-05-31Completed
A Multi-Center, Randomized, Open-label, Parallel, Active-controlled, Non-inferiority, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of Switching to Tenolid Tab (Tenofovir Disoproxil) From Viread Tab (Tenofovir Disoproxil Fumarate) in Chronic [NCT05286346]Phase 4113 participants (Actual)Interventional2018-10-12Completed
A Phase 2A Randomized, Double-blinded, Placebo-controlled, Multicenter, Dose Ranging Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepat [NCT04847440]Phase 240 participants (Actual)Interventional2021-03-30Terminated(stopped due to Terminated by the Sponsor)
Pilot Study of Raltegravir/Tenofovir/Emtricitabine Versus Efavirenz/Tenofovir/Emtricitabine for Adults With Acute HIV-1 Infection: Exploring the Role of Integrase Inhibition in Early HIV Pathogenesis [NCT00734344]18 participants (Actual)Interventional2008-09-30Completed
A Phase IIb, Dose Ranging Study of Oral GSK1265744 in Combination With Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus -1 (HIV-1) Virologic Suppression Followed by an Evaluation of Maintenance of Virologic Suppres [NCT01641809]Phase 2244 participants (Actual)Interventional2012-08-06Completed
Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and Antiretroviral Therapy (ART) [NCT01903031]Phase 284 participants (Actual)Interventional2014-12-30Completed
A Randomized, Open-label, Multi-part Study of the Relative Oral Bioavailability of AL-3778 Tablets and Drug Interaction With Entecavir or Tenofovir Disoproxil Fumarate in Healthy Volunteers [NCT03032536]Phase 154 participants (Actual)Interventional2017-01-31Terminated(stopped due to Sponsor decision.)
A Pilot Project to Operationalize the Prevention Strategy of Post Exposure Prophylaxis Following Sexual Exposure to HIV in Combination With Educational Programming and Behavioral Risk Reduction Strategies in Los Angeles County [NCT00949234]Phase 2267 participants (Actual)Interventional2010-03-31Completed
Effect of Substituting Truvada for Combivir or Trizivir vs Continuing Combivir or Trizivir on Physiologic Correlates of Mitochondrial Function in Subjects Infected With Human Immunodeficiency Virus on Highly Active Antiretroviral Therapy [NCT00960622]Phase 417 participants (Actual)Interventional2006-08-31Completed
PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men [NCT05353283]60 participants (Anticipated)Interventional2023-09-01Recruiting
IPrEP: A Combination HIV Prevention Strategy for Young Women at Risk for HIV in Kisumu, Kenya IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya [NCT04898699]120 participants (Anticipated)Interventional2021-10-31Not yet recruiting
DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV: an Open-label Randomized Clinical Trial [NCT04884139]Phase 4555 participants (Anticipated)Interventional2021-07-14Active, not recruiting
Decrease of Neuropsychiatric and Neurocognitive Side Effects Prevalence [NCT02447016]Phase 425 participants (Actual)Interventional2015-05-31Terminated(stopped due to no more participants taking atripla)
Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant With HBV-related Disease [NCT05063071]Phase 4150 participants (Anticipated)Interventional2021-07-29Active, not recruiting
An Open-label, Randomized, Crossover Study to Evaluate the Effect of PAS on the Pharmacokinetics of Tenofovir in Healthy Subjects [NCT03070405]Phase 120 participants (Anticipated)Interventional2016-10-31Active, not recruiting
A Phase 1, Blinded, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-64457744 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Ascending Doses [NCT05423106]Phase 160 participants (Actual)Interventional2022-07-04Terminated(stopped due to Strategic business decision, not due to safety concerns)
An Open-Label Randomized Clinical Trial to Evaluate the Efficacy and Safety of Short Course Antiretroviral Therapy for Acute or Recent HIV-1 Infection in Zimbabwe and the United States [NCT00414518]16 participants (Actual)Interventional2007-01-31Completed
A Comparative Study of the Antiviral Efficacy and Safety of Entecavir Plus Tenofovir Versus Adefovir Added to Continuing Lamivudine in Adults With Lamivudine- Resistant Chronic Hepatitis B Virus Infection [NCT00605384]Phase 34 participants (Actual)Interventional2008-08-31Terminated(stopped due to Business Objectives Have Changed)
A Randomized Controlled Pilot Trial Comparing Continued Antiretroviral Therapy With Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) With Switch to Tenofovir/Emtricitabine/Raltegravir (TDF/FTC/RAL) on Changes in Endothelial Function and Markers of Bone Met [NCT01270802]Phase 430 participants (Actual)Interventional2011-04-30Completed
A Pilot Project to Assess the Safety and Tolerability of Truvada Plus Raltegravir as Post-exposure Prophylaxis (nPEP) Following Sexual Exposure to Human Immunodeficiency Virus (HIV) [NCT01214759]Phase 4103 participants (Actual)Interventional2011-05-31Completed
A Real-World Study of Sequential Combination Therapy With Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B [NCT03357822]Phase 42,000 participants (Anticipated)Interventional2018-01-25Recruiting
The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community [NCT03120936]Phase 4158 participants (Actual)Interventional2017-08-08Completed
Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses [NCT02859558]Phase 2195 participants (Actual)Interventional2017-01-31Active, not recruiting
Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive. Randomized Clinical, Not Masked, Trial Comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 Weeks [NCT02470650]Phase 4150 participants (Anticipated)Interventional2015-06-30Recruiting
A Prospective, Single-Arm, Open-Label Study to Evaluate the Effect of Fixed-Dose Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate on T-Cell Activation, Absolute CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir in Treatment-Naïve HIV-1 [NCT01777997]Phase 438 participants (Actual)Interventional2013-04-25Completed
Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa [NCT02344498]1,350 participants (Actual)Observational2015-01-31Active, not recruiting
A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel [NCT01687218]Phase 2195 participants (Actual)Interventional2013-09-25Completed
Comparison of Pharmacokinetics of Tenofovir Alafenamide (TAF) With Tenofovir Disoproxil (TDF) in Pregnant and Postpartum Women and Their Infants in PrEP-PP Study [NCT04937881]Phase 350 participants (Actual)Interventional2022-06-13Completed
A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety, Efficacy and Dose-Response of BMS-663068 in Treatment-experienced HIV-1 Subjects, Followed by an Open-Label Period on the Recommended Dose [NCT01384734]Phase 2254 participants (Actual)Interventional2011-07-26Completed
Combined HIV Adolescent PrEP and Prevention: On Demand Pre-exposure Prophylaxis to Provide Protection From HIV in Men - Using Foreskin Tissue to Estimate Protection (Phase II) [NCT03986970]Phase 272 participants (Actual)Interventional2019-11-11Completed
Community-based Venues for Delivery of Healthcare Services in Umlazi, South Africa: Proof of Concept Pilot Conducted in Hair Salons [NCT04222504]500 participants (Anticipated)Interventional2021-02-08Recruiting
A Phase I, Single-center, Open Label Clinical Study, to Evaluate the Pharmacokinetic Character of GLS4 Combined With RTV or TAF Alone or GLS4 and RTV and TAF Combination Administration in Healthy Subjects [NCT04551261]Phase 128 participants (Actual)Interventional2021-01-10Completed
Randomized Clinical Trial to Evaluate the Interest of a Down-scaled Treatment Strategy Using Dual Therapy (Nucleoside Analogs) in HIV Infected Patients Already Being Treated Using Triple Therapy, Who Present With a Successful Virological Control and for W [NCT02302547]Phase 3224 participants (Actual)Interventional2014-12-31Completed
A Multi-centre, Prospective, Randomised Trial of Short Course Alendronate Therapy or Placebo Combined With Vitamin D and Calcium to Prevent Loss of Bone Mineral Density in Antiretroviral-naïve, HIV-1 Infected Subjects Initiating Antiretroviral Therapy [NCT02322099]Phase 453 participants (Actual)Interventional2016-05-31Terminated(stopped due to Due to the COVID-19 pandemic the study was terminated prematurely)
The Safety of Anti-viral Therapy in Preventing Mother-to-child Transmission of Hepatitis B Virus in Pregnant Women After Discontinuation [NCT03468907]Phase 4111 participants (Actual)Interventional2015-06-01Completed
An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment [NCT05398393]150 participants (Anticipated)Interventional2022-01-01Enrolling by invitation
A Phase 1b Randomized, Open Label, Active-Controlled Study to Assess the Safety, Viral Kinetics, and Anti-HBV Activity of GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B (CHB) Infection [NCT01671787]Phase 151 participants (Actual)Interventional2012-03-31Completed
A Phase II Randomized, Double-Blind, Study of the Safety and Tolerability of Maraviroc (MVC), Maraviroc + Emtricitabine (MVC+FTC), Maraviroc + Tenofovir Disoproxil Fumarate (MVC+TDF), or Tenofovir Disoproxil Fumarate + Emtricitabine (TDF+FTC) For Pre-Expo [NCT01505114]Phase 2594 participants (Actual)Interventional2012-06-30Completed
Prospective Pilot Study of the Efficacy, Safety and Tolerability of Bictegravir-Based HIV ART Same-Day Treatment Evaluations (B-HASTE) [NCT04249037]Phase 410 participants (Actual)Interventional2020-12-15Terminated(stopped due to Insufficient enrollment)
Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among Young Men Who Have Sex With Men (YMSM) in the United States [NCT01772823]Phase 2200 participants (Actual)Interventional2012-11-30Completed
Advancing New Computer-based Health Outreach Regarding Sexual Behavior (ANCHORS) Study: UH3 Project [NCT04331704]Phase 488 participants (Anticipated)Interventional2021-01-12Recruiting
An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r-Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of Plasmodium Falciparum Subclinical Parasitemia in HIV-infected Adults With CD4+ Counts >200 and <500 Cells/mm^3 [NCT01632891]Phase 1/Phase 252 participants (Actual)Interventional2014-01-10Completed
An Open-label Rollover Study in Chinese Patients After Finishing a 3-year Randomize Trial for Chronic Hepatitis B With High Serum Viral Load But Mild Elevated Aminotransferase [NCT02463019]Phase 4160 participants (Anticipated)Interventional2015-01-31Enrolling by invitation
Simplifying Hepatitis B Care in Pregnancy by Combining Birth-dose Vaccine and Tenofovir: The COMBAT HBV Feasibility Trial [NCT05705427]Phase 4560 participants (Anticipated)Interventional2023-08-17Recruiting
Utilization of Hepatitis B Virus Nucleic Acid Test Positive Donors for Hepatitis B Vaccinated Lung Transplant Candidates [NCT05404919]Phase 210 participants (Anticipated)Interventional2022-09-06Recruiting
Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir Combination Therapy-Multicenter Randomized [NCT03236610]Phase 3112 participants (Anticipated)Interventional2016-01-01Recruiting
"Phase IV, Single-center, Open Study to Evaluate the Benefits of the Start of Immediate Treatment Without Immunovirological Data (Same Day Treatment) Compared to Conventional Treatment With BIC / FTC / TAF (Bictegravir/Emtricitabina/Tenofovir) in Naive Pa [NCT05606055]Phase 4100 participants (Actual)Interventional2020-12-01Completed
The Incidence of Postpartum Hepatitis in Pregnant Women With High HBVDNA Loads [NCT03214302]560 participants (Anticipated)Interventional2017-01-01Recruiting
Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: An Open Label, Randomized Controlled Trial [NCT03933384]Phase 4420 participants (Anticipated)Interventional2019-08-19Recruiting
Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection [NCT04483674]Phase 266 participants (Anticipated)Interventional2020-12-04Recruiting
A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment [NCT02174276]Phase 2195 participants (Actual)Interventional2014-07-24Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00035932 (38) [back to overview]Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24
NCT00035932 (38) [back to overview]Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24
NCT00035932 (38) [back to overview]Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96
NCT00035932 (38) [back to overview]Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48
NCT00035932 (38) [back to overview]Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24
NCT00035932 (38) [back to overview]Mean Change From Baseline in HIV RNA at Week 96
NCT00035932 (38) [back to overview]Mean Change From Baseline in HIV RNA at Week 48
NCT00035932 (38) [back to overview]Mean Change From Baseline in HIV RNA at Week 2
NCT00035932 (38) [back to overview]Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24
NCT00035932 (38) [back to overview]Fasting Glucose Mean Change From Baseline at Week 48
NCT00035932 (38) [back to overview]HIV IC50 at Week 24
NCT00035932 (38) [back to overview]PR Interval and Change From Baseline by Analysis Time Point
NCT00035932 (38) [back to overview]Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)
NCT00035932 (38) [back to overview]Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)
NCT00035932 (38) [back to overview]Most Common AEs and AEs of Interest Through Week 48
NCT00035932 (38) [back to overview]Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)
NCT00035932 (38) [back to overview]Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)
NCT00035932 (38) [back to overview]Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values
NCT00035932 (38) [back to overview]Lipid Mean Percent Change From Baseline at Week 96, Observed Values
NCT00035932 (38) [back to overview]Lipid Mean Percent Change From Baseline at Week 48
NCT00035932 (38) [back to overview]Lipid Mean Percent Change From Baseline at Week 24
NCT00035932 (38) [back to overview]HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24
NCT00035932 (38) [back to overview]Grade 3/4 Laboratory Abnormalities Through Week 48
NCT00035932 (38) [back to overview]Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point
NCT00035932 (38) [back to overview]Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48
NCT00035932 (38) [back to overview]Inhibitory Quotient at Week 24
NCT00035932 (38) [back to overview]Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24
NCT00035932 (38) [back to overview]Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire
NCT00035932 (38) [back to overview]Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96
NCT00035932 (38) [back to overview]Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48
NCT00035932 (38) [back to overview]Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96
NCT00035932 (38) [back to overview]Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96
NCT00035932 (38) [back to overview]Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48
NCT00035932 (38) [back to overview]Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24
NCT00035932 (38) [back to overview]Change From Baseline in CD4 Cell Count at Week 24
NCT00035932 (38) [back to overview]Change From Baseline in CD4 Cell Count at Week 48
NCT00035932 (38) [back to overview]Change From Baseline in CD4 Cell Count at Week 96
NCT00035932 (38) [back to overview]Fasting Glucose Mean Change From Baseline at Week 24
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs
NCT00042289 (26) [back to overview]Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
NCT00042289 (26) [back to overview]Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
NCT00042289 (26) [back to overview]Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms
NCT00042289 (26) [back to overview]Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms
NCT00042289 (26) [back to overview]Plasma Concentration for Contraceptives
NCT00042289 (26) [back to overview]PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs
NCT00074581 (2) [back to overview]Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
NCT00074581 (2) [back to overview]All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
NCT00084136 (18) [back to overview]Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)
NCT00084136 (18) [back to overview]Time to Treatment Failure (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Treatment Failure (PI Comparison)
NCT00084136 (18) [back to overview]Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)
NCT00084136 (18) [back to overview]Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)
NCT00084136 (18) [back to overview]Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)
NCT00084136 (18) [back to overview]Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)
NCT00084136 (18) [back to overview]Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)
NCT00084136 (18) [back to overview]Time to Immunologic Failure (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Immunologic Failure (PI Comparison)
NCT00084136 (18) [back to overview]Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)
NCT00089505 (9) [back to overview]Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month
NCT00089505 (9) [back to overview]Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry
NCT00089505 (9) [back to overview]Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry
NCT00089505 (9) [back to overview]Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen.
NCT00089505 (9) [back to overview]Number of Participants Who Experienced Virologic Failure or Died.
NCT00089505 (9) [back to overview]Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality
NCT00089505 (9) [back to overview]CD4 Count Change From Randomization
NCT00089505 (9) [back to overview]Number of Participants Who Experienced HIV-related Disease Progression or Death
NCT00089505 (9) [back to overview]Percent of Participants Who Experienced Virologic Failure or Died
NCT00090779 (9) [back to overview]Number of Participants in IT Arm Off Treatment Before 36 Weeks
NCT00090779 (9) [back to overview]Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
NCT00090779 (9) [back to overview]Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
NCT00090779 (9) [back to overview]Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm
NCT00090779 (9) [back to overview]Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 72 and 76 for the IT Arm and Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 36 and 40 for the DT Arm
NCT00090779 (9) [back to overview]Number of Participants Experiencing Either a CDC Category B or C Diagnosis, CD4<200 Cells/mm^3 or CD4 Percent <14%.
NCT00090779 (9) [back to overview]Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm
NCT00090779 (9) [back to overview]Time to Treatment Initiation or Death
NCT00090779 (9) [back to overview]Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
NCT00099632 (5) [back to overview]Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping
NCT00099632 (5) [back to overview]Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.
NCT00099632 (5) [back to overview]Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.
NCT00099632 (5) [back to overview]Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12
NCT00099632 (5) [back to overview]Number of Participants Who Discontinued Study Treatment Prematurely
NCT00100048 (26) [back to overview]Change From Baseline in CD4 Cell Count at Week 96
NCT00100048 (26) [back to overview]Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)
NCT00100048 (26) [back to overview]Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)
NCT00100048 (26) [back to overview]Change From Baseline in Plasma HIV RNA at Week 240
NCT00100048 (26) [back to overview]Change From Baseline in Plasma HIV RNA at Week 96
NCT00100048 (26) [back to overview]Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48
NCT00100048 (26) [back to overview]Number of Patients With Laboratory Adverse Experiences (LAEs)
NCT00100048 (26) [back to overview]Number of Patients With Serious CAEs and Non-serious CAEs at Week 144
NCT00100048 (26) [back to overview]Change From Baseline in CD4 (T-helper) Cell Count at Week 240
NCT00100048 (26) [back to overview]Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96
NCT00100048 (26) [back to overview]Number of Patients With Drug-related LAEs
NCT00100048 (26) [back to overview]Number of Patients With Drug-related CAEs
NCT00100048 (26) [back to overview]Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)
NCT00100048 (26) [back to overview]Number of Patients With Clinical Adverse Experiences (CAEs)
NCT00100048 (26) [back to overview]Number of Patients That Discontinued With LAEs
NCT00100048 (26) [back to overview]Number of Patients That Discontinued With CAEs
NCT00100048 (26) [back to overview]Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)
NCT00100048 (26) [back to overview]Number of Patients With Serious LAEs
NCT00100048 (26) [back to overview]Number of Patients With Serious Drug-related LAEs
NCT00100048 (26) [back to overview]Number of Patients With Serious Drug-related CAEs
NCT00100048 (26) [back to overview]Number of Patients With Serious CAEs (Cohort I and II Combined)
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)
NCT00105079 (6) [back to overview]Number of Participants Assessed for Adverse Events (AEs)
NCT00105079 (6) [back to overview]Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count
NCT00105079 (6) [back to overview]Change From Baseline in HIV-1 RNA Viral Load
NCT00105079 (6) [back to overview]Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL
NCT00105079 (6) [back to overview]Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
NCT00105079 (6) [back to overview]Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm)
NCT00112047 (53) [back to overview]Change in Limb Fat (kg) From Week 48 to Week 96
NCT00112047 (53) [back to overview]Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96
NCT00112047 (53) [back to overview]Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144
NCT00112047 (53) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48.
NCT00112047 (53) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144
NCT00112047 (53) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
NCT00112047 (53) [back to overview]Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
NCT00112047 (53) [back to overview]Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96
NCT00112047 (53) [back to overview]Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
NCT00112047 (53) [back to overview]Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
NCT00112047 (53) [back to overview]Change in Limb Fat (kg) From Week 48 to Week 144
NCT00112047 (53) [back to overview]Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)
NCT00112047 (53) [back to overview]Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48
NCT00112047 (53) [back to overview]Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144
NCT00112047 (53) [back to overview]Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96
NCT00112047 (53) [back to overview]Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
NCT00112047 (53) [back to overview]Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144
NCT00112047 (53) [back to overview]Change in Total Body Fat (kg) From Week 48 to Week 144
NCT00112047 (53) [back to overview]Change in Total Body Fat (kg) From Week 48 to Week 96
NCT00112047 (53) [back to overview]Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Change in Trunk Fat (kg) From Week 48 to Week 144
NCT00112047 (53) [back to overview]Change in Trunk Fat (kg) From Week 48 to Week 96
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)
NCT00118898 (22) [back to overview]Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL
NCT00118898 (22) [back to overview]Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline
NCT00118898 (22) [back to overview]Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing Treatment Modification
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing Regimen Failure
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event
NCT00118898 (22) [back to overview]Change in Fasting Total Cholesterol Level From Baseline
NCT00118898 (22) [back to overview]Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline
NCT00118898 (22) [back to overview]Change in CD4 Count (Cells/mm3) From Baseline
NCT00118898 (22) [back to overview]Number of Participants With Virologic Failure and Emergence of Major Resistance
NCT00118898 (22) [back to overview]Number of Participants With Virologic Failure
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing Virologic Failure
NCT00118898 (22) [back to overview]Change in Fasting Triglyceride Level From Baseline
NCT00118898 (22) [back to overview]The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
NCT00118898 (22) [back to overview]Time From Randomization to Virologic Failure
NCT00118898 (22) [back to overview]Time From Treatment Dispensation to a Grade 3/4 Safety Event
NCT00118898 (22) [back to overview]Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)
NCT00118898 (22) [back to overview]Time From Treatment Dispensation to Treatment Modification
NCT00118898 (22) [back to overview]Number of Participants With a Grade 3/4 Safety Event
NCT00118898 (22) [back to overview]Number of Participants With Regimen Failure
NCT00118898 (22) [back to overview]Number of Participants With Treatment Modification
NCT00118898 (22) [back to overview]Amount of Study Follow-up
NCT00119106 (8) [back to overview]Adverse Events
NCT00119106 (8) [back to overview]HIV Viral Load Copies/mL Measured at First Positive HIV Test Result by Group
NCT00119106 (8) [back to overview]Number of Participants Reporting Injecting and Sharing Needles
NCT00119106 (8) [back to overview]Number of Participants With Tenofovir-associated Resistance Mutations.
NCT00119106 (8) [back to overview]Number Participants Who Reported More Than One Sexual Partner at Baseline
NCT00119106 (8) [back to overview]Rates of HIV Seroconversion
NCT00119106 (8) [back to overview]Adherence to Study Drug/Placebo
NCT00119106 (8) [back to overview]Renal Toxicity
NCT00119379 (6) [back to overview]Change in Fat mtDNA Content
NCT00119379 (6) [back to overview]Change in Lumbar Spine Bone Mineral Density (BMD)
NCT00119379 (6) [back to overview]Change in Trunk Fat
NCT00119379 (6) [back to overview]Change in PBMC mtDNA
NCT00119379 (6) [back to overview]Change in Limb Fat
NCT00119379 (6) [back to overview]Change in Hip Bone Mineral Density (BMD)
NCT00131677 (6) [back to overview]>5% Bone Mineral Density Decline at Femoral Neck
NCT00131677 (6) [back to overview]Adherence to Study Drug
NCT00131677 (6) [back to overview]Number of Breakthrough HIV Infections
NCT00131677 (6) [back to overview]Clinical Safety--Hypophosphatemia
NCT00131677 (6) [back to overview]Clinical Safety--Creatinine Elevations
NCT00131677 (6) [back to overview]Behavioral Safety--Unprotected Anal Sex (UAS)
NCT00214890 (6) [back to overview]Evaluate Change in Cellular Regulatory Enzymes Involved With Nucleoside Analogue Transport Across Cell Membranes as Assessed by RT-PCR of Specific mRNA Transcripts
NCT00214890 (6) [back to overview]Compare the Plasma Data of the Two Monotherapy Regimens to the Dual NRTI Regimen
NCT00214890 (6) [back to overview]Compare the Intracellular Pharmacokinetic (PK) Data of the Two Monotherapy Regimens to the Dual NRTI Regimen
NCT00214890 (6) [back to overview]Change in Short-term Virologic Response
NCT00214890 (6) [back to overview]Determine Total Number of NRTI-associated Mutations After 7 Days of ABC or TDF Monotherapy or After 7 Days of Dual NRTI Therapy With ABC + TDF
NCT00214890 (6) [back to overview]Compare the Relative Viral Potency of TDF Monotherapy Versus ABC Monotherapy
NCT00244712 (14) [back to overview]Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
NCT00244712 (14) [back to overview]Median Change From Baseline in CD4+ Cells at Weeks 48 and 96
NCT00244712 (14) [back to overview]Median Change From Baseline in HIV-1 RNA at Week 48 and 96
NCT00244712 (14) [back to overview]Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
NCT00244712 (14) [back to overview]Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
NCT00244712 (14) [back to overview]Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
NCT00298363 (38) [back to overview]Median DAVG in Plasma HBV DNA Levels at 96 Weeks Relative to Baseline
NCT00298363 (38) [back to overview]Median DAVG in Plasma HBV DNA Levels at 168 Weeks Relative to Baseline
NCT00298363 (38) [back to overview]Median DAVG in Plasma HBV DNA Levels at 144 Weeks Relative to Baseline
NCT00298363 (38) [back to overview]Median Change in Model for End-Stage Liver Disease (MELD) Score From Baseline at Week 48
NCT00298363 (38) [back to overview]Median Change in MELD Score From Baseline at Week 96
NCT00298363 (38) [back to overview]Median Change in MELD Score From Baseline at Week 168
NCT00298363 (38) [back to overview]Median Change in MELD Score From Baseline at Week 144
NCT00298363 (38) [back to overview]In the Subset of Participants Undergoing Liver Transplantation, Time to Recurrence of Hepatitis B, Defined as 2 Consecutive Plasma HBV DNA Concentrations ≥ 400 Copies/mL or 2 Consecutive HBsAg(+) Results
NCT00298363 (38) [back to overview]Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 96 (for Participants Who Were HBeAg Positive at Baseline)
NCT00298363 (38) [back to overview]Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline)
NCT00298363 (38) [back to overview]Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 144 (for Participants Who Were HBeAg Positive at Baseline)
NCT00298363 (38) [back to overview]Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96
NCT00298363 (38) [back to overview]Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48
NCT00298363 (38) [back to overview]Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168
NCT00298363 (38) [back to overview]Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 144
NCT00298363 (38) [back to overview]Percentage of Participants With Only Baseline Lamivudine-resistance (LAM-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
NCT00298363 (38) [back to overview]Percentage of Participants With Only Baseline Adefovir Dipivoxil Resistance (ADV-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
NCT00298363 (38) [back to overview]Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 96
NCT00298363 (38) [back to overview]Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 168
NCT00298363 (38) [back to overview]Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 144
NCT00298363 (38) [back to overview]Percentage of Participants With Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48
NCT00298363 (38) [back to overview]Percentage of Participants With Baseline ADV-R + LAM-R Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
NCT00298363 (38) [back to overview]Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 96
NCT00298363 (38) [back to overview]Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 168
NCT00298363 (38) [back to overview]Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 144
NCT00298363 (38) [back to overview]Percentage of Participants With an Increase in Child-Pugh Turcotte (CPT) Score of ≥ 2 Points at Weeks 48
NCT00298363 (38) [back to overview]Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 96
NCT00298363 (38) [back to overview]Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48
NCT00298363 (38) [back to overview]Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 168
NCT00298363 (38) [back to overview]Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 144
NCT00298363 (38) [back to overview]Percent Probability of Tolerability Failure
NCT00298363 (38) [back to overview]Percent Probability of a Confirmed Increase in Serum Creatinine of ≥ 0.5 mg/dL From Baseline or a Confirmed Serum Phosphorus Level < 2.0 mg/dL
NCT00298363 (38) [back to overview]Median Time-averaged Change (DAVG) in Plasma Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels at 48 Weeks Relative to Baseline
NCT00298363 (38) [back to overview]Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48
NCT00298363 (38) [back to overview]Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 48 (for Participants Who Were HBeAg Positive at Baseline)
NCT00298363 (38) [back to overview]Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 96
NCT00298363 (38) [back to overview]Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 168
NCT00298363 (38) [back to overview]Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 144
NCT00307489 (19) [back to overview]Percentage of Participants With Normal ALT at Week 48
NCT00307489 (19) [back to overview]Percentage of Participants With Normalized ALT at Week 168
NCT00307489 (19) [back to overview]Percentage of Participants With Normalized ALT at Week 48
NCT00307489 (19) [back to overview]Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 168
NCT00307489 (19) [back to overview]Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 168
NCT00307489 (19) [back to overview]Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48
NCT00307489 (19) [back to overview]Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 168
NCT00307489 (19) [back to overview]Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 48
NCT00307489 (19) [back to overview]Change From Baseline in log10 Plasma HBV DNA Levels at Week 168
NCT00307489 (19) [back to overview]Change From Baseline in log10 Plasma HBV DNA Levels at Week 48
NCT00307489 (19) [back to overview]HBeAg Seroconversion at Week 48
NCT00307489 (19) [back to overview]HBsAg Loss at Week 168
NCT00307489 (19) [back to overview]HBsAg Loss at Week 48
NCT00307489 (19) [back to overview]Hepatitis B Early Antigen (HBeAg) Loss at Week 168
NCT00307489 (19) [back to overview]Hepatitis B Early Antigen (HBeAg) Loss at Week 48
NCT00307489 (19) [back to overview]Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 48
NCT00307489 (19) [back to overview]Percentage of Participants With Normal ALT at Week 168
NCT00307489 (19) [back to overview]Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168
NCT00307489 (19) [back to overview]Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48
NCT00335322 (2) [back to overview]Time Weighted Mean Change From Baseline Plasma HIV-RNA
NCT00335322 (2) [back to overview]Time-weighted Mean Change From Baseline Plasma HIV-RNA.
NCT00344461 (6) [back to overview]Patients With Plasma HIV RNA < 50 Copies/mL
NCT00344461 (6) [back to overview]Number of Participants With Sustained Virologic Response
NCT00344461 (6) [back to overview]Patients With Grade 2, 3 and 4 Adverse Events and Laboratory Toxicities
NCT00344461 (6) [back to overview]Patients With Plasma HIV RNA < 400 Copies/mL
NCT00344461 (6) [back to overview]Change in Plasma HIV RNA From Baseline to Week 96
NCT00344461 (6) [back to overview]Changes in CD4 Cell Count From Baseline and Week 96
NCT00350272 (2) [back to overview]The Proportion Of Participants With Virologic Response For 10 mg/Day Elvucitabine In HIV-1-Infected Participants By 12 Weeks Compared With The Proportion Of Participants With Lamivudine 300 mg/Day
NCT00350272 (2) [back to overview]The Safety Profile Of Elvucitabine.
NCT00352053 (45) [back to overview]Change From Baseline to Week 288 in CD4 Percentage
NCT00352053 (45) [back to overview]Change From Baseline to Week 288 in CD4 Count
NCT00352053 (45) [back to overview]Change From Baseline to Week 240 in HIV-1 RNA
NCT00352053 (45) [back to overview]Change From Baseline to Week 240 in CD4 Percentage
NCT00352053 (45) [back to overview]Change From Baseline to Week 240 in CD4 Count
NCT00352053 (45) [back to overview]Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count
NCT00352053 (45) [back to overview]Change From Baseline to Week 24 in CD4 Percentage
NCT00352053 (45) [back to overview]Change From Baseline to Week 192 in HIV-1 RNA
NCT00352053 (45) [back to overview]Change From Baseline to Week 192 in CD4 Percentage
NCT00352053 (45) [back to overview]Change From Baseline to Week 192 in CD4 Count
NCT00352053 (45) [back to overview]Change From Baseline to Week 144 in HIV-1 RNA
NCT00352053 (45) [back to overview]Change From Baseline to Week 144 in CD4 Percentage
NCT00352053 (45) [back to overview]Change From Baseline to Week 144 in CD4 Count
NCT00352053 (45) [back to overview]Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA
NCT00352053 (45) [back to overview]Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA
NCT00352053 (45) [back to overview]Percentage of Participants With Virologic Failure Through Week 48
NCT00352053 (45) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
NCT00352053 (45) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
NCT00352053 (45) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288
NCT00352053 (45) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240
NCT00352053 (45) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
NCT00352053 (45) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
NCT00352053 (45) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
NCT00352053 (45) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
NCT00352053 (45) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
NCT00352053 (45) [back to overview]Change From Baseline to Week 24 in HIV-1 RNA
NCT00352053 (45) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288
NCT00352053 (45) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240
NCT00352053 (45) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24
NCT00352053 (45) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192
NCT00352053 (45) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
NCT00352053 (45) [back to overview]Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288
NCT00352053 (45) [back to overview]Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96
NCT00352053 (45) [back to overview]Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48
NCT00352053 (45) [back to overview]Change From Baseline to Week 48 in CD4 Count
NCT00352053 (45) [back to overview]Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24
NCT00352053 (45) [back to overview]Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192
NCT00352053 (45) [back to overview]Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144
NCT00352053 (45) [back to overview]Change From Baseline to Week 96 in HIV-1 RNA
NCT00352053 (45) [back to overview]Change From Baseline to Week 96 in CD4 Percentage
NCT00352053 (45) [back to overview]Change From Baseline to Week 96 in CD4 Count
NCT00352053 (45) [back to overview]Change From Baseline to Week 48 in HIV-1 RNA
NCT00352053 (45) [back to overview]Change From Baseline to Week 48 in CD4 Percentage
NCT00352053 (45) [back to overview]Change From Baseline to Week 288 in HIV-1 RNA
NCT00352053 (45) [back to overview]Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240
NCT00357552 (11) [back to overview]Change in CD4+ Cell Counts From Study Entry to Week 104
NCT00357552 (11) [back to overview]Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104
NCT00357552 (11) [back to overview]Percentage of Subjects Reporting Not Skipping Medications in the Last Month.
NCT00357552 (11) [back to overview]Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening.
NCT00357552 (11) [back to overview]Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma
NCT00357552 (11) [back to overview]Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.
NCT00357552 (11) [back to overview]Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification
NCT00357552 (11) [back to overview]Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.
NCT00357552 (11) [back to overview]Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy
NCT00357552 (11) [back to overview]Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.
NCT00357552 (11) [back to overview]Number of Participants With Study-targeted Diagnoses and Clinical Events
NCT00369941 (73) [back to overview]Change From Baseline in CD4 Cell Count at Week 240
NCT00369941 (73) [back to overview]Change From Baseline in CD4 Cell Count at Week 96
NCT00369941 (73) [back to overview]Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96
NCT00369941 (73) [back to overview]Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
NCT00369941 (73) [back to overview]Number of Participants Discontinued With Drug-related LAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants Discontinued With Drug-related LAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants Discontinued With Drug-related LAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants Discontinued With Drug-related LAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants Discontinued With LAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants Discontinued With LAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants Discontinued With LAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants Discontinued With LAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants That Died by Week 156
NCT00369941 (73) [back to overview]Number of Participants That Died by Week 240
NCT00369941 (73) [back to overview]Number of Participants That Died by Week 48
NCT00369941 (73) [back to overview]Number of Participants That Died by Week 96
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With CAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Drug-related CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Drug-related CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Drug-related CAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Drug-related CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious CAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants With CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Drug-related CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants With Drug-related CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With Drug-related CAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Drug-related CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With Drug-related LAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants With Drug-related LAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With Drug-related LAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Drug-related LAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48
NCT00369941 (73) [back to overview]Number of Participants With LAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants With LAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8
NCT00369941 (73) [back to overview]Number of Participants With Serious CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants With Serious CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With Serious CAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Serious CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related CAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related LAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related LAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related LAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related LAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With Serious LAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants With Serious LAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With Serious LAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Serious LAEs at Week 96
NCT00369941 (73) [back to overview]Change From Baseline in CD4 Cell Count at Week 156
NCT00369941 (73) [back to overview]Number of Participants With LAEs at Week 240
NCT00410072 (16) [back to overview]Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96
NCT00410072 (16) [back to overview]Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96
NCT00410072 (16) [back to overview]Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96
NCT00410072 (16) [back to overview]Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96
NCT00410072 (16) [back to overview]Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96
NCT00410072 (16) [back to overview]Percentage of Participants Who Achieved HBV DNA Levels
NCT00410072 (16) [back to overview]Percentage of Participants Who Achieved HBV DNA Levels
NCT00410072 (16) [back to overview]Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status
NCT00410072 (16) [back to overview]Number of Participants With Virologic Breakthrough at Week 96
NCT00410072 (16) [back to overview]Number of Participants With HBV Resistance Through Week 48
NCT00410072 (16) [back to overview]Number of Participants With HBV Resistance at Week 96
NCT00410072 (16) [back to overview]Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96
NCT00410072 (16) [back to overview]Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities
NCT00410072 (16) [back to overview]Mean Log 10 HBV DNA at Weeks 48 and 96
NCT00410072 (16) [back to overview]Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
NCT00410072 (16) [back to overview]Number of Participants With Virologic Breakthrough at Week 48
NCT00410202 (25) [back to overview]Percentage of Participants With HBV DNA by PCR Category at Week 48
NCT00410202 (25) [back to overview]Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to Adverse Events or Laboratory Abnormalities During Treatment
NCT00410202 (25) [back to overview]Number of Participants With Laboratory Abnormalities: Serum Chemistry
NCT00410202 (25) [back to overview]Number of Participants With Laboratory Abnormalities: Hematology
NCT00410202 (25) [back to overview]Cumulative Probability of Emergent Genotypic Resistance at Year 2
NCT00410202 (25) [back to overview]Cumulative Probability of Emergent Genotypic Resistance at Year 1
NCT00410202 (25) [back to overview]Change in Mean log10 From Baseline in HBV DNA at Week 48
NCT00410202 (25) [back to overview]Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48
NCT00410202 (25) [back to overview]Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 96
NCT00410202 (25) [back to overview]Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
NCT00410202 (25) [back to overview]Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96
NCT00410202 (25) [back to overview]Percentage of Participants With HBsAg Seroconversion at Week 96
NCT00410202 (25) [back to overview]Percentage of Participants With HBsAg Seroconversion at Week 48
NCT00410202 (25) [back to overview]Percentage of Participants With HBeAg Seroconversion at Week 96 (Treated HBeAg-positive Participants Only)
NCT00410202 (25) [back to overview]Percentage of Participants With HBeAg Seroconversion at Week 48 (Treated HBeAg-positive Participants Only)
NCT00410202 (25) [back to overview]Percentage of Participants With Confirmed HBeAg Loss at Week 96 (Treated HBeAg Positive Participants Only)
NCT00410202 (25) [back to overview]Percentage of Participants With Confirmed HBeAg Loss at Week 48 (Treated HBeAg Positive Participants Only)
NCT00410202 (25) [back to overview]Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 96
NCT00410202 (25) [back to overview]Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 48
NCT00410202 (25) [back to overview]Percentage of Participants With HBV DNA by PCR Category at Week 96
NCT00410202 (25) [back to overview]Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48
NCT00410202 (25) [back to overview]Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 96
NCT00410202 (25) [back to overview]Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 48
NCT00410202 (25) [back to overview]Change in Mean log10 From Baseline in HBV DNA at Week 96
NCT00410202 (25) [back to overview]Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 96
NCT00414518 (3) [back to overview]Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome
NCT00414518 (3) [back to overview]Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms
NCT00414518 (3) [back to overview]Viral Set Point
NCT00427297 (4) [back to overview]Immunologic Failure
NCT00427297 (4) [back to overview]Incidence of Severe Adverse Events (Excluding Mortality)
NCT00427297 (4) [back to overview]Viral Failure
NCT00427297 (4) [back to overview]Incidence of Mortality
NCT00442962 (11) [back to overview]Time to First Dose Modification
NCT00442962 (11) [back to overview]Percentage of Participants With Early Virologic Suppression
NCT00442962 (11) [back to overview]Percentage of Participants With Early Virologic Response
NCT00442962 (11) [back to overview]Percentage of Participants With Late Virologic Suppression
NCT00442962 (11) [back to overview]Early Changes in CD4 Count From Baseline
NCT00442962 (11) [back to overview]Time to First Safety Event
NCT00442962 (11) [back to overview]Time to Initial Virologic Response
NCT00442962 (11) [back to overview]Time to Initial Virological Failure
NCT00442962 (11) [back to overview]Late Change in CD4 Count From Baseline
NCT00442962 (11) [back to overview]Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm)
NCT00442962 (11) [back to overview]Percentage of Participants With Late Virologic Response
NCT00448669 (6) [back to overview]Rates of Adherence to Study Medication
NCT00448669 (6) [back to overview]Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts
NCT00448669 (6) [back to overview]Antiretroviral (ARV) Resistance Patterns in Seroconverters
NCT00448669 (6) [back to overview]CD4 Evaluation After HIV Seroconversion
NCT00448669 (6) [back to overview]HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms
NCT00448669 (6) [back to overview]Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms
NCT00507507 (13) [back to overview]Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192
NCT00507507 (13) [back to overview]Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192
NCT00507507 (13) [back to overview]Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192
NCT00507507 (13) [back to overview]Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192
NCT00507507 (13) [back to overview]Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192
NCT00507507 (13) [back to overview]Occurrence of HBV Resistance Mutations
NCT00507507 (13) [back to overview]Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192
NCT00507507 (13) [back to overview]Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144
NCT00507507 (13) [back to overview]Change From Baseline in HBV DNA at Week 192
NCT00507507 (13) [back to overview]Change From Baseline in HBV DNA at Week 144
NCT00507507 (13) [back to overview]Change From Baseline in HBV DNA at Week 48
NCT00507507 (13) [back to overview]Change From Baseline in HBV DNA at Week 96
NCT00507507 (13) [back to overview]Percentage of Participants With HBV DNA < 400 Copies/mL at Week 192
NCT00524173 (4) [back to overview]Number of Participants With HBV DNA <1000 IU/ml at Week 192
NCT00524173 (4) [back to overview]Number of Participants With Loss of HBsAg
NCT00524173 (4) [back to overview]Number of Participants With Normalized Alanine Aminotransferase (ALT)
NCT00524173 (4) [back to overview]Number of Subjects With Hepatitis b Virus (HBV) DNA <1000 IU/ml at Week 48
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Percentage at 144 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Percentage at 192 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Percentage at 240 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Percentage at 288 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Percentage at 336 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Percentage at 384 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Percentage at 432 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Percentage at 48 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Percentage at 480 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Percentage at 528 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Percentage at 96 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks
NCT00528957 (46) [back to overview]Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)
NCT00528957 (46) [back to overview]Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks
NCT00528957 (46) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks
NCT00528957 (46) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks
NCT00549198 (58) [back to overview]Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96
NCT00549198 (58) [back to overview]Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48
NCT00549198 (58) [back to overview]Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24
NCT00549198 (58) [back to overview]Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96
NCT00549198 (58) [back to overview]Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48
NCT00549198 (58) [back to overview]Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24
NCT00549198 (58) [back to overview]Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96
NCT00549198 (58) [back to overview]Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96
NCT00549198 (58) [back to overview]Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96
NCT00549198 (58) [back to overview]Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96
NCT00549198 (58) [back to overview]Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48
NCT00549198 (58) [back to overview]Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24
NCT00549198 (58) [back to overview]Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96
NCT00549198 (58) [back to overview]Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48
NCT00549198 (58) [back to overview]Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24
NCT00549198 (58) [back to overview]Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96
NCT00549198 (58) [back to overview]"Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized"
NCT00549198 (58) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
NCT00549198 (58) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
NCT00549198 (58) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
NCT00549198 (58) [back to overview]Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
NCT00549198 (58) [back to overview]Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
NCT00549198 (58) [back to overview]Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96
NCT00549198 (58) [back to overview]Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24
NCT00549198 (58) [back to overview]Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48
NCT00549198 (58) [back to overview]Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96
NCT00549198 (58) [back to overview]Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24
NCT00549198 (58) [back to overview]Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48
NCT00549198 (58) [back to overview]Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96
NCT00552240 (46) [back to overview]Proportion of Patients Reporting CNS Side Effects of Any Severity
NCT00552240 (46) [back to overview]Change in Framingham Score
NCT00552240 (46) [back to overview]Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio
NCT00552240 (46) [back to overview]Change in Fasting Plasma Triglycerides Level
NCT00552240 (46) [back to overview]Change in Fasting Plasma Total Cholesterol Level
NCT00552240 (46) [back to overview]Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level
NCT00552240 (46) [back to overview]Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level
NCT00552240 (46) [back to overview]Change in CD4+ Cell Count From Baseline to Week 8.
NCT00552240 (46) [back to overview]Change in CD4+ Cell Count From Baseline to Week 6.
NCT00552240 (46) [back to overview]Change in CD4+ Cell Count From Baseline to Week 48.
NCT00552240 (46) [back to overview]Change in CD4+ Cell Count From Baseline to Week 4.
NCT00552240 (46) [back to overview]Change in CD4+ Cell Count From Baseline to Week 36.
NCT00552240 (46) [back to overview]Change in CD4+ Cell Count From Baseline to Week 24.
NCT00552240 (46) [back to overview]Change in CD4+ Cell Count From Baseline to Week 2.
NCT00552240 (46) [back to overview]Change in CD4+ Cell Count From Baseline to Week 12.
NCT00552240 (46) [back to overview]AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death
NCT00552240 (46) [back to overview]Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
NCT00552240 (46) [back to overview]Number of Participants With Virologic Response (VR)
NCT00552240 (46) [back to overview]Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
NCT00552240 (46) [back to overview]Number of Participants With Virologic Success (FDA Definition)
NCT00552240 (46) [back to overview]Number of Patients With Virologic Rebound to >400 Copies/ml
NCT00552240 (46) [back to overview]Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities
NCT00552240 (46) [back to overview]Percentage Adherence by Pill Count
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment
NCT00552240 (46) [back to overview]Incidence of Patients With AIDS Progression at Each Visit
NCT00552240 (46) [back to overview]Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml
NCT00552240 (46) [back to overview]Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants
NCT00552240 (46) [back to overview]Proportion of Patients Reporting Rash of Any Severity
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment
NCT00552240 (46) [back to overview]Proportion of Patients Reporting Hepatic Events of Any Severity
NCT00557245 (11) [back to overview]Head Circumference Among Infants Born to Female Participants Taking Study Drug
NCT00557245 (11) [back to overview]Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants
NCT00557245 (11) [back to overview]Length Among Infants Born to Female Participants Taking Study Drug
NCT00557245 (11) [back to overview]Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up
NCT00557245 (11) [back to overview]Study Drug Adherence: Self-reported Missed Doses of Study Drug
NCT00557245 (11) [back to overview]Weight Among Infants Born to Female Participants Taking Study Drug
NCT00557245 (11) [back to overview]Prevalence of Unprotected Sex During Follow-up
NCT00557245 (11) [back to overview]Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.
NCT00557245 (11) [back to overview]Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC
NCT00557245 (11) [back to overview]Number of Participants With Serious Adverse Events (SAEs)
NCT00557245 (11) [back to overview]Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.
NCT00592124 (9) [back to overview]Length of Time Vaginal Sexual Intercourse Took Place After Using Gel.
NCT00592124 (9) [back to overview]Number of Days Product Missed
NCT00592124 (9) [back to overview]Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol
NCT00592124 (9) [back to overview]Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use)
NCT00592124 (9) [back to overview]Self-reported Adherence to Each Regimen
NCT00592124 (9) [back to overview]Reported Sharing of Product
NCT00592124 (9) [back to overview]Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet.
NCT00592124 (9) [back to overview]Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel.
NCT00592124 (9) [back to overview]Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet.
NCT00594646 (2) [back to overview]Number of HIV-1 Infected Participants
NCT00594646 (2) [back to overview]Medication Regimen Completion Rates
NCT00605384 (1) [back to overview]Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs or Laboratory Abnormalities
NCT00608569 (8) [back to overview]Time to First Grade 3 or 4 Lab Event
NCT00608569 (8) [back to overview]Time to First Grade 3 or 4 Lab or Sign/Symptom Event
NCT00608569 (8) [back to overview]Adherence to Second Line HAART Regimen
NCT00608569 (8) [back to overview]Time to First Grade 3 or 4 Sign or Symptom
NCT00608569 (8) [back to overview]CD4 Count at Follow-up Visits
NCT00608569 (8) [back to overview]CD8 Count at Follow-up Visits
NCT00608569 (8) [back to overview]Confirmed Virologic Failure at or Prior to Week 24
NCT00608569 (8) [back to overview]Confirmed Virologic Failure at or Prior to Week 48
NCT00625404 (12) [back to overview]Participant Report of Change in Number of Sexual Partners
NCT00625404 (12) [back to overview]HIV Infection
NCT00625404 (12) [back to overview]FTC and/or Tenofovir Resistance
NCT00625404 (12) [back to overview]Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration
NCT00625404 (12) [back to overview]Confirmed Grade 3 or Higher AST Elevation
NCT00625404 (12) [back to overview]Confirmed Grade 3 or Higher ALT Elevation
NCT00625404 (12) [back to overview]CD4+ T-cell Count
NCT00625404 (12) [back to overview]Confirmed Grade 3 or Higher Reduction in Phosphorus
NCT00625404 (12) [back to overview]Confirmed Grade 2 or Higher Serum Creatinine Toxicity
NCT00625404 (12) [back to overview]Pregnancy Complications
NCT00625404 (12) [back to overview]Pill Counts and Participant Report of Adherence to Once-daily Pill Taking
NCT00625404 (12) [back to overview]Plasma HIV RNA Level (HIV-1 Viral Load)
NCT00632970 (1) [back to overview]Absolute Change in CD4 Cell Counts
NCT00641641 (1) [back to overview]Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)
NCT00654147 (6) [back to overview]Time to Virologic Failure
NCT00654147 (6) [back to overview]Time to Confirmed Virologic Failure
NCT00654147 (6) [back to overview]Study Medication Toxicity-related Discontinuation .
NCT00654147 (6) [back to overview]Study Medication Tolerability
NCT00654147 (6) [back to overview]Weeks to HIV-1 RNA <200 Copies/ml
NCT00654147 (6) [back to overview]Change From Baseline CD4+ and CD8+ Cell Counts
NCT00662545 (5) [back to overview]HIV RNA < 75 Copies/ml
NCT00662545 (5) [back to overview]Hepatitis B Virus (HBV) DNA
NCT00662545 (5) [back to overview]Incidence of Permanent Discontinuation Due to Toxicity
NCT00662545 (5) [back to overview]Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)
NCT00662545 (5) [back to overview]Incidence of ALT Flares
NCT00705679 (11) [back to overview]Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms
NCT00705679 (11) [back to overview]Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
NCT00705679 (11) [back to overview]Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms
NCT00705679 (11) [back to overview]Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms
NCT00705679 (11) [back to overview]Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
NCT00705679 (11) [back to overview]Person-years of Follow-up of Oral TDF and Oral Placebo Arms
NCT00705679 (11) [back to overview]Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms
NCT00705679 (11) [back to overview]Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
NCT00705679 (11) [back to overview]Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product
NCT00705679 (11) [back to overview]Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events
NCT00705679 (11) [back to overview]Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms
NCT00711009 (82) [back to overview]Mean Change From Baseline in Eosinophils (x 10^9/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Hematocrit (Fraction)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Hips Measurement (cm)
NCT00711009 (82) [back to overview]Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)
NCT00711009 (82) [back to overview]Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey
NCT00711009 (82) [back to overview]Mean Change From Baseline in Basophils (x 10^9/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Bicarbonate (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)
NCT00711009 (82) [back to overview]Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey
NCT00711009 (82) [back to overview]Mean Change From Baseline in Calcium (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Chest Measurement (cm)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Chloride (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Cholesterol (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Creatinine (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Albumin (Grams/Liter)
NCT00711009 (82) [back to overview]Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values
NCT00711009 (82) [back to overview]Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events
NCT00711009 (82) [back to overview]Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm
NCT00711009 (82) [back to overview]Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Hemoglobin (Grams/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)
NCT00711009 (82) [back to overview]Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.
NCT00711009 (82) [back to overview]Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit
NCT00711009 (82) [back to overview]Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672
NCT00711009 (82) [back to overview]Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication
NCT00711009 (82) [back to overview]Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication
NCT00711009 (82) [back to overview]Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)
NCT00711009 (82) [back to overview]Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm
NCT00711009 (82) [back to overview]Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir
NCT00711009 (82) [back to overview]Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Weight (kg)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Waist Measurement (cm)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Urine Specific Gravity
NCT00711009 (82) [back to overview]Mean Change From Baseline in Urine pH
NCT00711009 (82) [back to overview]Mean Change From Baseline in Uric Acid (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Triglycerides (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Total Protein (Grams/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Temperature (°F)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Sodium (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Potassium (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Platelet Count (x 10^9/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Neutrophils (x 10^9/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Monocytes (x 10^9/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Mid-Thigh Measurement (cm)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Mid-Arm Measurement (cm)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Magnesium (Millimoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Lymphocytes (x 10^9/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Lipase (Units/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Leptin (Nanograms/Milliliter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Lactate (Millimoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Insulin (Picomoles/Liter)
NCT00724711 (14) [back to overview]Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Fasting Lipid Parameters at Week 48
NCT00724711 (14) [back to overview]Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48
NCT00724711 (14) [back to overview]Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48
NCT00724711 (14) [back to overview]Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm
NCT00724711 (14) [back to overview]Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Fasting Glucose at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48
NCT00724711 (14) [back to overview]Change From Baseline C-Reactive Protein at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Fibrinogen at Week 48
NCT00724711 (14) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
NCT00734162 (37) [back to overview]Change From Baseline in Z-score for Whole Body BMD at Week 192
NCT00734162 (37) [back to overview]Percentage of Participants With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL and Normalized ALT at Weeks 48, 72, 96, 144, and 192
NCT00734162 (37) [back to overview]Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192
NCT00734162 (37) [back to overview]Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192
NCT00734162 (37) [back to overview]Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192
NCT00734162 (37) [back to overview]Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192
NCT00734162 (37) [back to overview]Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72
NCT00734162 (37) [back to overview]Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72
NCT00734162 (37) [back to overview]Percent Change From Baseline in Whole Body BMD at Week 96
NCT00734162 (37) [back to overview]Percent Change From Baseline in Whole Body BMD at Week 72
NCT00734162 (37) [back to overview]Percent Change From Baseline in Whole Body BMD at Week 48
NCT00734162 (37) [back to overview]Percent Change From Baseline in Whole Body BMD at Week 192
NCT00734162 (37) [back to overview]Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192
NCT00734162 (37) [back to overview]Percent Change From Baseline in Whole Body BMD at Week 144
NCT00734162 (37) [back to overview]Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48
NCT00734162 (37) [back to overview]Percent Change From Baseline in Spine BMD at Week 96
NCT00734162 (37) [back to overview]Percent Change From Baseline in Spine BMD at Week 72
NCT00734162 (37) [back to overview]Percent Change From Baseline in Spine BMD at Week 192
NCT00734162 (37) [back to overview]Percent Change From Baseline in Spine BMD at Week 144
NCT00734162 (37) [back to overview]Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192
NCT00734162 (37) [back to overview]Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192
NCT00734162 (37) [back to overview]Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192
NCT00734162 (37) [back to overview]Change From Baseline in Z-score for Whole Body BMD at Week 96
NCT00734162 (37) [back to overview]Change From Baseline in Z-score for Whole Body BMD at Week 72
NCT00734162 (37) [back to overview]Change From Baseline in Z-score for Whole Body BMD at Week 48
NCT00734162 (37) [back to overview]Change From Baseline in Z-score for Whole Body BMD at Week 144
NCT00734162 (37) [back to overview]Change From Baseline in Z-score for Spine BMD at Week 96
NCT00734162 (37) [back to overview]Number of Participants With Changes in Drug-Resistant Mutations During the Study
NCT00734162 (37) [back to overview]Change From Baseline in Z-score for Spine BMD at Week 72
NCT00734162 (37) [back to overview]Change From Baseline in Z-score for Spine BMD at Week 48
NCT00734162 (37) [back to overview]Change From Baseline in Z-score for Spine BMD at Week 192
NCT00734162 (37) [back to overview]Change From Baseline in Z-score for Spine BMD at Week 144
NCT00734162 (37) [back to overview]Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192
NCT00734162 (37) [back to overview]Percentage of Participants Who Were HBeAg-Positive With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL, Normalized ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192
NCT00734162 (37) [back to overview]Percentage of Participants Who Were HBeAg-Positive at Baseline Who Had HBV DNA < 400 Copies/mL, Normal ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192
NCT00734162 (37) [back to overview]Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192
NCT00734162 (37) [back to overview]Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192
NCT00734344 (32) [back to overview]Mean Hematocrit Between Treatment Groups at 2 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 4 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 5 Months
NCT00734344 (32) [back to overview]Mean Hematocrit Between Treatment Groups at 4 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 6 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 7 Months
NCT00734344 (32) [back to overview]Mean Hematocrit Between Treatment Groups at 6 Months
NCT00734344 (32) [back to overview]Mean White Blood Cell Count Between Treatment Groups at 8 Months
NCT00734344 (32) [back to overview]Mean White Blood Cell Count Between Treatment Groups at 6 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 8 Months
NCT00734344 (32) [back to overview]Mean White Blood Cell Count Between Treatment Groups at 4 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 2 Months
NCT00734344 (32) [back to overview]Mean White Blood Cell Count Between Treatment Groups at 14 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 9 Months
NCT00734344 (32) [back to overview]Mean Hematocrit Between Treatment Groups at 10 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 11 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 10 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 1 Months
NCT00734344 (32) [back to overview]Mean Platelet Count Between Treatment Groups at 10 Months
NCT00734344 (32) [back to overview]Mean Platelet Count Between Treatment Groups at 12 Months
NCT00734344 (32) [back to overview]Mean Platelet Count Between Treatment Groups at 14 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 3 Months
NCT00734344 (32) [back to overview]Mean Platelet Count Between Treatment Groups at 2 Months
NCT00734344 (32) [back to overview]Mean Hematocrit Between Treatment Groups at 8 Months
NCT00734344 (32) [back to overview]Mean Platelet Count Between Treatment Groups at 4 Months
NCT00734344 (32) [back to overview]Mean Platelet Count Between Treatment Groups at 6 Months
NCT00734344 (32) [back to overview]Mean Platelet Count Between Treatment Groups at 8 Months
NCT00734344 (32) [back to overview]Mean White Blood Cell Count Between Treatment Groups at 10 Months
NCT00734344 (32) [back to overview]Mean White Blood Cell Count Between Treatment Groups at 12 Months
NCT00734344 (32) [back to overview]Mean Hematocrit Between Treatment Groups at 12 Months
NCT00734344 (32) [back to overview]Mean Hematocrit Between Treatment Groups at 14 Months
NCT00734344 (32) [back to overview]Mean White Blood Cell Count Between Treatment Groups at 2 Months
NCT00736190 (10) [back to overview]Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48
NCT00736190 (10) [back to overview]Summary of Resistance Surveillance for Participants Without Virologic Breakthrough
NCT00736190 (10) [back to overview]Summary of Resistance Surveillance for Participants With Virologic Breakthrough
NCT00736190 (10) [back to overview]Summary of Resistance Surveillance for Participants Who Discontinued the Study Early
NCT00736190 (10) [back to overview]Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion
NCT00736190 (10) [back to overview]Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL)
NCT00736190 (10) [back to overview]Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48
NCT00736190 (10) [back to overview]Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48
NCT00736190 (10) [back to overview]Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48
NCT00736190 (10) [back to overview]Change From Baseline in FibroTest Value
NCT00752856 (4) [back to overview]To Compare the Phase 1 Viral Decay Rates Between LPV/r + RAL vs. EFV/TDF/FTC Treatment Combinations.
NCT00752856 (4) [back to overview]Compare Late Activated CD4+ T-cell Recovery Rates Between Treatment Regimens From Baseline to Week 48
NCT00752856 (4) [back to overview]Compare Early Activated CD4+ T-cell Recovery Rates From Baseline to Week 4.
NCT00752856 (4) [back to overview]Viral Suppression Efficacy at 48 Weeks
NCT00757783 (16) [back to overview]Change From Baseline in Glucose at Week 12 and 48.
NCT00757783 (16) [back to overview]Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48
NCT00757783 (16) [back to overview]Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48.
NCT00757783 (16) [back to overview]Change From Baseline in Insulin at Week 12 and 48.
NCT00757783 (16) [back to overview]Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).
NCT00757783 (16) [back to overview]Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.
NCT00757783 (16) [back to overview]Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.
NCT00757783 (16) [back to overview]Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12
NCT00757783 (16) [back to overview]Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.
NCT00757783 (16) [back to overview]Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.
NCT00757783 (16) [back to overview]Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.
NCT00757783 (16) [back to overview]Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.
NCT00757783 (16) [back to overview]Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.
NCT00757783 (16) [back to overview]Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)
NCT00757783 (16) [back to overview]Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).
NCT00757783 (16) [back to overview]Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.
NCT00762892 (5) [back to overview]Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks
NCT00762892 (5) [back to overview]Change From Baseline in Homocysteine at 6 Months
NCT00762892 (5) [back to overview]Change From Baseline in CD4 Count at 48 Weeks
NCT00762892 (5) [back to overview]Change From Baseline in Lipids at 48 Weeks
NCT00762892 (5) [back to overview]Change From Baseline in Log HIV Viral Load at 48 Weeks
NCT00768989 (28) [back to overview]Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)
NCT00768989 (28) [back to overview]Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval
NCT00768989 (28) [back to overview]Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants
NCT00768989 (28) [back to overview]Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24
NCT00768989 (28) [back to overview]Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24
NCT00768989 (28) [back to overview]Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose
NCT00768989 (28) [back to overview]Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)
NCT00768989 (28) [back to overview]Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4
NCT00768989 (28) [back to overview]Atazanavir Terminal Elimination Half Life
NCT00768989 (28) [back to overview]Atazanavir Individual Inhibitory Quotient (IQ)
NCT00768989 (28) [back to overview]Raltegravir Cmin 12 Hours Postdose
NCT00768989 (28) [back to overview]Raltegravir Cmax in 1 Dosing Interval
NCT00768989 (28) [back to overview]Raltegravir AUC (0-12h) in 1 Dosing Interval
NCT00768989 (28) [back to overview]Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96
NCT00768989 (28) [back to overview]Atazanavir Cmin Prior to the Morning Dose
NCT00768989 (28) [back to overview]Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval
NCT00768989 (28) [back to overview]Raltegravir Cmin Prior to the Morning Dose
NCT00768989 (28) [back to overview]Raltegravir Terminal Elimination Half Life
NCT00768989 (28) [back to overview]Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval
NCT00768989 (28) [back to overview]Raltegravir Tmax
NCT00768989 (28) [back to overview]Baseline and Mean Change From Baseline in Total Cholesterol Levels
NCT00768989 (28) [back to overview]Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4
NCT00768989 (28) [back to overview]Mean Change From Baseline in Electrocardiogram Findings
NCT00768989 (28) [back to overview]Mean Change From Baseline in Total Bilirubin Level
NCT00768989 (28) [back to overview]Number of Nonresponders at Week 8
NCT00768989 (28) [back to overview]Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48
NCT00768989 (28) [back to overview]Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation
NCT00768989 (28) [back to overview]Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count
NCT00805675 (9) [back to overview]Percentage of Patients Who Are Polymerase Chain Reaction(PCR)Negative at Week 12
NCT00805675 (9) [back to overview]Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Weeks 2, 4 and 8.
NCT00805675 (9) [back to overview]Characterization of Very Early Viral Kinetics Through Efficiency Factor of Blocking Virus Production.
NCT00805675 (9) [back to overview]"Percentage of Patients Who Achieve Hepatitis B e Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 12"
NCT00805675 (9) [back to overview]Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12.
NCT00805675 (9) [back to overview]Characterization of Very Early Viral Kinetics Through Estimated Viral Load
NCT00805675 (9) [back to overview]Characterization of Very Early Viral Kinetics Through Half-live of Free Virus
NCT00805675 (9) [back to overview]Characterization of Very Early Viral Kinetics Through Rate of Infected Cell Loss
NCT00805675 (9) [back to overview]Characterization of Very Early Viral Kinetics Through Viral Clearance
NCT00811954 (19) [back to overview]Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96
NCT00811954 (19) [back to overview]Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96
NCT00811954 (19) [back to overview]Cumulative Incidence of First Adverse Event by Week 96
NCT00811954 (19) [back to overview]Cumulative Probability of First Virologic Failure by Week 96
NCT00811954 (19) [back to overview]Incidence of Death or AIDS Defining Events (CDC Category C)
NCT00811954 (19) [back to overview]Incidence of Targeted Serious Non-AIDS Defining Events (Renal Failure, Liver Disease, Serious Metabolic Disorder, and CVD)
NCT00811954 (19) [back to overview]Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance
NCT00811954 (19) [back to overview]Presence of Mutations Associated With INI Resistance
NCT00811954 (19) [back to overview]Presence of Mutations Associated With NRTI Resistance
NCT00811954 (19) [back to overview]Change in Waist Circumference From Baseline
NCT00811954 (19) [back to overview]Change in Framingham 10-year Risk of MI or Coronary Death From Baseline
NCT00811954 (19) [back to overview]Change in Fasting Triglycerides Level From Baseline
NCT00811954 (19) [back to overview]Change in Fasting Total Cholesterol Level From Baseline
NCT00811954 (19) [back to overview]Change in Fasting Plasma Glucose Level From Baseline
NCT00811954 (19) [back to overview]Change in Fasting HDL Cholesterol Level From Baseline
NCT00811954 (19) [back to overview]CD4+ T-cell Count Changes From Baseline
NCT00811954 (19) [back to overview]CD4+ T-cell Count
NCT00811954 (19) [back to overview]Change in Waist:Height Ratio From Baseline
NCT00811954 (19) [back to overview]Self-reported Adherence
NCT00827112 (16) [back to overview]Number of Participants With Phenotypic Resistance
NCT00827112 (16) [back to overview]Time-Averaged Difference (TAD) in log10 Viral Load
NCT00827112 (16) [back to overview]Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
NCT00827112 (16) [back to overview]Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
NCT00827112 (16) [back to overview]Number of Participants With Genotypic Resistance
NCT00827112 (16) [back to overview]Average Observed Plasma Concentration (Cavg) of Maraviroc
NCT00827112 (16) [back to overview]HIV-1 RNA Levels at Baseline
NCT00827112 (16) [back to overview]Minimum Observed Plasma Concentration (Cmin) of Maraviroc
NCT00827112 (16) [back to overview]Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
NCT00827112 (16) [back to overview]Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay
NCT00827112 (16) [back to overview]Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
NCT00827112 (16) [back to overview]Time to Loss of Virological Response (TLOVR)
NCT00827112 (16) [back to overview]Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
NCT00827112 (16) [back to overview]Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)
NCT00827112 (16) [back to overview]Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
NCT00827112 (16) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Maraviroc
NCT00851799 (27) [back to overview]Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96
NCT00851799 (27) [back to overview]Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96
NCT00851799 (27) [back to overview]Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT)
NCT00851799 (27) [back to overview]Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96
NCT00851799 (27) [back to overview]CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144
NCT00851799 (27) [back to overview]Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96
NCT00851799 (27) [back to overview]Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24
NCT00851799 (27) [back to overview]Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96
NCT00851799 (27) [back to overview]Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96
NCT00851799 (27) [back to overview]Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48
NCT00851799 (27) [back to overview]Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48
NCT00851799 (27) [back to overview]Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96
NCT00851799 (27) [back to overview]Percent Change in Lean Mass From Study Entry to Week 96
NCT00851799 (27) [back to overview]Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144
NCT00851799 (27) [back to overview]Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96
NCT00851799 (27) [back to overview]Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96
NCT00851799 (27) [back to overview]Percent Change in Total Limb Fat From Study Entry to Week 96
NCT00851799 (27) [back to overview]Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96
NCT00851799 (27) [back to overview]Percent Change in Trunk Fat From Study Entry to Week 96
NCT00851799 (27) [back to overview]Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96
NCT00851799 (27) [back to overview]Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96
NCT00851799 (27) [back to overview]Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96
NCT00851799 (27) [back to overview]Fold Change in D-dimer From Study Entry to Weeks 48 and 96
NCT00851799 (27) [back to overview]Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96
NCT00851799 (27) [back to overview]Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96
NCT00851799 (27) [back to overview]Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96
NCT00851799 (27) [back to overview]Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96
NCT00856323 (4) [back to overview]Self-reported Methamphetamine Use in Previous 30 Days.
NCT00856323 (4) [back to overview]Post-Exposure Prophylaxis Medication Adherence
NCT00856323 (4) [back to overview]HIV-related Sexual Risk Behaviors in Previous 30 Days.
NCT00856323 (4) [back to overview]Description of Incident STI Infections.
NCT00862823 (2) [back to overview]Area Under the Concentration Time Curve for Tenofovir, Emtricitabine and Efavirenz
NCT00862823 (2) [back to overview]Maximum Concentration for Tenofovir, Emtricitabine and Efavirenz
NCT00869960 (8) [back to overview]Atazanavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
NCT00869960 (8) [back to overview]Ritonavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
NCT00869960 (8) [back to overview]Tenofovir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
NCT00869960 (8) [back to overview]Tenofovir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
NCT00869960 (8) [back to overview]Ritonavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
NCT00869960 (8) [back to overview]Emtricitabine Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
NCT00869960 (8) [back to overview]Emtricitabine Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
NCT00869960 (8) [back to overview]Atazanavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
NCT00885664 (11) [back to overview]IL-10
NCT00885664 (11) [back to overview]IL-4
NCT00885664 (11) [back to overview]IL-6
NCT00885664 (11) [back to overview]IL-7
NCT00885664 (11) [back to overview]IL-8
NCT00885664 (11) [back to overview]INF Gamma
NCT00885664 (11) [back to overview]TNF Alpha
NCT00885664 (11) [back to overview]Symptom Score
NCT00885664 (11) [back to overview]SF-12 Physical Capacity Score
NCT00885664 (11) [back to overview]SF-12 Mental Capacity Score
NCT00885664 (11) [back to overview]IL-1 Beta
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for AUC24hr)
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Etravirine (ETR) (Results for AUC12hr)
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for AUC24hr)
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for AUC24hr)
NCT00896051 (18) [back to overview]Change From Pre-Baseline in Log10 Viral Load Over Time
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax)
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Etravirine (ETR) (Results for C0h, Cmin, and Cmax)
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for C0h, Cmin, and Cmax)
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for C0h, Cmin, and Cmax)
NCT00896051 (18) [back to overview]The Percentage of Participants With a Virologic Response (Plasma Viral Load < 50 Copies/mL) at Week 48 Using the Snapshot Analysis Method
NCT00896051 (18) [back to overview]The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method
NCT00896051 (18) [back to overview]The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method
NCT00896051 (18) [back to overview]Time to Confirmed Virologic Response
NCT00896051 (18) [back to overview]Time to Virologic Failure
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for C0h, Cmin, and Cmax)
NCT00896051 (18) [back to overview]Change From Prebaseline in CD4+ Cell Count Over Time
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for AUC24hr)
NCT00896051 (18) [back to overview]Percentage of Participants With Undetectable Plasma Viral Load (VL) Values (<50 Copies/mL) at Week 48
NCT00924898 (6) [back to overview]Number of Participants Without Virologic Failure at Week 48
NCT00924898 (6) [back to overview]Number of Participants Without Virologic Failure at Week 24
NCT00924898 (6) [back to overview]Number of Participants With HIV RNA Suppression at Week 96
NCT00924898 (6) [back to overview]Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment
NCT00924898 (6) [back to overview]Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications
NCT00924898 (6) [back to overview]Time to HIV RNA Suppression <50 Copies/mL
NCT00928187 (13) [back to overview]Patients With Plasma HIV RNA < 200 Copies/ml
NCT00928187 (13) [back to overview]Number of Patients With WHO Stage 3 and 4 HIV Related Events
NCT00928187 (13) [back to overview]Number of Patients With Resistance Mutations
NCT00928187 (13) [back to overview]Number of Patients With Plasma HIV RNA < 50 Copies/mL
NCT00928187 (13) [back to overview]Number of Patients With HIV Plasma Viral Load < 50 Copies/ml
NCT00928187 (13) [back to overview]Number of Patients With HIV Plasma Viral Load < 200 Copies/ml
NCT00928187 (13) [back to overview]Tolerance: Neuropathies (Grade 1 to 4)
NCT00928187 (13) [back to overview]Adherence
NCT00928187 (13) [back to overview]Development of Metabolic Syndrome
NCT00928187 (13) [back to overview]Gain in CD4 Cells Between Baseline and W48
NCT00928187 (13) [back to overview]Number of Patients Discontinuing Study Treatment
NCT00928187 (13) [back to overview]Tolerance: Gastrointestinal Complains
NCT00928187 (13) [back to overview]Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)
NCT00931801 (4) [back to overview]Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
NCT00931801 (4) [back to overview]The Change in Adherence to Study Treatment Arm From Baseline to Week 48
NCT00931801 (4) [back to overview]The Difference in CD4 From Baseline to Week 48
NCT00931801 (4) [back to overview]Maintenance of Virologic Suppression
NCT00959894 (25) [back to overview]Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]The Proportion of Participants With HIV RNA <50 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]The Proportion of Participants With HIV RNA <50 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]The Proportion of Participants With HIV RNA <200 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]The Proportion of Participants With HIV RNA <200 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]The Proportion of Participants With HIV RNA <200 Copies/mL at Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]Probability of Remaining Free of a Safety/Tolerability Event at 96 Weeks
NCT00959894 (25) [back to overview]Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults
NCT00959894 (25) [back to overview]Resistance Mutations in the Subset of Patients With Confirmed Virologic Failure Who Have HIV RNA >500 Copies/mL and Genotype Resistance Results
NCT00959894 (25) [back to overview]Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults: Etravirine AUC-24 Hours at Steady State
NCT00959894 (25) [back to overview]Tolerability of Etravirine in HIV-1 Infected Adults Initiating Antiretroviral Therapy
NCT00959894 (25) [back to overview]Pharmacokinetics of Etravirine in Genital Secretions of up to 10 Men and up to 10 Women at Week 4 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]Change in CD4+ Cell Count From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]Change in CD4+ Cell Count From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]The Antiretroviral Activity of Etravirine 400 mg Given Once Daily, With Fixed-dose Truvada Once Daily, Among Treatment-naïve HIV-1 Infected Adults as Measured by the Percentage of Participants With HIV RNA < 50 Copies/mL at Week 24
NCT00959894 (25) [back to overview]Change in CD4+ Cell Count From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00959894 (25) [back to overview]Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
NCT00960622 (1) [back to overview]Change in Peak Oxygen Uptake.
NCT00962871 (2) [back to overview]Mean Change From Baseline in HBV-DNA log10
NCT00962871 (2) [back to overview]Mean Change From Baseline in Viral Quantitative e Antibody
NCT00998582 (2) [back to overview]Change in Small Artery Elasticity (mL/mmHg x100) From Baseline to Week 24
NCT00998582 (2) [back to overview]Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24
NCT01003990 (1) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death
NCT01025427 (1) [back to overview]Mean Change in Estimated Ultrasensitive Plasma HIV RNA Levels Between Baseline and Week 24
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
NCT01033942 (96) [back to overview]Actual Number of Study Visits Completed by 24 Weeks
NCT01033942 (96) [back to overview]Number of Missed Doses Based on Medication Refill Dates-Overall
NCT01033942 (96) [back to overview]Number of Missed Doses Based on Medication Refill Dates-Week 12
NCT01033942 (96) [back to overview]Number of Missed Doses Based on Medication Refill Dates-Week 16
NCT01033942 (96) [back to overview]Number of Missed Doses Based on Medication Refill Dates-Week 20
NCT01033942 (96) [back to overview]Number of Missed Doses Based on Medication Refill Dates-Week 4
NCT01033942 (96) [back to overview]Number of Missed Doses Based on Medication Refill Dates-Week 8
NCT01033942 (96) [back to overview]Number of Missed Doses Based on Self-Report Calendar Data-Week 12
NCT01033942 (96) [back to overview]Number of Missed Doses Based on Self-Report Calendar Data-Week 16
NCT01033942 (96) [back to overview]Number of Missed Doses Based on Self-Report Calendar Data-Week 20
NCT01033942 (96) [back to overview]Number of Missed Doses Based on Self-Report Calendar Data-Week 24
NCT01033942 (96) [back to overview]Number of Missed Doses Based on Self-Report Calendar Data-Week 4
NCT01033942 (96) [back to overview]Number of Missed Doses Based on Self-Report Calendar Data-Week 8
NCT01033942 (96) [back to overview]Number of Missed Doses Over Time Based on Self-Report Calendar Data
NCT01033942 (96) [back to overview]Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline
NCT01033942 (96) [back to overview]Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8
NCT01033942 (96) [back to overview]Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12
NCT01033942 (96) [back to overview]Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16
NCT01033942 (96) [back to overview]Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20
NCT01033942 (96) [back to overview]Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24
NCT01033942 (96) [back to overview]Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4
NCT01033942 (96) [back to overview]Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8
NCT01033942 (96) [back to overview]Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline
NCT01033942 (96) [back to overview]Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12
NCT01033942 (96) [back to overview]Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16
NCT01033942 (96) [back to overview]Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20
NCT01033942 (96) [back to overview]Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24
NCT01033942 (96) [back to overview]Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4
NCT01033942 (96) [back to overview]Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8
NCT01033942 (96) [back to overview]Acceptability of Being Contacted by the Research Team in Between Visits
NCT01033942 (96) [back to overview]Acceptability of Being Randomly Assigned to a Group
NCT01033942 (96) [back to overview]Acceptability of Having an HIV Test at Every Visit
NCT01033942 (96) [back to overview]Acceptability of Health Clinic for Study Visits
NCT01033942 (96) [back to overview]Acceptability of Participating in Group Sessions
NCT01033942 (96) [back to overview]Acceptability of Physical Examination by a Doctor
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Felt Sick or Ill
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Ran Out of Study Pills
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Simply Forgot
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Was Away From Home
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things
NCT01033942 (96) [back to overview]Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12
NCT01033942 (96) [back to overview]Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16
NCT01033942 (96) [back to overview]Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20
NCT01033942 (96) [back to overview]Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24
NCT01033942 (96) [back to overview]Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
NCT01033942 (96) [back to overview]Acceptability of Questions About Sexual Behavior at Every Visit
NCT01033942 (96) [back to overview]Acceptability of Risk Reduction Counseling at Every Visit
NCT01033942 (96) [back to overview]Acceptability of Size of Pill
NCT01033942 (96) [back to overview]Acceptability of Taking Part in the Study
NCT01033942 (96) [back to overview]Acceptability of Taking the Pill Everyday
NCT01033942 (96) [back to overview]Acceptability of the Color of the Pill
NCT01033942 (96) [back to overview]Acceptability of the Taste of the Pill
NCT01033942 (96) [back to overview]Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
NCT01033942 (96) [back to overview]Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
NCT01033942 (96) [back to overview]Perceived Risk of Becoming HIV Positive at Week 12
NCT01033942 (96) [back to overview]Perceived Risk of Becoming HIV Positive at Week 16
NCT01033942 (96) [back to overview]Perceived Risk of Becoming HIV Positive at Week 20
NCT01033942 (96) [back to overview]Perceived Risk of Becoming HIV Positive at Week 24
NCT01033942 (96) [back to overview]Perceived Risk of Becoming HIV Positive at Week 4
NCT01033942 (96) [back to overview]Perceived Risk of Becoming HIV Positive at Week 8
NCT01044771 (2) [back to overview]Patients Without HIV Re-bound
NCT01044771 (2) [back to overview]Patients With Reduced or Resolved Proteinuria
NCT01061151 (28) [back to overview]Maternal Health Component: Other Targeted Medical Conditions
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence Rate of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence Rate of Death or Any Condition of Particular Concern
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence Rate of Cardiovascular or Other Metabolic Events
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of Tuberculosis
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death
NCT01061151 (28) [back to overview]Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of HIV/AIDS-related Event or World Health Organization (WHO) Clinical Stage 2 or 3 Events
NCT01061151 (28) [back to overview]Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of Death
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of AIDS-defining Illness
NCT01061151 (28) [back to overview]Antepartum Component: Number of Infant HIV Infections
NCT01061151 (28) [back to overview]Antepartum Component: Number of Confirmed Infant HIV Infections
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of HIV/AIDS-related Events
NCT01061151 (28) [back to overview]Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)
NCT01061151 (28) [back to overview]Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)
NCT01061151 (28) [back to overview]Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
NCT01061151 (28) [back to overview]Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
NCT01061151 (28) [back to overview]Antepartum Component: Number of Mothers With Obstetrical Complications
NCT01061151 (28) [back to overview]Antepartum Component: Number of Mothers With Obstetrical Complications
NCT01061151 (28) [back to overview]Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of HIV/AIDS-related Event or Death
NCT01061151 (28) [back to overview]Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures
NCT01061151 (28) [back to overview]Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery
NCT01061151 (28) [back to overview]Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery
NCT01061151 (28) [back to overview]Postpartum Component: Incidence of Confirmed Infant HIV Infection
NCT01061151 (28) [back to overview]Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)
NCT01061151 (28) [back to overview]Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
NCT01063036 (11) [back to overview]Percentage of Participants With a Virologic Response at Week 48 - Treated Population
NCT01063036 (11) [back to overview]Change From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population
NCT01063036 (11) [back to overview]Number of Participants on Treatment With Study Drug With Laboratory Test Abnormalities Meeting Selected Criteria on Treatment - Treated Population
NCT01063036 (11) [back to overview]Number of Participants With Emergence of Genotypic Resistance to Study Drugs at Weeks 48 and 96- Treated Population
NCT01063036 (11) [back to overview]Percentage of Participants With a Virologic Response at Week 24 and at Week 96 - Treated Population
NCT01063036 (11) [back to overview]Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBsAg-Positive at Baseline
NCT01063036 (11) [back to overview]Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 24, 48, 96 - Treated Population Who Were HBsAg-Positive at Baseline
NCT01063036 (11) [back to overview]Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline
NCT01063036 (11) [back to overview]Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population
NCT01063036 (11) [back to overview]Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline
NCT01063036 (11) [back to overview]Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) on Treatment, and Discontinuation of Study Drug Due to Adverse Events (AE) - Treated Population
NCT01140880 (4) [back to overview]Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)
NCT01140880 (4) [back to overview]Course Completion
NCT01140880 (4) [back to overview]Medication Adherence
NCT01140880 (4) [back to overview]Time From Exposure to Truvada Initiation
NCT01154673 (1) [back to overview]Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART.
NCT01195467 (2) [back to overview]The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment
NCT01195467 (2) [back to overview]The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment
NCT01214759 (2) [back to overview]Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study
NCT01214759 (2) [back to overview]Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months
NCT01232127 (7) [back to overview]Number of Participants With Abnormalities in Laboratory Test Results
NCT01232127 (7) [back to overview]Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir
NCT01232127 (7) [back to overview]Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest
NCT01232127 (7) [back to overview]Number of Participants With Abnormalities in Vital Signs
NCT01232127 (7) [back to overview]Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings
NCT01232127 (7) [back to overview]Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir
NCT01232127 (7) [back to overview]Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir
NCT01270802 (2) [back to overview]Change in Flow-mediated Dilation (FMD) of the Brachial Artery
NCT01270802 (2) [back to overview]Change in Serum Levels of Vitamin D
NCT01283555 (23) [back to overview]Number of Participants Reporting Suggestions Regarding Ease of Use or Comfort
NCT01283555 (23) [back to overview]Number of Participants Reporting Applicator Preference (User-filled or Prefilled) Across a Variety of Factors
NCT01283555 (23) [back to overview]Number of Participants Reporting Applicator Easy to Insert
NCT01283555 (23) [back to overview]Number of Participants Reporting Applicator Easy to Fill
NCT01283555 (23) [back to overview]Number of Participants Reporting That They Would Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention
NCT01283555 (23) [back to overview]Number of Colposcopic Findings (Baseline and After One Week of Product Use)
NCT01283555 (23) [back to overview]Number of Respondents Reporting Confidence With Filling the User-filled Applicator
NCT01283555 (23) [back to overview]Reasons Given by Participants for Knowing When the Applicator Was Filled Correctly
NCT01283555 (23) [back to overview]Number of Participants Reporting That Both Applicators Were Acceptable
NCT01283555 (23) [back to overview]Filling Precision (5% Range)
NCT01283555 (23) [back to overview]Filling Precision (10% Range)
NCT01283555 (23) [back to overview]Number of Participants Reporting That the Instructions for Use Were Helpful
NCT01283555 (23) [back to overview]Filled Volume
NCT01283555 (23) [back to overview]Dosing Volume (Expressed Volume)
NCT01283555 (23) [back to overview]Dosing Precision, 5% (Expressed Volume)
NCT01283555 (23) [back to overview]Dosing Precision, 10% (Expressed Volume)
NCT01283555 (23) [back to overview]Filling Accuracy (% of Target Dose)
NCT01283555 (23) [back to overview]Dosing Accuracy (% of Target Dose Delivered)
NCT01283555 (23) [back to overview]Number of Participants Reporting That the Gel Was Easy to Dispense
NCT01283555 (23) [back to overview]Number of Participants Reporting That They Would Not Want to Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention
NCT01283555 (23) [back to overview]Number of Participants Reporting That They Would Recommend the User-filled Applicator for HIV Prevention
NCT01283555 (23) [back to overview]Number of Participants Reporting That the Cost of the Applicator Would Influence Their Choice of Applicator
NCT01283555 (23) [back to overview]Number of Participants Reporting That Applicator Was Comfortable to Use
NCT01285050 (1) [back to overview]HCV RNA
NCT01300234 (15) [back to overview]Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240
NCT01300234 (15) [back to overview]Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2.
NCT01300234 (15) [back to overview]Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48
NCT01300234 (15) [back to overview]Number of Participants in the Indicated Category for Renal Laboratory Abnormalities
NCT01300234 (15) [back to overview]Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs)
NCT01300234 (15) [back to overview]Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240
NCT01300234 (15) [back to overview]Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE)
NCT01300234 (15) [back to overview]Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus
NCT01300234 (15) [back to overview]Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240
NCT01300234 (15) [back to overview]Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240
NCT01300234 (15) [back to overview]Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline
NCT01300234 (15) [back to overview]Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240
NCT01300234 (15) [back to overview]Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48
NCT01300234 (15) [back to overview]Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240
NCT01300234 (15) [back to overview]Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240.
NCT01327651 (28) [back to overview]A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
NCT01327651 (28) [back to overview]Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)
NCT01327651 (28) [back to overview]Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing
NCT01327651 (28) [back to overview]Self-reported Side Effect or Symptom Scores
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]The Total Pills Actually Used Over the Follow-up Period
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01327651 (28) [back to overview]The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data
NCT01327651 (28) [back to overview]The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)
NCT01327651 (28) [back to overview]A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
NCT01332227 (7) [back to overview]Mean Changes in Fasting Lipid Levels From Baseline to Week 48
NCT01332227 (7) [back to overview]Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
NCT01332227 (7) [back to overview]Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
NCT01332227 (7) [back to overview]Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48
NCT01332227 (7) [back to overview]Number of Participants With Virologic Rebound at Weeks 24 and 48
NCT01332227 (7) [back to overview]Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24
NCT01332227 (7) [back to overview]Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs
NCT01335620 (2) [back to overview]Cerebral Function; Changes in Global Cognitive Z-score
NCT01335620 (2) [back to overview]Drug Levels in Blood
NCT01340196 (8) [back to overview]Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22
NCT01340196 (8) [back to overview]Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15
NCT01340196 (8) [back to overview]Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22
NCT01340196 (8) [back to overview]Number of Patients With Drug Related Adverse Events During the Trial
NCT01340196 (8) [back to overview]Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG
NCT01340196 (8) [back to overview]Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22
NCT01340196 (8) [back to overview]Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15
NCT01340196 (8) [back to overview]Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15
NCT01345630 (25) [back to overview]The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA).
NCT01345630 (25) [back to overview]Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria.
NCT01345630 (25) [back to overview]Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin
NCT01345630 (25) [back to overview]Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF).
NCT01345630 (25) [back to overview]Tropism Change Between Screening or Baseline and PDTF
NCT01345630 (25) [back to overview]Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)
NCT01345630 (25) [back to overview]Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD
NCT01345630 (25) [back to overview]Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD
NCT01345630 (25) [back to overview]Severity of Abnormal Laboratory Values
NCT01345630 (25) [back to overview]Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%)
NCT01345630 (25) [back to overview]Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%)
NCT01345630 (25) [back to overview]Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria
NCT01345630 (25) [back to overview]Number of Participants With Abnormal Laboratory Values
NCT01345630 (25) [back to overview]Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48.
NCT01345630 (25) [back to overview]Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48
NCT01345630 (25) [back to overview]Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3)
NCT01345630 (25) [back to overview]Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3)
NCT01345630 (25) [back to overview]Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48
NCT01345630 (25) [back to overview]Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD
NCT01345630 (25) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL.
NCT01345630 (25) [back to overview]Number of Treatment-related AEs
NCT01345630 (25) [back to overview]Number of Participants With Treatment-emergent Serious Adverse Events
NCT01345630 (25) [back to overview]Number of Participants With Grade 3 or 4 AEs
NCT01345630 (25) [back to overview]Number of Participants Who Discontinued Due to AEs
NCT01345630 (25) [back to overview]Frequency of Adverse Events (AE).
NCT01352117 (12) [back to overview]Percentage of Participants With Etoposide Dose Modification
NCT01352117 (12) [back to overview]Percentage of Participants With ARV Dose Modification
NCT01352117 (12) [back to overview]Change in Peripheral Blood CD4+ Lymphocyte Cell Count
NCT01352117 (12) [back to overview]Change in Peripheral Blood CD4+ Lymphocyte Cell Count
NCT01352117 (12) [back to overview]Number of Participants With Grade 3 or Higher Adverse Events
NCT01352117 (12) [back to overview]Cumulative Incidence of KS-IRIS
NCT01352117 (12) [back to overview]Cumulative Incidence of KS Response After Initiation of Delayed Etoposide in Arm A
NCT01352117 (12) [back to overview]Cumulative Incidence of KS Progressive Disease After Initiation of Delayed Etoposide in Arm A
NCT01352117 (12) [back to overview]Cumulative Incidence of Initial KS Progressive Disease by Week 96
NCT01352117 (12) [back to overview]Cumulative Incidence of Initial KS Partial or Complete Response by Week 96
NCT01352117 (12) [back to overview]Percentage of Participants With HIV-1 RNA Suppression
NCT01352117 (12) [back to overview]Percentage of Participants With HIV-1 RNA Suppression
NCT01352715 (9) [back to overview]Number of Participants With a New AIDS-defining Events or Death
NCT01352715 (9) [back to overview]Number of Participants Discontinuing Randomized Treatment for Toxicity
NCT01352715 (9) [back to overview]Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure
NCT01352715 (9) [back to overview]Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline
NCT01352715 (9) [back to overview]Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline
NCT01352715 (9) [back to overview]Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death
NCT01352715 (9) [back to overview]Change in CD4+ Cell Count From Baseline to Week 48
NCT01352715 (9) [back to overview]Cumulative Probability of Virologic Failure by Week 48
NCT01352715 (9) [back to overview]Percentage of Time Spent in Hospital
NCT01369212 (18) [back to overview]Number of Participants With HBV DNA<1000 IU/mL at Week 192
NCT01369212 (18) [back to overview]Number of Participants With HBsAg Seroconversion at Week 240
NCT01369212 (18) [back to overview]Number of Participants With HBsAg Seroconversion at Week 192
NCT01369212 (18) [back to overview]Number of Participants With HBeAg Seroconversion at Week 240
NCT01369212 (18) [back to overview]Number of Participants With HBeAg Seroconversion at Week 192
NCT01369212 (18) [back to overview]Number of Participants With HBeAg Loss at Week 240
NCT01369212 (18) [back to overview]Number of Participants With Alanine Transaminase(ALT) Levels <= 38 U/L for Males and <=25 for Females at Week 192
NCT01369212 (18) [back to overview]Cumulative Percent of Participants With HBsAg Loss at Week 192
NCT01369212 (18) [back to overview]Number of Participants With Adverse Events
NCT01369212 (18) [back to overview]Cumulative Percent of Participants With HBsAg Loss at Week 240
NCT01369212 (18) [back to overview]Number of Participants With Serious Adverse Events
NCT01369212 (18) [back to overview]Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240
NCT01369212 (18) [back to overview]Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 240
NCT01369212 (18) [back to overview]Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 192
NCT01369212 (18) [back to overview]Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 192
NCT01369212 (18) [back to overview]Number of Participants With HBV DNA<20 IU/mL at Week 240
NCT01369212 (18) [back to overview]Number of Participants With HBV DNA<20 IU/mL at Week 192
NCT01369212 (18) [back to overview]Number of Participants With HBV DNA<1000 IU/mL at Week 240
NCT01379508 (4) [back to overview]eGFR Change From Baseline in Telbivudine Arm vs Tenofovir Arm Over the Course of the Study
NCT01379508 (4) [back to overview]Percentage of Participants Achieving HBV DNA < 300 Copies/mL (51 IU/mL) at Week 52 (rITT Population) -
NCT01379508 (4) [back to overview]Percentage of Participants Achieving Secondary Efficacy Endpoints at Week 156 (mITT)
NCT01379508 (4) [back to overview]Percentage of Patients Achieving Secondary Efficacy Endpoints (rITT)
NCT01384734 (17) [back to overview]Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy
NCT01384734 (17) [back to overview]Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period
NCT01384734 (17) [back to overview]Number of Participants With Newly-emergent Genotypic Substitutions at Week 24
NCT01384734 (17) [back to overview]Number of Participants With Newly-emergent Genotypic Substitutions at Week 96
NCT01384734 (17) [back to overview]Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period
NCT01384734 (17) [back to overview]Number of Participants With SAE and Discontinuation Due to AEs During Primary Study
NCT01384734 (17) [back to overview]Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24
NCT01384734 (17) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study
NCT01384734 (17) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period
NCT01384734 (17) [back to overview]Number of Participants With Newly-emergent Genotypic Substitutions at Week 48
NCT01384734 (17) [back to overview]Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48
NCT01384734 (17) [back to overview]Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96
NCT01384734 (17) [back to overview]Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24
NCT01384734 (17) [back to overview]Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA
NCT01384734 (17) [back to overview]Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24
NCT01384734 (17) [back to overview]Change From Baseline in CD4+ T-cell Count
NCT01384734 (17) [back to overview]Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy
NCT01387022 (4) [back to overview]Change in CD4+ Cell Count From Randomisation to 12 Months Post-randomisation
NCT01387022 (4) [back to overview]Reported Adverse Events With Severity Grades 3 and 4 Based on the DAIDS Toxicity Grading Tables
NCT01387022 (4) [back to overview]Tenofovir Resistance, Defined as Presence of K65R, K70E or Any of the TAMS Mutations
NCT01387022 (4) [back to overview]The Antiretroviral Treatment Failure Rate at 12 Months.
NCT01400412 (20) [back to overview]Percentage Change in Expression of CD38+/HLA-DR+ on CD8+ T Cells From Baseline to Week 48
NCT01400412 (20) [back to overview]Percentage Change in Expression of CD38+/HLA-DR+ on CD4+ T Cells From Baseline to Week 48
NCT01400412 (20) [back to overview]Percent Change in Lumbar Spine Bone Mineral Density (BMD)
NCT01400412 (20) [back to overview]Percent Change in Expression of RANKL+ on CD8+ T Cells From Baseline to Week 48
NCT01400412 (20) [back to overview]Percent Change in Expression of CD57+ on CD8+ T Cells From Baseline to Week 48
NCT01400412 (20) [back to overview]Percent Change in Expression of CD28+ on CD8+ T Cells From Baseline to Week 48
NCT01400412 (20) [back to overview]Percent Change From Baseline in Total Hip Bone Mineral Density (BMD)
NCT01400412 (20) [back to overview]Number of Participants Who Died During the Study
NCT01400412 (20) [back to overview]Number of Participants Who Developed Grade 3 or 4 Primary Adverse Events
NCT01400412 (20) [back to overview]Change in CD4 Count From Baseline to Week 24
NCT01400412 (20) [back to overview]Percent Change in Expression of CD28+/CD57+ on CD8+ T Cells From Baseline to Week 48
NCT01400412 (20) [back to overview]CD8+ T-cell Change From Baseline to Week 48
NCT01400412 (20) [back to overview]Change in Level of IP-10 From Baseline to Week 48
NCT01400412 (20) [back to overview]Change in Levels of D-dimer From Baseline
NCT01400412 (20) [back to overview]Change in Levels of IL-6 From Baseline to Week 48
NCT01400412 (20) [back to overview]Change in Levels of sCD14 From Baseline
NCT01400412 (20) [back to overview]Number of Participants Who Experienced Bone Fractures
NCT01400412 (20) [back to overview]Change in Levels of sCD163 From Baseline to Week 48
NCT01400412 (20) [back to overview]Cumulative Probability of Virologic Failure by Week 48
NCT01400412 (20) [back to overview]Change in CD4 Count From Baseline to Week 48
NCT01435018 (37) [back to overview]Self-reported Adherence to ART Therapy
NCT01435018 (37) [back to overview]Number of Participants With Treatment-related Toxicities and Adverse Events (AEs)
NCT01435018 (37) [back to overview]Number of Participants With Symptomatic Peripheral Neuropathy (SPN)
NCT01435018 (37) [back to overview]Number of Participants With Peripheral Neuropathy (PN)
NCT01435018 (37) [back to overview]Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4
NCT01435018 (37) [back to overview]Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3
NCT01435018 (37) [back to overview]Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2
NCT01435018 (37) [back to overview]Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Time to IERC-confirmed KS Progression or Death for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Time to IERC-confirmed KS Progression or Death for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Number of Participants With Objective Response for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Number of Participants With Objective Response for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Duration of Objective Response for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Duration of Objective Response for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of IERC-confirmed KS Progression by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Death for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Death for BV+ART vs PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Change in KS Treatment by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of Change in KS Treatment by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of AIDS-defining Event by Week 48 for ET+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of AIDS-defining Event by Week 48 for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for BV+ART vs. PTX+ART
NCT01448616 (4) [back to overview]HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo
NCT01448616 (4) [back to overview]Within-person Changes in Log-copy Numbers of HSV
NCT01448616 (4) [back to overview]Genital Lesion Rate
NCT01448616 (4) [back to overview]Asymptomatic Shedding (Shedding on Days Without Genital Lesions)
NCT01450189 (30) [back to overview]Cumulative Incidence Herpes Simplex Virus Type 2
NCT01450189 (30) [back to overview]Number of Adverse Events
NCT01450189 (30) [back to overview]Unprotected Sex Acts in Previous One Week - 52 Weeks
NCT01450189 (30) [back to overview]Number of Partners Reporting for HIV Testing
NCT01450189 (30) [back to overview]Proportion of Participants Completing Full Course of ARVs in Arm BIA
NCT01450189 (30) [back to overview]Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.
NCT01450189 (30) [back to overview]Proportion of Partners Reporting for HIV Testing
NCT01450189 (30) [back to overview]Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening
NCT01450189 (30) [back to overview]Proportion of Persons Completing All Scheduled Visits in Each Study Arm
NCT01450189 (30) [back to overview]Prevalence of AHI Among Persons Screened
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 26, Women
NCT01450189 (30) [back to overview]Proportion of Persons With AHI Successfully Recruited Into the Study
NCT01450189 (30) [back to overview]Suppression of HIV RNA to <1000c/ml at 12 Weeks
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 52, Women
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 52, Men
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 26, Men
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 12, Women
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 12, Men
NCT01450189 (30) [back to overview]Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
NCT01450189 (30) [back to overview]Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
NCT01450189 (30) [back to overview]Unprotected Sex Acts in Previous One Month - 52 Weeks
NCT01450189 (30) [back to overview]Cumulative Incidence Herpes Simplex Virus Type 2
NCT01450189 (30) [back to overview]Blood HIV RNA Concentration at Week 52
NCT01450189 (30) [back to overview]Blood HIV RNA Concentration at Week 26
NCT01450189 (30) [back to overview]Blood HIV RNA Concentration at Week 12
NCT01450189 (30) [back to overview]Time to HIV RNA Suppression <1000 c/ml
NCT01450189 (30) [back to overview]Unprotected Sex Acts in Previous One Month - 12 Weeks
NCT01450189 (30) [back to overview]Unprotected Sex Acts in Previous One Month - 26 Weeks
NCT01450189 (30) [back to overview]Unprotected Sex Acts in Previous One Week - 12 Weeks
NCT01450189 (30) [back to overview]Unprotected Sex Acts in Previous One Week - 26 Weeks
NCT01505114 (1) [back to overview]Occurrence of Grade 3 or Higher Adverse Events (AEs)
NCT01525628 (24) [back to overview]AUC 0-6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
NCT01525628 (24) [back to overview]AUC 0-6hr of Deleobuvir Reduction Metabolite CD 6168
NCT01525628 (24) [back to overview]Cmax of Deleobuvir (BI 207127)
NCT01525628 (24) [back to overview]Cmax of 1-OH-Midazolam (1-hydroxy-midazolam)
NCT01525628 (24) [back to overview]AUC 0-6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
NCT01525628 (24) [back to overview]Cmax of Tolbutamide
NCT01525628 (24) [back to overview]Cmax of Midazolam
NCT01525628 (24) [back to overview]Cmax of Faldaprevir (BI 201335)
NCT01525628 (24) [back to overview]Cmax of Deleobuvir Reduction Metabolite CD 6168
NCT01525628 (24) [back to overview]Cmax of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
NCT01525628 (24) [back to overview]Cmax of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
NCT01525628 (24) [back to overview]C6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
NCT01525628 (24) [back to overview]C6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
NCT01525628 (24) [back to overview]C6hr of Deleobuvir Reduction Metabolite CD 6168
NCT01525628 (24) [back to overview]Cmax of Caffeine
NCT01525628 (24) [back to overview]C6hr of Deleobuvir (BI 207127)
NCT01525628 (24) [back to overview]C24hr of Faldaprevir (BI 201335)
NCT01525628 (24) [back to overview]AUC 0-infinity of Tolbutamide
NCT01525628 (24) [back to overview]AUC 0-infinity of Midazolam
NCT01525628 (24) [back to overview]AUC 0-infinity of Caffeine
NCT01525628 (24) [back to overview]AUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam)
NCT01525628 (24) [back to overview]AUC 0-6hr of Deleobuvir (BI 207127)
NCT01525628 (24) [back to overview]Area Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours
NCT01525628 (24) [back to overview]Number of Participants With Sustained Virological Response (SVR12)
NCT01605890 (12) [back to overview]Number of Participants With Treatment Switch or Discontinuation
NCT01605890 (12) [back to overview]Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48
NCT01605890 (12) [back to overview]Median Change of CD4 Lymphocytes at Week 48
NCT01605890 (12) [back to overview]Percentage of Participants in Therapeutic Success
NCT01605890 (12) [back to overview]Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24
NCT01605890 (12) [back to overview]Number of Clinical and Biological Events
NCT01605890 (12) [back to overview]Median Change in CD4 Lymphocytes Count at Week 12
NCT01605890 (12) [back to overview]Number of Participants With Clinical Progression
NCT01605890 (12) [back to overview]Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL
NCT01605890 (12) [back to overview]Number of Virological Failure Participants With Resistance Mutations
NCT01605890 (12) [back to overview]Minimal Median of the Lower Dimension Out of the 4 Dimensions of the Quality of Life Questionnaire
NCT01605890 (12) [back to overview]Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence
NCT01632891 (7) [back to overview]Change in log10(Pf Gametocyte Density) From Entry to Day 30
NCT01632891 (7) [back to overview]Number of Participants With Detectable Pf Gametocyte Density
NCT01632891 (7) [back to overview]Proportion of Participants With Plasmodium Falciparum (Pf) Subclinical Parasitemia (SCP) Clearance
NCT01632891 (7) [back to overview]Change in log10(Pf Parasite Density) From Entry to Day 30
NCT01632891 (7) [back to overview]Number of Participants With Uncomplicated Clinical Malaria
NCT01632891 (7) [back to overview]Time to First Pf SCP Clearance
NCT01632891 (7) [back to overview]Log10(Pf Parasite Density)
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Total Cholesterol
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Glucose
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol
NCT01641367 (60) [back to overview]Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Change From Baseline in CD4+ T-cell Count
NCT01641367 (60) [back to overview]Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks
NCT01641367 (60) [back to overview]Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
NCT01641367 (60) [back to overview]Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks
NCT01641367 (60) [back to overview]Time to First Dose Modification Due to Grade 3 or 4 Toxicity
NCT01641367 (60) [back to overview]Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
NCT01641367 (60) [back to overview]Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to Treatment Modification or Discontinuation.
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to the First of Death or Hospitalization.
NCT01641367 (60) [back to overview]Number of Weeks of Follow-up [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Number of Weeks of Follow-up
NCT01641367 (60) [back to overview]Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
NCT01641367 (60) [back to overview]Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants With Confirmed Virologic Failure by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants With Confirmed Virologic Failure by Week 48
NCT01641367 (60) [back to overview]Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48
NCT01641367 (60) [back to overview]Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity
NCT01641367 (60) [back to overview]Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48
NCT01641367 (60) [back to overview]Percent of Participants With Death or Hospitalization by Week 48
NCT01641367 (60) [back to overview]Percent of Participants With Death or Hospitalization by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants With Treatment Modification or Discontinuation by Week 48
NCT01641367 (60) [back to overview]Percent of Participants With Treatment Modification or Discontinuation by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Triglycerides
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to Death
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to Death [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS)
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48
NCT01641367 (60) [back to overview]Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48
NCT01641367 (60) [back to overview]Percent of Participants Experiencing Death by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants Experiencing Death by Week 48
NCT01641809 (57) [back to overview]Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
NCT01641809 (57) [back to overview]Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm
NCT01641809 (57) [back to overview]Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase
NCT01641809 (57) [back to overview]Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase
NCT01641809 (57) [back to overview]Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events
NCT01641809 (57) [back to overview]Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
NCT01641809 (57) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase
NCT01641809 (57) [back to overview]Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2
NCT01641809 (57) [back to overview]Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2
NCT01641809 (57) [back to overview]Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
NCT01641809 (57) [back to overview]Number of Participants With AEs and SAEs Over Time
NCT01641809 (57) [back to overview]Number of Participants With AEs and SAEs-Induction Phase
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase
NCT01641809 (57) [back to overview]Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in CD4+ Cell Count Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in CD4+ Cell Count Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in ALT, AST and CK Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in ALT, AST and CK Over Time by Visit
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase
NCT01641809 (57) [back to overview]Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase
NCT01641809 (57) [back to overview]Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease
NCT01641809 (57) [back to overview]Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance
NCT01641809 (57) [back to overview]Number of Participants With Treatment Emergent Phenotypic Resistance
NCT01641809 (57) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase
NCT01641809 (57) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase
NCT01641809 (57) [back to overview]Number of Participants With Adherence to Study Treatment
NCT01641809 (57) [back to overview]Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
NCT01641809 (57) [back to overview]Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis
NCT01641809 (57) [back to overview]Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Number of Participants With Adherence to Study Treatment
NCT01641809 (57) [back to overview]Number of Participants With Adherence to Study Treatment
NCT01641809 (57) [back to overview]Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Hemoglobin Level Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Hemoglobin Level Over Time by Visit
NCT01641809 (57) [back to overview]Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2
NCT01651403 (29) [back to overview]Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 48
NCT01651403 (29) [back to overview]Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 96
NCT01651403 (29) [back to overview]Percent Change From Baseline in BMD of Spine at Week 192
NCT01651403 (29) [back to overview]Percent Change From Baseline in BMD of Spine at Week 48
NCT01651403 (29) [back to overview]Percentage of Participants With ≥ 4% Decrease From Baseline in Spine BMD at Week 192
NCT01651403 (29) [back to overview]Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density (BMD) at Week 48
NCT01651403 (29) [back to overview]Percentage of Participants With HBsAg Loss at Week 192
NCT01651403 (29) [back to overview]Percentage of Participants With HBsAg Loss at Week 48
NCT01651403 (29) [back to overview]Percentage of Participants With HBsAg Seroconversion at Week 192
NCT01651403 (29) [back to overview]Percentage of Participants With HBsAg Seroconversion at Week 48
NCT01651403 (29) [back to overview]Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48
NCT01651403 (29) [back to overview]Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48
NCT01651403 (29) [back to overview]Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48, Based on the American Association for the Study of Liver Diseases (AASLD) Normal Range
NCT01651403 (29) [back to overview]Percentage of Participants With Normal ALT at Week 192, Based on the AASLD Normal Range
NCT01651403 (29) [back to overview]Percentage of Participants With Normal ALT at Week 192, Based on the Central Lab Normal Range
NCT01651403 (29) [back to overview]Percentage of Participants With Normal ALT at Week 48, Based on the Central Lab Normal Range
NCT01651403 (29) [back to overview]Percentage of Participants With Normalized ALT at Week 192, Based on the AASLD Normal Range
NCT01651403 (29) [back to overview]Percentage of Participants With Normalized ALT at Week 192, Based on the Central Lab Normal Range
NCT01651403 (29) [back to overview]Percentage of Participants With Normalized ALT at Week 48, Based on the AASLD Normal Range
NCT01651403 (29) [back to overview]Percentage of Participants With Normalized ALT at Week 48, Based on the Central Lab Normal Range
NCT01651403 (29) [back to overview]Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach)
NCT01651403 (29) [back to overview]Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)
NCT01651403 (29) [back to overview]Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 192
NCT01651403 (29) [back to overview]Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 192
NCT01651403 (29) [back to overview]Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 48
NCT01651403 (29) [back to overview]Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 192
NCT01651403 (29) [back to overview]Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 48
NCT01651403 (29) [back to overview]Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 144
NCT01651403 (29) [back to overview]Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 192
NCT01687218 (12) [back to overview]Pharmacokinetics: End Period Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Tissue
NCT01687218 (12) [back to overview]Pharmacokinetics: End Period Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Tissue
NCT01687218 (12) [back to overview]Pharmacokinetics: End Period Tenofovir-Diphosphate (TFV-DP) Concentrations (log10 ng/mg) in Rectal Tissue
NCT01687218 (12) [back to overview]Safety: Grade 2 or Higher Adverse Events
NCT01687218 (12) [back to overview]Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?
NCT01687218 (12) [back to overview]Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it?
NCT01687218 (12) [back to overview]Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently?
NCT01687218 (12) [back to overview]Adherence: Percentage of Prescribed Doses Taken Orally or Administered Rectally in an 8-week Period
NCT01687218 (12) [back to overview]Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge
NCT01687218 (12) [back to overview]Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma
NCT01687218 (12) [back to overview]Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge
NCT01687218 (12) [back to overview]Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma
NCT01691768 (8) [back to overview]Human Papillomavirus Incidence Rates
NCT01691768 (8) [back to overview]Percentage of Participants With Detectable Tenofovir Levels From Vaginal Samples at 12 Months of Follow-up
NCT01691768 (8) [back to overview]Mean Number of Returned Used Applicators Per Month (i.e in 30 Days)
NCT01691768 (8) [back to overview]Pregnancy Incidence Rates
NCT01691768 (8) [back to overview]Percentage of Participants Achieving Adherence >80%.
NCT01691768 (8) [back to overview]Product Acceptability
NCT01691768 (8) [back to overview]HIV Viral Load Among HIV Seroconverters
NCT01691768 (8) [back to overview]HIV Incidence Rates
NCT01709084 (6) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48
NCT01709084 (6) [back to overview]Percentage of Participant With Treatment Adherence Based on Tablet Count
NCT01709084 (6) [back to overview]Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations
NCT01709084 (6) [back to overview]Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48
NCT01709084 (6) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.
NCT01709084 (6) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.
NCT01745822 (5) [back to overview]Percentage of Infants With Hepatitis B Infection at or After 6 Months Through 12 Months of Age
NCT01745822 (5) [back to overview]Percentage of Participants With Flares After Study Treatment Interruption
NCT01745822 (5) [back to overview]Percentage of Participants With Adverse Events
NCT01745822 (5) [back to overview]Weight, Height and Head Circumference for Age
NCT01745822 (5) [back to overview]Percentage of Infants With Hepatitis B Infection at 6 Months of Age
NCT01769456 (12) [back to overview]Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48
NCT01769456 (12) [back to overview]Number of Participants Using Text Messaging Reminders
NCT01769456 (12) [back to overview]Number of Participants With Decrease in Bone Mineral Density
NCT01769456 (12) [back to overview]Acceptability of PrEP Regimen and Study Visits
NCT01769456 (12) [back to overview]Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex
NCT01769456 (12) [back to overview]Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48
NCT01769456 (12) [back to overview]Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
NCT01769456 (12) [back to overview]Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
NCT01769456 (12) [back to overview]Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study
NCT01769456 (12) [back to overview]Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48
NCT01769456 (12) [back to overview]Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners
NCT01769456 (12) [back to overview]Total Body Bone Mineral Density: Percent Change From Baseline to Week 48
NCT01772823 (15) [back to overview]Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age)
NCT01772823 (15) [back to overview]Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders
NCT01772823 (15) [back to overview]Lumbar Spine Bone Mineral Density at Baseline and at Week 48
NCT01772823 (15) [back to overview]Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)
NCT01772823 (15) [back to overview]Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders
NCT01772823 (15) [back to overview]Femoral Neck Bone Mineral Density at Baseline and at Week 48
NCT01772823 (15) [back to overview]Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48
NCT01772823 (15) [back to overview]Number of Participants With Unprotected Sex Acts
NCT01772823 (15) [back to overview]Number of Sex Partners
NCT01772823 (15) [back to overview]Total Body Bone Mineral Density at Baseline and at Week 48
NCT01772823 (15) [back to overview]Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)
NCT01772823 (15) [back to overview]Total Hip Bone Mineral Density at Baseline and at Week 48
NCT01772823 (15) [back to overview]Number of Participants With Serum Creatinine Event of Grade 1 or Higher
NCT01772823 (15) [back to overview]Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure
NCT01772823 (15) [back to overview]Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load)
NCT01777997 (9) [back to overview]Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay
NCT01777997 (9) [back to overview]Change in Quality of Life (QoL) Index
NCT01777997 (9) [back to overview]Change in Levels of D-dimer
NCT01777997 (9) [back to overview]Change in Levels of CD8+ T-cell Activation
NCT01777997 (9) [back to overview]Change in CD4+ T-cell Count
NCT01777997 (9) [back to overview]Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+)
NCT01777997 (9) [back to overview]Number of Subjects Who Experience Grade 3 or 4 Signs and Symptoms or Laboratory Abnormalities, Diagnoses (Any Grade), or Other Serious Adverse Events (SAEs)
NCT01777997 (9) [back to overview]Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART
NCT01777997 (9) [back to overview]Change in Levels of Interleukin (IL)-6
NCT01781806 (3) [back to overview]Number of Participants With a Grade 2 or Higher Adverse Event by Cohort
NCT01781806 (3) [back to overview]Number of HIV Seroconversions by Cohort.
NCT01781806 (3) [back to overview]Cohort H PrEP Engagement by Study Visit
NCT01803074 (28) [back to overview]Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B
NCT01803074 (28) [back to overview]Maximum Observed Plasma Concentrations (Cmax) - Part B
NCT01803074 (28) [back to overview]Maximum Observed Plasma Concentrations (Cmax) - Part A and C
NCT01803074 (28) [back to overview]Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C
NCT01803074 (28) [back to overview]Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B
NCT01803074 (28) [back to overview]Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C
NCT01803074 (28) [back to overview]Accumulation Index (AI): Part A and C
NCT01803074 (28) [back to overview]Time to Maximum Decline in Log 10 HIV-1 RNA - Part B
NCT01803074 (28) [back to overview]Plasma Half-life: Part A and C
NCT01803074 (28) [back to overview]Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11
NCT01803074 (28) [back to overview]Apparent Total Body Clearance: Part A and C
NCT01803074 (28) [back to overview]Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C
NCT01803074 (28) [back to overview]Degree of Fluctuation (DF): Part A and C
NCT01803074 (28) [back to overview]Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C
NCT01803074 (28) [back to overview]Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B
NCT01803074 (28) [back to overview]Number of Participants With Clinically Significant Changes in Heart Rate
NCT01803074 (28) [back to overview]Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C
NCT01803074 (28) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) - Part B
NCT01803074 (28) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C
NCT01803074 (28) [back to overview]Plasma Concentration 24 Hours Post-Dose (C24) - Part B
NCT01803074 (28) [back to overview]Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C
NCT01803074 (28) [back to overview]Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B
NCT01803074 (28) [back to overview]Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C
NCT01803074 (28) [back to overview]Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the Study
NCT01803074 (28) [back to overview]Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline
NCT01803074 (28) [back to overview]Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
NCT01803074 (28) [back to overview]Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
NCT01803074 (28) [back to overview]Number of Participants With Abnormal Changes in Physical Examination
NCT01855867 (3) [back to overview]Number of Participants With Self-Reported Missed Doses
NCT01855867 (3) [back to overview]nPEP Failure (HIV Infection During Study Participation)
NCT01855867 (3) [back to overview]Number of Adverse Event Occurrences
NCT01903031 (21) [back to overview]ATV PK Parameter Cmax Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]Proportion of Participants With Progesterone Levels Greater Than 5 ng/mL.
NCT01903031 (21) [back to overview]Ritonavir (RTV) PK Parameter AUC(0-24h) Calculated Based on Intensive RTV PK Samples Obtained From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]RTV PK Parameter CLss/F Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]RTV PK Parameter Cmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]RTV PK Parameter Tmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]Ethinyl Estradiol Concentrations at Study Day 21
NCT01903031 (21) [back to overview]Etonogestrel Concentrations at Study Day 21
NCT01903031 (21) [back to overview]Percentage of Participants With Signs and Symptoms of Grade 2 or Higher Deemed Possibly, Probably or Definitely Related to Study Treatment
NCT01903031 (21) [back to overview]ATV PK Parameter AUC(0-24h) Calculated Based on Intensive Atazanavir (ATV) PK Samples Obtained From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]ATV PK Parameter CLss/F Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]RTV PK Parameter Cmin Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]ATV PK Parameter Cmin Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]ATV PK Parameter Time to Cmax (Tmax) Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]EFV PK Parameter Area Under the Concentration-Time Curve (AUC0-24hours) Calculated Based on Intensive EFV PK Samples Obtained From Individual Participants Enrolled in Arm B
NCT01903031 (21) [back to overview]EFV PK Parameter Clearance (CLss/F) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
NCT01903031 (21) [back to overview]EFV PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
NCT01903031 (21) [back to overview]EFV PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
NCT01903031 (21) [back to overview]Ethinyl Estradiol Concentrations Obtained on Study Days 7 and 14.
NCT01903031 (21) [back to overview]Etonogestrel Concentrations Obtained on Study Days 7 and 14
NCT01903031 (21) [back to overview]Proportion of Participants With Plasma HIV-1 RNA Levels <40 Copies/mL
NCT01910402 (48) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups
NCT01910402 (48) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase
NCT01910402 (48) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)
NCT01910402 (48) [back to overview]Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase)
NCT01910402 (48) [back to overview]Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)
NCT01910402 (48) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase
NCT01910402 (48) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups
NCT01910402 (48) [back to overview]Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Albumin at Indicated Timepoints
NCT01910402 (48) [back to overview]Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase
NCT01910402 (48) [back to overview]Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
NCT01910402 (48) [back to overview]Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase
NCT01910402 (48) [back to overview]Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase
NCT01910402 (48) [back to overview]Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline
NCT01910402 (48) [back to overview]Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS
NCT01910402 (48) [back to overview]Change From Baseline in TC/HDL Ratio at Week 48
NCT01910402 (48) [back to overview]Change From Baseline in Triglycerides at Week 48
NCT01910402 (48) [back to overview]Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase
NCT01910402 (48) [back to overview]Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase
NCT01910402 (48) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48
NCT01910402 (48) [back to overview]Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase
NCT01910402 (48) [back to overview]Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With AEs by Maximum Toxicity-Continuation Phase
NCT01910402 (48) [back to overview]Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Creatinine Clearance at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Erythrocytes at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Hematocrit Count at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Lipase at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
NCT01910402 (48) [back to overview]Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase
NCT01910402 (48) [back to overview]Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48
NCT01910402 (48) [back to overview]HIVTSQs Total Score at Indicated Timepoints
NCT01910402 (48) [back to overview]Number of Participants With AEs by Maximum Toxicity-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With Any AEs, and SAEs in Continuation Phase
NCT01910402 (48) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase
NCT01910402 (48) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase
NCT01929759 (8) [back to overview]Neurocognitive Changes
NCT01929759 (8) [back to overview]Change in Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS)
NCT01929759 (8) [back to overview]Change in Other Neurometabolite Measured by MRS Between Week 0 and Week 8
NCT01929759 (8) [back to overview]Effect of EFV and Its Metabolites
NCT01929759 (8) [back to overview]Fasting Lipid Profile
NCT01929759 (8) [back to overview]Markers of Immune Activation
NCT01929759 (8) [back to overview]Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)
NCT01929759 (8) [back to overview]Sleep Quality
NCT02022657 (1) [back to overview]Steady State Concentrations of TFV-DP for Different Dosing Patterns of Truvada
NCT02116660 (1) [back to overview]Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
NCT02174276 (19) [back to overview]Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 48
NCT02174276 (19) [back to overview]Mean Change in Serum HBsAg From Baseline to Week 24
NCT02174276 (19) [back to overview]Number of Participants With Drug-Resistance Mutations at Week 48 or at the Last Visit Available
NCT02174276 (19) [back to overview]Percentage of Participants Experiencing Virologic Breakthrough at Week 24
NCT02174276 (19) [back to overview]Percentage of Participants Experiencing Virologic Breakthrough at Week 48
NCT02174276 (19) [back to overview]Percentage of Participants With HBeAg Loss at Week 24
NCT02174276 (19) [back to overview]Percentage of Participants With HBeAg Loss at Week 48
NCT02174276 (19) [back to overview]Percentage of Participants With HBsAg Loss at Week 24
NCT02174276 (19) [back to overview]Percentage of Participants With HBsAg Loss at Week 48
NCT02174276 (19) [back to overview]Percentage of Participants With HBV DNA < LLOQ at Week 48
NCT02174276 (19) [back to overview]Percentage of Participants With HBV DNA < Lower Limit of Quantification (LLOQ) at Week 24
NCT02174276 (19) [back to overview]Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 12
NCT02174276 (19) [back to overview]Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 48
NCT02174276 (19) [back to overview]Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 24
NCT02174276 (19) [back to overview]Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 24
NCT02174276 (19) [back to overview]Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24
NCT02174276 (19) [back to overview]Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48
NCT02174276 (19) [back to overview]Mean Change in HBsAg From Baseline to Week 12
NCT02174276 (19) [back to overview]Mean Change in HBsAg From Baseline to Week 48
NCT02180438 (12) [back to overview]Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events
NCT02180438 (12) [back to overview]Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)
NCT02180438 (12) [back to overview]Interim 24 Weeks Analysis of Death
NCT02180438 (12) [back to overview]Grade 3 or 4 Adverse Events
NCT02180438 (12) [back to overview]Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF
NCT02180438 (12) [back to overview]< 50 CD4 T-cell Increase at 48 Weeks From Baseline
NCT02180438 (12) [back to overview]CD4 T-cell Count at 48 Weeks < Baseline
NCT02180438 (12) [back to overview]Death
NCT02180438 (12) [back to overview]Switching Off Stribild Prior to 48 Weeks
NCT02180438 (12) [back to overview]New WHO Stage 3 or 4 Event
NCT02180438 (12) [back to overview]Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event
NCT02180438 (12) [back to overview]Interim Analysis at 24 Weeks of HIV-2 Virologic Failure
NCT02195518 (18) [back to overview]Change From Baseline in Hemoglobin (Hb)
NCT02195518 (18) [back to overview]Percentage of Participants With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48 and 96
NCT02195518 (18) [back to overview]Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, and 144 in Participants Who Had Abnormal ALT at Baseline
NCT02195518 (18) [back to overview]Percentage of Participants Who Experienced Viral Breakthrough up to Week 144
NCT02195518 (18) [back to overview]Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144
NCT02195518 (18) [back to overview]Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144
NCT02195518 (18) [back to overview]Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144
NCT02195518 (18) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs
NCT02195518 (18) [back to overview]Change From Baseline in Red Blood Cells (RBC)
NCT02195518 (18) [back to overview]Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144
NCT02195518 (18) [back to overview]Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
NCT02195518 (18) [back to overview]Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine
NCT02195518 (18) [back to overview]Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
NCT02195518 (18) [back to overview]Change From Baseline in Chemistry Parameters: Albumin, Total Protein
NCT02195518 (18) [back to overview]Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
NCT02195518 (18) [back to overview]Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
NCT02195518 (18) [back to overview]Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose.
NCT02195518 (18) [back to overview]Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Unit Per Milliliter (IU/mL) at Week 144
NCT02213328 (11) [back to overview]Number of Participants With Acceptability as Per Questionnaire Administered at Week 48
NCT02213328 (11) [back to overview]The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package
NCT02213328 (11) [back to overview]Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit
NCT02213328 (11) [back to overview]Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP
NCT02213328 (11) [back to overview]Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events
NCT02213328 (11) [back to overview]Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period
NCT02213328 (11) [back to overview]Number of Adolescents Enrolled and Retained in the Study
NCT02213328 (11) [back to overview]Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit
NCT02213328 (11) [back to overview]Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 52
NCT02213328 (11) [back to overview]Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment
NCT02213328 (11) [back to overview]Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36
NCT02224456 (24) [back to overview]Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240
NCT02224456 (24) [back to overview]Change From Baseline in Red Blood Cells (RBC)
NCT02224456 (24) [back to overview]Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA
NCT02224456 (24) [back to overview]Change From Baseline in Hemoglobin (Hb)
NCT02224456 (24) [back to overview]Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
NCT02224456 (24) [back to overview]Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
NCT02224456 (24) [back to overview]Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)
NCT02224456 (24) [back to overview]Change From Baseline in Chemistry Parameters: Albumin and Total Protein
NCT02224456 (24) [back to overview]Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
NCT02224456 (24) [back to overview]Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
NCT02224456 (24) [back to overview]Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240
NCT02224456 (24) [back to overview]Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192
NCT02224456 (24) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs
NCT02224456 (24) [back to overview]Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240
NCT02224456 (24) [back to overview]Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.
NCT02224456 (24) [back to overview]Percentage of Participants Who Experienced Viral Breakthrough
NCT02224456 (24) [back to overview]Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline
NCT02224456 (24) [back to overview]Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240
NCT02224456 (24) [back to overview]Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240
NCT02224456 (24) [back to overview]Percentage of Participants With Histological Improvement at Week 216
NCT02224456 (24) [back to overview]Percentage of Participants With Disease Progression at Week 240
NCT02224456 (24) [back to overview]Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240
NCT02224456 (24) [back to overview]Percentage of Participants With Cirrhosis Reversal at Week 216
NCT02224456 (24) [back to overview]Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate
NCT02251236 (4) [back to overview]Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline
NCT02251236 (4) [back to overview]Concentration of Elvitegravir in Cerebrospinal Fluid at Week 24
NCT02251236 (4) [back to overview]Concentration of Tenofovir in Cerebrospinal Fluid at Week 24
NCT02251236 (4) [back to overview]Concentration of Tenofovir in Cerebrospinal Fluid at Baseline
NCT02386098 (8) [back to overview]Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1
NCT02386098 (8) [back to overview]Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24-Stage 1
NCT02386098 (8) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1
NCT02386098 (8) [back to overview]Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1
NCT02386098 (8) [back to overview]Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1
NCT02386098 (8) [back to overview]Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1
NCT02386098 (8) [back to overview]Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1
NCT02386098 (8) [back to overview]Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1
NCT02397096 (12) [back to overview]Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
NCT02397096 (12) [back to overview]Percentage of Participants Experiencing ≥1 Adverse Event (AE)
NCT02397096 (12) [back to overview]Percentage of Participants Experiencing ≥1 Serious Adverse Event (SAE)
NCT02397096 (12) [back to overview]Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
NCT02397096 (12) [back to overview]Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
NCT02397096 (12) [back to overview]Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
NCT02397096 (12) [back to overview]Percentage of Participants With HIV-1 RNA >=50 Copies/mL
NCT02397096 (12) [back to overview]Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
NCT02397096 (12) [back to overview]Mean Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
NCT02397096 (12) [back to overview]Mean Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
NCT02397096 (12) [back to overview]Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
NCT02397096 (12) [back to overview]Percentage of Participants Maintaining HIV-1 RNA <50 Copies/mL
NCT02401230 (13) [back to overview]Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration
NCT02401230 (13) [back to overview]Median Cumulative Amount of p24
NCT02401230 (13) [back to overview]Median Rectal Tissue Tenofovir (TDF) Concentration
NCT02401230 (13) [back to overview]Median Rectal Tissue Emtricitabine (FTC) Concentration
NCT02401230 (13) [back to overview]Median Rectal Secretion Tenofovir (TDF) Concentration
NCT02401230 (13) [back to overview]Median Rectal Secretion Emtricitabine (FTC) Concentration
NCT02401230 (13) [back to overview]Median Plasma Tenofovir (TDF) Concentration
NCT02401230 (13) [back to overview]Median Plasma Emtricitabine (FTC) Concentration
NCT02401230 (13) [back to overview]Median Peripheral Blood Mononuclear Cell (PBMC) Tenofovir (TDF) Concentration
NCT02401230 (13) [back to overview]Median Peripheral Blood Mononuclear Cell (PBMC) Emtricitabine (FTC) Concentration
NCT02401230 (13) [back to overview]Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration
NCT02401230 (13) [back to overview]Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration
NCT02401230 (13) [back to overview]Median Percentage of CD4 Positive T-Cells
NCT02403674 (14) [back to overview]Change From Baseline in Fasting Non-HDL-C at Week 48
NCT02403674 (14) [back to overview]Change From Baseline in Fasting Triglycerides at Week 48
NCT02403674 (14) [back to overview]Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
NCT02403674 (14) [back to overview]Percentage of Participants Experiencing ≥1 AE
NCT02403674 (14) [back to overview]Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
NCT02403674 (14) [back to overview]Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
NCT02403674 (14) [back to overview]Percentage of Participants With HIV-1 RNA Below the Limit of Quantification (BLoQ) at Week 48
NCT02403674 (14) [back to overview]Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)
NCT02403674 (14) [back to overview]Percentage of Participants With Tier-2 Neuropsychiatric AEs
NCT02403674 (14) [back to overview]Plasma Concentration of Doravirine at Week 48
NCT02403674 (14) [back to overview]Change From Baseline in CD4 Cell Counts at Week 48
NCT02403674 (14) [back to overview]Change From Baseline in Fasting Cholesterol at Week 48
NCT02403674 (14) [back to overview]Change From Baseline in Fasting HDL-C at Week 48
NCT02403674 (14) [back to overview]Change From Baseline in Fasting LDL-C at Week 48
NCT02431247 (64) [back to overview]Change From Reference in log10 HIV-1 RNA Levels at Week 96
NCT02431247 (64) [back to overview]Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula
NCT02431247 (64) [back to overview]Change From Reference in Serum Creatinine
NCT02431247 (64) [back to overview]Change From Reference in UACR
NCT02431247 (64) [back to overview]Change From Reference in UB2MGCR
NCT02431247 (64) [back to overview]Change From Reference in UPCR
NCT02431247 (64) [back to overview]Change From Reference in URBPCR
NCT02431247 (64) [back to overview]Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Week 48
NCT02431247 (64) [back to overview]Percent Change From Reference in Urine FEPO4
NCT02431247 (64) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies Per mL at Week 96 Defined by FDA Snapshot Approach
NCT02431247 (64) [back to overview]Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies Per mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach
NCT02431247 (64) [back to overview]Plasma Concentrations 2 Hours After Dosing (C0-2h) of Tenofovir Alafenamide
NCT02431247 (64) [back to overview]Predose (Trough) Plasma Concentration (C0h) of Darunavir
NCT02431247 (64) [back to overview]CD4+ Cell Count Post-Week From 96 to End of Extension
NCT02431247 (64) [back to overview]Change From Baseline in Alkaline Phosphatase (ALP) Levels at Weeks 24 and 48
NCT02431247 (64) [back to overview]Change From Baseline in BMD T-score of Hip and Spine
NCT02431247 (64) [back to overview]Change From Baseline in Levels of 25-Hydroxyvitamin D (25-OH Vitamin D), at Week 24 and 48
NCT02431247 (64) [back to overview]Change From Baseline in Levels of Parathyroid Hormone (PTH) at Weeks 24 and 48
NCT02431247 (64) [back to overview]Change From Baseline in Levels of Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) at Weeks 24 and 48
NCT02431247 (64) [back to overview]Change From Baseline in Levels of Serum Procollagen 1 N-Terminal Propeptide (P1NP) at Weeks 24 and 48
NCT02431247 (64) [back to overview]Change From Reference in BMD T-score of Hip and Spine at Week 96
NCT02431247 (64) [back to overview]Number of Participants With ARV Resistance
NCT02431247 (64) [back to overview]Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD)
NCT02431247 (64) [back to overview]Percent Change From Reference in Hip and Spine BMD
NCT02431247 (64) [back to overview]Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability
NCT02431247 (64) [back to overview]Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability
NCT02431247 (64) [back to overview]Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability
NCT02431247 (64) [back to overview]Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 48
NCT02431247 (64) [back to overview]Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 96
NCT02431247 (64) [back to overview]Percentage of Participants With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations Due to Adverse Events Post-Week 96 to End of Extension
NCT02431247 (64) [back to overview]Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension
NCT02431247 (64) [back to overview]Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm
NCT02431247 (64) [back to overview]Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm
NCT02431247 (64) [back to overview]Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm
NCT02431247 (64) [back to overview]Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine by Cockcroft-Gault Formula
NCT02431247 (64) [back to overview]Change From Reference in eGFRcr by CKD-EPI Formula
NCT02431247 (64) [back to overview]Change From Reference in CD4+ Cell Count at Week 96
NCT02431247 (64) [back to overview]Change From Reference in ALP Levels
NCT02431247 (64) [back to overview]Change From Baseline in Urine Retinol Binding Protein To Creatinine Ratio (URBPCR) at Week 48
NCT02431247 (64) [back to overview]Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48
NCT02431247 (64) [back to overview]Change From Baseline in Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Week 48
NCT02431247 (64) [back to overview]Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) at Week 48
NCT02431247 (64) [back to overview]Change From Baseline in Serum Creatinine at Week 48
NCT02431247 (64) [back to overview]Change From Baseline in log10 HIV-1 RNA Levels at Week 48
NCT02431247 (64) [back to overview]Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula at Week 48
NCT02431247 (64) [back to overview]Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine by (Cockcroft-Gault Formula) at Week 48
NCT02431247 (64) [back to overview]Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula at Week 48
NCT02431247 (64) [back to overview]Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Week 48
NCT02431247 (64) [back to overview]Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) of Darunavir
NCT02431247 (64) [back to overview]Area Under the Plasma Concentration Time Curve Across the Dosing Interval (AUCtau) of Tenofovir Alafenamide
NCT02431247 (64) [back to overview]Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach
NCT02431247 (64) [back to overview]Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach
NCT02431247 (64) [back to overview]Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach
NCT02431247 (64) [back to overview]Percentage of Participants With Non-PDVF by Kaplan-Meier Estimates
NCT02431247 (64) [back to overview]Percentage of Participants With PDVF Post-week 96 to End of Extension
NCT02431247 (64) [back to overview]Percentage of Participants With Protocol-defined Virologic Failure (PDVF)
NCT02431247 (64) [back to overview]Percentage of Participants With Protocol-defined Virologic Failure (PDVF)
NCT02431247 (64) [back to overview]Percentage of Participants With Protocol-defined Virologic Failure (PDVF)
NCT02431247 (64) [back to overview]Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates
NCT02431247 (64) [back to overview]Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates
NCT02431247 (64) [back to overview]Change From Reference in Levels of Serum CTX
NCT02431247 (64) [back to overview]Change From Reference in Levels of PTH
NCT02431247 (64) [back to overview]Change From Reference in Levels of 25-OH Vitamin D
NCT02431247 (64) [back to overview]Change From Reference in Levels of Serum P1NP
NCT02452528 (1) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs)
NCT02479880 (1) [back to overview]Percentage of Participants With Bone-Related Adverse Events and/or a ≥ 4% Reduction in Bone Mineral Density (BMD) From Baseline to Week 96
NCT02495779 (1) [back to overview]Number of Participants With PrEP Adherence
NCT02556333 (1) [back to overview]HIV RNA Change From Baseline to Day 10
NCT02577029 (1) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment
NCT02603120 (7) [back to overview]Spine Bone Mineral Density (BMD) at Baseline
NCT02603120 (7) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm
NCT02603120 (7) [back to overview]Percentage Change From Baseline in Spine BMD at Week 48
NCT02603120 (7) [back to overview]Percentage Change From Baseline in Hip BMD at Week 48
NCT02603120 (7) [back to overview]Hip Bone Mineral Density at Baseline
NCT02603120 (7) [back to overview]Change From Baseline in CD4+ Cell Count at Week 48
NCT02603120 (7) [back to overview]Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm
NCT02604199 (3) [back to overview]Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113
NCT02604199 (3) [back to overview]Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
NCT02604199 (3) [back to overview]Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) Over Time
NCT02604212 (26) [back to overview]Change From Baseline at Day 29 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 15 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 15 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 15 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 113 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 113 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 85 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113
NCT02604212 (26) [back to overview]Change From Baseline at Day 113 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs
NCT02604212 (26) [back to overview]Change From Baseline in Log qHBsAg Over Time
NCT02604212 (26) [back to overview]Change From Baseline at Day 99 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 99 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 99 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 85 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 85 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 71 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 71 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 71 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 57 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 57 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 57 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 43 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 43 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 43 in Log qHBsAg, by Category
NCT02604212 (26) [back to overview]Change From Baseline at Day 29 in Log qHBsAg, by Category
NCT02629822 (14) [back to overview]Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96
NCT02629822 (14) [back to overview]Change From Baseline in CD4 Cell Count at Week 48
NCT02629822 (14) [back to overview]Change From Baseline in CD4 Cell Count at Week 192
NCT02629822 (14) [back to overview]Time to Loss of Virologic Response
NCT02629822 (14) [back to overview]Change From Baseline in CD4 Cell Count at Week 96
NCT02629822 (14) [back to overview]Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96
NCT02629822 (14) [back to overview]Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48.
NCT02629822 (14) [back to overview]Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96
NCT02629822 (14) [back to overview]Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48
NCT02629822 (14) [back to overview]Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96
NCT02629822 (14) [back to overview]Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48
NCT02629822 (14) [back to overview]Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 192
NCT02629822 (14) [back to overview]Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 192
NCT02629822 (14) [back to overview]Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48
NCT02652260 (20) [back to overview]Number of Participants With One or More Drug-related SAEs Through Study Week 12
NCT02652260 (20) [back to overview]Percentage of Participants With HIV-1 RNA <50 and <40 Copies/ml at Week 24 Post-switch for the Combined Treatment Groups
NCT02652260 (20) [back to overview]CNS Toxicity Scores at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups
NCT02652260 (20) [back to overview]Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups
NCT02652260 (20) [back to overview]Change From Baseline in Fasting Lipids at Week 12
NCT02652260 (20) [back to overview]Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Week 4
NCT02652260 (20) [back to overview]Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups
NCT02652260 (20) [back to overview]Percentage of Participants With at Least One Central Nervous System (CNS) Toxicity of at Least Grade 2 Intensity at Week 12
NCT02652260 (20) [back to overview]Number of Participants With One or More Serious Adverse Events (SAEs) Through Study Week 12
NCT02652260 (20) [back to overview]Number of Participants With One or More SAEs for the Combined Treatment Groups 24 Weeks After the Switch
NCT02652260 (20) [back to overview]Number of Participants With One or More Drug-related SAEs for the Combined Treatment Groups 24 Weeks After the Switch
NCT02652260 (20) [back to overview]Number of Participants With One or More Drug-related AEs Through Study Week 12
NCT02652260 (20) [back to overview]Change From Baseline in CNS Toxicity Score at Week 12
NCT02652260 (20) [back to overview]Number of Participants With One or More Drug-related AEs for the Combined Treatment Groups 24 Weeks After the Switch
NCT02652260 (20) [back to overview]Number of Participants With One or More AEs for the Combined Treatment Groups 24 Weeks After the Switch
NCT02652260 (20) [back to overview]Number of Participants With One or More Adverse Events (AEs) Through Study Week 12
NCT02652260 (20) [back to overview]Number of Participants Who Discontinued Treatment Due to an AE Through Study Week 12
NCT02652260 (20) [back to overview]Number of Participants Who Discontinued Treatment Due to an AE for the Combined Treatment Groups 24 Weeks After the Switch
NCT02652260 (20) [back to overview]Change From Baseline in CNS Toxicity Score at Week 4
NCT02652260 (20) [back to overview]Change From Time of Switch to Week 24 Post Switch in CD4 T-cell Count for the Combined Treatment Groups
NCT02738008 (1) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
NCT02797522 (2) [back to overview]Number of Participants With TEAEs: CHB Participants
NCT02797522 (2) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy Volunteers
NCT02815566 (2) [back to overview]% Change in Bone Mineral Density From Baseline at the Femoral Neck
NCT02815566 (2) [back to overview]Percent Change in Bone Mineral Density From Baseline at the Lumbar Spine
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 96
NCT02831673 (64) [back to overview]Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48
NCT02831673 (64) [back to overview]Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96
NCT02831673 (64) [back to overview]Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144
NCT02831673 (64) [back to overview]Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48
NCT02831673 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24
NCT02831673 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96
NCT02831673 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48
NCT02831673 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144
NCT02831673 (64) [back to overview]Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48
NCT02831673 (64) [back to overview]Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48
NCT02831673 (64) [back to overview]Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144
NCT02831673 (64) [back to overview]Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 24 and 48
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48
NCT02831673 (64) [back to overview]Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48
NCT02831673 (64) [back to overview]Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48
NCT02831673 (64) [back to overview]Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48
NCT02831673 (64) [back to overview]Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48
NCT02831673 (64) [back to overview]CD4+ Cell Counts at Weeks 24 and 48
NCT02831673 (64) [back to overview]Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144
NCT02831673 (64) [back to overview]Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48
NCT02831673 (64) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96
NCT02831673 (64) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
NCT02831673 (64) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144
NCT02831673 (64) [back to overview]Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96
NCT02831673 (64) [back to overview]Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144
NCT02831673 (64) [back to overview]Number of Participants Who Discontinue Treatment Due to AEs Over Week 144
NCT02831673 (64) [back to overview]Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum RBP at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum RBP at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in EQ-5D-5L Utility Score at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in EQ-5D-5L Utility Score at Week 144
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups
NCT02831673 (64) [back to overview]Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144
NCT02831673 (64) [back to overview]CD4+ Cell Counts at Week 96
NCT02831673 (64) [back to overview]Number of Participants With AEs by Maximum Severity Grades up to Week 144
NCT02831673 (64) [back to overview]Number of Participants With Any AE and SAE up to Week 148
NCT02831673 (64) [back to overview]Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144
NCT02831673 (64) [back to overview]Number of Participants With HIV-1 Disease Progression up to Week 144
NCT02831673 (64) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144
NCT02831673 (64) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144
NCT02831673 (64) [back to overview]CD4+ Cell Counts at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum RBP at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in EQ-5D-5L Utility Score at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144
NCT02831764 (64) [back to overview]CD4+ Cell Counts at Week 96
NCT02831764 (64) [back to overview]CD4+ Cell Counts at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in EQ-5D-5L Utility Score at Week 96
NCT02831764 (64) [back to overview]Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144
NCT02831764 (64) [back to overview]Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48
NCT02831764 (64) [back to overview]Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96
NCT02831764 (64) [back to overview]Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144
NCT02831764 (64) [back to overview]Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48
NCT02831764 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24
NCT02831764 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96
NCT02831764 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48
NCT02831764 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144
NCT02831764 (64) [back to overview]Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48
NCT02831764 (64) [back to overview]Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48
NCT02831764 (64) [back to overview]Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144
NCT02831764 (64) [back to overview]Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144
NCT02831764 (64) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144
NCT02831764 (64) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144
NCT02831764 (64) [back to overview]Number of Participants With HIV-1 Disease Progression up to Week 144
NCT02831764 (64) [back to overview]Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148
NCT02831764 (64) [back to overview]Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) up to Week 148
NCT02831764 (64) [back to overview]Number of Participants With AEs by Maximum Severity Grades up to Week 148
NCT02831764 (64) [back to overview]Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96
NCT02831764 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups
NCT02831764 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups
NCT02831764 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups
NCT02831764 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 24 and 48
NCT02831764 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48
NCT02831764 (64) [back to overview]Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24, 48
NCT02831764 (64) [back to overview]Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48
NCT02831764 (64) [back to overview]Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48
NCT02831764 (64) [back to overview]Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48
NCT02831764 (64) [back to overview]CD4+ Cell Counts at Weeks 24 and 48
NCT02831764 (64) [back to overview]Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48
NCT02831764 (64) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96
NCT02831764 (64) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
NCT02831764 (64) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144
NCT02831764 (64) [back to overview]Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96
NCT02831764 (64) [back to overview]Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144
NCT02831764 (64) [back to overview]Number of Participants Who Discontinue Treatment Due to AEs Over Week 144
NCT02831764 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 96
NCT02831764 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum RBP at Week 96
NCT02859558 (4) [back to overview]Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation
NCT02859558 (4) [back to overview]Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)
NCT02859558 (4) [back to overview]HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
NCT02859558 (4) [back to overview]HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
NCT02888106 (13) [back to overview]Percentage of Patients With HBsAg Negativation
NCT02888106 (13) [back to overview]Percentage of Patients With HВsAg Response
NCT02888106 (13) [back to overview]Percentage of Patients With Negative HBV DNA by PCR
NCT02888106 (13) [back to overview]Percentage of Patients With Normalized ALT
NCT02888106 (13) [back to overview]The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.
NCT02888106 (13) [back to overview]Percentage of Patients With Negative HDV RNA by PCR
NCT02888106 (13) [back to overview]Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
NCT02888106 (13) [back to overview]Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).
NCT02888106 (13) [back to overview]Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.
NCT02888106 (13) [back to overview]Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment
NCT02888106 (13) [back to overview]Change in the Gene Expression Analyses From Baseline to Post-treatment
NCT02888106 (13) [back to overview]Percentage of Patients With Combined Response
NCT02888106 (13) [back to overview]Percentage of Patients With Negative HDV RNA by PCR
NCT02962739 (1) [back to overview]Steady State Concentrations of TFV-DP for Different Dosing Patterns of Descovy
NCT02968576 (2) [back to overview]Area Under the Concentration-time Curve (AUC)
NCT02968576 (2) [back to overview]Peak Plasma Concentration (Cmax)
NCT03048422 (23) [back to overview]Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event
NCT03048422 (23) [back to overview]Maternal Change in Creatinine Clearance
NCT03048422 (23) [back to overview]Percentage of Infants Born Small for Gestational Age
NCT03048422 (23) [back to overview]Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome
NCT03048422 (23) [back to overview]Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome
NCT03048422 (23) [back to overview]Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly
NCT03048422 (23) [back to overview]Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure
NCT03048422 (23) [back to overview]Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum
NCT03048422 (23) [back to overview]Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory
NCT03048422 (23) [back to overview]Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm
NCT03048422 (23) [back to overview]Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm
NCT03048422 (23) [back to overview]Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery
NCT03048422 (23) [back to overview]Change in Maternal Weight Antepartum
NCT03048422 (23) [back to overview]Change in Maternal Weight Overall
NCT03048422 (23) [back to overview]Change in Maternal Weight Postpartum
NCT03048422 (23) [back to overview]Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis
NCT03048422 (23) [back to overview]Infant Creatinine Clearance
NCT03048422 (23) [back to overview]Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery
NCT03048422 (23) [back to overview]Percentage of Mother-Infant Pairs With Preterm Deliveries
NCT03048422 (23) [back to overview]Cumulative Probability of Infant Deaths
NCT03048422 (23) [back to overview]Cumulative Probability of Infant HIV-infection
NCT03048422 (23) [back to overview]Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event
NCT03048422 (23) [back to overview]Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event
NCT03126370 (6) [back to overview]Change From Week 12 Plasma Tenofovir Area Under the Plasma Concentration vs. Time Curve From Time 0 to 24 Hours (AUC0-24) at 24 and 28 Weeks
NCT03126370 (6) [back to overview]Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS)
NCT03126370 (6) [back to overview]Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs) at 24 and 28 Weeks
NCT03126370 (6) [back to overview]Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: eGFR
NCT03126370 (6) [back to overview]Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: UPCR
NCT03126370 (6) [back to overview]Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: B2M/Cr Ratio, and RBP/Cr Ratio
NCT03164564 (2) [back to overview]Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2
NCT03164564 (2) [back to overview]Number of Pariicipants With Documented Incident HIV Infections
NCT03202511 (2) [back to overview]PBMC TFV-DP AUC GMR
NCT03202511 (2) [back to overview]Plasma TFV AUC0-INF GMR
NCT03218592 (4) [back to overview]Whole Blood Antiretroviral Concentrations
NCT03218592 (4) [back to overview]Plasma Antiretroviral Concentrations
NCT03218592 (4) [back to overview]Peripheral Blood Mononuclear Cells (PBMC) Antiretroviral Concentrations
NCT03218592 (4) [back to overview]Hair Antiretroviral Imaging
NCT03258710 (36) [back to overview]Percentage of Eosinophils at Indicated Time Points
NCT03258710 (36) [back to overview]Percentage of Basophils at Indicated Time Points
NCT03258710 (36) [back to overview]Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Values
NCT03258710 (36) [back to overview]Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96
NCT03258710 (36) [back to overview]Absolute Values for Hematology Parameter: Hemoglobin
NCT03258710 (36) [back to overview]Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
NCT03258710 (36) [back to overview]Absolute Values for Hematology Parameter: Prothrombin Time
NCT03258710 (36) [back to overview]Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count
NCT03258710 (36) [back to overview]Absolute Values for Hematology Parameter: Hematocrit
NCT03258710 (36) [back to overview]Absolute Values for Heart Rate
NCT03258710 (36) [back to overview]Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid
NCT03258710 (36) [back to overview]Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN)
NCT03258710 (36) [back to overview]Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase
NCT03258710 (36) [back to overview]Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24, 48 and 96
NCT03258710 (36) [back to overview]Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH)
NCT03258710 (36) [back to overview]Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein
NCT03258710 (36) [back to overview]Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR)
NCT03258710 (36) [back to overview]Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance
NCT03258710 (36) [back to overview]Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)
NCT03258710 (36) [back to overview]Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count
NCT03258710 (36) [back to overview]Percentage of Participants Who Achieved 0.25 Log10 HBsAg Reduction From the Baseline at Weeks 24 and 96
NCT03258710 (36) [back to overview]Absolute Values for Temperature
NCT03258710 (36) [back to overview]Change From Baseline Log Values for HBcrAg Titer at Weeks 24, 48 and 96
NCT03258710 (36) [back to overview]Change From Baseline Log Values for HBsAg Titer at Weeks 24, 48 and 96
NCT03258710 (36) [back to overview]Change From Baseline Values for Beta-2-microglobulin
NCT03258710 (36) [back to overview]Change From Baseline Values for Bone Density
NCT03258710 (36) [back to overview]Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate
NCT03258710 (36) [back to overview]Number of Participants Who Reported Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)
NCT03258710 (36) [back to overview]Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48
NCT03258710 (36) [back to overview]Percentage of Total Neutrophils at Indicated Time Points
NCT03258710 (36) [back to overview]Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24, 48 and 96
NCT03258710 (36) [back to overview]Percentage of Participants Who Achieved HBsAg Loss at Weeks 24, 48 and 96
NCT03258710 (36) [back to overview]Percentage of Participants Who Achieved HBeAg Loss at Weeks 24, 48 and 96
NCT03258710 (36) [back to overview]Percentage of Participants Who Achieved 0.25 Logarithm to the Base 10 (Log10) Hepatitis B Surface Antigen (HBsAg) Reduction From the Baseline at Week 48
NCT03258710 (36) [back to overview]Percentage of Monocytes at Indicated Time Points
NCT03258710 (36) [back to overview]Percentage of Lymphocytes at Indicated Time Points
NCT03272347 (18) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
NCT03272347 (18) [back to overview]Change From Baseline in Mature T-helper (CD4+ T)-Cell Count at Week 24
NCT03272347 (18) [back to overview]Change From Baseline in CD4+ T-cell Count at Week 96
NCT03272347 (18) [back to overview]Change From Baseline in CD4+ T-cell Count at Week 192 (Part 4)
NCT03272347 (18) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After Starting Open-label Doravirine/Islatravir Regimen (Part 4)
NCT03272347 (18) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After 3TC and Placebo Are Discontinued From the Regimen
NCT03272347 (18) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen
NCT03272347 (18) [back to overview]Number of Participants Discontinuing Study Drug Due to AEs up to Week 144
NCT03272347 (18) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 24
NCT03272347 (18) [back to overview]Number of Participants Experiencing AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen
NCT03272347 (18) [back to overview]Number of Participants Experiencing AEs From Week 96 Through Study Duration
NCT03272347 (18) [back to overview]Number of Participants Experiencing AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)
NCT03272347 (18) [back to overview]Change From Baseline in CD4+ T-cell Count at Week 144
NCT03272347 (18) [back to overview]Number of Participants Discontinuing Study Drug Due to AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)
NCT03272347 (18) [back to overview]Number of Participants Discontinuing Study Drug Due to AEs From Week 96 Through Study Duration
NCT03272347 (18) [back to overview]Number of Participants Discontinuing Study Drug Due to AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen
NCT03272347 (18) [back to overview]Number of Participants Experiencing Adverse Events (AEs) up to Week 144
NCT03272347 (18) [back to overview]Change From Baseline in CD4+ T-cell Count at Week 48
NCT03332095 (38) [back to overview]Summary of Changes in CD4 Count From Baseline to Week 96 (Cohort 2)
NCT03332095 (38) [back to overview]Summary of Changes in CD4 Count From Baseline to Week 48 (Cohort 2)
NCT03332095 (38) [back to overview]Summary of Changes in CD4 Count From Baseline to Week 24 (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: Single-dose Maximum Concentration (Cmax) of DOR (Cohort 1)
NCT03332095 (38) [back to overview]PK Parameter: Single-dose 24 Hour-concentration (C24hr) of DOR (Cohort 1)
NCT03332095 (38) [back to overview]PK Parameter: Cmax of Tenofovir (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: Cmax of DOR (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: Cmax of 3TC (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: C24hr of DOR (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: C24hr of 3TC (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events Assessed as Related to Study Drug
NCT03332095 (38) [back to overview]Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug (Cohort 2) Through End of Study
NCT03332095 (38) [back to overview]Summary of log10 Drop From Baseline to Week 48 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 24 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 48 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 96 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Serious Adverse Events (SAEs) Assessed as Related to Study Drug
NCT03332095 (38) [back to overview]Percentage of Participants With Serious Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study
NCT03332095 (38) [back to overview]Pharmacokinetic (PK) Parameter: Single-dose Area-under-the-curve (AUC0-∞) of Doravirine (DOR) (Cohort 1)
NCT03332095 (38) [back to overview]PK Parameter: AUC0-24hr of 3TC (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: AUC0-24hr of DOR (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: AUC0-24hr of Tenofovir (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Grade 3 or Higher Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study
NCT03332095 (38) [back to overview]Percentage of Participants With Grade 3 or Higher Adverse Events (AEs) Assessed as Related to Study Drug
NCT03332095 (38) [back to overview]Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 48 (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: C24hr of Tenofovir (Cohort 2)
NCT03332095 (38) [back to overview]Summary of log10 Drop From Baseline to Week 96 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)
NCT03332095 (38) [back to overview]Summary of log10 Drop From Baseline to Week 24 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)
NCT03332095 (38) [back to overview]Summary of Changes in CD4% From Baseline to Week 96 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 96 (Cohort 2)
NCT03332095 (38) [back to overview]Summary of Changes in CD4% From Baseline to Week 48 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 24 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 96 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 48 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 24 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study
NCT03332095 (38) [back to overview]Summary of Changes in CD4% From Baseline to Week 24 (Cohort 2)
NCT03387462 (4) [back to overview]DOT Diary Mobile App Ease of Use
NCT03387462 (4) [back to overview]Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP
NCT03387462 (4) [back to overview]Assessment of Situations and Reasons for Sub-optimal Use of the App
NCT03387462 (4) [back to overview]DOT Diary Mobile App Acceptability
NCT03471624 (4) [back to overview]The Mean Bone Mass Density (T-score) Change
NCT03471624 (4) [back to overview]Number of Participants With Normal Alanine Aminotransferase (ALT).
NCT03471624 (4) [back to overview]Calculated eGFR
NCT03471624 (4) [back to overview]Number of Participants With HBV DNA <20 IU Per mL
NCT03510468 (1) [back to overview]Plasma Area Under the Curve (AUC) for Tenofovir (TFV) During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)
NCT03512964 (4) [back to overview]Number of Patients Who Accepted Rapid HIV Treatment Initiation
NCT03512964 (4) [back to overview]Rapid HIV Treatment Initiation Acceptability as Assessed by the Number of Patients Who Respond Yes to Starting ART Same Day
NCT03512964 (4) [back to overview]Number of Patients Who Receive Rapid HIV Treatment Initiation
NCT03512964 (4) [back to overview]Number of Patients Offered Rapid HIV Treatment Initiation
NCT03537404 (10) [back to overview]AUCtau of Raltegravir
NCT03537404 (10) [back to overview]AUCtau of Narlaprevir
NCT03537404 (10) [back to overview]AUCtau of Tenofovir
NCT03537404 (10) [back to overview]Number of Patients With Abnormal ECG Changes
NCT03537404 (10) [back to overview]Number of Patients With Changes in Vital Signs
NCT03537404 (10) [back to overview]Number of Patients With Adverse Events
NCT03537404 (10) [back to overview]Cmax of Tenofovir
NCT03537404 (10) [back to overview]Cmax of Raltegravir
NCT03537404 (10) [back to overview]Cmax of Narlaprevir
NCT03537404 (10) [back to overview]Number of Patients With Abnormal Laboratory Values
NCT03546621 (8) [back to overview]Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
NCT03546621 (8) [back to overview]Combined Response: HDV RNA Response and Normal ALT at Treatment Week 24
NCT03546621 (8) [back to overview]Durability of HDV RNA Response
NCT03546621 (8) [back to overview]Changes in ALT Values
NCT03546621 (8) [back to overview]Change in Hepatitis B Surface Antigen
NCT03546621 (8) [back to overview]Change (Absence of Increase) in Fibrosis Marker
NCT03546621 (8) [back to overview]Absence of a Fibrosis Progression According to the Findings of Transient Elastometry
NCT03546621 (8) [back to overview]Change in HBV DNA Levels at Week 24 and Week 48 Compared to Baseline
NCT03567382 (5) [back to overview]Number of Infants Receiving Timely Birth Dose Vaccination
NCT03567382 (5) [back to overview]Number of Participants With Lab Testing Acceptability Survey Scores >80%
NCT03567382 (5) [back to overview]Number of Mothers With Infant Vaccination Acceptability Survey Scores >80%
NCT03567382 (5) [back to overview]Number of Mothers With High-risk HBV Demonstrating Adherence to Tenofovir Therapy
NCT03567382 (5) [back to overview]Number of Infants With HBV Positivity at 6 Months of Life to Indicate Mother-to-Child Transmission of HBV
NCT03576066 (12) [back to overview]Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
NCT03576066 (12) [back to overview]Number of Participants With a Clinically-significant Change in Vital Signs
NCT03576066 (12) [back to overview]Number of Participants With a Clinically-significant Electrocardiogram Abnormality
NCT03576066 (12) [back to overview]Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy
NCT03576066 (12) [back to overview]Number of Participants With One or More Abnormal Safety Laboratory Result
NCT03576066 (12) [back to overview]Number of Participants With One or More Adverse Events
NCT03576066 (12) [back to overview]Number of Participants With Premature Study Discontinuation
NCT03576066 (12) [back to overview]Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
NCT03576066 (12) [back to overview]Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
NCT03576066 (12) [back to overview]Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
NCT03576066 (12) [back to overview]Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
NCT03576066 (12) [back to overview]Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
NCT03593655 (4) [back to overview]Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets
NCT03593655 (4) [back to overview]Number of Participant-Visits Reporting Acceptability of Study Product
NCT03593655 (4) [back to overview]Number of Participants With Grade 2 or Higher Adverse Events (AEs)
NCT03593655 (4) [back to overview]Number of Participant-Visits With No Product Use
NCT03656783 (5) [back to overview]Change in Serum Biomarkers of Inflammation (Hs-CRP (in mg/L))
NCT03656783 (5) [back to overview]Change in Myocyte Injury and Strain (hs Troponin (in ng/L))
NCT03656783 (5) [back to overview]Change in Myocyte Injury and Strain (NT-proBNP (in pg/mL))
NCT03656783 (5) [back to overview]Change in Peak Stress Global MBF
NCT03656783 (5) [back to overview]Change in Global CFR
NCT03717129 (9) [back to overview]EVG Cmax
NCT03717129 (9) [back to overview]AUC0-∞ for FTC
NCT03717129 (9) [back to overview]Area Under the Curve From 0 to Infinity (AUC0-∞) for EVG
NCT03717129 (9) [back to overview]TFV Half-life
NCT03717129 (9) [back to overview]TFV Cmax
NCT03717129 (9) [back to overview]FTC Half-life
NCT03717129 (9) [back to overview]EVG Half-life
NCT03717129 (9) [back to overview]FTC Cmax
NCT03717129 (9) [back to overview]AUC0-∞ for Tenofovir (TFV)
NCT03780543 (5) [back to overview]Number of Subjects With Suppression/Loss of Viral HBeAg Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy
NCT03780543 (5) [back to overview]Sustained Viral Response (SVR) at 24 Weeks Off Treatment
NCT03780543 (5) [back to overview]Number of Subjects With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at End of Treatment (EOT) and End of Study (EOS)
NCT03780543 (5) [back to overview]Number of Subjects With Adverse Events
NCT03780543 (5) [back to overview]Number of Subjects With Suppression/Loss of Viral Core-related Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy
NCT03797014 (10) [back to overview]ALT Normalization at Week 24
NCT03797014 (10) [back to overview]HBeAg Loss at Week 48
NCT03797014 (10) [back to overview]CD4 Cell Count Change at Week 24
NCT03797014 (10) [back to overview]CD4 Cell Count Change at Week 48
NCT03797014 (10) [back to overview]HBsAg Loss at Week 48
NCT03797014 (10) [back to overview]HBV DNA at Week 24
NCT03797014 (10) [back to overview]HBV DNA at Week 48
NCT03797014 (10) [back to overview]HIV-1 RNA at Week 24
NCT03797014 (10) [back to overview]HIV-1 RNA at Week 48
NCT03797014 (10) [back to overview]ALT Normalization at Week 48
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Hematology Parameter of MCV
NCT03836729 (107) [back to overview]Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254
NCT03836729 (107) [back to overview]Period 2: Tmax of FTC
NCT03836729 (107) [back to overview]Period 2: Tmax of TAF
NCT03836729 (107) [back to overview]Period 2: Tmax of TFV
NCT03836729 (107) [back to overview]Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE)
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Blood Pressure
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Specific Gravity of Urine
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Respiratory Rate
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Pulse Rate
NCT03836729 (107) [back to overview]Period 1: Absolute Values of pH of Urine
NCT03836729 (107) [back to overview]Period 2: Absolute Values of Pulse Rate
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Heart Rate
NCT03836729 (107) [back to overview]Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
NCT03836729 (107) [back to overview]Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF
NCT03836729 (107) [back to overview]Period 1: AUC (0-tau) of FTC
NCT03836729 (107) [back to overview]Period 1: AUC (0-tau) of Tenofovir (TFV)
NCT03836729 (107) [back to overview]Period 1: Cmax of TFV
NCT03836729 (107) [back to overview]Period 1: Ctau of TFV
NCT03836729 (107) [back to overview]Period 1: Maximum Observed Concentration (Cmax) of TAF
NCT03836729 (107) [back to overview]Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC
NCT03836729 (107) [back to overview]Period 1: Tmax of FTC
NCT03836729 (107) [back to overview]Period 1: Tmax of TAF
NCT03836729 (107) [back to overview]Period 1: Tmax of TFV
NCT03836729 (107) [back to overview]Period 1:Cmax of FTC
NCT03836729 (107) [back to overview]Period 2: AUC (0-tau) of FTC
NCT03836729 (107) [back to overview]Period 2: AUC (0-tau) of GSK3640254
NCT03836729 (107) [back to overview]Period 2: AUC (0-tau) of TAF
NCT03836729 (107) [back to overview]Period 2: AUC (0-tau) of TFV
NCT03836729 (107) [back to overview]Period 2: Cmax of GSK3640254
NCT03836729 (107) [back to overview]Period 2: Cmax of TAF
NCT03836729 (107) [back to overview]Period 2: Cmax of TFV
NCT03836729 (107) [back to overview]Period 2: Ctau of FTC
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Blood Pressure
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK)
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Heart Rate
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Hematology Parameter of Erythrocytes
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Hematology Parameter of Hematocrit
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Hematology Parameter of Hemoglobin
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH)
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Pulse Rate
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Respiratory Rate
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Specific Gravity of Urine
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Temperature
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Urine Urobilinogen
NCT03836729 (107) [back to overview]Period 2: Absolute Values of Blood Pressure
NCT03836729 (107) [back to overview]Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase
NCT03836729 (107) [back to overview]Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
NCT03836729 (107) [back to overview]Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
NCT03836729 (107) [back to overview]Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
NCT03836729 (107) [back to overview]Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
NCT03836729 (107) [back to overview]Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
NCT03836729 (107) [back to overview]Period 2: Absolute Values of Heart Rate
NCT03836729 (107) [back to overview]Period 2: Absolute Values of pH of Urine
NCT03836729 (107) [back to overview]Period 2: Absolute Values of Respiratory Rate
NCT03836729 (107) [back to overview]Period 2: Absolute Values of Specific Gravity of Urine
NCT03836729 (107) [back to overview]Period 2: Absolute Values of Temperature
NCT03836729 (107) [back to overview]Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
NCT03836729 (107) [back to overview]Period 2: Absolute Values of the Hematology Parameter: Erythrocytes
NCT03836729 (107) [back to overview]Period 2: Absolute Values of the Hematology Parameter: Hematocrit
NCT03836729 (107) [back to overview]Period 2: Absolute Values of the Hematology Parameter: Hemoglobin
NCT03836729 (107) [back to overview]Period 2: Absolute Values of the Hematology Parameter: MCH
NCT03836729 (107) [back to overview]Period 2: Absolute Values of the Hematology Parameter: MCV
NCT03836729 (107) [back to overview]Period 2: Absolute Values of Urine Urobilinogen
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Blood Pressure
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Heart Rate
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Hematology Parameter of Erythrocytes
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Hematology Parameter of Hematocrit
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Hematology Parameter of Hemoglobin
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Hematology Parameter of MCH
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in pH of Urine
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Pulse Rate
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Respiratory Rate
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Specific Gravity of Urine
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Temperature
NCT03836729 (107) [back to overview]Period 2: Change From Baseline in Urine Urobilinogen
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Urine Urobilinogen
NCT03836729 (107) [back to overview]Period 1: Absolute Values of the Hematology Parameter: MCV
NCT03836729 (107) [back to overview]Period 1: Absolute Values of the Hematology Parameter: MCH
NCT03836729 (107) [back to overview]Period 1: Absolute Values of the Hematology Parameter: Hemoglobin
NCT03836729 (107) [back to overview]Period 1: Absolute Values of the Hematology Parameter: Hematocrit
NCT03836729 (107) [back to overview]Period 1: Absolute Values of the Hematology Parameter: Erythrocytes
NCT03836729 (107) [back to overview]Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Temperature
NCT03836729 (107) [back to overview]Period 2: Ctau of GSK3640254
NCT03836729 (107) [back to overview]Period 2: Ctau of TFV
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
NCT03836729 (107) [back to overview]Period 2:Cmax of FTC
NCT03836729 (107) [back to overview]Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV)
NCT03917420 (11) [back to overview]Average Tenofovir Concentrations in Plasma.
NCT03917420 (11) [back to overview]Average Tenofovir Diphosphate Concentrations Measured in Mixed Rectal Cells During the Late (High Estradiol) Follicular Phases of the Menstrual Cycle.
NCT03917420 (11) [back to overview]Average Emtricitabine Concentrations in Peripheral Blood Mononuclear Cells.
NCT03917420 (11) [back to overview]Average Emtricitabine Concentrations in Plasma.
NCT03917420 (11) [back to overview]Average Emtricitabine Triphosphate Concentrations Measured in Mixed Rectal Cells During the Early (Low Estradiol) Follicular Phases of the Menstrual Cycle.
NCT03917420 (11) [back to overview]Average Emtricitabine Triphosphate Concentrations Measured in Mixed Rectal Cells During the Late (High Estradiol) Follicular Phases of the Menstrual Cycle.
NCT03917420 (11) [back to overview]Average Tenofovir Diphosphate Concentrations in Peripheral Blood Mononuclear Cells.
NCT03917420 (11) [back to overview]Average Tenofovir Diphosphate Concentrations in Mixed Rectal Cells During the Early (Low Estradiol) Follicular Phases of the Menstrual Cycle.
NCT03917420 (11) [back to overview]Average Progesterone Concentrations in Serum.
NCT03917420 (11) [back to overview]Average Estradiol Concentrations in Serum.
NCT03917420 (11) [back to overview]Average Testosterone Concentrations in Serum.
NCT03976752 (40) [back to overview]Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
NCT03976752 (40) [back to overview]Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Elvitegravir (EVG)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Tenofovir (TFN)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Tenofovir (TFN)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Tenofovir (TFN)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Tenofovir (TFN)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Emtricitabine (FTC)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Emtricitabine (FTC)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Emtricitabine (FTC)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Emtricitabine (FTC)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Elvitegravir (EVG)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Elvitegravir (EVG)
NCT03976752 (40) [back to overview]Rectal Tissue Concentration of Elvitegravir (EVG)
NCT03976752 (40) [back to overview]Plasma Concentration of Tenofovir (TFV)
NCT03976752 (40) [back to overview]Plasma Concentration of Tenofovir (TFV)
NCT03976752 (40) [back to overview]Plasma Concentration of Tenofovir (TFV)
NCT03976752 (40) [back to overview]Plasma Concentration of Tenofovir (TFV)
NCT03976752 (40) [back to overview]Plasma Concentration of Emtricitabine (FTC)
NCT03976752 (40) [back to overview]Plasma Concentration of Emtricitabine (FTC)
NCT03976752 (40) [back to overview]Plasma Concentration of Emtricitabine (FTC)
NCT03976752 (40) [back to overview]Plasma Concentration of Emtricitabine (FTC)
NCT03976752 (40) [back to overview]Plasma Concentration of Elvitegravir (EVG)
NCT03976752 (40) [back to overview]Plasma Concentration of Elvitegravir (EVG)
NCT03976752 (40) [back to overview]Plasma Concentration of Elvitegravir (EVG)
NCT03976752 (40) [back to overview]Plasma Concentration of Elvitegravir (EVG)
NCT03976752 (40) [back to overview]Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
NCT03976752 (40) [back to overview]Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
NCT03976752 (40) [back to overview]Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
NCT03976752 (40) [back to overview]Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
NCT03976752 (40) [back to overview]Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
NCT03976752 (40) [back to overview]Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
NCT03998176 (4) [back to overview]Percentage of Participants With Grade 3 or Greater Adverse Events
NCT03998176 (4) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm
NCT03998176 (4) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm
NCT03998176 (4) [back to overview]Percentage of Participants With Grade 3 or Greater Adverse Events
NCT04050371 (3) [back to overview]Tenofovir Diphosphate Concentration in Dried Blood Spots (DBS)
NCT04050371 (3) [back to overview]Estradiol Concentration
NCT04050371 (3) [back to overview]Total Testosterone
NCT04140266 (26) [back to overview]Number of Infant Participants With Grade 3 or Higher AEs in Both Study Arms
NCT04140266 (26) [back to overview]Participant Willingness to Use Their Assigned Study Products During Breastfeeding in the Future (Y/N)
NCT04140266 (26) [back to overview]Proportion of Participants Who Find Their Study Product to be at Least as Acceptable as Other HIV Prevention Methods
NCT04140266 (26) [back to overview]Geometric Mean of Infant DPV Concentrations From Plasma by Visit
NCT04140266 (26) [back to overview]Geometric Mean of Infant FTC-TP Concentration by Visit
NCT04140266 (26) [back to overview]Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit
NCT04140266 (26) [back to overview]Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations
NCT04140266 (26) [back to overview]Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations
NCT04140266 (26) [back to overview]Geometric Mean of Maternal TFV-DP Concentrations by Visit
NCT04140266 (26) [back to overview]Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit
NCT04140266 (26) [back to overview]Geometric Mean of Maternal FTC-TP Concentrations by Visit
NCT04140266 (26) [back to overview]Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit
NCT04140266 (26) [back to overview]Geometric Mean of Maternal DPV Concentrations From Plasma by Visit
NCT04140266 (26) [back to overview]Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations
NCT04140266 (26) [back to overview]Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations
NCT04140266 (26) [back to overview]Geometric Mean of Infant TFV-DP Concentrations by Visit
NCT04140266 (26) [back to overview]Number of Mother Participants With Serious Adverse Events (SAEs) Including Maternal Deaths in Both Study Arms
NCT04140266 (26) [back to overview]Number and Proportion of Infants With Detectable TFV-DP Concentrations
NCT04140266 (26) [back to overview]Number and Proportion of Infants With Detectable Plasma DPV Concentrations
NCT04140266 (26) [back to overview]Number and Proportion of Infants With Detectable FTC-TP Concentrations
NCT04140266 (26) [back to overview]Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations
NCT04140266 (26) [back to overview]The Number of Mothers Non-adherent to Study Product for Each Month of Product Use by Study Product
NCT04140266 (26) [back to overview]Residual Drug Levels in Returned VRs
NCT04140266 (26) [back to overview]Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations
NCT04140266 (26) [back to overview]Number of Mother Participants With Grade 3 or Higher Adverse Events (AEs) in Both Study Arms
NCT04140266 (26) [back to overview]Number of Infant Participants With SAEs Including Infant Deaths in Both Study Arms
NCT04233879 (8) [back to overview]Change From Baseline in Body Weight at Week 48
NCT04233879 (8) [back to overview]Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 48
NCT04233879 (8) [back to overview]Incidence of Viral Resistance-Associated Substitutions (RASs) at Week 48
NCT04233879 (8) [back to overview]Percentage of Participants Who Discontinued Study Treatment Due to an AE up to Week 48
NCT04233879 (8) [back to overview]Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
NCT04233879 (8) [back to overview]Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
NCT04233879 (8) [back to overview]Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
NCT04233879 (8) [back to overview]Percentage of Participants Who Experienced an Adverse Event (AE) up to Week 48
NCT04318210 (7) [back to overview]Number of Sex Acts by Condom Usage
NCT04318210 (7) [back to overview]Self-reported Drug Adherence Over the Past 3 Days
NCT04318210 (7) [back to overview]Serious Adverse Events
NCT04318210 (7) [back to overview]Number of Sex Partners
NCT04318210 (7) [back to overview]HIV Seroconversion
NCT04318210 (7) [back to overview]Extracellular Tenofovir (TFV) for Recent Drug Exposure
NCT04318210 (7) [back to overview]Intracellular Tenofovir-diphosphate (TFV-DP)
NCT04465916 (2) [back to overview]HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment
NCT04465916 (2) [back to overview]Virologic Failure Rate
NCT04686279 (3) [back to overview]Acceptability of TFV Douche as Assessed by Product Acceptability Questionnaire
NCT04686279 (3) [back to overview]Safety of TFV Douche as Assessed by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events
NCT04686279 (3) [back to overview]Tenofovir Diphosphate (TFV-DP) Concentration
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 HBV RNA Off-Treatment
NCT04820686 (20) [back to overview]Number of Participants With One or More Adverse Events (AEs)
NCT04820686 (20) [back to overview]Number of Participants With One or More Abnormal Laboratory Result
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) On-Treatment
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 HBV RNA On-Treatment
NCT04820686 (20) [back to overview]Number of Participants With Premature Treatment Discontinuation Due to AEs
NCT04820686 (20) [back to overview]Number of Participants With Premature Treatment Discontinuation Due to AEs
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) Off-Treatment
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) Off-Treatment
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 HBV RNA On-Treatment
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 HBV RNA Off-Treatment
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 HBV RNA Off-Treatment
NCT04820686 (20) [back to overview]Number of Participants With Premature Treatment Discontinuation Due to AEs
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 HBV RNA Off-Treatment
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
NCT04820686 (20) [back to overview]Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
NCT04897737 (2) [back to overview]Participant Partners Who Tested for HIV
NCT04897737 (2) [back to overview]Recent PrEP Adherence

Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24

(NCT00035932)
Timeframe: Week 24

Interventionparticipants (Number)
ATV 300 mg / RTV95
ATV 400 mg / SQV74
LPV / RTV93

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Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24

Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. (NCT00035932)
Timeframe: Week 24

Interventionparticipants (Number)
ATV 300 mg / RTV46
ATV 400 mg / SQV25
LPV / RTV50

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Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96

Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. (NCT00035932)
Timeframe: Week 96

Interventionparticipants (Number)
ATV 300 mg / RTV52
LPV / RTV53

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Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48

Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. (NCT00035932)
Timeframe: Week 48

Interventionparticipants (Number)
ATV 300 mg / RTV64
ATV 400 mg / SQV42
LPV / RTV67

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Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24

Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. (NCT00035932)
Timeframe: Week 24

Interventionparticipants (Number)
ATV 300 mg / RTV76
ATV 400 mg / SQV50
LPV / RTV74

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Mean Change From Baseline in HIV RNA at Week 96

(NCT00035932)
Timeframe: Baseline, Week 96

Interventionlog10 c/mL (Mean)
ATV 300 mg / RTV-2.29
LPV / RTV-2.08

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Mean Change From Baseline in HIV RNA at Week 48

(NCT00035932)
Timeframe: Baseline, Week 48

Interventionlog10 c/mL (Mean)
ATV 300 mg / RTV-1.93
ATV 400 mg / SQV-1.55
LPV / RTV-1.87

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Mean Change From Baseline in HIV RNA at Week 2

(NCT00035932)
Timeframe: Baseline, Week 2

Interventionlog10 c/mL (Mean)
ATV 300 mg / RTV-1.18
ATV 400 mg / SQV-1.14
LPV / RTV-1.30

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Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24

(NCT00035932)
Timeframe: Baseline, Week 24

Interventionlog10 c/mL (Mean)
ATV 300 mg / RTV-1.86
ATV 400 mg / SQV-1.52
LPV / RTV-1.89

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Fasting Glucose Mean Change From Baseline at Week 48

(NCT00035932)
Timeframe: Week 48

Interventionmg/dL (Mean)
ATV 300 mg / RTV4
ATV 400 mg / SQV-1
LPV / RTV1

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HIV IC50 at Week 24

IC50: inhibitory concentration of drug required to reduce viral replication by 50%. (NCT00035932)
Timeframe: Week 24

Interventionng/mL (Mean)
ATV 300 mg / RTV17.83
ATV 400 mg / SQV22.84

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PR Interval and Change From Baseline by Analysis Time Point

The PR interval is measured from the beginning of the P wave to the beginning of the QRS complex, and reflects the time the electrical impulse takes to travel from the sinus node through the atrioventricular (AV) node and entering the ventricles. The PR interval is therefore a good estimate of AV node function. (NCT00035932)
Timeframe: Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48

,,
Interventionmsec (Mean)
Baseline Mean (n=119, 110, 118)Mean Change at Week 4 predose (n=117, 104, 110)Mean Change Wk 4 2-3 hrs postdose (n=113,102,106)Mean Change Wk 4 6-12 hrs postdose (n=112,101,105)Mean Change at Week 12 (n=110, 97, 107)Mean Change at Week 24 (n=108, 92, 109)Mean Change at Week 48 (n=89, 75, 97)
ATV 300 mg / RTV153412520
ATV 400 mg / SQV155966772
LPV / RTV154312854

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Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)

Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI. (NCT00035932)
Timeframe: Baseline, Week 48

,,
Interventionparticipants (Number)
Overall (n=120, 115, 123)PI Sensitive (n=88, 84, 88)PI Resistant (n=32, 30, 33)
ATV 300 mg / RTV776512
ATV 400 mg / SQV60527
LPV / RTV846716

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Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)

Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI. (NCT00035932)
Timeframe: Baseline, Week 24

,,
Interventionparticipants (Number)
Overall (n=120, 115, 123)PI Sensitive (n=88, 83, 88)PI Resistant (n=32, 30, 33)
ATV 300 mg / RTV957916
ATV 400 mg / SQV745815
LPV / RTV937219

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Most Common AEs and AEs of Interest Through Week 48

Prespecified AEs of interest included jaundice, ocular icterus, and hyperbilirubinemia. (NCT00035932)
Timeframe: From Enrollment to Week 48

,,
Interventionparticipants (Number)
Diarrhea (Most Common)Headache (Most Common)Nausea (Most Common)Jaundice (AE of Interest)Ocular Icterus (AE of Interest)Hyperbilirubinemia (AE of Interest)
ATV 300 mg / RTV252119191324
ATV 400 mg / SQV292424638
LPV / RTV541815001

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Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)

The EQ-5D has a Visual Analog Scale (VAS), which is a feeling thermometer-like scale with a range between 0 and 100. Patients are required to draw a line from a box on the VAS scale to an actual mark on the thermometer-like scale that corresponds with a number that reflects their self-assessed health status at the time they are completing the questionnaire. Higher VAS scores indicate better overall health. There is no minimum clinically important difference reported in the literature for VAS. (NCT00035932)
Timeframe: Baseline, Week 24, Week 48

,,
Interventionunits on a scale (Mean)
Baseline (n=98, 85, 101)Mid-Study (n=102, 83, 97)Final (n=95, 81, 96)
ATV 300 mg / RTV81.3384.8982.77
ATV 400 mg / SQV81.7283.3485.80
LPV / RTV81.5285.0986.16

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Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)

The EQ-5D is a 5-item questionnaire to assess health-related quality of life in 5 health dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) are scored on a 3-level scale: no problems (1), some problems (2), extreme problems (3). Using a standard algorithm, responses are summarized into a single score, the EQ-5D Health Index Score (HIS), which ranges between 1 (representing perfect health) and 0 (representing the worst imaginable health state or death). The smallest coefficient of change is 0.03. (NCT00035932)
Timeframe: Baseline, Week 24, Week 48

,,
Interventionunits on a scale (Mean)
Baseline (n=99, 86, 100)Mid-Study (n=103, 83, 95)Final (n=93, 84, 96)
ATV 300 mg / RTV0.830.870.84
ATV 400 mg / SQV0.850.860.85
LPV / RTV0.860.890.88

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Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values

"The minimum or trough concentration (Cmin) of a drug observed after its administration and just prior to the administration of a subsequent dose." (NCT00035932)
Timeframe: collected at the pre-dose time point after receiving atazanavir for at least four weeks

,
Interventionng/mL (Mean)
ATV (n=40,23)RTV (n=40,0)SQV (n=0,19)
ATV 300 mg / RTV719.53154.83NA
ATV 400 mg / SQV312.01NA52.15

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Lipid Mean Percent Change From Baseline at Week 96, Observed Values

Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides. (NCT00035932)
Timeframe: Week 96

,,
Interventionpercent change in lipid values (Number)
Total Cholesterol (n=60, 46, 54)HDL Cholesterol (n=60, 46, 54)Fasting LDL Cholesterol (n=52, 39, 43)Fasting Triglycerides (n=52, 40, 43)
ATV 300 mg / RTV-7-5-11-2
ATV 400 mg / SQV-13-74
LPV / RTV97130

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Lipid Mean Percent Change From Baseline at Week 48

Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides. (NCT00035932)
Timeframe: Week 48

,,
Interventionpercent change in lipid values (Number)
Total CholesterolHDL CholesterolFasting LDL CholesterolFasting Triglycerides
ATV 300 mg / RTV-8-7-10-4
ATV 400 mg / SQV-44-3-14
LPV / RTV62130

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Lipid Mean Percent Change From Baseline at Week 24

Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides. (NCT00035932)
Timeframe: Baseline, Week 24

,,
Interventionpercent change (Number)
Total CholesterolHigh Density Lipoprotein (HDL) CholesterolFasting Low Density Lipoprotein (LDL) CholesterolFasting Triglycerides
ATV 300 mg / RTV-8-7-10-2
ATV 400 mg / SQV-9-1-11-14
LPV / RTV30-431

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HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24

Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins. (NCT00035932)
Timeframe: Baseline, Week 24

,
Interventionlog10 c/mL (Mean)
Baseline ValuesWeek 24 ValuesChange from Baseline at Week 24
ATV 300 mg / RTV4.532.62-1.91
ATV 400 mg / SQV4.412.83-1.57

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Grade 3/4 Laboratory Abnormalities Through Week 48

Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Abnormal values: absolute neutrophil count: ≥500 to <750/mm3 (grade 3), <500/mm3 (grade 4); platelets: 20,000-49,999/mm3 (grade 3), <20,000/mm3 or diffuse petechiae (grade 4); alanine transaminase (ALT): 5.1-10 x upper limit of normal (ULN; grade 3), >10 x ULN (grade 4); aspartate transaminase (AST): 5.1-10 x ULN (grade 3), >10 x ULN (grade 4); bilirubin: 2.6-5 x ULN (grade 3), >5 x ULN (grade 4). (NCT00035932)
Timeframe: From Enrollment to Week 48

,,
Interventionparticipants (Number)
Neutrophil ReductionPlatelet ReductionALT ElevationAST ElevationTotal Bilirubin Elevation
ATV 300 mg / RTV825458
ATV 400 mg / SQV844222
LPV / RTV103441

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Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point

The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval was corrected for heart rate using Fridericia's (QTcF) formula. (NCT00035932)
Timeframe: Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48

,,
Interventionmsec (Mean)
Baseline Mean (n=119, 110, 118)Mean Change at Week 4 predose (n=117, 104, 110)Mean Change Wk 4 2-3 hrs postdose (n=113,102,106)Mean Change Wk 4 6-12 hrs postdose (n=112,101,105)Mean Change at Week 12 (n=110, 97, 107)Mean Change at Week 24 (n=108, 92, 109)Mean Change at Week 48 (n=89, 75, 97)
ATV 300 mg / RTV390-3-2-421-1
ATV 400 mg / SQV3871-3-133-1
LPV / RTV390-2-7-8220

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Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48

AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. (NCT00035932)
Timeframe: From Enrollment through Week 48

,,
Interventionparticipants (Number)
Deaths (n = 120, 115, 123)AEs leading to discontinuation (n = 119, 110, 118)SAEs (n = 120, 115, 123)AEs, grades 1-4 (n = 119, 110, 118)AEs, grades 3-4 (n = 119, 110, 118)
ATV 300 mg / RTV06129711
ATV 400 mg / SQV18149318
LPV / RTV151110312

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Inhibitory Quotient at Week 24

Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50. (NCT00035932)
Timeframe: Baseline, Week 24

Interventionratio (Mean)
ATV 300 mg / RTV136.94
ATV 400 mg / SQV25.04

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Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24

Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 24 were explored. (NCT00035932)
Timeframe: Baseline, Week 24

,
InterventionPearson Correlation Coefficient (Number)
ATV CminIQ (<10; >=10)# of PI Mutations at baseline (<4; >=4)
ATV 300 mg / RTV0.370.376-0.395
ATV 400 mg / SQV-0.210.105-0.227

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Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire

The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance. (NCT00035932)
Timeframe: Baseline, Week 24, Week 48

,,
Interventionparticipants (Number)
Adherent at Baseline (n=27, 25, 33)Adherent at Week 24 (n=18, 11, 25)Adherent at Week 48 (n=11, 4, 20)
ATV 300 mg / RTV12108
ATV 400 mg / SQV1052
LPV / RTV182313

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Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96

(NCT00035932)
Timeframe: Week 96

InterventionParticipants (Number)
ATV 300 mg / RTV61
LPV / RTV57

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Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48

(NCT00035932)
Timeframe: Week 48

InterventionParticipants (Number)
ATV 300 mg / RTV76
ATV 400 mg / SQV60
LPV / RTV84

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Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96

Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 96. (NCT00035932)
Timeframe: Baseline, Week 96

Interventionparticipants (Number)
ATV 300 mg / RTV61
LPV / RTV58

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Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96

Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. (NCT00035932)
Timeframe: Week 96

Interventionparticipants (Number)
ATV 300 mg / RTV38
LPV / RTV41

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Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48

Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. (NCT00035932)
Timeframe: Week 48

Interventionparticipants (Number)
ATV 300 mg / RTV43
ATV 400 mg / SQV28
LPV / RTV52

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Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24

Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 24 were explored. (NCT00035932)
Timeframe: Baseline, Week 24

,
InterventionPearson Correlation Coefficient (Number)
ATV CminIQ (<10; >=10)# of PI Mutations at baseline (<4; >=4)
ATV 300 mg / RTV-0.056-0.3910.306
ATV 400 mg / SQV0.254-0.0810.437

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Change From Baseline in CD4 Cell Count at Week 24

(NCT00035932)
Timeframe: Baseline, Week 24

Interventioncells/mm3 (Mean)
ATV 300 mg / RTV83
ATV 400 mg / SQV59
LPV / RTV90

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Change From Baseline in CD4 Cell Count at Week 48

(NCT00035932)
Timeframe: Baseline, Week 48

Interventioncells/mm3 (Mean)
ATV 300 mg / RTV110
ATV 400 mg / SQV72
LPV / RTV121

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Change From Baseline in CD4 Cell Count at Week 96

(NCT00035932)
Timeframe: Baseline, Week 96

Interventioncells/mm3 (Mean)
ATV 300 mg / RTV122
LPV / RTV154

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Fasting Glucose Mean Change From Baseline at Week 24

(NCT00035932)
Timeframe: Baseline, Week 24

Interventionmg/dL (Mean)
ATV 300 mg / RTV0
ATV 400 mg / SQV-3
LPV / RTV0

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PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

,,,
Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
ETR 200mg b.i.d.4.58.35.3
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)14.916.127.1
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.7296133
RAL 400mg b.i.d.6.65.411.6

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PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24 (area under the curve from 0 to 24 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

,,,,,,,,,,,,,
Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
ATV/COBI 300/150 mg q.d.25.3318.8536.20
ATV/RTV Arm 1: 300/100mg q.d.88.241.957.9
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.30.645.748.8
DRV/COBI 800/150 mg q.d.50.0042.0595.55
DRV/RTV 800/100mg q.d.64.663.5103.9
DTG 50mg q.d.47.649.265.0
EFV 600 mg q.d. (Outside THA)47.3060.0262.70
EVG/COBI 150/150mg q.d.15.314.021.0
TAF 10mg q.d. w/COBI0.1970.2060.216
TAF 25mg q.d.0.1710.2120.271
TAF 25mg q.d. w/COBI or RTV Boosting0.1810.2570.283
TFV 300mg q.d.1.92.43.0
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.14.528.839.6
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.26.237.758.7

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PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

Interventionmg*hour/L (Median)
3rd TrimesterPostpartum
EFV 600mg q.d.55.458.3

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PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
RPV 25mg q.d.1.9691.6692.387

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PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

Interventionmg/L (Median)
3rd TrimesterPostpartum
EFV 600mg q.d.5.445.10

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PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

,,,,,,,,,,,,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ATV/COBI 300/150 mg q.d.2.822.203.90
ATV/RTV Arm 1: 300/100mg q.d.NA3.64.1
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.3.114.514.52
DRV/COBI 800/150 mg q.d.4.593.677.04
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.6.226.558.96
DRV/RTV 600/100mg b.i.d.5.645.537.78
DRV/RTV 800/100mg q.d.6.775.788.11
DTG 50mg q.d.3.623.544.85
EFV 600 mg q.d. (Outside THA)3.875.134.41
FPV/RTV 700/100mg b.i.d.5.615.126.75
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)3.893.625.37
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA5.15.0
TFV 300mg q.d.0.2500.2450.298
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.1.22.54.1
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.2.733.565.43

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PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ETR 200mg b.i.d.0.701.010.63
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.8.410.714.6
RAL 400mg b.i.d.2.2501.7703.035
RPV 25mg q.d.0.1450.1340.134

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PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

Interventionng/mL (Median)
3rd TrimesterPostpartum
MVC 150 or 300mg b.i.d.448647

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PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

,,,
Interventionng/mL (Median)
2nd Trimester3rd TrimesterPostpartum
EVG/COBI 150/150mg q.d.1447.11432.81713.1
TAF 10mg q.d. w/COBI80.491.298.2
TAF 25mg q.d.69.796133
TAF 25mg q.d. w/COBI or RTV Boosting87.8107141

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PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

Interventionng/mL (Geometric Mean)
3rd TrimesterPostpartum
MVC 150 or 300mg b.i.d.108128

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PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.2.842.524.51
DRV/RTV 600/100mg b.i.d.2.122.222.51
FPV/RTV 700/100mg b.i.d.2.121.642.87
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA0.470.52

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PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ETR 200mg b.i.d.0.360.480.38
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)0.130.130.28
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.3.75.17.2
RAL 400mg b.i.d.0.06210.0640.0797

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PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs

"Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose.~For the TAF 25 mg q.d., 10 mg q.d. w/COBI, and 25 mg q.d. w/COBI or RTV boosting arms, samples were all below the limit of quantification and statistical analyses were not conducted." (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

,,,,,,,,,,,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ATV/COBI 300/150 mg q.d.0.210.210.61
ATV/RTV Arm 1: 300/100mg q.d.2.00.71.2
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.0.490.710.90
DRV/COBI 800/150 mg q.d.0.330.271.43
DRV/RTV 800/100mg q.d.0.991.172.78
DTG 50mg q.d.0.730.931.28
EFV 600 mg q.d. (Outside THA)1.491.481.94
EVG/COBI 150/150mg q.d.0.02580.04870.3771
TAF 10mg q.d. w/COBI0.001950.001950.00195
TAF 25mg q.d.0.001950.001950.00195
TAF 25mg q.d. w/COBI or RTV Boosting0.001950.001950.00195
TFV 300mg q.d.0.0390.0540.061
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.0.30.50.8
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.0.440.571.26

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PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

Interventionmg/L (Median)
3rd TrimesterPostpartum
EFV 600mg q.d.1.602.05

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PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
RPV 25mg q.d.0.0630.0560.081

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PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs

Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

Interventionng*hour/mL (Geometric Mean)
2nd Trimester3rd TrimesterPostpartum
MVC 150 or 300mg b.i.d.NA27173645

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Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs

Infant plasma concentrations were collected and measured during the first 9 days of life. (NCT00042289)
Timeframe: Blood samples were collected at 2-10, 18-28, 36-72 hours and 5-9 days after birth.

,,,
Interventionmcg/mL (Median)
2-10 hours after birth18-28 hours after birth36-72 hours after birth5-9 days after birth
DRV/COBI 800/150 mg q.d.0.351.431.871.72
DTG 50mg q.d.1.731.531.000.06
EFV 600 mg q.d. (Outside THA)1.11.00.90.4
EVG/COBI 150/150mg q.d.0.1320.0320.0050.005

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Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.

,,,,,,,,,,,,,,,,,,,,,,
InterventionParticipants (Count of Participants)
2nd Trimester3rd TrimesterPostpartum
ATV/RTV Arm 1: 300/100mg q.d.11212
DRV/COBI 800/150 mg q.d.3414
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.71622
DRV/RTV 600/100mg b.i.d.71922
DRV/RTV 800/100mg q.d.91922
DTG 50mg q.d.92023
EFV 600 mg q.d. (Outside THA)123334
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.82927
ETR 200mg b.i.d.5137
EVG/COBI 150/150mg q.d.81018
FPV/RTV 700/100mg b.i.d.82622
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)101926
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.93027
ATV/COBI 300/150 mg q.d.125
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA1514
RAL 400mg b.i.d.113330
RPV 25mg q.d.142625
TAF 10mg q.d. w/COBI152322
TAF 25mg q.d.132324
TAF 25mg q.d. w/COBI or RTV Boosting102418
TFV 300mg q.d.22727
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.11112
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.72332

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Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.

,
InterventionParticipants (Count of Participants)
3rd TrimesterPostpartum
EFV 600mg q.d.2021
MVC 150 or 300mg b.i.d.87

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Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8, 12, and 24 hours post dosing.

,
Interventionmcg*hr/mL (Median)
Before contraceptive initiationAfter contraceptive initiation
ATV/RTV/TFV 300/100/300mg q.d. With ENG53.9655.25
EFV 600mg q.d. With ENG53.6456.65

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Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8 and 12 hours post dosing.

Interventionmcg*hr/mL (Median)
Before contraceptive initiationAfter contraceptive initiation
LPV/RTV 400/100 b.i.d. With ENG115.97100.20

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Plasma Concentration for Contraceptives

Serum concentrations of the contraceptives. Note that no historical controls were provided by team pharmacologists and thus no comparisons were done for contraceptive concentrations in women using hormonal contraceptives and selected ARV drugs as compared to historical controls not using those ARV drugs. (NCT00042289)
Timeframe: Measured at 6-7 weeks after contraceptive initiation postpartum

Interventionpg/mL (Median)
ATV/RTV/TFV 300/100/300mg q.d. With ENG604
LPV/RTV 400/100 b.i.d. With ENG428
EFV 600mg q.d. With ENG125

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PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs

Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio. For arms with zero overall participants analyzed, samples were below the limit of quantification and ratios could not be calculated. (NCT00042289)
Timeframe: Measured at time of delivery with single cord blood and single maternal plasma sample.

Interventionunitless (Median)
TAF 10mg q.d. w/COBI0.97
EFV 600 mg q.d. (Outside THA)0.67
EFV 600mg q.d.0.49
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.0.2
RAL 400mg b.i.d.1.5
ETR 200mg b.i.d.0.52
MVC 150 or 300mg b.i.d.0.33
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.0.14
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.0.16
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.0.19
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)0.12
RPV 25mg q.d.0.55
ATV/RTV 300/100mg q.d. or TFV/ATV/RTV 300/300/100mg q.d.0.18
DRV/RTV 800/100mg q.d. or DRV/RTV 600/100mg b.i.d.0.18

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PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs

Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio. (NCT00042289)
Timeframe: Measured at time of delivery with single cord blood and single maternal plasma sample.

Interventionunitless (Median)
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.0.15
DTG 50mg q.d.1.25
EVG/COBI 150/150mg q.d.0.91
DRV/COBI 800/150 mg q.d.0.07
ATV/COBI 300/150 mg q.d.0.07
TFV 300mg q.d.0.88

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PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

,,,
Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.55.151.879.6
DRV/RTV 600/100mg b.i.d.45.845.961.7
FPV/RTV 700/100mg b.i.d.43.5032.1551.60
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA34.233.5

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Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs

Infant plasma concentrations were collected and measured during the first 9 days of life. Half-life is defined as 0.693/k, where k, the elimination rate constant, is the slope of the decline in concentrations. (NCT00042289)
Timeframe: Infant plasma samples at 2-10, 18-28, 36-72 hours and 5-9 days after birth.

Interventionhour (Median)
DTG 50mg q.d.32.8
EVG/COBI 150/150mg q.d.7.6
DRV/COBI 800/150 mg q.d.NA
EFV 600 mg q.d. (Outside THA)65.6

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Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms

incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner. (NCT00074581)
Timeframe: Throughout study

Interventionevent rate per 100 person-yr (Number)
Early-ART0.07
Delayed-ART1.03

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All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms

All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. (NCT00074581)
Timeframe: Throughout study

Interventionevent rate per 100 person-yr (Number)
Early-ART0.44
Delayed-ART1.41

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Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)

Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 96 (using follow-up through to study closure on May 31,2010)

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
TDF/FTC+EFV024NA
ZDV/3TC+EFV016NA

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Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)

Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 96 using follow-up through study closure on May 31,2010

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
TDF/FTC+EFV00NA
ZDV/3TC+EFV0032

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Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)

Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
ddI+FTC+ATV0048
ZDV/3TC+EFV016NA

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Time to Treatment Failure (NRTI Comparison)

Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). (NCT00084136)
Timeframe: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010).

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
TDF/FTC+EFV1640NA
ZDV/3TC+EFV1640NA

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Time to Treatment Failure (PI Comparison)

Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). (NCT00084136)
Timeframe: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008).

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
ddI+FTC+ATV1624120
ZDV/3TC+EFV1640NA

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Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)

Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). (NCT00084136)
Timeframe: weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)

,
Interventioncells/mm^3 (Median)
Change from screening to week 24 (N=490; N=502)Change from screening to week 48 (N=474; N=477)Change from screening to week 96 (N= 188; N=188)
ddI+FTC+ATV146.5187.0256.0
ZDV/3TC+EFV112.5152.0216.0

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Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)

Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). (NCT00084136)
Timeframe: weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)

,
Interventioncells/mm^3 (Median)
Change from screening to week 24 (N=490; N=498)Change from screening to week 48 (N=480; N=485)Change from screening to week 96 (N=458; N=471)
TDF/FTC+EFV120.5159226
ZDV/3TC+EFV112.5151.5220.5

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Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)

Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). (NCT00084136)
Timeframe: Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
ddI+FTC+ATV71876
ZDV/3TC+EFV1634NA

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Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)

Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. (NCT00084136)
Timeframe: At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)

,
Interventionparticipants (Number)
Week 24: Number with RNA <400 c/mL (N=495; N=500)Week 48: Number with RNA <400 c/mL (N=482; N=487)
TDF/FTC+EFV448455
ZDV/3TC+EFV459442

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Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)

Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. (NCT00084136)
Timeframe: At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)

,
Interventionparticipants (Number)
Week 24: Number with RNA <400 c/mL (N=495; N=506)Week 48: Number with RNA <400 c/mL (N=476; N=478)
ddI+FTC+ATV431424
ZDV/3TC+EFV459437

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Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)

Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). (NCT00084136)
Timeframe: Throughout follow-up until study closed (May 31,2010)

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
TDF/FTC+EFV1836201
ZDV/3TC+EFV1634163

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Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)

Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00084136)
Timeframe: Throughout study follow-up until study closure (May 31, 2010)

,
Interventionweeks (Number)
10th percentile25th percentile50th percentile
TDF/FTC+EFV432224
ZDV/3TC+EFV412112

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Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)

Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00084136)
Timeframe: Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)

,
Interventionweeks (Number)
10th percentile25th percentile50th percentile
ddI+FTC+ATV432144
ZDV/3TC+EFV41296

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Time to Immunologic Failure (NRTI Comparison)

Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. (NCT00084136)
Timeframe: At or after Week 48 (including all follow-up through study closure - May 31,2010)

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile
TDF/FTC+EFV48104NA
ZDV/3TC+EFV48128NA

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Time to Immunologic Failure (PI Comparison)

Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. (NCT00084136)
Timeframe: At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)

,
Interventionweeks (Number)
1st percentile5th percentile
ddI+FTC+ATV48NA
ZDV/3TC+EFV48112

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Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)

Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up through study closure on May 31,2010)

,
Interventionweeks (Number)
5th percentile10th percentile
TDF/FTC+EFV024
ZDV/3TC+EFV016

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Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)

Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 using follow-up through study closure on May 31,2010

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
TDF/FTC+EFV00NA
ZDV/3TC+EFV0032

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Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)

Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
ddI+FTC+ATV0048
ZDV/3TC+EFV0032

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Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month

Self-reported adherence at week 48 and 96 while participants remained on randomized regimen. Adherence interviews for each antiretroviral drug drug the participant is taking was performed by site personnel every 24 weeks. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.

,,,
Interventionpercent of participants (Number)
week 48 percent of full adherence in past monthweek 96 percent of full adherence in past month
NoNVP/LPV_r8687
NoNVP/NVP9093
NVP/LPV_r8895
NVP/NVP8994

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Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry

5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks.

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
NoNVP/LPV_r1236132
NoNVP/NVP2436NA

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Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry

5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks.

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
NVP/LPV_r6084NA
NVP/NVP121260

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Number of Participants Who Experienced Virologic Failure or Died.

Virologic failure (VF) is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.

Interventionparticipants (Number)
NVP/NVP32
NVP/LPV_r10
NoNVP/NVP42
NoNVP/LPV_r50

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Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality

Any grade of rash or grade 2+ liver lab abnormality events that were claimed to be NVP associated (definitely, probably, or possibly) by site investigators were evaluated. Grade 2+ liver lab abnormality is defined as aspartate aminotransferase (AST)>=2.6 x ULN or alanine aminotransferase (ALT)>=2.6 x ULN. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm.

Interventionparticipants (Number)
NVP/NVP20
NoNVP/NVP51

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CD4 Count Change From Randomization

Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (last CD4 before/on treatment start date). For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96.

,,,
Interventioncells/mm^3 (Median)
Week 48 CD4 count change from randomizationWeek 96 CD4 count change from randomization
NoNVP/LPV_r172256
NoNVP/NVP172223
NVP/LPV_r201278
NVP/NVP191291

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Percent of Participants Who Experienced Virologic Failure or Died

Results report cumulative percent of participants reaching virologic failure (VF) or death by week 48 and week 96 calculated using the Kaplan-Meier method. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.

,,,
InterventionPercent of participants (Number)
week 48 percent of virologic failure or deathweek 96 percent of virologic failure or death
NoNVP/LPV_r1420
NoNVP/NVP1417
NVP/LPV_r412
NVP/NVP2331

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Number of Participants in IT Arm Off Treatment Before 36 Weeks

The study provided fixed-dose combination emtricitabine/tenofovir DF 200/300 mg orally once daily and lopinavir/ritonavir 200/50 mg administered either as two tablets twice daily or four tablets once daily, for the first 36 weeks for individuals in the IT arm. (NCT00090779)
Timeframe: At Week 36

Interventionparticipants (Number)
IT Arm8

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Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation

The clinical, virologic, or immunologic criteria for treatment initiation or re-initiation include CD4 count below 350 cells/mm^3 on two consecutive determinations at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, (2) confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, (3) confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or (4) CDC Category B or C diagnosis. (NCT00090779)
Timeframe: 96 weeks since randomization

InterventionParticipants (Number)
IT Arm7
DT Arm23

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Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation

5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization for DT arm or from week 36 for IT arm to meeting the criteria for treatment initiation or re-initiation which include two consecutive CD4 count below 350 cells/mm^3 at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis. (NCT00090779)
Timeframe: 96 weeks since randomization

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile50th percentile75th percentile90th percentile
DT Arm6.912.326.360.096.096.0
IT Arm5.110.422.758.1NANA

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Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm

"The primary endpoint is (i) the average of log10 viral loads (VL) at wks 72 and 76 for participants who continued to wk 72 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the failures who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D." (NCT00090779)
Timeframe: At Weeks 72 and 76

Interventionrank (Median)
IT Arm26.0
DT Arm49.3

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Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 72 and 76 for the IT Arm and Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 36 and 40 for the DT Arm

"The primary endpoint is (i) average wk 36 and 40 VL for those who continued to wk 36 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the failures who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D." (NCT00090779)
Timeframe: IT arm (weeks 72 and 76) and DT arm ( weeks 36 and 40)

Interventionrank (Median)
IT Arm26.0
DT Arm48.5

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Number of Participants Experiencing Either a CDC Category B or C Diagnosis, CD4<200 Cells/mm^3 or CD4 Percent <14%.

(NCT00090779)
Timeframe: 96 weeks since randomization

Interventionparticipants (Number)
IT Arm2
DT Arm8

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Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm

(NCT00090779)
Timeframe: IT arm (weeks 36, 60, 72, 84 and 96) and DT arm (weeks 0, 24, 36, 48 and 60)

,
InterventionChange in Log10 transformed CD4 Counts (Mean)
IT arm (wk 60- wk 36) vs. DT arm (wk 24- wk 0)IT arm (wk 72- wk 36) vs. DT arm (wk 36- wk 0)IT arm (wk 84- wk 36) vs. DT arm (wk 48- wk 0)IT arm (wk 96- wk 36) vs. DT arm (wk 60- wk 0)
DT Arm-0.02-0.03-0.06-0.02
IT Arm-0.11-0.10-0.10-0.12

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Time to Treatment Initiation or Death

5th, 10th, 25th, 50th and 75th percentiles in weeks from randomization to treatment initiation or death (NCT00090779)
Timeframe: 5 years since randomization

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile50th percentile75th percentile
DT Arm13.920.943.797.3157.7
IT Arm3636.967.196.4163.3

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Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation

5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization to meeting the criteria for treatment initiation or re-initiation which include CD4 count below 350 cells/mm^3 on two consecutive measurements at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis. (NCT00090779)
Timeframe: 96 weeks since randomization

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile50th percentile75th percentile90th percentile
DT Arm6.912.326.360.096.096.0
IT Arm6.313.036.472.0NANA

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Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping

"For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed to the primary endpoint; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed to primary endpoint.~10 participants who did not have resistance samples available were excluded from the primary endpoint analysis." (NCT00099632)
Timeframe: 2 and 6 weeks after completion of treatment

Interventionparticipants (Number)
7-day Lamivudine/Zidovudine (3TC/ZDV)1
21-day Lamivudine/Zidovudine (3TC/ZDV)0
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0
7-day Lopinavir/Ritonavir (LPV/r)3
21-day Lopinavir/Ritonavir (LPV/r)1

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Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.

For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed. (NCT00099632)
Timeframe: 2 and 6 weeks after completion of treatment

Interventionparticipants (Number)
7-day Lamivudine/Zidovudine (3TC/ZDV)0
21-day Lamivudine/Zidovudine (3TC/ZDV)1
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)1
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)1
7-day Lopinavir/Ritonavir (LPV/r)1
21-day Lopinavir/Ritonavir (LPV/r)0

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Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.

For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed. (NCT00099632)
Timeframe: 2 and 6 weeks after completion of treatment

Interventionparticipants (Number)
7-day Lamivudine/Zidovudine (3TC/ZDV)0
21-day Lamivudine/Zidovudine (3TC/ZDV)0
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0
7-day Lopinavir/Ritonavir (LPV/r)0
21-day Lopinavir/Ritonavir (LPV/r)0

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Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12

"Grade 3 or higher signs and symptoms, laboratory abnormalities, events that are reported through the EAE system, and any grade event that leads to a treatment change from first day of study treatment to week 12.~Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death" (NCT00099632)
Timeframe: From first day of study treatment to week 12

Interventionparticipants (Number)
7-day Lamivudine/Zidovudine (3TC/ZDV)5
21-day Lamivudine/Zidovudine (3TC/ZDV)1
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)1
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0
7-day Lopinavir/Ritonavir (LPV/r)2
21-day Lopinavir/Ritonavir (LPV/r)2

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Number of Participants Who Discontinued Study Treatment Prematurely

participants assigned to 7-day treatment arm and 21-day treatment arm were supposed to stay in study treatment for 7 days and 21 days respectively. (NCT00099632)
Timeframe: From first day of study treatment to last day of study treatment (up to 21 days)

Interventionparticipants (Number)
7-day Lamivudine/Zidovudine (3TC/ZDV)0
21-day Lamivudine/Zidovudine (3TC/ZDV)2
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0
7-day Lopinavir/Ritonavir (LPV/r)0
21-day Lopinavir/Ritonavir (LPV/r)5

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Change From Baseline in CD4 Cell Count at Week 96

(NCT00100048)
Timeframe: Baseline and Week 96

Interventioncells/mm3 (Mean)
MK0518 b.i.d.221.2
EFV Combo Therapy232.4

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Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)

Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3) (NCT00100048)
Timeframe: Baseline and Week 24

Interventioncells/mm3 (Mean)
MK0518 100 mg b.i.d.184
MK0518 200 mg b.i.d122
MK0518 400 mg b.i.d.147
MK0518 600 mg b.i.d.134
EFV Combo Therapy101

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Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)

Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL) (NCT00100048)
Timeframe: Baseline and Week 24

Interventioncopies/mL (Mean)
MK0518 100 mg b.i.d.-2.39
MK0518 200 mg b.i.d-2.20
MK0518 400 mg b.i.d.-2.33
MK0518 600 mg b.i.d.-2.49
EFV Combo Therapy-2.44

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Change From Baseline in Plasma HIV RNA at Week 240

HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay. (NCT00100048)
Timeframe: Baseline and Week 240

InterventionLog10Copies/mL (Mean)
MK-0518 b.i.d.-2.29
EVF Combo Therapy-2.07

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Change From Baseline in Plasma HIV RNA at Week 96

(NCT00100048)
Timeframe: Baseline and Week 96

Interventioncopies/mL (Mean)
MK0518 b.i.d.-2.30
EFV Combo Therapy-2.28

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Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)

Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL) (NCT00100048)
Timeframe: Baseline and Day 10

Interventioncopies/mL (Mean)
MK0518 100 mg b.i.d.-1.93
MK0518 200 mg b.i.d-1.98
MK0518 400 mg b.i.d.-1.66
MK0518 600 mg b.i.d.-2.16
Placebo-0.17

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Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)

(NCT00100048)
Timeframe: Week 24

Interventionparticipants (Number)
MK0518 100 mg b.i.d.31
MK0518 200 mg b.i.d27
MK0518 400 mg b.i.d.35
MK0518 600 mg b.i.d.32
EFV Combo Therapy32

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Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240

HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay. (NCT00100048)
Timeframe: Week 240

InterventionParticipants (Number)
MK-0518 b.i.d.115
EVF Combo Therapy25

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Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48

(NCT00100048)
Timeframe: 48 weeks

Interventionparticipants (Number)
MK0518 100 mg b.i.d.38
MK0518 200 mg b.i.d34
MK0518 400 mg b.i.d.40
MK0518 600 mg b.i.d.36
EFV Combo Therapy33

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Number of Patients With Laboratory Adverse Experiences (LAEs)

A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00100048)
Timeframe: 48 Weeks

,,,,
Interventionparticipants (Number)
With LAEsWithout LAEs
EFV Combo Therapy830
MK0518 100 mg b.i.d.831
MK0518 200 mg b.i.d.733
MK0518 400 mg b.i.d.1130
MK0518 600 mg b.i.d.535

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Number of Patients With Serious CAEs and Non-serious CAEs at Week 144

"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product~An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product" (NCT00100048)
Timeframe: 144 Weeks

,
Interventionparticipants (Number)
With CAEsWithout CAEsWith serious CAEsWithout serious CAEs
EFV Combo Therapy353434
MK0518 b.i.d.153718142

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Change From Baseline in CD4 (T-helper) Cell Count at Week 240

Change in number of CD4 cells/mm^3 from baseline to Week 240. (NCT00100048)
Timeframe: Baseline and Week 240

Interventioncells/mm^3 (Mean)
MK-0518 b.i.d.301.7
EVF Combo Therapy275.6

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Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96

(NCT00100048)
Timeframe: 96 Weeks

,
Interventionparticipants (Number)
HIV RNA <50 copies/mLHIV RNA <400 copies/mL
EFV Combo Therapy3232
MK0518 b.i.d.133135

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Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)

"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.~Serious CAEs are any AEs occurring at any dose that; Results~in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or~prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an~overdose." (NCT00100048)
Timeframe: 10 days

,,,,
Interventionparticipants (Number)
With CAEsWithout CAEsWith Serious CAEsWithout Serious CAEs
MK0518 100 mg b.i.d.4307
MK0518 200 mg b.i.d.2507
MK0518 400 mg b.i.d.3306
MK0518 600 mg b.i.d.5308
Placebo5207

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Number of Patients With Clinical Adverse Experiences (CAEs)

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. (NCT00100048)
Timeframe: 48 weeks

,,,,
Interventionparticipants (Number)
With CAEsWithout CAEs
EFV Combo Therapy344
MK0518 100 mg b.i.d.318
MK0518 200 mg b.i.d.355
MK0518 400 mg b.i.d.365
MK0518 600 mg b.i.d.355

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Number of Patients That Discontinued With LAEs

(NCT00100048)
Timeframe: 48 Weeks

,,,,
Interventionparticipants (Number)
Discontinued With LAEsDid Not Discontinue With LAEs
EFV Combo Therapy038
MK0518 100 mg b.i.d.039
MK0518 200 mg b.i.d040
MK0518 400 mg b.i.d.041
MK0518 600 mg b.i.d.139

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Number of Patients That Discontinued With CAEs

(NCT00100048)
Timeframe: 48 Weeks

,,,,
Interventionparticipants (Number)
Discontinued with CAEsDid Not Discontinue with CAEs
EFV Combo Therapy038
MK0518 100 mg b.i.d.039
MK0518 200 mg b.i.d040
MK0518 400 mg b.i.d.041
MK0518 600 mg b.i.d.040

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Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)

"An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to its use. Any worsening of a preexisting condition which was temporally associated with the use of the study drug, was also an AE.~A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was cancer, or was an overdose." (NCT00100048)
Timeframe: Week 240

,
InterventionParticipants (Number)
Adverse experiencesSerious adverse experiences
EVF Combo Therapy354
MK-0518 b.i.d.15425

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Number of Patients With Serious LAEs

Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00100048)
Timeframe: 48 Weeks

,,,,
Interventionparticipants (Number)
With serious LAEsWithout serious LAEs
EFV Combo Therapy038
MK0518 100 mg b.i.d.039
MK0518 200 mg b.i.d.040
MK0518 400 mg b.i.d.041
MK0518 600 mg b.i.d.040

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Number of Patients With Serious CAEs (Cohort I and II Combined)

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00100048)
Timeframe: 48 weeks

,,,,
Interventionparticipants (Number)
With Serious CAEsWithout Serious CAEs
EFV Combo Therapy236
MK0518 100 mg b.i.d.237
MK0518 200 mg b.i.d.535
MK0518 400 mg b.i.d.041
MK0518 600 mg b.i.d.238

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Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240

HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay. (NCT00100048)
Timeframe: Week 240

InterventionParticipants (Number)
MK-0518 b.i.d.110
EFV Combo Therapy24

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Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)

(NCT00100048)
Timeframe: Week 24

Interventionparticipants (Number)
MK0518 100 mg b.i.d.28
MK0518 200 mg b.i.d27
MK0518 400 mg b.i.d.33
MK0518 600 mg b.i.d.32
EFV Combo Therapy31

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Number of Participants Assessed for Adverse Events (AEs)

Detailed information for Adverse Events and Serious Adverse Events will be represented in the SAE/AE section of PRS. (NCT00105079)
Timeframe: reported up to 28 days after the last dose of study treatment. (Up to 52 weeks)

Interventionparticipants (Number)
Saquinavir/Ritonavir163
Lopinavir/Ritonavir168

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Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count

Summary statistics for change from baseline in CD4+ lymphocyte count were presented by treatment arm. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week x) - (CD4+ count at baseline). (NCT00105079)
Timeframe: Baseline to Week 48

,
Interventioncells/mm^3 (Median)
Baseline (n=166,169)Week 48 (n=122,131)Change from Baseline to Week 48 (n=121,130)
Lopinavir/Ritonavir142.0348.0204.0
Saquinavir/Ritonavir141.5319.0178.0

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Change From Baseline in HIV-1 RNA Viral Load

Descriptive statistics for change from baseline in log10 transformed plasma HIV-1 RNA load (copies/mL) were presented by treatment arm. Logarithmic transformation (base 10) was applied to HIV-1 RNA viral load at baseline and at each study visit. Change from baseline in plasma HIV-1 RNA was derived as follows: Change from baseline = Log10 (HIV-1 RNA at week x) - Log10 (HIV-1 RNA at baseline) (NCT00105079)
Timeframe: Baseline to Week 48

,
Interventioncopies/mL (Mean)
BaselineWeek 48 (n=126,133)Change from Baseline to Week 48 (n=126,133)
Lopinavir/Ritonavir5.171.83-3.36
Saquinavir/Ritonavir5.201.80-3.39

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Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL

"The secondary objectives of the study were to evaluate the safety, adherence, and tolerability of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.~Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL and the number of participants with HIV-1 RNA results <400 copies/mL are reported." (NCT00105079)
Timeframe: Week 48

,
Interventionparticipants (Number)
Patients with <50 Copies/mLPatients with <400 Copies/mL
Lopinavir/Ritonavir108127
Saquinavir/Ritonavir108121

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Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL

"The primary objective of this study was to evaluate the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.~Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL is reported." (NCT00105079)
Timeframe: Week 48

,
Interventionparticipants (Number)
Pts. with HIV-1 RNA Viral Load <50 copies/mL - YESPts. with HIV-1 RNA Viral Load <50 copies/mL - NO
Lopinavir/Ritonavir10862
Saquinavir/Ritonavir10859

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Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters

Routine clinical testing, including hematology and standard chemistry panel was performed at all study visits. Laboratory tests for a fasting lipid profile and fasting insulin determination were obtained at baseline, weeks 24 and 48, and the 4-week follow-up visit. The number of participants who discontinued treatment due to an abnormal laboratory result at any visit is reported. (NCT00105079)
Timeframe: baseline and all study visits (Up to Week 52)

Interventionparticipants (Number)
Saquinavir/Ritonavir0
Lopinavir/Ritonavir0

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm

Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 240 visit. (NCT00112047)
Timeframe: Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
All Atripla85

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm)

Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 48 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 48 visit. (NCT00112047)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
EFV+FTC+TDF79.5
CBV+EFV70.4

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Change in Limb Fat (kg) From Week 48 to Week 96

Change from Week 48 to Week 96 in limb fat = Week 96 limb fat value minus Week 48 limb fat value. (NCT00112047)
Timeframe: Week 48 to Week 96

Interventionlimb fat (kg) (Mean)
EFV+FTC+TDF0.74
CBV+EFV-0.77

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Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48

The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: 48 Weeks

InterventionPercentage of Participants (Number)
EFV+FTC+TDF74.5
CBV+EFV66.9

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144

"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144

InterventionPercentage of Participants (Number)
EFV+FTC+TDF28
CBV+EFV41

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48

"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Baseline to 48 weeks

InterventionPercentage of Participants (Number)
EFV+FTC+TDF19
CBV+EFV30

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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96

Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 96

InterventionPercentage of Participants (Number)
EFV+FTC+TDF20
CBV+EFV23

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Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in total body fat = Week 240 (Atripla Week 96) total body fat value minus Week 144 (Atripla Baseline) total body fat value (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Interventiontotal body fat (kg) (Mean)
All Atripla0.37

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96

TLOVR for participants with confirmed virologic response (2 consecutive HIV-1 RNA < 400 c/mL) prior to study drug discontinuation, was the time to the earliest of premature study regimen discontinuation, or confirmed HIV-1 RNA > 400 c/mL (2 consecutive HIV-1 RNA ≥ 400 c/mL, or the last HIV-1 RNA ≥ 400 c/mL followed by premature study regimen discontinuation due to loss to follow-up). Participants who did not achieve confirmed virologic response before premature study regimen discontinuation or last HIV-1 RNA, were assumed to have lost virologic response on Study Day 1. (NCT00112047)
Timeframe: Week 96

InterventionPercentage of Participants (Number)
EFV+FTC+TDF25
CBV+EFV37

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)

"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
All Atripla13

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144

"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144

InterventionPercentage of Participants (Number)
EFV+FTC+TDF34
CBV+EFV43

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48

"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Baseline to 48 Weeks

InterventionPercentage of Participants (Number)
EFV+FTC+TDF23
CBV+EFV32

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)

"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
All Atripla15

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Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144

The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 144

InterventionPercentage of Participants (Number)
EFV+FTC+TDF63.1
CBV+EFV51.6

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Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96)

The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
EFV+FTC+TDF/Atripla (From Study Baseline)87
All Atripla (From Atripla Baseline)85

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Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48.

The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: 48 weeks

InterventionPercentage of Participants (Number)
EFV+FTC+TDF80.4
CBV+EFV69.3

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Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144

The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 144

InterventionPercentage of Participants (Number)
EFV+FTC+TDF60.8
CBV+EFV50.4

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Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96)

The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
EFV+FTC+TDF/Atripla (From Study Baseline)84
All Atripla (From Atripla Baseline)82

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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48

Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Baseline to 48 Weeks

InterventionPercentage of Participants (Number)
EFV+FTC+TDF9
CBV+EFV16

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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96

Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 96

InterventionPercentage of Participants (Number)
EFV+FTC+TDF9
CBV+EFV17

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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48

Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Baseline to 48 Weeks

InterventionPercentage of participants (Number)
EFV+FTC+TDF16
CBV+EFV24

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Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144

Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 144

InterventionPercentage of participants (Number)
EFV+FTC+TDF11
CBV+EFV17

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Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96)

Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
EFV+FTC+TDF/Atripla (From Study Baseline)11
All Atripla (From Atripla Baseline)2

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Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144

Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 144

InterventionPercentage of Participants (Number)
EFV+FTC+TDF21
CBV+EFV25

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Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96)

Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
EFV+FTC+TDF/Atripla (From Study Baseline)22
All Atripla (From Atripla Baseline)4

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Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey MCS. The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the MCS. PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and a SD of 10 (in the general population). (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

InterventionComposite Score (Mean)
All Atripla0.9

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Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey: Physical Component Summary (PCS). The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and SD of 10 (in the general population). (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

InterventionComposite Score (Mean)
All Atripla0.0

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Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.

"Participants were asked: How bothered are you with the side effects of your current treatment regimen? Possible responses were on a 4-category scale: does not bother me; bothers me a little bit; bothers me a lot; and bothers me terribly. For the evaluation of the change in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into does not bother me and bothers me (bothers me included bothers me a little bit; bothers me a lot; bothers me terribly)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

InterventionParticipants (Number)
Bothers me (W 144 and W 240)Does not bother me (W 144 and W 240)Bothers me (W 144); does not bother me (W 240)Does not bother me (W 144); bothers me (W 240)
All Atripla411263128

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Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.

"Participants were asked: In general, how satisfied are you with your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

InterventionParticipants (Number)
Very satisfied (W 144 and W 240)Not very satisfied (W 144 and W 240)Very satisfied (W 144); not very satisfied (W 240)Not very satisfied (W 144); very satisfied (W 240)
All Atripla18010923

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Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.

"Participants were asked: In general, how satisfied are you with the convenience and simplicity of your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

InterventionParticipants (Number)
Very satisfied (W 144 and W 240)Not very satisfied (W 144 and W 240)Very satisfied (W 144); not very satisfied (W 240)Not very satisfied (W 144); very satisfied (W 240)
All Atripla1826829

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96

"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 96

InterventionPercentage of Participants (Number)
EFV+FTC+TDF32
CBV+EFV38

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Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.

"Participants were asked: In general, how satisfied are you with the ability of your current treatment regimen to control your HIV infection? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

InterventionParticipants (Number)
Very satisfied (W 144 and W 240)Not very satisfied (W 144 and W 240)Very satisfied (W 144); not very satisfied (W 240)Not very satisfied (W 144); very satisfied (W 240)
All Atripla1928917

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Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.

"Participants were asked: In general, how satisfied are you with your ability to tolerate your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

InterventionParticipants (Number)
Very satisfied (W 144 and W 240)Not very satisfied (W 144 and W 240)Very satisfied (W 144); not very satisfied (W 240)Not very satisfied (W 144); very satisfied (W 240)
All Atripla166211326

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Change in Limb Fat (kg) From Week 48 to Week 144

Change from Week 48 to Week 144 in limb fat = Week 144 limb fat value minus Week 48 limb fat value (NCT00112047)
Timeframe: Week 48 to Week 144

Interventionlimb fat (kg) (Mean)
EFV+FTC+TDF1.13
CBV+EFV-1.09

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Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in limb fat = Week 240 (Atripla Week 96) limb fat value minus Week 144 (Atripla Baseline) limb fat value (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Interventionlimb fat (kg) (Mean)
All Atripla0.12

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Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96

Change from study baseline to Week 96 in HIV-1 RNA in log10 scale (Week 96 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). (NCT00112047)
Timeframe: Study baseline to Week 96

InterventionLog10 c/mL (Mean)
EFV+FTC+TDF-3.30
CBV+EFV-3.25

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)

Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 96 visit. (NCT00112047)
Timeframe: Week 96

InterventionPercentage of Participants (Number)
EFV+FTC+TDF67.2
CBV+EFV60.9

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Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48

Change from study baseline to Week 48 in HIV-1 RNA in log10 scale (Week 48 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). (NCT00112047)
Timeframe: Study baseline to Week 48

InterventionLog10 c/mL (Mean)
EFV+FTC+TDF-3.31
CBV+EFV-3.26

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Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144

Change from study baseline to Week 144 in HIV-1 RNA in log10 scale (Week 144 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). (NCT00112047)
Timeframe: Study baseline to Week 144

InterventionLog10 c/mL (Mean)
EFV+FTC+TDF-3.32
CBV+EFV-3.30

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Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96

Change from study baseline to Week 96 in CD4 cell count = Week 96 CD4 cell count value minus study baseline CD4 cell count value (NCT00112047)
Timeframe: Baseline to Week 96

InterventionCD4 Cell Count (cells/mm^3) (Mean)
EFV+FTC+TDF270
CBV+EFV237

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Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48

Change from study baseline to Week 48 in CD4 cell count = Week 48 CD4 cell count value minus study baseline CD4 cell count value (NCT00112047)
Timeframe: Study baseline to Week 48

InterventionCD4 Cell Count (cells/mm^3) (Mean)
EFV+FTC+TDF190
CBV+EFV158

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Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144

Change from study baseline to Week 144 in CD4 cell count = Week 144 CD4 cell count value minus study baseline CD4 cell count value (NCT00112047)
Timeframe: Baseline to Week 144

InterventionCD4 Cell Count (cells/mm^3) (Mean)
EFV+FTC+TDF312
CBV+EFV271

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Change in Total Body Fat (kg) From Week 48 to Week 144

Change from Week 48 to Week 144 in total body fat = Week 144 total body fat value minus Week 48 total body fat value (NCT00112047)
Timeframe: Week 48 to Week 144

Interventiontotal body fat (kg) (Mean)
EFV+FTC+TDF2.47
CBV+EFV-1.18

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Change in Total Body Fat (kg) From Week 48 to Week 96

Change from Week 48 to Week 96 in total body fat = Week 96 total body fat value minus Week 48 total body fat value (NCT00112047)
Timeframe: 48 weeks to 96 weeks

Interventiontotal body fat (kg) (Mean)
EFV+FTC+TDF1.69
CBV+EFV-0.82

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Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in trunk fat = Week 240 (Atripla Week 96) trunk fat value minus Week 144 (Atripla Baseline) trunk fat value (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Interventiontrunk fat (kg) (Mean)
All Atripla0.27

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Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96)

Change from baseline to Week 240 (Atripla Week 96) in CD4 cell count = Week 240 (Atripla Week 96) CD4 cell count value minus baseline CD4 cell count value (NCT00112047)
Timeframe: Study/Atripla baseline to Week 240 (Atripla Week 96)

InterventionCD4 Cell count (Cells/mm^3) (Mean)
EFV+FTC+TDF/Atripla (From Study Baseline)346
All Atripla (From Atripla Baseline)42

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Change in Trunk Fat (kg) From Week 48 to Week 144

Change from Week 48 to Week 144 in trunk fat = Week 144 trunk fat value minus Week 48 trunk fat value (NCT00112047)
Timeframe: Week 48 to Week 144

Interventiontrunk fat (kg) (Mean)
EFV+FTC+TDF1.30
CBV+EFV-0.10

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Change in Trunk Fat (kg) From Week 48 to Week 96

Change from Week 48 to Week 96 in trunk fat = Week 96 trunk fat value minus Week 48 trunk fat value (NCT00112047)
Timeframe: Week 48 to Week 96

Interventiontrunk fat (kg) (Mean)
EFV+FTC+TDF0.94
CBV+EFV-0.04

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)

Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 144 visit (i.e., the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV-1 RNA levels < 400 c/mL prior to Week 144 visit. (NCT00112047)
Timeframe: 144 weeks

InterventionPercentage of Participants (Number)
EFV+FTC+TDF70.9
CBV+EFV58.1

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm

Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 240 visit. (NCT00112047)
Timeframe: Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
All Atripla87

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm

Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 48 visit. (NCT00112047)
Timeframe: 48 weeks

InterventionPercentage of participants (Number)
EFV+FTC+TDF84.4
CBV+EFV72.8

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)

Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 96 visit. (NCT00112047)
Timeframe: 96 Weeks

InterventionPercentage of Participants (Number)
EFV+FTC+TDF74.6
CBV+EFV61.9

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)

Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL (c/mL) had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 144 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV-1 RNA levels < 50 c/mL prior to Week 144 visit. (NCT00112047)
Timeframe: Week 144

InterventionPercentage of participants (Number)
EFV+FTC+TDF64.3
CBV+EFV56.3

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Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL

(NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
InterventionParticipants (Number)
Number of Participants with RNA data at Week 48Number with HIV-1 RNA <200 copies/ml at Week 48Number of Participants with RNA data at Week 96Number with HIV-1 RNA <200 copies/ml at Week 96
EFV, FTC/TDF, and Placebo ABC/3TC415398379362
EFV, Placebo FTC/TDF, and ABC/3TC400377361342
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC416391384368
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC411372374346

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Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC89
EFV, Placebo FTC/TDF, and ABC/3TC1011
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC54
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC87

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Cumulative Probability of Not Experiencing Treatment Modification

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC8073
EFV, Placebo FTC/TDF, and ABC/3TC6756
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC8677
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC7362

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Cumulative Probability of Not Experiencing Regimen Failure

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC7970
EFV, Placebo FTC/TDF, and ABC/3TC6454
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC8073
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC6657

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Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC7870
EFV, Placebo FTC/TDF, and ABC/3TC6458
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC7973
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC7366

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Change in Fasting Total Cholesterol Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC2223
EFV, Placebo FTC/TDF, and ABC/3TC3533
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC1114
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC3025

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Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC1413.5
EFV, Placebo FTC/TDF, and ABC/3TC2318
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC810
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC2018

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Change in CD4 Count (Cells/mm3) From Baseline

Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values). (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
InterventionCells/mm3 (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC163220.5
EFV, Placebo FTC/TDF, and ABC/3TC188250.5
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC175251.5
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC177.5250.3

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Number of Participants With Virologic Failure and Emergence of Major Resistance

Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC27
EFV, Placebo FTC/TDF, and ABC/3TC41
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC5
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC12

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Number of Participants With Virologic Failure

Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC57
EFV, Placebo FTC/TDF, and ABC/3TC72
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC57
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC83

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Cumulative Probability of Not Experiencing Virologic Failure

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC9490
EFV, Placebo FTC/TDF, and ABC/3TC8885
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC9289
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC8883

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Change in Fasting Triglyceride Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC109
EFV, Placebo FTC/TDF, and ABC/3TC1514
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC1411
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC2433

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The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL

(NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
InterventionParticipants (Number)
Number of Participants with RNA data at Week 48Number with HIV-1 RNA <50 copies/ml at Week 48Number of Participants with RNA data at Week 96Number with HIV-1 RNA <50 copies/ml at Week 96
EFV, FTC/TDF, and Placebo ABC/3TC415372379345
EFV, Placebo FTC/TDF, and ABC/3TC400346361328
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC416348384345
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC411322374317

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Time From Randomization to Virologic Failure

Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

,,,
InterventionWeeks (Number)
5th percentile time to virologic failure10th percentile time to virologic failure
EFV, FTC/TDF, and Placebo ABC/3TC3696
EFV, Placebo FTC/TDF, and ABC/3TC2436
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC2484
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC2436

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Time From Treatment Dispensation to a Grade 3/4 Safety Event

Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00118898)
Timeframe: All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.

,,,
InterventionWeeks (Number)
5th percentile time to a grade 3/4 safety event10th percentile time to a grade 3/4 safety event25th percentile time to a grade 3/4 safety event
EFV, FTC/TDF, and Placebo ABC/3TC2.67.959.3
EFV, Placebo FTC/TDF, and ABC/3TC1.32.016.0
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC3.08.181.4
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC1.33.944.4

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Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)

Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

,,,
InterventionWeeks (Number)
5th percentile time to regimen failure10th percentile time to regimen failure25th percentile time to regimen failure
EFV, FTC/TDF, and Placebo ABC/3TC41672
EFV, Placebo FTC/TDF, and ABC/3TC4424
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC41684
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC4436

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Time From Treatment Dispensation to Treatment Modification

Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

,,,
InterventionWeeks (Number)
5th percentile time to treatment modification10th percentile time to treatment modification25th percentile time to treatment modification
EFV, FTC/TDF, and Placebo ABC/3TC3.415.083.7
EFV, Placebo FTC/TDF, and ABC/3TC1.42.127.4
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC7.924.9108.9
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC1.65.043.6

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Number of Participants With a Grade 3/4 Safety Event

Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. (NCT00118898)
Timeframe: Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC145
EFV, Placebo FTC/TDF, and ABC/3TC182
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC137
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC156

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Number of Participants With Regimen Failure

Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC162
EFV, Placebo FTC/TDF, and ABC/3TC246
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC157
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC233

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Number of Participants With Treatment Modification

Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC152
EFV, Placebo FTC/TDF, and ABC/3TC239
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC138
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC216

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Amount of Study Follow-up

Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks

InterventionWeeks (Median)
EFV, FTC/TDF, and Placebo ABC/3TC141.4
EFV, Placebo FTC/TDF, and ABC/3TC133.3
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC141.6
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC137.3

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Adverse Events

Number of Participants with adverse clinical events in tenofovir and placebo arms (NCT00119106)
Timeframe: Up to 6.9 years

Interventionparticipants (Number)
Tenofovir1098
Placebo1083

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HIV Viral Load Copies/mL Measured at First Positive HIV Test Result by Group

Plasma HIV RNA concentrations. (NCT00119106)
Timeframe: Among people who seroconverted, viral load was measured at month 1, 2, and every 4 months after HIV seroconversion

InterventionCopies/mL (Mean)
Tenofovir929829
Placebo120061

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Number of Participants Reporting Injecting and Sharing Needles

"Number of Participants reporting injecting and sharing needles:~Assessed injecting and sharing at baseline and every 3 months during follow-up. We used GEE to determine if there was a significant decline in injecting and sharing." (NCT00119106)
Timeframe: Participants were asked about injecting and needle sharing behaviors at enrollment and every 3 month visit, up to 6.9 years

Interventionparticipants (Number)
Tenofovir58
Placebo59

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Number of Participants With Tenofovir-associated Resistance Mutations.

Measure tenofovir associated resistance mutations (ie, K65R and K70E) in amplified viral RNA specimens from HIV-positive participants in the placebo and tenofovir groups. (NCT00119106)
Timeframe: Specimens collected at the time of HIV seroconversion

InterventionParticipants (Count of Participants)
Tenofovir0
Placebo0

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Number Participants Who Reported More Than One Sexual Partner at Baseline

Number of participants (NCT00119106)
Timeframe: At enrolment

InterventionParticipants (Count of Participants)
Tenofovir Group251
Placebo Group271

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Rates of HIV Seroconversion

Kaplan Meier survival curve. (NCT00119106)
Timeframe: From date of randomization until the date of first documented seroconversion or date of death from any cause, whichever came first, assessed for an average of 4.0 years, with a maximum duration of 6.9 years

InterventionInfections/ 100 person-years (Number)
Tenofovir17
Placebo33

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Adherence to Study Drug/Placebo

Mean number of days that participants took study drug based on study drug diaries by study group. (NCT00119106)
Timeframe: Participants were asked about adherence at 3 month visits, up to 6.9 years.

Interventiondays (Mean)
Tenofovir84
Placebo84

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Renal Toxicity

Number of Participants with Grade 3 or 4 Renal Laboratory Toxicities (NCT00119106)
Timeframe: Blood tested for creatinine level at enrollment and every 3 months, up to 6.9 years

Interventionparticipants (Number)
Tenofovir3
Placebo3

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Change in Fat mtDNA Content

Subcutaneous abdominal fat mitochondrial DNA (mtDNA) (NCT00119379)
Timeframe: Baseline to Week 48

Interventioncopies/cell (Median)
Uridine Supplementation-169
Switch to TDF321

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Change in Lumbar Spine Bone Mineral Density (BMD)

Change in lumbar spine bone mineral density (BMD) as measured by dual-energy x-ray absorbtiometry (DEXA) scan (NCT00119379)
Timeframe: Baseline to Week 48

Interventionlumbar spine BMD, g/cm^2 (Median)
Uridine Supplementation0.39
Switch to TDF0.0

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Change in Trunk Fat

Change in trunk fat as measured by dual-energy x-ray absorbtiometry (DEXA) scan (NCT00119379)
Timeframe: Baseline to Week 48

Interventiontrunk fat (kg) (Median)
Uridine Supplementation0.2
Switch to TDF0.7

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Change in PBMC mtDNA

Peripheral blood mononuclear cell (PBMC) mitochondrial DNA (mtDNA), measured in copies/cell (NCT00119379)
Timeframe: Baseline to Week 48

Interventioncopies/cell (Median)
Uridine Supplementation-24
Switch to TDF-52

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Change in Limb Fat

Change in limb fat as measured by dual-energy x-ray absorbtiometry (DEXA) scan (NCT00119379)
Timeframe: Baseline to Week 48

Interventionlimb fat (kg) (Median)
Uridine Supplementation0.1
Switch to TDF0.4

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Change in Hip Bone Mineral Density (BMD)

Change in hip bone mineral density (BMD) as measured by dual-energy x-ray absorbtiometry (DEXA) scan (NCT00119379)
Timeframe: Baseline to Week 48

Interventionhip BMD, g/cm^2 (Median)
Uridine Supplementation0.45
Switch to TDF-3.3

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>5% Bone Mineral Density Decline at Femoral Neck

Percent of San Francisco participants in the TDF vs. placebo groups who were found to have >5% decline in Bone Mineral Density at the femoral neck. (NCT00131677)
Timeframe: 24 months (immediate arm), 15 months (delayed arm)

Interventionpercentage of participants (Number)
Tenofovir Disoproxil Fumarate13
Placebo6

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Adherence to Study Drug

Estimated exposure to study drug (active and placebo) as assessed by Medication Event Monitoring System (MEMS) caps. (NCT00131677)
Timeframe: 24 months (immediate arm) and 15 months (delayed arm)

Interventionpercentage of doses (Number)
Treatment Emergent Cohort77

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Number of Breakthrough HIV Infections

Number of participants with HIV seroconversions occuring while on study drug (NCT00131677)
Timeframe: 24 months (immediate arm) and 15 months (delayed arm)

Interventionparticipants (Number)
Tenofovir Disoproxil Fumarate0
Placebo4

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Clinical Safety--Hypophosphatemia

Grade 3 or 4 hypophosphatemia (per National Institutes of Health Division of AIDS toxicity scale) (NCT00131677)
Timeframe: 24 months (immediate arm), 15 months (delayed arm)

Interventionparticipants (Number)
Tenofovir Disoproxil Fumarate1
Placebo5

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Clinical Safety--Creatinine Elevations

Grade 3 or 4 Creatinine elevations (per National Institutes of Health Division of AIDS toxicity scale) (NCT00131677)
Timeframe: 24 months (immediate arm) and 15 months (delayed arm)

InterventionParticipants (Number)
Tenofovir Disoproxil Fumarate0
Placebo0

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Behavioral Safety--Unprotected Anal Sex (UAS)

Change in percent of participants reporting unprotected anal intercourse--baseline vs. months 3 through 9 on study. (NCT00131677)
Timeframe: Nine months

Interventionpercentage of ppts reporting UAS (Number)
All Enrolled Participants-9

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Evaluate Change in Cellular Regulatory Enzymes Involved With Nucleoside Analogue Transport Across Cell Membranes as Assessed by RT-PCR of Specific mRNA Transcripts

"At day 1 and day 63 a PBMC sample for RT-PCR of nucleoside analogue transport enzymes (enzymes for efflux, influx) will be collected. The day 1 specimen should be stored and sent with day 8 PK specimens to USC. Day 63 specimen should be sent to USC after collection and processing.~Blood volume: 20 mL Blood volume: 20 mL" (NCT00214890)
Timeframe: Day 1 and Day 63

,
Interventionfmol/10^6 cells (Median)
dGTP concentrationsdATP concentrations
Abacavir24643314
Tenofovir40263238

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Compare the Plasma Data of the Two Monotherapy Regimens to the Dual NRTI Regimen

"At day 49 of Sequence 2 a 24-hour post dose plasma sample should be collected and processed. All 7 samples from the sparse PK (time 0, 30-min, 1-hr, 2-hr, 3-hr, 6-hr and 24-hr post dose) should be sent overnight to appropriate off-site lab for analysis. Since the patient is on dual therapy and the each drug is measured in separate labs each PBMC samples should be split at each time-point with half of the samples shipped to Gilead and half shipped to USC (two separate shipments). ALL plasma samples should be sent to USC. Since samples have to be split we will need to collect double the blood for the intracellular (PBMC) PK:~Blood volume (PBMC-plasma): 40 mL - each draw Blood volume (plasma only): 3 mL - each draw Blood volume: 169 mL- over 2 days~Plasma NRTI and intracellular ddNTP concentrations were measured 7 days after treatment with ABC or TDF alone and were compared to levels obtained after 7 days of treatment with both drugs" (NCT00214890)
Timeframe: 49 days

,
Intervention(mcg/mL)*hr (Median)
monotherapydual therapy
Abacavir12.5413.62
Tenofovir3.824.09

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Compare the Intracellular Pharmacokinetic (PK) Data of the Two Monotherapy Regimens to the Dual NRTI Regimen

"At day 49 of Sequence 2 a 24-hour post dose intracellular (PBMC) should be collected and processed. All 7 samples from the sparse PK (time 0, 30-min, 1-hr, 2-hr, 3-hr, 6-hr and 24-hr post dose) should be sent overnight to appropriate off-site lab for analysis. Since the patient is on dual therapy and the each drug is measured in separate labs each PBMC samples should be split at each time-point with half of the samples shipped to Gilead and half shipped to USC (two separate shipments). ALL intracellular (PBMC) samples should be sent to USC. Since samples have to be split we will need to collect double the blood for the intracellular (PBMC) PK:~Blood volume (PBMC-plasma): 40 mL - each draw Blood volume (plasma only): 3 mL - each draw Blood volume: 169 mL- over 2 days~Intracellular ddNTP concentrations were measured after 7 days on monotherapy and after 7 days on dual therapy" (NCT00214890)
Timeframe: 49 days

,
Interventionfmol/10^6 cells (Median)
monotherapydual therapy
Abacavir72.280.9
Tenofovir49.3108.1

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Change in Short-term Virologic Response

Relative potencies of two monotherapy regimens (TDF alone vs. ABC alone) compared to the dual NRTI regimen of TDF+ABC as assessed by the short-term virologic response. (Change in HIV RNA copies/mL at baseline and day 7 for monotherapy, baseline and day 49 for dual therapy.) (NCT00214890)
Timeframe: 49 days

,
Interventionlog(10) copies/mL per day (Median)
monotherapydual therapy (combined TDF+ABC)
Abacavir-.15-.16
Tenofovir-.11-.16

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Determine Total Number of NRTI-associated Mutations After 7 Days of ABC or TDF Monotherapy or After 7 Days of Dual NRTI Therapy With ABC + TDF

Subjects will be randomized to either TDF or ABC PO route for 7 days, which involves a fixed number of subjects. A sample size of 20 subjects (10 ABC and 10 TDF monotherapy and 20 ABC+TDF dual-therapy in HIV-positive patients). We determined the count of NRTI-associated mutations that emerged after 7 days of ABC or TDF monotherapy or after 7 days of dual NRTI therapy with ABC + TDF. (NCT00214890)
Timeframe: 7 days

Interventionmutations (Number)
Tenofovir0
Abacavir0

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Compare the Relative Viral Potency of TDF Monotherapy Versus ABC Monotherapy

Eligible patients will be randomized into two monotherapy arms (TDF and ABC) for a short (one week) viral dynamics and pharmacokinetics evaluation to determine their potency. After a one-month washout period, all patients will start a dual-therapy of ABC+TDF. Viral dynamics and pharmacokinetics of the dual-therapy will be evaluated during the first week of the treatment. EFV will be added to the regimen after one week of the dual-therapy administered. Relative potencies of two monotherapy regimens (TDF alone vs. ABC alone) assessed by the short-term virologic response. (Change in HIV RNA copies/mL at baseline and day 7 for monotherapy) (NCT00214890)
Timeframe: Baseline and day 7

Interventionlog(10) copies/mL per day (Median)
Tenofovir-0.11
Abacavir-0.15

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Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction

The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated. (NCT00244712)
Timeframe: Baseline through 96 weeks

,
Interventionparticipants (Number)
Participants (Par.) with suspected ABC HSRMild or Grade 1Moderate or Grade 2Severe or Grade 3Not ApplicablePar. with proximal renal tubule dysfunction
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)1418410
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV302105

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Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Weeks 48 and 96

,
Interventionpercentage of participants (Number)
M=F, Switch Included, Week 48TLOVR, Week 48Obs, Week 48M/D=F, Week 48M=F, Switch Included, Week 96TLOVR, Week 96Obs, Week 96M/D=F, Week 96
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)75.270.993.871.463.958.492.860.1
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV71.366.492.266.261.256.396.356.9

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Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96

,
Interventionpercentage of participants (Number)
M=F, Switch Included, Week 48TLOVR, Week 48Obs, Week 48M/D=F, Week 48M=F, Switch Included, Week 96TLOVR, Week 96Obs, Week 96M/D=F, Week 96
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)7672947265609261
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV7166916560559756

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Week 48

,
Interventionpercentage of participants (Number)
TLOVRObsM/D=F
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)62.684.364.3
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV61.186.862.3

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Week 96

,
Interventionpercentage of participants (Number)
M=F, Switch IncludedTLOVRObsM/D=F
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)59.952.186.956.4
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV58.051.091.354.5

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96

,
Interventionpercentage of participants (Number)
M=F, Switch Included, Week 48TLOVR, Week 48Obs, Week 48MD=F, Week 48M=F, Switch Included, Week 96TLOVR, Week 96Obs, Week 96MD=F, Week 96
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)7167896863578959
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV6962886258529454

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96

,
Interventionpercentage of participants (Number)
M=F, Switch Included, Week 48TLOVR, Week 48Obs, Week 48M/D=F, Week 48M=F, Switch Included, Week 96TLOVR, Week 96Obs, Week 96M/D=F, Week 96
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)6357785956468454
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV6560866258518855

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Median Change From Baseline in CD4+ Cells at Weeks 48 and 96

A blood sample was drawn to determine the CD4+ cell count at Weeks 48 and 96. Change from baseline was defined as CD4+ cell count at week 96 minus CD4+ cell count at baseline. (NCT00244712)
Timeframe: Weeks 48 and 96

,
Interventioncells per cmm (Median)
Week 48Week 96
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)201.0250.0
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV173.0246.5

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Median Change From Baseline in HIV-1 RNA at Week 48 and 96

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. Change from baseline was defined as HIV-1 RNA level at Weeks 48 and 96 minus HIV-1 RNA level at baseline. (NCT00244712)
Timeframe: Weeks 48 and 96

,
Interventionlog10 copies/mL (Median)
Week 48Week 96
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)-3.142-3.114
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV-3.131-3.165

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Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility

A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class. (NCT00244712)
Timeframe: Baseline and time of virologic failure (up to Week 96)

,
Interventionparticipants (Number)
Resistance NRTI class (M184V, M/V,M/I,A/V,I,M/I/V)Reduced pheno susceptibility to lamivudine/M184VReduced phen susceptibility to lamivudine/M184M/VReduced pheno susceptibility to lamivudine/M184M/IReduced pheno susceptibility to lamivudine/M184A/VReduced pheno susceptibility to lamivudine/M184IReduced pheno suscept. to lamivudine/M184M/I/VReduced pheno suscept. to emtricitabine/M184VReduced pheno suscept. to emtricitabine/M184M/VReduced pheno suscept. to emtricitabine/M184M/IReduced pheno suscept. to emtricitabine/M184A/VReduced pheno suscept. to emtricitabine/M184IReduced pheno suscept. to emtricitabine/M184M/I/V
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)11430000430000
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV17901111901111

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Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks

A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. (NCT00244712)
Timeframe: Baseline and time of virologic failure (up to Week 96)

,
Interventionparticipants (Number)
No. with paired genotypes at baseline and wk 96Participants with treatment-emergent mutationsNRTI-associated mutationsNNRTI-associated mutationsPI-associated mutations
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)451811411
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV41221737

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Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96

The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA <200 copies/mL or HIV-1 RNA rebound >= 200 copies/mL on two consecutive occasions. (NCT00244712)
Timeframe: Baseline to Week 96

,
Interventionparticipants (Number)
Protocol-defined virologic failureFail to confirm HIV-1 RNA <200 copies/mL by wk 24Confirmed HIV-1 RNA rebound to >= 200 copies/mLSuspected HIV-1 RNA rebound to >= 200 copies/mL
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)49212812
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV48242411

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)67.5
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV67.2

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Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96

,
Interventionpercentage of participants (Number)
M=F, Switch Included, Week 48TLOVR, Week 48Obs, Week 48M/D=F, Week 48M=F, Switch Included, Week 96TLOVR, Week 96Obs, Week 96M/D=F, Week 96
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)7570947163569359
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV7167946863589658

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Median DAVG in Plasma HBV DNA Levels at 96 Weeks Relative to Baseline

Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 96 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value. (NCT00298363)
Timeframe: Baseline to 96 weeks

Interventionlog_10 copies/mL (Median)
Tenofovir DF-3.06
FTC/TDF-4.06
Entecavir-3.32
Overall-3.40

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Median DAVG in Plasma HBV DNA Levels at 168 Weeks Relative to Baseline

Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 168 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value. (NCT00298363)
Timeframe: Baseline to 168 weeks

Interventionlog_10 copies/mL (Median)
Tenofovir DF-3.16
FTC/TDF-4.06
Entecavir-3.77
Overall-3.66

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Median DAVG in Plasma HBV DNA Levels at 144 Weeks Relative to Baseline

Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 144 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value. (NCT00298363)
Timeframe: Baseline to 144 weeks

Interventionlog _10 copies/mL (Median)
Tenofovir DF-3.07
FTC/TDF-3.82
Entecavir-3.76
Overall-3.49

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Median Change in Model for End-Stage Liver Disease (MELD) Score From Baseline at Week 48

MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. (NCT00298363)
Timeframe: Baseline to Week 48

Interventionunits on a scale (Median)
Tenofovir DF-2.0
FTC/TDF-2.0
Entecavir-2.0
Overall-2.0

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Median Change in MELD Score From Baseline at Week 96

MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. (NCT00298363)
Timeframe: Baseline to Week 96

Interventionunits on a scale (Median)
Tenofovir DF-2.0
FTC/TDF-3.0
Entecavir-3.0
Overall-2.0

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Median Change in MELD Score From Baseline at Week 168

MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. (NCT00298363)
Timeframe: Baseline to Week 168

Interventionunits on a scale (Median)
Tenofovir DF-2.0
FTC/TDF-2.0
Entecavir-2.0
Overall-2.0

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Median Change in MELD Score From Baseline at Week 144

MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. (NCT00298363)
Timeframe: Baseline to Week 144

Interventionunits on a scale (Median)
Tenofovir DF-2.0
FTC/TDF-1.5
Entecavir-2.0
Overall-2.0

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In the Subset of Participants Undergoing Liver Transplantation, Time to Recurrence of Hepatitis B, Defined as 2 Consecutive Plasma HBV DNA Concentrations ≥ 400 Copies/mL or 2 Consecutive HBsAg(+) Results

(NCT00298363)
Timeframe: Baseline to Week 168

InterventionDays (Number)
Tenofovir DFNA
FTC/TDFNA
EntecavirNA
OverallNA

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Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 96 (for Participants Who Were HBeAg Positive at Baseline)

Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 96

,,,
Interventionpercentage of participants (Number)
HBeAg LossHBeAg Seroconversion
Entecavir0.00.0
FTC/TDF33.313.3
Overall20.011.4
Tenofovir DF14.314.3

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Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline)

Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 168

,,,
Interventionpercentage of participants (Number)
HBeAg LossHBeAg Seroconversion
Entecavir16.70.0
FTC/TDF35.721.4
Overall27.318.2
Tenofovir DF23.123.1

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Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 144 (for Participants Who Were HBeAg Positive at Baseline)

Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 144

,,,
Interventionpercentage of participants (Number)
HBeAg LossHBeAg Seroconversion
Entecavir16.70.0
FTC/TDF33.313.3
Overall22.911.4
Tenofovir DF14.314.3

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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96

The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 96 was summarized. (NCT00298363)
Timeframe: Week 96

Interventionpercentage of participants (Number)
Tenofovir DF59.1
FTC/TDF79.5
Entecavir57.1
Overall66.3

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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48

The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 48 was summarized. (NCT00298363)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Tenofovir DF70.5
FTC/TDF87.8
Entecavir72.7
Overall77.6

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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168

The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 168 was summarized. (NCT00298363)
Timeframe: Week 168

Interventionpercentage of participants (Number)
Tenofovir DF50.0
FTC/TDF75.7
Entecavir52.4
Overall60.0

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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 144

The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 144 was summarized. (NCT00298363)
Timeframe: Week 144

Interventionpercentage of participants (Number)
Tenofovir DF50.0
FTC/TDF77.5
Entecavir52.4
Overall61.0

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Percentage of Participants With Only Baseline Lamivudine-resistance (LAM-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks

LAM resistance mutations are defined as the presence of the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation. (NCT00298363)
Timeframe: Baseline to Week 168

Interventionpercentage of participants (Number)
Tenofovir DF100
FTC/TDF100
Entecavir100

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Percentage of Participants With Only Baseline Adefovir Dipivoxil Resistance (ADV-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks

ADV resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation. (NCT00298363)
Timeframe: Baseline to Week 168

Interventionpercentage of participants (Number)
Tenofovir DF100
FTC/TDF100

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Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 96

Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point. (NCT00298363)
Timeframe: Baseline to Week 96

Interventionpercentage of participants (Number)
Tenofovir DF50.0
FTC/TDF58.3
Entecavir31.3
Overall48.5

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Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 168

Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point. (NCT00298363)
Timeframe: Baseline to Week 168

Interventionpercentage of participants (Number)
Tenofovir DF29.2
FTC/TDF60.0
Entecavir37.5
Overall43.1

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Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 144

Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point. (NCT00298363)
Timeframe: Baseline to Week 144

Interventionpercentage of participants (Number)
Tenofovir DF34.6
FTC/TDF64.0
Entecavir37.5
Overall46.3

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Percentage of Participants With Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48

Normalized ALT is defined as having a baseline ALT value > the upper limit of the normal range (ULN), and a decrease in ALT value to ≤ ULN at the given time point. (NCT00298363)
Timeframe: Baseline to Week 48

Interventionpercentage of participants (Number)
Tenofovir DF46.2
FTC/TDF64.0
Entecavir41.2
Overall51.5

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Percentage of Participants With Baseline ADV-R + LAM-R Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks

ADV resistance mutation + LAM resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation, and the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation. (NCT00298363)
Timeframe: Baseline to Week 168

Interventionpercentage of participants (Number)
Tenofovir DF50

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Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 96

CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 96

Interventionpercentage of participants (Number)
Tenofovir DF0.0
FTC/TDF0.0
Entecavir0.0
Overall0.0

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Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 168

CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 168

Interventionpercentage of participants (Number)
Tenofovir DF2.4
FTC/TDF0.0
Entecavir0.0
Overall1.0

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Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 144

CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 144

Interventionpercentage of participants (Number)
Tenofovir DF0.0
FTC/TDF2.5
Entecavir0.0
Overall1.0

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Percentage of Participants With an Increase in Child-Pugh Turcotte (CPT) Score of ≥ 2 Points at Weeks 48

CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 48

Interventionpercentage of participants (Number)
Tenofovir DF0.0
FTC/TDF2.6
Entecavir0.0
Overall1.0

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Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 96

CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 96

Interventionpercentage of participants (Number)
Tenofovir DF23.1
FTC/TDF52.0
Entecavir50.0
Overall39.3

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Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48

CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 48

Interventionpercentage of participants (Number)
Tenofovir DF25.9
FTC/TDF48.0
Entecavir41.7
Overall37.5

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Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 168

CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 168

Interventionpercentage of participants (Number)
Tenofovir DF24.0
FTC/TDF45.8
Entecavir45.5
Overall36.7

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Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 144

CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 144

Interventionpercentage of participants (Number)
Tenofovir DF25.9
FTC/TDF51.9
Entecavir45.5
Overall40.0

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Percent Probability of Tolerability Failure

Tolerability failure was defined as permanent discontinuation of study drug due to a treatment-emergent adverse event (AE), including any subject who temporarily discontinued study drug due to an AE and did not restart. Results are expressed as proportions of participants who experience tolerability failure using the Kaplan-Meier (KM) method of estimation. (NCT00298363)
Timeframe: Baseline to Week 168

Interventionpercent probability (KM estimate) (Number)
Tenofovir DF18
FTC/TDF4
TDF or FTC/TDF11
Entecavir14

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Percent Probability of a Confirmed Increase in Serum Creatinine of ≥ 0.5 mg/dL From Baseline or a Confirmed Serum Phosphorus Level < 2.0 mg/dL

Results are expressed as proportions of participants who experience a confirmed increase in serum creatinine of ≥ 0.5 mg/dL from baseline or a confirmed serum phosphorus level < 2.0 mg/dL using the KM method of estimation. (NCT00298363)
Timeframe: Baseline to Week 168

Interventionpercent probability (KM estimate) (Number)
Tenofovir DF15
FTC/TDF14
TDF or FTC/TDF14
Entecavir10

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Median Time-averaged Change (DAVG) in Plasma Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels at 48 Weeks Relative to Baseline

Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 48 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value. (NCT00298363)
Timeframe: Baseline to 48 weeks

Interventionlog_10 copies/mL (Median)
Tenofovir DF-2.93
FTC/TDF-3.45
Entecavir-3.61
Overall-3.19

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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48

Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 48

,,,
Interventionpercentage of participants (Number)
HBsAg LossHBsAg Seroconversion
Entecavir0.00.0
FTC/TDF0.00.0
Overall0.00.0
Tenofovir DF0.00.0

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Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 48 (for Participants Who Were HBeAg Positive at Baseline)

Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 48

,,,
Interventionpercentage of participants (Number)
HBeAg LossHBeAg Seroconversion
Entecavir0.00.0
FTC/TDF26.713.3
Overall19.413.9
Tenofovir DF21.421.4

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Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 96

Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 96

,,,
Interventionpercentage of participants (Number)
HBsAg LossHBsAg Seroconversion
Entecavir0.00.0
FTC/TDF0.00.0
Overall0.00.0
Tenofovir DF0.00.0

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Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 168

Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 168

,,,
Interventionpercentage of participants (Number)
HBsAg LossHBsAg Seroconversion
Entecavir0.00.0
FTC/TDF0.00.0
Overall0.00.0
Tenofovir DF0.00.0

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Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 144

Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 144

,,,
Interventionpercentage of participants (Number)
HBsAg LossHBsAg Seroconversion
Entecavir0.00.0
FTC/TDF0.00.0
Overall0.00.0
Tenofovir DF0.00.0

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Percentage of Participants With Normal ALT at Week 48

ULN for males = 43 U/L; 34 U/L for females (NCT00307489)
Timeframe: 48 Weeks

Interventionpercentage of participants (Number)
Tenofovir DF66.7
Emtricitibine/Tenofovir DF73.1

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Percentage of Participants With Normalized ALT at Week 168

Subjects with elevated ALT at baseline that return to normal by Week 48. (NCT00307489)
Timeframe: 168 weeks

InterventionPercent of Participants (Number)
Tenofovir DF68.0
Emtricitibine/Tenofovir DF70.8

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Percentage of Participants With Normalized ALT at Week 48

Subjects with elevated ALT at baseline that return to normal by Week 48. (NCT00307489)
Timeframe: 48 Weeks

Interventionpercentage of participants (Number)
Tenofovir DF40.7
Emtricitibine/Tenofovir DF61.5

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Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 168

P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use. (NCT00307489)
Timeframe: 168 weeks

InterventionPercent of Participants (Number)
Tenofovir DF80.4
Emtricitibine/Tenofovir DF78.0

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Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 168

Defined as having negative serum BHsAg and positive serum antibody to HBsAg (anti-HBs) for subject with positive serum BHsAg at baseline. (NCT00307489)
Timeframe: 168 weeks

InterventionParticipants (Number)
Tenofovir DF1
Emtricitibine/Tenofovir DF0

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Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48

(NCT00307489)
Timeframe: 48 weeks

Interventionpercentage of participants (Number)
Tenofovir DF75.5
Emtricitibine/Tenofovir DF69.2

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Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 168

(NCT00307489)
Timeframe: 168 weeks

InterventionU/mL (Mean)
Tenofovir DF-26.8
Emtricitibine/Tenofovir DF-54.5

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Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 48

(NCT00307489)
Timeframe: 48 Weeks

InterventionU/mL (Mean)
Tenofovir DF-21.6
Emtricitibine/Tenofovir DF-41.4

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Change From Baseline in log10 Plasma HBV DNA Levels at Week 168

(NCT00307489)
Timeframe: 168 weeks

Interventionlog10 copies/mL (Mean)
Tenofovir DF-3.79
Emtricitibine/Tenofovir DF-3.48

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Change From Baseline in log10 Plasma HBV DNA Levels at Week 48

(NCT00307489)
Timeframe: 48 Weeks

Interventionlog10 copies/mL (Mean)
Tenofovir DF-3.58
Emtricitibine/Tenofovir DF-3.34

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HBeAg Seroconversion at Week 48

Defined as having negative serum HBeAg and positive serum antibody to HBeAg [anti-HBe] for subjects with positive serum HBeAg at baseline. (NCT00307489)
Timeframe: 48 Weeks

Interventionparticipants (Number)
Tenofovir DF2
Emtricitibine/Tenofovir DF3

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HBsAg Loss at Week 168

Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline. (NCT00307489)
Timeframe: 168 weeks

InterventionParticipants (Number)
Tenofovir DF1
Emtricitibine/Tenofovir DF0

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HBsAg Loss at Week 48

Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline. (NCT00307489)
Timeframe: 48 Weeks

Interventionparticipants (Number)
Tenofovir DF1
Emtricitibine/Tenofovir DF0

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Hepatitis B Early Antigen (HBeAg) Loss at Week 168

Defined as having negative serum HBeAg for subjecst with positive HBeAg at baseline. (NCT00307489)
Timeframe: 168 weeks

InterventionPercent of Participants (Number)
Tenofovir DF21.6
Emtricitibine/Tenofovir DF24.3

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Hepatitis B Early Antigen (HBeAg) Loss at Week 48

Defined as having negative serum HBeAg for subjects with positive HBeAg at baseline. (NCT00307489)
Timeframe: 48 Weeks

Interventionparticipants (Number)
Tenofovir DF3
Emtricitibine/Tenofovir DF3

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Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 48

Defined as having negative serum HBsAg and positive serum antibody to HBsAg [anti-HBs] for subject with positive serum HBsAg at baseline. (NCT00307489)
Timeframe: 48 Weeks

Interventionparticipants (Number)
Tenofovir DF1
Emtricitibine/Tenofovir DF0

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Percentage of Participants With Normal ALT at Week 168

ULN for males = 43 U/L; ULN for females = 34 U/L (NCT00307489)
Timeframe: 168 weeks

InterventionPercent of Participants (Number)
Tenofovir DF74.0
Emtricitibine/Tenofovir DF74.0

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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168

(NCT00307489)
Timeframe: 168 weeks

InterventionPercent of Participants (Number)
Tenofovir DF82.4
Emtricitibine/Tenofovir DF84.0

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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48

(NCT00307489)
Timeframe: 48 Weeks

Interventionpercentage of participants (Number)
Tenofovir DF81.1
Emtricitibine/Tenofovir DF80.8

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Time Weighted Mean Change From Baseline Plasma HIV-RNA

(NCT00335322)
Timeframe: 144 weeks

Interventionlog copies/mL (Mean)
TDF/FTC+EFV-2.77
TDF/FTC+ r/ATV-2.88
TDF/FTC + AZT+ABC-2.54

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Time-weighted Mean Change From Baseline Plasma HIV-RNA.

(NCT00335322)
Timeframe: 48 weeks

Interventionlog copies/mL (Mean)
TDF/FTC+EFV-2.59
TDF/FTC+r/ATV-2.69
TDF/FTC+AZT+ABC-2.39

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Patients With Plasma HIV RNA < 50 Copies/mL

The number of participants with plasma HIV RNA < 50 copies/mL (NCT00344461)
Timeframe: 96 weeks.

InterventionParticipants (Count of Participants)
Single Group (TDF/FTC & NVP)32

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Number of Participants With Sustained Virologic Response

The primary outcome is sustained Virologic response, defined as HIV-1 RNA <500 copies/mL until trial completion at 96 weeks. (NCT00344461)
Timeframe: 96 Weeks

InterventionParticipants (Count of Participants)
Single Group (TDF/FTC & NVP)33

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Patients With Grade 2, 3 and 4 Adverse Events and Laboratory Toxicities

The number of participants with grades 2,3 and 4 adverse events and laboratory toxicities. (NCT00344461)
Timeframe: Protocol length is 96 weeks

InterventionParticipants (Count of Participants)
Nevirapine, FTC, Tenofovir13

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Patients With Plasma HIV RNA < 400 Copies/mL

The number of participants with plasma HIV RNA < 400 copies/mL (NCT00344461)
Timeframe: 96 weeks

InterventionParticipants (Count of Participants)
Nevirapine, FTC, Tenofovir32

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Change in Plasma HIV RNA From Baseline to Week 96

Percent Change From Baseline in Plasma HIV RNA at 96 weeks (NCT00344461)
Timeframe: Baseline to week 96

Interventionpercentage of change (Mean)
Nevirapine, FTC, Tenofovir3.32

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Changes in CD4 Cell Count From Baseline and Week 96

To determine the mean change from Baseline in CD4 cell count to week 96. (NCT00344461)
Timeframe: Baseline to week 96

Interventionpercentage of CD4 Increase (Mean)
Nevirapine, FTC, Tenofovir252

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The Proportion Of Participants With Virologic Response For 10 mg/Day Elvucitabine In HIV-1-Infected Participants By 12 Weeks Compared With The Proportion Of Participants With Lamivudine 300 mg/Day

The proportion of participants having achieved a virologic response for elvucitabine 10 mg/day in combination with efavirenz and tenofovir in HIV-1-infected participants over 12 weeks compared with the proportion of participants having achieved a virologic response for lamivudine 300 mg/day in combination with efavirenz and tenofovir. Virologic response was defined as having achieved undetectable (<50 copies/mL) HIV-1 RNA levels from baseline assessment. (NCT00350272)
Timeframe: 12 weeks

,
Interventionpercentage of participants (Number)
Week 2Week 4Week 6Week 8Week 10Week 12
Elvucitabine13.516.227.035.154.156.8
Lamivudine8.110.835.154.156.870.3

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The Safety Profile Of Elvucitabine.

Determination of the safety profile of elvucitabine as defined by the frequency, type and severity of treatment-emergent adverse events (AEs) and the frequency of Grade 3 and Grade 4 laboratory abnormalities. (NCT00350272)
Timeframe: 12 weeks

,
Interventionparticipants (Number)
Treatment emergent adverse eventsTreatment emergent severe adverse eventsTreatment related serious adverse eventsDiscontinuations due to adverse eventsTreatment emergent Grade 3/4 lab abnormalities
Elvucitabine, Efavirenz,Tenofovir363026
Lamivudine,Efavirenz,Tenofovir352005

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Change From Baseline to Week 288 in CD4 Percentage

CD4 percentage is the percentage of total lymphocytes that are CD4 cells. (NCT00352053)
Timeframe: Baseline to 288 weeks

InterventionPercentage of CD4 lymphocytes (Median)
Tenofovir DF7.4
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL4.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL11.9

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Change From Baseline to Week 288 in CD4 Count

(NCT00352053)
Timeframe: Baseline to 288 weeks

Interventioncells/mm^3 (Median)
Tenofovir DF310
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL100
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL309

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Change From Baseline to Week 240 in HIV-1 RNA

(NCT00352053)
Timeframe: Baseline to 240 weeks

Interventionlog10 copies/mL (Median)
Tenofovir DF-2.5
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL-0.4
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL-1.4

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Change From Baseline to Week 240 in CD4 Percentage

CD4 percentage is the percentage of total lymphocytes that are CD4 cells. (NCT00352053)
Timeframe: Baseline to 240 weeks

InterventionPercentage of CD4 lymphocytes (Median)
Tenofovir DF10.0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL8.9
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL18.9

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Change From Baseline to Week 240 in CD4 Count

(NCT00352053)
Timeframe: Baseline to 240 weeks

Interventioncells/mm^3 (Median)
Tenofovir DF221
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL571
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL258

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Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count

(NCT00352053)
Timeframe: Baseline to 24 weeks

Interventioncells/mm3 (Median)
Tenofovir DF69
Placebo49
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL-43
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL-12

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Change From Baseline to Week 24 in CD4 Percentage

CD4 percentage is the percentage of total lymphocytes that are CD4 cells. (NCT00352053)
Timeframe: Baseline to 24 weeks

InterventionPercentage of CD4 lymphocytes (Median)
Tenofovir DF3.0
Placebo2.0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL0.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL-1.0

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Change From Baseline to Week 192 in HIV-1 RNA

(NCT00352053)
Timeframe: Baseline to 192 weeks

Interventionlog10 copies/mL (Median)
Tenofovir DF-2.0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL0.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL-0.1

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Change From Baseline to Week 192 in CD4 Percentage

CD4 percentage is the percentage of total lymphocytes that are CD4 cells. (NCT00352053)
Timeframe: Baseline to 192 weeks

InterventionPercentage of CD4 lymphocytes (Median)
Tenofovir DF5.0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL1.9
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL4.8

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Change From Baseline to Week 192 in CD4 Count

(NCT00352053)
Timeframe: Baseline to 192 weeks

Interventioncells/mm^3 (Median)
Tenofovir DF166
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL-70
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL-23

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Change From Baseline to Week 144 in HIV-1 RNA

(NCT00352053)
Timeframe: Baseline to 144 weeks

Interventionlog10 copies/mL (Median)
Tenofovir DF-2.5
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL0.2
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL0.7

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Change From Baseline to Week 144 in CD4 Percentage

CD4 percentage is the percentage of total lymphocytes that are CD4 cells. (NCT00352053)
Timeframe: Baseline to 144 weeks

InterventionPercentage of CD4 lymphocytes (Median)
Tenofovir DF6.5
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL0.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL5.5

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Change From Baseline to Week 144 in CD4 Count

(NCT00352053)
Timeframe: Baseline to 144 weeks

Interventioncells/mm^3 (Median)
Tenofovir DF188
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL-88
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL33

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Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA

"DAVG48 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 48 minus the baseline value. DAVG48 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.~Data for participants who discontinued the double-blind phase of the study early were included up until the point of discontinuation from the study (ie, missing data were not imputed)." (NCT00352053)
Timeframe: Baseline to 48 weeks

Interventionlog10 copies/mL (Median)
Tenofovir DF-1.423
Placebo-1.352

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Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA

"DAVG24 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 24 minus the baseline value. DAVG24 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.~Data for participants who discontinued the randomized (double-blind) phase of the study early were included up until the point of study discontinuation (missing data not imputed)." (NCT00352053)
Timeframe: Baseline to 24 Weeks

Interventionlog10 copies/mL (Median)
Tenofovir DF-1.580
Placebo-1.549

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Percentage of Participants With Virologic Failure Through Week 48

"Virologic failure was defined as either nonresponse or viral rebound.~Nonresponse (failure to achieve response). Response was defined as either~A ≥ 0.5 log10 copies/mL decrease in HIV-1 RNA from baseline at 2 consecutive visits, or~HIV-1 RNA < 400 copies/mL at 2 consecutive visits.~Viral rebound was defined as either~Participants who achieved a ≥ 0.5 log10 copies/mL decrease from baseline in plasma HIV-1 RNA at 2 consecutive visits, who then subsequently achieved plasma HIV-1 RNA values ≥ 1.0 log10 copies/mL above their on-study nadir (lowest value) and/or plasma HIV-1 RNA values ≥ the baseline value at 2 consecutive visits, or~Participants who achieved plasma HIV-1 RNA levels of < 400 copies/mL at 2 consecutive visits, and then subsequently had plasma HIV-1 RNA levels > 1000 copies/mL at 2 consecutive visits.~The virologic failure rate was estimated from Kaplan-Meier product limit method by including all HIV-1 RNA data collected during the double-blind phase." (NCT00352053)
Timeframe: Up to 48 weeks

InterventionKaplan-Meier percentage (Number)
Tenofovir DF51
Placebo39

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

(NCT00352053)
Timeframe: Week 96

InterventionPercentage of participants (Number)
Tenofovir DF47.4
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL58.8
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL33.3

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

(NCT00352053)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Tenofovir DF27.3
Placebo36.6
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL61.1
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL0

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288

(NCT00352053)
Timeframe: Week 288

InterventionPercentage of participants (Number)
Tenofovir DF0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL100.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL0

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240

(NCT00352053)
Timeframe: Week 240

InterventionPercentage of participants (Number)
Tenofovir DF75.0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL100.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL100.0

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24

(NCT00352053)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Tenofovir DF20.5
Placebo34.1
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL77.8
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL0

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192

(NCT00352053)
Timeframe: Week 192

InterventionPercentage of participants (Number)
Tenofovir DF42.9
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL60.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL50.0

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144

(NCT00352053)
Timeframe: Week 144

InterventionPercentage of participants (Number)
Tenofovir DF70.0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL45.5
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL0

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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96

(NCT00352053)
Timeframe: Week 96

InterventionPercentage of participants (Number)
Tenofovir DF63.2
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL70.6
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL33.3

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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48

(NCT00352053)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Tenofovir DF34.1
Placebo43.9
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL77.8
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL0

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Change From Baseline to Week 24 in HIV-1 RNA

(NCT00352053)
Timeframe: Baseline to 24 weeks

Interventionlog10 copies/mL (Median)
Tenofovir DF-1.23
Placebo-1.27
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL0.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL-0.1

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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288

(NCT00352053)
Timeframe: Week 288

InterventionPercentage of participants (Number)
Tenofovir DF0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL100.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL0

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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240

(NCT00352053)
Timeframe: Week 240

InterventionPercentage of participants (Number)
Tenofovir DF75.0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL100.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL100.0

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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24

(NCT00352053)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Tenofovir DF40.9
Placebo41.5
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL83.3
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL6.3

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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192

(NCT00352053)
Timeframe: Week 192

InterventionPercentage of participants (Number)
Tenofovir DF57.1
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL80.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL50.0

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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144

(NCT00352053)
Timeframe: Week 144

InterventionPercentage of participants (Number)
Tenofovir DF70.0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL72.7
Placebo/TDF, HIV-1 RNA >= 1000 Copies/mL0

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Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288

(NCT00352053)
Timeframe: Baseline to 288 weeks

InterventionPercentage of participants (Number)
Tenofovir DF100.0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL0

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Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96

(NCT00352053)
Timeframe: Baseline to 96 weeks

InterventionPercentage of participants (Number)
Tenofovir DF73.7
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL5.9
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL33.3

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Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48

(NCT00352053)
Timeframe: Baseline to 48 weeks

InterventionPercentage of participants (Number)
Tenofovir DF47.7
Placebo53.7
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL0

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Change From Baseline to Week 48 in CD4 Count

(NCT00352053)
Timeframe: Baseline to 48 weeks

Interventioncells/mm3 (Median)
Tenofovir DF152
Placebo148
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL15
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL-47

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Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24

(NCT00352053)
Timeframe: Baseline to 24 weeks

InterventionPercentage of participants (Number)
Tenofovir DF56.8
Placebo51.2
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL12.5

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Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192

(NCT00352053)
Timeframe: Baseline to 192 weeks

InterventionPercentage of participants (Number)
Tenofovir DF71.4
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL50.0

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Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144

(NCT00352053)
Timeframe: Baseline to 144 weeks

InterventionPercentage of participants (Number)
Tenofovir DF90.0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL0

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Change From Baseline to Week 96 in HIV-1 RNA

(NCT00352053)
Timeframe: Baseline to 96 weeks

Interventionlog10 copies/mL (Median)
Tenofovir DF-2.1
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL0.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL0.1

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Change From Baseline to Week 96 in CD4 Percentage

CD4 percentage is the percentage of total lymphocytes that are CD4 cells. (NCT00352053)
Timeframe: Baseline to 96 weeks

InterventionPercentage of CD4 lymphocytes (Median)
Tenofovir DF5.0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL2.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL9.0

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Change From Baseline to Week 96 in CD4 Count

(NCT00352053)
Timeframe: Baseline to 96 weeks

Interventioncells/mm3 (Median)
Tenofovir DF152
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL-6
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL-69

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Change From Baseline to Week 48 in HIV-1 RNA

(NCT00352053)
Timeframe: Baseline to 48 weeks

Interventionlog10 copies/mL (Median)
Tenofovir DF-0.97
Placebo-1.53
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL0.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL0.2

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Change From Baseline to Week 48 in CD4 Percentage

CD4 percentage is the percentage of total lymphocytes that are CD4 cells. (NCT00352053)
Timeframe: Baseline to 48 weeks

InterventionPercentage of CD4 lymphocytes (Median)
Tenofovir DF6.0
Placebo5.0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL2.0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL-1.0

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Change From Baseline to Week 288 in HIV-1 RNA

(NCT00352053)
Timeframe: Baseline to 288 weeks

Interventionlog10 copies/mL (Median)
Tenofovir DF-1.1
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL-0.8
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL0.6

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Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240

(NCT00352053)
Timeframe: Baseline to 240 weeks

InterventionPercentage of participants (Number)
Tenofovir DF100.0
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL0
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL100.0

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Change in CD4+ Cell Counts From Study Entry to Week 104

(NCT00357552)
Timeframe: Study entry and week 104

Interventioncells/mm^3 (Median)
LPV/r Monotherapy213

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Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104

(NCT00357552)
Timeframe: At Weeks 0, 12, 16, 20, 24, 32, 40, 48, 56, 68, 80, 92, 104

Interventionproportion of participants (Number)
week 0 (N=123)week 12 (N=122)week 16 (N=121)week 20 (N=115)week 24 (N=122)week 32 (N=121)week 40 (N=118)week 48 (N=118)week 56 (N=120)week 68 (N=116)week 80 (N=117)week 92 (N=116)week 104 (N=117)
LPV/r Monotherapy0.020.750.870.840.840.830.840.870.860.910.850.870.89

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Percentage of Subjects Reporting Not Skipping Medications in the Last Month.

The percentage of subjects reporting never missing medications in the last month. (NCT00357552)
Timeframe: Study entry and weeks 2, 4, 8, 12, 16, 20, and 24

Interventionpercentage of subjects with data (Number)
week 2 (N=120)week 4 (N=121)week 8 (N=123)week 12 (N=123)week 16 (N=122)week 20 (N=120)week 24 (N=122)
LPV/r Monotherapy9086.887.886.286.190.989.4

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Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening.

Number of screened subjects with at least one NNRTI, or NRTI-associated resistance mutation. Resistance interpretations used the November 30, 2011 Stanford algorithm. (NCT00357552)
Timeframe: Screening

Interventionnumber of screened subjects (Number)
At least one NNRTI-associated mutationAt least one NRTI-associated mutation
All Screened Subjects With Available Sequences201197

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Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma

Proportion of DBS samples with HIV-1 RNA level <= 400 copies/mL, proportion of plasma samples with HIV-1 RNA level <= 400 copies/mL and proportion of paired DBS and plasma samples that are concordant (both <= 400 copies/mL or both > 400 copies/mL). Results are pooled over 4 different storage temperature conditions (-80C, -20C, 4C and room temperature). (NCT00357552)
Timeframe: At study entry and weeks 24 and 48

Interventionproportion of samples (Number)
study entry DBS <= 400 cp/mLstudy entry plasma <= 400 cp/mLstudy entry DBS & plasma concordanceweek 24 DBS <= 400 cp/mLweek 24 plasma <= 400 cp/mLweek 24 DBS & plasma concordanceweek 48 DBS <= 400 cp/mLweek 48 plasma <= 400 cp/mLweek 48 DBS & plasma concordance
LPV/r Monotherapy0.170.000.830.820.800.800.940.910.97

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Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.

25th percentile in weeks from study entry to treatment failure, defined as the first occurrence of death, disease progression, or virologic failure. Virologic failure was defined as HIV-1 >= 400 copies/mL after week 24 or 2 consecutive HIV-1 RNA >= 400 copies/mL after week 16 following suppression on LPV/r monotherapy. (NCT00357552)
Timeframe: Study entry to Week 104

Interventionweeks (Number)
LPV/r Monotherapy48.0

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Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification

25th percentile in weeks from study entry to first new grade 3 or 4 sign or symptom or laboratory toxicity following LPV/r intensification. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004. (NCT00357552)
Timeframe: From LPV/r intensification to week 104

Interventionweeks (Number)
LPV/r Monotherapy26.0

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Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.

Probability of Grade 3 or 4 sign or symptom, or laboratory toxicity over 24 weeks on study using Kaplan-Meier estimates of the cumulative probability of Grade 3 or 4 sign or symptom, or laboratory toxicity at week 24. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004. (NCT00357552)
Timeframe: From study entry to week 24

Interventioncumulative probability of grade 3 or 4 (Number)
LPV/r Monotherapy0.23

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Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy

Virologic success at week 24 on LPV/r monotherapy was defined as remaining on LPV/r monotherapy at week 24 without prior virologic failure. Virologic failure was met with either of these two conditions: (i) failure to suppress HIV-1 RNA to < 400 copies/mL by week 24 or (ii) confirmed HIV-1 RNA >= 400 copies/mL after confirmed HIV-1 RNA < 400 copies/mL. (NCT00357552)
Timeframe: From study entry to week 24

Interventionpercentage of enrolled subjects (Number)
LPV/r Monotherapy87

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Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.

Number of subjects with at least one new PI-associated resistance mutation at time of virologic failure. Resistance interpretations used the May 6, 2009 Stanford algorithm. (NCT00357552)
Timeframe: At time of virologic failure

Interventionparticipants (Number)
Virologic Failures by Week 24.2

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Number of Participants With Study-targeted Diagnoses and Clinical Events

Cardiac disorders, Infections and infestations, Metabolism and nutrition disorders, Neoplasms benign, malignant and unspecified (including cysts and polyps), Pregnancy, puerperium and perinatal conditions, Vascular disorders, were specified a priori as study-targeted events by the study chair. (NCT00357552)
Timeframe: Study entry to week 104

Interventionparticipants (Number)
LPV/r Monotherapy39

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Change From Baseline in CD4 Cell Count at Week 240

Mean change from baseline at Week 240 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 240

InterventionCD4 Cell Count (cells/mm3) (Mean)
MK-0518 400 mg b.i.d.373.7
Efavirenz 600 mg q.h.s.311.6

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Change From Baseline in CD4 Cell Count at Week 96

Mean change from baseline at Week 96 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 96

InterventionCD4 Cell Count (cells/mm3) (Mean)
MK-0518 400 mg b.i.d.239.6
Efavirenz 600 mg q.h.s.224.8

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Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48

Mean change from baseline at Week 48 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 48

InterventionCD4 Cell Count (cells/mm3) (Mean)
MK-0518 400 mg b.i.d.189.1
Efavirenz 600 mg q.h.s.163.3

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Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 156. (NCT00369941)
Timeframe: 156 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.224
Efavirenz 600 mg q.h.s.203

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Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 240. (NCT00369941)
Timeframe: 240 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.206
Efavirenz 600 mg q.h.s.181

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Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48. (NCT00369941)
Timeframe: 48 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.252
Efavirenz 600 mg q.h.s.241

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Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 96. (NCT00369941)
Timeframe: 96 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.240
Efavirenz 600 mg q.h.s.229

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Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 156. (NCT00369941)
Timeframe: 156 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.212
Efavirenz 600 mg q.h.s.192

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Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 240. (NCT00369941)
Timeframe: 240 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.198
Efavirenz 600 mg q.h.s.171

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Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 96. (NCT00369941)
Timeframe: 96 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.228
Efavirenz 600 mg q.h.s.222

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Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48. (NCT00369941)
Timeframe: 48 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.241
Efavirenz 600 mg q.h.s.230

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Number of Participants Discontinued With LAEs at Week 156

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
Discontinued With LAEsDid Not Discontinue With LAEs
Efavirenz 600 mg q.h.s.3279
MK-0518 400 mg b.i.d.0281

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Number of Participants Discontinued With LAEs at Week 240

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
Discontinued With LAEsDid Not Discontinue With LAEs
Efavirenz 600 mg q.h.s.3279
MK-0518 400 mg b.i.d.0281

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Number of Participants Discontinued With LAEs at Week 48

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
Discontinued with LAEsDid Not Discontinue with LAEs
Efavirenz 600 mg q.h.s.1281
MK-0518 400 mg b.i.d.0281

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Number of Participants Discontinued With LAEs at Week 96

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
Discontinued With LAEsDid Not Discontinue With LAEs
Efavirenz 600 mg q.h.s.2280
MK-0518 400 mg b.i.d.0281

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Number of Participants That Died by Week 156

All participant deaths in the span of 156 weeks on study were recorded. (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
DiedDid Not Die
Efavirenz 600 mg q.h.s.1281
MK-0518 400 mg b.i.d.4277

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Number of Participants That Died by Week 240

All participant deaths in the span of 240 weeks on study were recorded. (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
DiedDid Not Die
Efavirenz 600 mg q.h.s.5277
MK-0518 400 mg b.i.d.5276

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Number of Participants That Died by Week 48

All participant deaths in the span of 48 weeks on study were recorded. (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
DiedDid Not Die
Efavirenz 600 mg q.h.s.0282
MK-0518 400 mg b.i.d.2279

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Number of Participants That Died by Week 96

All participant deaths in the span of 96 weeks on study were recorded. (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
DiedDid Not Die
Efavirenz 600 mg q.h.s.0282
MK-0518 400 mg b.i.d.3278

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Number of Participants That Discontinued With CAEs at Week 156

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
Discontinued With CAEsDid Not Discontinue With CAEs
Efavirenz 600 mg q.h.s.21261
MK-0518 400 mg b.i.d.13268

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Number of Participants That Discontinued With CAEs at Week 240

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
Discontinued With CAEsDid Not Discontinue With CAEs
Efavirenz 600 mg q.h.s.25257
MK-0518 400 mg b.i.d.14267

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Number of Participants That Discontinued With CAEs at Week 48

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
Discontinued with CAEsDid Not Discontinue with CAEs
Efavirenz 600 mg q.h.s.17265
MK-0518 400 mg b.i.d.9272

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Number of Participants That Discontinued With CAEs at Week 96

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
Discontinued With CAEsDid Not Discontinue With CAEs
Efavirenz 600 mg q.h.s.17265
MK-0518 400 mg b.i.d.10271

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Number of Participants That Discontinued With Serious CAEs at Week 156

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
Discontinued With Serious CAEsDid Not Discontinue With Serious CAEs
Efavirenz 600 mg q.h.s.6276
MK-0518 400 mg b.i.d.10271

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Number of Participants That Discontinued With Serious CAEs at Week 240

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
Discontinued With Serious CAEsDid Not Discontinue With Serious CAEs
Efavirenz 600 mg q.h.s.10272
MK-0518 400 mg b.i.d.11270

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Number of Participants That Discontinued With Serious CAEs at Week 48

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
Discontinued with Serious CAEsDid Not Discontinue with Serious CAEs
Efavirenz 600 mg q.h.s.4278
MK-0518 400 mg b.i.d.7274

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Number of Participants That Discontinued With Serious CAEs at Week 96

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
Discontinued With Serious CAEsDid Not Discontinue With Serious CAEs
Efavirenz 600 mg q.h.s.5277
MK-0518 400 mg b.i.d.8273

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Number of Participants With CAEs at Week 156

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
With CAEsWithout CAEs
Efavirenz 600 mg q.h.s.2766
MK-0518 400 mg b.i.d.26714

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Number of Participants With CAEs at Week 240

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
With CAEsWithout CAEs
Efavirenz 600 mg q.h.s.2766
MK-0518 400 mg b.i.d.27110

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Number of Participants With CAEs at Week 96

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
With CAEsWithout CAEs
Efavirenz 600 mg q.h.s.2748
MK-0518 400 mg b.i.d.26516

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Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
With CAEsWithout CAEs
Efavirenz 600 mg q.h.s.27210
MK-0518 400 mg b.i.d.25328

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Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
With LAEsWithout LAEs
Efavirenz 600 mg q.h.s.41241
MK-0518 400 mg b.i.d.27254

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Number of Participants With LAEs at Week 156

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
With LAEsWithout LAEs
Efavirenz 600 mg q.h.s.63219
MK-0518 400 mg b.i.d.41240

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Number of Participants With LAEs at Week 96

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
With LAEsWithout LAEs
Efavirenz 600 mg q.h.s.53229
MK-0518 400 mg b.i.d.33248

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Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8

Participants with dizziness, insomnia, somnolence, concentration impaired, depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, auditory hallucination, completed suicide, and major depression (NCT00369941)
Timeframe: 8 Weeks

,
InterventionParticipants (Number)
With Nervous System SymptomsWithout Nervous System Symptoms
Efavirenz 600 mg q.h.s.147135
MK-0518 400 mg b.i.d.57224

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Number of Participants With Serious CAEs at Week 156

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
Efavirenz 600 mg q.h.s.46236
MK-0518 400 mg b.i.d.46235

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Number of Participants With Serious CAEs at Week 240

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
Efavirenz 600 mg q.h.s.57225
MK-0518 400 mg b.i.d.57224

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Number of Participants With Serious CAEs at Week 48

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
Efavirenz 600 mg q.h.s.27255
MK-0518 400 mg b.i.d.28253

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Number of Participants With Serious CAEs at Week 96

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
Efavirenz 600 mg q.h.s.33249
MK-0518 400 mg b.i.d.37244

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Number of Participants With Serious LAEs at Week 156

"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
With Serious LAEsWithout Serious LAEs
Efavirenz 600 mg q.h.s.2280
MK-0518 400 mg b.i.d.0281

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Number of Participants With Serious LAEs at Week 240

"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
With Serious LAEsWithout Serious LAEs
Efavirenz 600 mg q.h.s.2280
MK-0518 400 mg b.i.d.0281

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Number of Participants With Serious LAEs at Week 48

"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
With Serious LAEsWithout Serious LAEs
Efavirenz 600 mg q.h.s.1281
MK-0518 400 mg b.i.d.0281

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Number of Participants With Serious LAEs at Week 96

"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
With Serious LAEsWithout Serious LAEs
Efavirenz 600 mg q.h.s.1281
MK-0518 400 mg b.i.d.0281

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Change From Baseline in CD4 Cell Count at Week 156

Mean change from baseline at Week 156 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 156

InterventionCD4 Cell Count (cells/mm3) (Mean)
MK-0518 400 mg b.i.d.331.7
Efavirenz 600 mg q.h.s.295.2

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Number of Participants With LAEs at Week 240

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
With LAEsWithout LAEs
Efavirenz 600 mg q.h.s.77205
MK-0518 400 mg b.i.d.56225

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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96

HBsAg = A part of the hepatitis B virus. When found in the blood, HBsAg is an early marker of infection. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. (NCT00410072)
Timeframe: At Weeks 48 and 96

,
InterventionPercent of participants (Number)
Week 48Week 96
ETV 0.5 mg3.24.0
ETV 0.5 mg +TDF 300 mg1.45.1

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Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96

HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. (NCT00410072)
Timeframe: At Weeks 48 and 96

,
InterventionPercentage of participants (Number)
Week 48Week 96
ETV 0.5 mg25.43.97
ETV 0.5 mg +TDF 300 mg19.629.7

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Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96

HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. (NCT00410072)
Timeframe: At Weeks 48 and 96

,
InterventionPercentage of participants (Number)
Week 48Week 96
ETV 0.5 mg0.81.6
ETV 0.5 mg +TDF 300 mg0.72.9

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Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96

HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. (NCT00410072)
Timeframe: At Weeks 48 and 96

,
InterventionPercentage of participants (Number)
Week 48Week 96
ETV 0.5 mg22.232.5
ETV 0.5 mg +TDF 300 mg18.121.7

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Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96

ALT normalization= ≤1*upper limit of normal (ULN). Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. (NCT00410072)
Timeframe: At Weeks 48 and 96

,
InterventionPercentage of participants (Number)
Overall at Week 48Overall at Week 96
ETV 0.5 mg83.081.9
ETV 0.5 mg +TDF 300 mg72.668.0

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Percentage of Participants Who Achieved HBV DNA Levels

LOQ=lower limit of quantitation. LOQ=29 IU/mL, or approximately 169 copies/mL. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. (NCT00410072)
Timeframe: At Weeks 48 and 96

,
InterventionPercentage of participants (Number)
Overall at Week 48Overall at Week 96
ETV 0.5 mg67.674.7
ETV 0.5 mg +TDF 300 mg74.681.7

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Percentage of Participants Who Achieved HBV DNA Levels

LOD=Lower limit of detection. LOD) LOD=10 IU/mL, or approximately 58 copies/mL. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. (NCT00410072)
Timeframe: At Weeks 48 and 96

,
InterventionPercentage of participants (Number)
Overall at Week 48Overall at Week 96
ETV 0.5 mg58.268.1
ETV 0.5 mg +TDF 300 mg66.076.6

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Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status

HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. (NCT00410072)
Timeframe: At Weeks 48 and 96

,
InterventionPercentage of participants (Number)
HBeAg+ at Week 48 (n=126, n=138)HBeAg- at Week 48 (n=56, n=59)HBeAg+ at Week 96 (n=126, n=138)HBeAg- at Week 96 (n=56, n=59)
ETV 0.5 mg61.191.169.891.1
ETV 0.5 mg +TDF 300 mg74.693.280.489.8

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Number of Participants With Virologic Breakthrough at Week 96

ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir (NCT00410072)
Timeframe: Week 96

,
InterventionParticipants (Number)
ETVrTDFr
ETV 0.5 mg00
ETV 0.5 mg +TDF 300 mg00

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Number of Participants With HBV Resistance Through Week 48

ETVr=entecavir resistance; TDFr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used. (NCT00410072)
Timeframe: Week 48

,
InterventionParticipants (Number)
ETVrTDFr
ETV 0.5 mg00
ETV 0.5 mg +TDF 300 mg00

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Number of Participants With HBV Resistance at Week 96

ETVr=entecavir resistance; TFDr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used. (NCT00410072)
Timeframe: Week 96

,
InterventionParticipants (Number)
ETVrTDFr
ETV 0.5 mg00
ETV 0.5 mg +TDF 300 mg00

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Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96

Using the Roche COBAS TaqMan - HPS assay. Lower limit of Quantitation (LOQ) is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific. (NCT00410072)
Timeframe: At Weeks 48 and 96

,
InterventionPercentage of participants (Number)
< LOQ (29 IU/mL) at Week 48LOQ - <50 IU/mL at Week 4850 - <172 IU/mL at Week 48172 - <1720 IU/mL at Week 481720 - <17,200 IU/mL at Week 4817,200 - <172,000 IU/mL at Week 48≥172,000 IU/mL at Week 48Missing at Week 48< LOQ (29 IU/mL) at Week 96LOQ - <50 IU/mL at Week 9650 - <172 IU/mL at Week 96172 - <1720 IU/mL at Week 961720 - <17,200 IU/mL at Week 9617,200 - <172,000 IU/mL at Week 96≥172,000 IU/mL at Week 96Missing at Week 96
ETV 0.5 mg67.62.77.17.79.31.60.53.374.71.63.35.54.90.509.3
ETV 0.5 mg +TDF 300 mg74.65.66.64.10.5008.681.71.51.01.5000.513.7

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Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities

AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. (NCT00410072)
Timeframe: From enrollment through Week 100 + 24-week follow-up

,
InterventionParticipants (Number)
DeathsSAEsAdverse eventsDiscontinuations due to AEsRelated AEs
ETV 0.5 mg012132239
ETV 0.5 mg +TDF 300 mg314131549

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Mean Log 10 HBV DNA at Weeks 48 and 96

HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan - HPS assay. Reduction in Log 10 HBV count=reduced viral load. (NCT00410072)
Timeframe: Baseline, Weeks 48 and 96

,
Interventionlog10 copies/mL (Mean)
Baseline (n=182, 197)Overall at Week 48 (n=176, 180)Overall at Week 96 (n=165, 170)
ETV 0.5 mg7.481.881.68
ETV 0.5 mg +TDF 300 mg7.531.561.51

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Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96

HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. (NCT00410072)
Timeframe: At Week 96

InterventionPercentage of participants (Number)
ETV 0.5 mg76.4
ETV 0.5 mg +TDF 300 mg83.2

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Number of Participants With Virologic Breakthrough at Week 48

ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough= confirmed >= 1 log10 increase in HBV DNA from the on-treatment nadir (NCT00410072)
Timeframe: Week 48

,
InterventionParticipants (Number)
ETVrTDFr
ETV 0.5 mg00
ETV 0.5 mg +TDF 300 mg00

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Percentage of Participants With HBV DNA by PCR Category at Week 48

HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. (NCT00410202)
Timeframe: Week 48

,,
Interventionpercentage of participants (Number)
< LOQ (29 IU/mL)LOQ to < 5050 to < 172172 to < 1,7201,720 to < 17,20017,200 to < 172,000>= 172,000Missing
ADV+LVD Combination Therapy16.82.95.812.431.424.84.41.5
ETV Monotherapy13.62.92.97.922.125.723.61.4
ETV+ADV Combination Therapy25.408.026.128.38.00.73.6

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Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to Adverse Events or Laboratory Abnormalities During Treatment

AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Grade 1 = mild, Grade 2= moderate, Grade 3 = severe, Grade 4 = life threatening/disabling, Grade 5 = death. (NCT00410202)
Timeframe: From start of study therapy through Week 100 + 5 days

,,
Interventionparticipants (Number)
DeathsSAEsDiscontinuations due to AEsAEsGrade 2-4 Related AEsGrade 3-4 Related AEs
ADV+LVD Combination Therapy11229219
ETV Monotherapy0172109127
ETV+ADV Combination Therapy011110125

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Number of Participants With Laboratory Abnormalities: Serum Chemistry

ULN=upper limit of normal (Normal ranges are Central lab data and vary according to the site). ALT:>1.25*ULN, AST:>1.25*ULN, ALP:>1.25*ULN, Total Bilirubin:>1.1*ULN, Serum Lipase:>1.10*ULN, Creatinine:>1.1*ULN, Blood Urea Nitrogen:1.25*ULN, Hyperglycemia:>116 mg/dL, Hypoglycemia:<64 mg/dL, Hyponatremia:<132meq/L, Hypokalemia:<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, <3 g/dL; Hypernatremia:>148 meq/L, Hyperkalemia:>5.6 meq/L, Hypokalemia:<3.4 meq/L, Hyperchloremia:>113 meq/L, Hypochloremia:<93 meq/L; ALT flare: on treatment (OT), >2*Baseline and >10*ULN; off treatment (OF), 2*end of dosing value and >10*ULN (NCT00410202)
Timeframe: On treatment : Day 1 through Week 100 + 5 days; Offtreatment = End of OT period through 24 weeks

,,
Interventionparticipants (Number)
Alanine aminotransferase (ALT)Aspartate aminotransferase (AST)Alkaline Phosphatase (ALP)AlbuminSerum LipaseCreatinineBlood Urea NitrogenHyperglycemiaHypoglycemiaHypernatremiaHyponatremiaHyperkalemiaHypokalemiaHyperchloremiaHypochloremiaALT flare - OntreatmentALT flare - Offtreatment
ADV+LVD Combination Therapy7453612442379100521020
ETV Monotherapy8362413321465100421020
ETV+ADV Combination Therapy7660812420399100341130

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Number of Participants With Laboratory Abnormalities: Hematology

Criteria for hematology abnormalities were: Hemoglobin: <=11.0 g/dL; White Blood Cells: <4000/mm^3; Absolute Neutrophils (includes absolute bands): <1500/mm^3; Platelets: <=99,000/mm^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline. (NCT00410202)
Timeframe: From start of study through Week 100 + 5 days

,,
Interventionparticipants (Number)
HemoglobinWhite Blood CellsNeutrophilsPlateletsInternational Normalized Ratio
ADV+LVD Combination Therapy113815129
ETV Monotherapy94817147
ETV+ADV Combination Therapy85314138

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Cumulative Probability of Emergent Genotypic Resistance at Year 2

"Cumulative probability (CP): Ptotal=1-(1-Pyr1)*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An event is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a ≥ 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only)." (NCT00410202)
Timeframe: Year 2

,,
Interventionpercentage of participants (Number)
ETVr : n=130, 128, 131ADVr/TDFr : n=132, 134, 131ETVr or ADVr/TDFr : n=128, 125, 127ETVr and ADVr/TDFr : n=134, 137, 135ETVr with VBT: n=130, 128, 131ADVr/TDFr with VBT: n=132, 134, 131ETVr or ADVr/TDFr with VBT: n=128, 125, 127ETVr and ADVr/TDFr with VBT: n=134, 137, 135
ADV+LVD Combination Therapy1.52.23.800000
ETV Monotherapy9.81.510.70.76.20.76.30.7
ETV+ADV Combination Therapy0.80.71.500000

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Cumulative Probability of Emergent Genotypic Resistance at Year 1

"yr=year. Cumulative probability (CP): Ptotal=1-(1-Pyr1)*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An event is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a ≥ 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only)." (NCT00410202)
Timeframe: Year 1

,,
Interventionpercentage of participants (Number)
ETVr : n=134, 134, 134ADVr /TDFr : n=137, 137, 135ETVr or TDFr/ADVr : n=133, 132, 132ETVr and TDFr/ADVr : n=138, 139, 137ETVr with VBT: n=134, 134, 134ADVr /TDFr with VBT: n=137, 137, 135ETVr or ADVr/TDFr with VBT: n=133, 132, 132ETVr and ADVr/TDFr with VBT: n=138, 139, 137
ADV+LVD Combination Therapy0.71.52.300000
ETV Monotherapy30.73.800.700.80
ETV+ADV Combination Therapy00.70.800000

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Change in Mean log10 From Baseline in HBV DNA at Week 48

HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load, negative values means reduction. (NCT00410202)
Timeframe: Baseline, Week 48

,,
Interventionlog10 (IU/mL (Mean)
HBV DNA at Week 48Change from baseline
ADV+LVD Combination Therapy3.36-4.11
ETV Monotherapy4.01-3.35
ETV+ADV Combination Therapy2.79-4.65

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Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48

HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. HBV DNA less than (<)50 International units per milliliter (IU/mL) = approximately 300 copies/mL. Percentage of participants calculated n/N; n= number of participants with HBV DNA <50 IU/mL; N = number of participants analyzed. (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy25.4
ETV Monotherapy16.4
ADV+LVD Combination Therapy19.7

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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 96

HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week. (NCT00410202)
Timeframe: Week 96

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy0
ETV Monotherapy0
ADV+LVD Combination Therapy0

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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48

HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week. (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy0.7
ETV Monotherapy0
ADV+LVD Combination Therapy0.7

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Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96

HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. HBV DNA < 50 IU/mL = approximately 300 copies/mL. Percentage n/N: n= number of participants with HBV DNA <50 IU/mL; N = number of participants analyzed. (NCT00410202)
Timeframe: Week 96

InterventionPercentage of participants (Number)
ETV+ADV Combination Therapy43.5
ETV Monotherapy39.3
ADV+LVD Combination Therapy28.5

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Percentage of Participants With HBsAg Seroconversion at Week 96

HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb. (NCT00410202)
Timeframe: Week 96

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy0
ETV Monotherapy0
ADV+LVD Combination Therapy0

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Percentage of Participants With HBsAg Seroconversion at Week 48

HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb. (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy0.7
ETV Monotherapy0
ADV+LVD Combination Therapy0

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Percentage of Participants With HBeAg Seroconversion at Week 96 (Treated HBeAg-positive Participants Only)

HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb). (NCT00410202)
Timeframe: Week 96

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy7.2
ETV Monotherapy3.6
ADV+LVD Combination Therapy5.1

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Percentage of Participants With HBeAg Seroconversion at Week 48 (Treated HBeAg-positive Participants Only)

HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb). (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy5.1
ETV Monotherapy2.9
ADV+LVD Combination Therapy3.7

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Percentage of Participants With Confirmed HBeAg Loss at Week 96 (Treated HBeAg Positive Participants Only)

HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week (NCT00410202)
Timeframe: Week 96

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy12.3
ETV Monotherapy10.7
ADV+LVD Combination Therapy13.9

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Percentage of Participants With Confirmed HBeAg Loss at Week 48 (Treated HBeAg Positive Participants Only)

HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy7.2
ETV Monotherapy6.5
ADV+LVD Combination Therapy5.9

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Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 96

ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L. (NCT00410202)
Timeframe: Baseline, Week 96

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy76.9
ETV Monotherapy74.4
ADV+LVD Combination Therapy79.7

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Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 48

ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 or 48 U/L. (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy75.6
ETV Monotherapy78.0
ADV+LVD Combination Therapy76.8

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Percentage of Participants With HBV DNA by PCR Category at Week 96

HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. (NCT00410202)
Timeframe: Week 96

,,
Interventionpercentage of participants (Number)
< LOQ (29 IU/mL)LOQ to < 5050 to < 172172 to < 1,7201,720 to < 17,20017,200 to < 172,000>= 172,000Missing
ADV+LVD Combination Therapy25.52.95.818.224.813.92.95.8
ETV Monotherapy36.42.93.66.410.015.716.48.6
ETV+ADV Combination Therapy38.45.110.115.220.35.805.1

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Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48

HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed. (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy25.4
ETV Monotherapy13.6
ADV+LVD Combination Therapy16.8

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Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 96

HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest amount or concentration of analyte in a sample, which can be reliably detected, but not necessarily quantified. (NCT00410202)
Timeframe: Week 96

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy33.3
ETV Monotherapy27.1
ADV+LVD Combination Therapy20.4

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Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 48

HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific. (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy20.3
ETV Monotherapy11.4
ADV+LVD Combination Therapy11.7

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Change in Mean log10 From Baseline in HBV DNA at Week 96

HBV DNA was analyzed by PCR, using the Roche COBAS® TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load. (NCT00410202)
Timeframe: Baseline, Week 96

Interventionparticipants (Mean)
ETV+ADV Combination Therapy-5.06
ETV Monotherapy-4.17
ADV+LVD Combination Therapy-4.49

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Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 96

HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed. (NCT00410202)
Timeframe: Week 96

InterventionPercentage of participants (Number)
ETV+ADV Combination Therapy38.4
ETV Monotherapy36.4
ADV+LVD Combination Therapy25.5

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Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome

(NCT00414518)
Timeframe: At Week 24

Interventionparticipants (Number)
Arm A1
Arm B1

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Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms

(NCT00414518)
Timeframe: At Week 24

InterventionLog 10 copies of virus/ml (Mean)
12 Week Treatment Arm Followed by Treatment Interruption4.8627
CD4 T Cell Guided Therapyh4.2620

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Viral Set Point

set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus (NCT00414518)
Timeframe: Throughout study

InterventionLog 10 copies virus/ml (Mean)
12 Week Treatment Folllowed by Treatment Interruption4.8627
CD4 T Cell Guided Therapy4.2434

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Immunologic Failure

Immunologic treatment failure was defined as CD4% dropping below 15%, after a previous result greater than or equal to 15% (following along WHO Guidelines). (NCT00427297)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
NVP-containing2
NVP-sparing1

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Incidence of Severe Adverse Events (Excluding Mortality)

(NCT00427297)
Timeframe: 2 years

Interventionevent (Number)
NVP-containing21
NVP-sparing6

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Viral Failure

Virologic treatment failure was defined as follow-up (at least 24 weeks after enrollment date) viral load > 400 copies. (NCT00427297)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
NVP-containing2
NVP-sparing2

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Incidence of Mortality

Death during follow-up (NCT00427297)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
NVP-containing4
NVP-sparing5

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Time to First Dose Modification

Time from starting study treatment to first dose/drug modification. (NCT00442962)
Timeframe: Throughout study

Interventionweeks (Number)
10th percentile15th percentile20th percentile
EFV + FTC/TDF1.924.925.7

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Percentage of Participants With Early Virologic Suppression

Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml (NCT00442962)
Timeframe: At Weeks 24

Interventionpercentage of participants (Number)
EFV + FTC/TDF72.0

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Percentage of Participants With Early Virologic Response

Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NCT00442962)
Timeframe: At Week 24

Interventionpercentage of participants (Number)
EFV + FTC/TDF80.8

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Percentage of Participants With Late Virologic Suppression

Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml (NCT00442962)
Timeframe: At Week 48

Interventionpercentage (Number)
EFV + FTC/TDF70.5

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Early Changes in CD4 Count From Baseline

Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline. (NCT00442962)
Timeframe: At weeks 0(baseline), 4, 8, 16, 24

Interventioncells/mm^3 (Mean)
Change from baseline to week 4Change from baseline to week 8Change from baseline to week 16Change from baseline to week 24
EFV + FTC/TDF105118138147

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Time to First Safety Event

Time from starting study treatment to first grade 3 or 4 sign/symptom or laboratory abnormality and at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00442962)
Timeframe: Throughout study

Interventionweeks (Number)
5th percentile10th percentile15th percentile
EFV + FTC/TDF4.124.433.1

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Time to Initial Virologic Response

Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL. (NCT00442962)
Timeframe: Throughout study

Interventionweeks (Number)
50th percentile75th percentile95th percentile
EFV + FTC/TDF2824

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Time to Initial Virological Failure

Virologic failure defined as two consecutive measurements of plasma HIV-1 RNA at least 400 copies/mL at or after the week 16 study visit. Time measured from enrollment. (NCT00442962)
Timeframe: Throughout study

Interventionweeks (Number)
5th percentile10th percentile15th percentile
EFV + FTC/TDF161624

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Late Change in CD4 Count From Baseline

Change in CD4+ lymphocyte counts between week 48 study visit and baseline. (NCT00442962)
Timeframe: At week 48

Interventioncells/mm^3 (Mean)
EFV + FTC/TDF194

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Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm)

(NCT00442962)
Timeframe: Throughout study

Interventionweeks (Number)
10th percentile15th percentile20th percentile
EFV + FTC/TDF162424

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Percentage of Participants With Late Virologic Response

Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NCT00442962)
Timeframe: At Week 48

Interventionpercentage (Number)
EFV + FTC/TDF80.43

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Rates of Adherence to Study Medication

The rates of adherence to study medication by treatment arm was assessed over the entire course of the study. This comparison was done by assessing the percentage of pills taken by participants within each study arm. The difference between the 2 arms was compared with a Fisher' exact test. (NCT00448669)
Timeframe: 36 months

InterventionPercentage of pills taken (Mean)
TDF-FTC, Condoms, Risk Counseling93.5
Placebo, Condoms, Risk Counseling93.6

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Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts

We assessed condom use of the enrolled participants by face-to-face interviews (at baseline and monthly thereafter) and provided a comprehensive package of HIV prevention services, including individualized counseling on risk reduction, free male and female condoms, and screening for sexually transmitted infections followed, if applicable, by partner notification and treatment. (NCT00448669)
Timeframe: 12 months

,
InterventionParticipants (Count of Participants)
BaselineMonth 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9Month 10Month 11Month 12
Placebo, Condoms, Risk Counseling113869083666167454945363330
TDF-FTC, Condoms, Risk Counseling124949792736770555755513654

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Antiretroviral (ARV) Resistance Patterns in Seroconverters

Participants who seroconverted had blood samples taken at the time of infection and at one month and six months post seroconversion to detect any HIV resistance mutations. (NCT00448669)
Timeframe: At time HIV infection diagnosed,1 month post-time of HIV infection diagnosis, and 6 months post-time of HIV infection diagnosis

InterventionParticipants (Count of Participants)
TDF-FTC, Condoms, Risk Counseling1
Placebo, Condoms, Risk Counseling1

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CD4 Evaluation After HIV Seroconversion

Study medication was stopped when HIV infected was diagnosed. Seroconvertors were referred for clinical care and followed an additional year with scheduled quarterly CD4+ cell count assessments. A model-estimated geometric mean of the CD4+ cell counts by each treatment group was evaluated. (NCT00448669)
Timeframe: 1-year post seroconversion

Interventioncells/microliter (Geometric Mean)
TDF-FTC Seroconvertor Group500
Placebo Seroconvertor Group466

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HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms

Study visits were scheduled every 30 days until completion of the study and during monthly study visits, we performed testing for HIV infection. At completion of the study, we tested all participants for HIV infection, using an enzyme-linked immunosorbent assay (ELISA).The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The initial efficacy analysis included all study participants who were randomly assigned to receive a study medication (intention-to-treat cohort). (NCT00448669)
Timeframe: Monthly, for up to 3 years

Interventioninfections/100 person-years (Number)
TDF-FTC, Condoms, Risk Counseling1.2
Placebo, Condoms, Risk Counseling3.1

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Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms

Study visits were scheduled every 30 days until completion of the study, and participants were instructed to return to the clinic for evaluation in the event of an illness. Participants reported any adverse effects at monthly visits and interim visits. (NCT00448669)
Timeframe: Monthly, for up to 3 years

Interventionpercentage of participants with AE (Number)
TDF-FTC, Condoms, Risk Counseling91.2
Placebo, Condoms, Risk Counseling88.2

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Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192

"The number of participants with HBeAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.~No statistical analysis is presented for Week 48 because no participants met the criteria at that time point." (NCT00507507)
Timeframe: Weeks 48, 96, 144, and 192

,
Interventionparticipants (Number)
Week 48Week 96Week 144Week 192
FTC+Tenofovir DF0001
Tenofovir DF0244

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Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192

The number of participants with HBsAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. (NCT00507507)
Timeframe: Weeks 48, 96, 144, and 192

,
Interventionparticipants (Number)
Week 48Week 96Week 144Week 192
FTC+Tenofovir DF0000
Tenofovir DF0000

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Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192

Range of normal ALT was 6 to 34 U/L for females, 6 to 43 U/L for males. Participants with missing data were considered to have failed to achieve the criteria for evaluation. (NCT00507507)
Timeframe: Weeks 48, 96, 144, and 192

,
Interventionparticipants (Number)
Week 48Week 96Week 144Week 192
FTC+Tenofovir DF54504644
Tenofovir DF52525141

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Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192

"The number of participants with seroconversion to anti-HBe at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.~No statistical analysis is presented for Week 48 because no participants met the criteria at that time point." (NCT00507507)
Timeframe: Weeks 48, 96, 144, and 192

,
Interventionparticipants (Number)
Week 48Week 96Week 144Week 192
FTC+Tenofovir DF0000
Tenofovir DF0243

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Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192

The number of participants with seroconversion to anti-HBs at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00507507)
Timeframe: Weeks 48, 96, 144, and 192

,
Interventionparticipants (Number)
Week 48Week 96Week 144Week 192
FTC+Tenofovir DF0000
Tenofovir DF0000

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Occurrence of HBV Resistance Mutations

The development of HBV resistance mutations (occurrence of conserved site changes and/or polymorphic site changes) was analyzed for the overall study period (through Week 192). (NCT00507507)
Timeframe: Baseline to Week 192

,
Interventionparticipants (Number)
Conserved (with/without polymorphic) site changesPolymorphic site changes only
FTC+Tenofovir DF59
Tenofovir DF616

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Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192

The percentage of participants with HBV DNA < 169 copies/mL at Weeks 48, 96, 144, and 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation. (NCT00507507)
Timeframe: Weeks 48, 96, 144, and 192

,
Interventionpercentage of participants (Number)
Week 48Week 96Week 144Week 192
FTC+Tenofovir DF33.964.572.669.4
Tenofovir DF29.745.350.045.3

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Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144

The percentage of participants with HBV DNA < 400 copies/mL at Weeks 48, 96, and 144 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation. (NCT00507507)
Timeframe: Weeks 48, 96, and 144

,
Interventionpercentage of participants (Number)
Week 48Week 96Week 144
FTC+Tenofovir DF59.775.880.6
Tenofovir DF40.653.162.5

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Change From Baseline in HBV DNA at Week 192

The change from baseline in HBV DNA at Week 192 was analyzed. (NCT00507507)
Timeframe: Baseline to Week 192

Interventionlog_10 copies/mL (Mean)
Tenofovir DF-6.32
FTC+Tenofovir DF-6.70

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Change From Baseline in HBV DNA at Week 144

The change from baseline in HBV DNA at Week 144 was analyzed. (NCT00507507)
Timeframe: Baseline to Week 144

Interventionlog_10 copies/mL (Mean)
Tenofovir DF-6.66
FTC+Tenofovir DF-6.62

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Change From Baseline in HBV DNA at Week 48

The change from baseline in HBV DNA at Week 48 was analyzed. (NCT00507507)
Timeframe: Baseline to Week 48

Interventionlog_10 copies/mL (Mean)
Tenofovir DF-6.22
FTC+Tenofovir DF-6.49

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Change From Baseline in HBV DNA at Week 96

The change from baseline in HBV DNA at Week 96 was analyzed. (NCT00507507)
Timeframe: Baseline to Week 96

Interventionlog_10 copies/mL (Mean)
Tenofovir DF-6.46
FTC+Tenofovir DF-6.55

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Percentage of Participants With HBV DNA < 400 Copies/mL at Week 192

The percentage of participants with HBV DNA < 400 copies/mL at Week 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation. (NCT00507507)
Timeframe: Week 192

Interventionpercentage of participants (Number)
Tenofovir DF54.7
FTC+Tenofovir DF75.8

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Number of Participants With HBV DNA <1000 IU/ml at Week 192

Number of participants whose serum HBV DNA level was <1000 IU/ml at Week 192 (NCT00524173)
Timeframe: At Week 192

InterventionParticipants (Count of Participants)
Tenofovir Only12
Tenofovir & Emtricitabine12

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Number of Participants With Loss of HBsAg

The number of participants whose serum hepatitis B surface antigen was no longer detectable. (NCT00524173)
Timeframe: 192 weeks

InterventionParticipants (Count of Participants)
Tenofovir Only1
Tenofovir & Emtricitabine0

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Number of Participants With Normalized Alanine Aminotransferase (ALT)

Number of participants whose serum ALT levels were measured within normal limits. (NCT00524173)
Timeframe: 192 weeks

InterventionParticipants (Count of Participants)
Tenofovir Only8
Tenofovir & Emtricitabine13

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Number of Subjects With Hepatitis b Virus (HBV) DNA <1000 IU/ml at Week 48

Number of subjects whose serum HBV DNA level was <1000 IU/ml at Week 48 (NCT00524173)
Timeframe: At Week 48

InterventionParticipants (Count of Participants)
Tenofovir Only11
Tenofovir & Emtricitabine13

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Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks

This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 384 weeks

Interventioncells/mm^3 (Mean)
Tenofovir DF-620
(Stavudine or Zidovudine)/TDF-305
All TDF-512

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Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks

This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 432 weeks

Interventioncells/mm^3 (Mean)
Tenofovir DF-795
(Stavudine or Zidovudine)/TDF-302
All TDF-631

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Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks

This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug. (NCT00528957)
Timeframe: Baseline and 48 weeks

Interventioncells/mm^3 (Mean)
Tenofovir DF-97
Stavudine or Zidovudine-11
All TDF2

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Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks

This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 480 weeks

Interventioncells/mm^3 (Mean)
Tenofovir DF-923
(Stavudine or Zidovudine)/TDF-448
All TDF-813

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Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks

This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 528 weeks

Interventioncells/mm^3 (Mean)
Tenofovir DF-710
All TDF-710

[back to top]

Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks

This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 96 weeks

Interventioncells/mm^3 (Mean)
Tenofovir DF-77
(Stavudine or Zidovudine)/TDF-56
All TDF-67

[back to top]

Change From Baseline in CD4 Percentage at 144 Weeks

This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 144 weeks

Interventionpercentage (Mean)
Tenofovir DF0.8
(Stavudine or Zidovudine)/TDF-0.1
All TDF0.3

[back to top]

Change From Baseline in CD4 Percentage at 192 Weeks

This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 192 weeks

Interventionpercentage (Mean)
Tenofovir DF1.1
(Stavudine or Zidovudine)/TDF0.6
All TDF0.8

[back to top]

Change From Baseline in CD4 Percentage at 240 Weeks

This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 240 weeks

Interventionpercentage (Mean)
Tenofovir DF1.3
(Stavudine or Zidovudine)/TDF-0.9
All TDF0.1

[back to top]

Change From Baseline in CD4 Percentage at 288 Weeks

This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 288 weeks

Interventionpercentage (Mean)
Tenofovir DF2.0
(Stavudine or Zidovudine)/TDF0.5
All TDF1.3

[back to top]

Change From Baseline in CD4 Percentage at 336 Weeks

This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 336 weeks

Interventionpercentage (Mean)
Tenofovir DF2.0
(Stavudine or Zidovudine)/TDF0.8
All TDF1.4

[back to top]

Change From Baseline in CD4 Percentage at 384 Weeks

This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 384 weeks

Interventionpercentage (Mean)
Tenofovir DF0.5
(Stavudine or Zidovudine)/TDF1.6
All TDF0.9

[back to top]

Change From Baseline in CD4 Percentage at 432 Weeks

This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 432 weeks

Interventionpercentage (Mean)
Tenofovir DF0.3
(Stavudine or Zidovudine)/TDF2.9
All TDF1.1

[back to top]

Change From Baseline in CD4 Percentage at 48 Weeks

This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug. (NCT00528957)
Timeframe: Baseline and 48 weeks

Interventionpercentage (Mean)
Tenofovir DF0.3
Stavudine or Zidovudine1.1
All TDF0.6

[back to top]

Change From Baseline in CD4 Percentage at 480 Weeks

This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 480 weeks

Interventionpercentage (Mean)
Tenofovir DF2.3
(Stavudine or Zidovudine)/TDF5.0
All TDF2.9

[back to top]

Change From Baseline in CD4 Percentage at 528 Weeks

This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 528 weeks

Interventionpercentage (Mean)
Tenofovir DF4.5
All TDF4.5

[back to top]

Change From Baseline in CD4 Percentage at 96 Weeks

This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 96 weeks

Interventionpercentage (Mean)
Tenofovir DF1.3
(Stavudine or Zidovudine)/TDF-0.1
All TDF0.6

[back to top]

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks

This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 192 weeks of exposure to TDF. (NCT00528957)
Timeframe: 192 weeks

Interventionpercentage of participants (Number)
Tenofovir DF70.6
(Stavudine or Zidovudine)/TDF82.5
All TDF77.0

[back to top]

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks

This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 240 weeks of exposure to TDF. (NCT00528957)
Timeframe: 240 weeks

Interventionpercentage of participants (Number)
Tenofovir DF70.6
(Stavudine or Zidovudine)/TDF75.7
All TDF73.2

[back to top]

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks

This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 288 weeks of exposure to TDF. (NCT00528957)
Timeframe: 288 weeks

Interventionpercentage of participants (Number)
Tenofovir DF81.5
(Stavudine or Zidovudine)/TDF67.6
All TDF73.4

[back to top]

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks

This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 336 weeks of exposure to TDF. (NCT00528957)
Timeframe: 336 weeks

Interventionpercentage of participants (Number)
Tenofovir DF90.9
(Stavudine or Zidovudine)/TDF100.0
All TDF95.3

[back to top]

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks

This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 384 weeks of exposure to TDF. (NCT00528957)
Timeframe: 384 weeks

Interventionpercentage of participants (Number)
Tenofovir DF100.0
(Stavudine or Zidovudine)/TDF100.0
All TDF100.0

[back to top]

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks

This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 432 weeks of exposure to TDF. (NCT00528957)
Timeframe: 432 weeks

Interventionpercentage of participants (Number)
Tenofovir DF100.0
(Stavudine or Zidovudine)/TDF85.7
All TDF95.0

[back to top]

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks

This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 480 weeks of exposure to TDF. (NCT00528957)
Timeframe: 480 weeks

Interventionpercentage of participants (Number)
Tenofovir DF88.9
(Stavudine or Zidovudine)/TDF100.0
All TDF90.9

[back to top]

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks

This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 528 weeks of exposure to TDF. (NCT00528957)
Timeframe: 528 weeks

Interventionpercentage of participants (Number)
Tenofovir DF100.0
All TDF100.0

[back to top]

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144

This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF. (NCT00528957)
Timeframe: 144 weeks

Interventionpercentage of participants (Number)
Tenofovir DF73.7
(Stavudine or Zidovudine)/TDF87.5
All TDF80.8

[back to top]

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48

This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug. (NCT00528957)
Timeframe: 48 weeks

Interventionpercentage of participants (Number)
Tenofovir DF83.3
Stavudine or Zidovudine91.8
All TDF85.4

[back to top]

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96

This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF. (NCT00528957)
Timeframe: 96 weeks

Interventionpercentage of participants (Number)
Tenofovir DF81.6
(Stavudine or Zidovudine)/TDF85.4
All TDF83.5

[back to top]

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks

This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF. (NCT00528957)
Timeframe: 144 weeks

Interventionpercentage of participants (Number)
Tenofovir DF63.2
(Stavudine or Zidovudine)/TDF75.0
All TDF69.2

[back to top]

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks

This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 192 weeks of exposure to TDF. (NCT00528957)
Timeframe: 192 weeks

Interventionpercentage of participants (Number)
Tenofovir DF67.6
(Stavudine or Zidovudine)/TDF75.0
All TDF71.6

[back to top]

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks

This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 240 weeks of exposure to TDF. (NCT00528957)
Timeframe: 240 weeks

Interventionpercentage of participants (Number)
Tenofovir DF70.6
(Stavudine or Zidovudine)/TDF73.0
All TDF71.8

[back to top]

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks

This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 288 weeks of exposure to TDF. (NCT00528957)
Timeframe: 288 weeks

Interventionpercentage of participants (Number)
Tenofovir DF81.5
(Stavudine or Zidovudine)/TDF62.2
All TDF70.3

[back to top]

Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)

This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT00528957)
Timeframe: 48 weeks

Interventionpercentage of participants (Number)
Tenofovir DF75.0
Stavudine or Zidovudine81.3

[back to top]

Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)

This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT00528957)
Timeframe: 48 weeks

Interventionpercentage of participants (Number)
Tenofovir DF88.6
Stavudine or Zidovudine89.6

[back to top]

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks

This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF. (NCT00528957)
Timeframe: 96 weeks

Interventionpercentage of participants (Number)
Tenofovir DF76.3
(Stavudine or Zidovudine)/TDF68.3
All TDF72.2

[back to top]

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks

This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 528 weeks of exposure to TDF. (NCT00528957)
Timeframe: 528 weeks

Interventionpercentage of participants (Number)
Tenofovir DF100.0
All TDF100.0

[back to top]

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks

This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 480 weeks of exposure to TDF. (NCT00528957)
Timeframe: 480 weeks

Interventionpercentage of participants (Number)
Tenofovir DF77.8
(Stavudine or Zidovudine)/TDF50.0
All TDF72.7

[back to top]

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks

This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug. (NCT00528957)
Timeframe: 48 weeks

Interventionpercentage of participants (Number)
Tenofovir DF70.8
Stavudine or Zidovudine85.7
All TDF68.5

[back to top]

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks

This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 432 weeks of exposure to TDF. (NCT00528957)
Timeframe: 432 weeks

Interventionpercentage of participants (Number)
Tenofovir DF100.0
(Stavudine or Zidovudine)/TDF71.4
All TDF90.0

[back to top]

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks

This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 384 weeks of exposure to TDF. (NCT00528957)
Timeframe: 384 weeks

Interventionpercentage of participants (Number)
Tenofovir DF88.2
(Stavudine or Zidovudine)/TDF100.0
All TDF92.3

[back to top]

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks

This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 336 weeks of exposure to TDF. (NCT00528957)
Timeframe: 336 weeks

Interventionpercentage of participants (Number)
Tenofovir DF86.4
(Stavudine or Zidovudine)/TDF90.5
All TDF88.4

[back to top]

Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks

This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 144 weeks

Interventioncells/mm^3 (Mean)
Tenofovir DF-139
(Stavudine or Zidovudine)/TDF-146
All TDF-142

[back to top]

Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks

This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 192 weeks

Interventioncells/mm^3 (Mean)
Tenofovir DF-304
(Stavudine or Zidovudine)/TDF-177
All TDF-233

[back to top]

Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks

This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 240 weeks

Interventioncells/mm^3 (Mean)
Tenofovir DF-369
(Stavudine or Zidovudine)/TDF-296
All TDF-329

[back to top]

Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks

This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 288 weeks

Interventioncells/mm^3 (Mean)
Tenofovir DF-346
(Stavudine or Zidovudine)/TDF-256
All TDF-302

[back to top]

Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks

This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 336 weeks

Interventioncells/mm^3 (Mean)
Tenofovir DF-415
(Stavudine or Zidovudine)/TDF-283
All TDF-350

[back to top]

Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96

mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
>=10 mL/min, MDRD>=10 mL/min, Cockcroft-Gault>=20 mL/min, MDRD>=20 mL/min, Cockcroft-Gault>=10%, MDRD>=10%, Cockcroft-Gault>=20%, MDRD>=20%, Cockcroft-Gault
ABC/3TC FDC151144151233
TDF/FTC FDC381975271664

[back to top]

Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48

mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
>=10 mL/min, MDRD>=10 mL/min, Cockcroft-Gault>=20 mL/min, MDRD>=20 mL/min, Cockcroft-Gault>=10%, MDRD>=10%, Cockcroft-Gault>=20%, MDRD>=20%, Cockcroft-Gault
ABC/3TC FDC231544211143
TDF/FTC FDC21143221920

[back to top]

Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24

mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
>=10 mL/min, MDRD>=10 mL/min, Cockcroft-Gault>=20 mL/min, MDRD>=20 mL/min, Cockcroft-Gault>=10%, MDRD>=10%, Cockcroft-Gault>=20%, MDRD>=20%, Cockcroft-Gault
ABC/3TC FDC161643151022
TDF/FTC FDC262064241733

[back to top]

Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96

BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
>=2%, spine, n=59, 79>=6%, spine, n=59, 79>=2%, hip, n=58, 76>=6%, hip, n=58, 76
ABC/3TC FDC213331
TDF/FTC FDC3985213

[back to top]

Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48

BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
>=2%, spine, n=125, 141>=6%, spine, n=125, 141>=2%, hip, n=119, 140>=6%, hip, n=119, 140
ABC/3TC FDC515543
TDF/FTC FDC841311117

[back to top]

Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24

BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
>=2%, spine, n=142, 165>=6%, spine, n=142, 165>=2%, hip, n=137, 160>=6%, hip, n=137, 160
ABC/3TC FDC7310381
TDF/FTC FDC11517936

[back to top]

Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96

"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 96

,
Interventionparticipants (Number)
Osteopenia, spine, n=64, 82Osteporosis, spine, n=64, 82Osteopenia, hip, n=65, 80Osteoporosis, hip, n=65, 80
ABC/3TC FDC215200
TDF/FTC FDC343310

[back to top]

Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96

Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionug/L (Geometric Mean)
ABC/3TC FDC3.01
TDF/FTC FDC5.79

[back to top]

Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline NAG value by the urine creatinine value. NAG, N-acetyl-B-glucosaminidase (measured in micromoles per hour per millimole [umol/h/mmol]). (NCT00549198)
Timeframe: Baseline, Week 96

Interventionratio (Geometric Mean)
ABC/3TC FDC0.868
TDF/FTC FDC0.939

[back to top]

Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96

Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionug/L (Geometric Mean)
ABC/3TC FDC1.111
TDF/FTC FDC2.542

[back to top]

Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline B2M value by the urine creatinine value. B2M, beta 2 microglobulin (measured in mg/mmol). (NCT00549198)
Timeframe: Baseline, Week 96

Interventionratio (Geometric Mean)
ABC/3TC FDC0.542
TDF/FTC FDC0.984

[back to top]

Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48

CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 48

Interventioncells/mm^3 (Median)
ABC/3TC FDC150.0
TDF/FTC FDC150.0

[back to top]

Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96

Change from baseline was calculated as the Week 96 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram. (NCT00549198)
Timeframe: Baseline, Week 96

InterventionmL/min (Mean)
ABC/3TC FDC4.37
TDF/FTC FDC2.68

[back to top]

Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24

CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 24

Interventioncells/millimeters cubed (mm^3) (Median)
ABC/3TC FDC110.0
TDF/FTC FDC100.0

[back to top]

Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96

P1NP is a bone biomarker that was analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionmicrograms per Liter (ug/L) (Geometric Mean)
ABC/3TC FDC1.2
TDF/FTC FDC1.4

[back to top]

Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline albumin value by the urine creatinine value. Albumin is measured in milligrams per millimole (mg/mmol). (NCT00549198)
Timeframe: Baseline, Week 96

Interventionratio (Geometric Mean)
ABC/3TC FDC0.872
TDF/FTC FDC0.973

[back to top]

Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96

CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 96

Interventioncells/mm^3 (Median)
ABC/3TC FDC235.0
TDF/FTC FDC220.0

[back to top]

Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48

"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 48

,
Interventionparticipants (Number)
Osteopenia, spine, n=132, 147Osteporosis, spine, n=132, 147Osteopenia, hip, n=130, 147Osteoporosis, hip, n=130, 147
ABC/3TC FDC4115374
TDF/FTC FDC575500

[back to top]

Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
Desirable to desirableDesirable to borderline highDesirable to highBorderline high to desirableBorderline high to borderline highBorderline high to highHigh to desirableHigh to borderline highHigh to high
ABC/3TC FDC4652361210003
TDF/FTC FDC96379198002

[back to top]

Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24

"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 24

,
Interventionparticipants (Number)
Osteopenia, spine, n=147, 173Osteporosis, spine, n=147, 173Osteopenia, hip, n=149, 170Osteoporosis, hip, n=149, 170
ABC/3TC FDC4116384
TDF/FTC FDC689541

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Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96

An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 96

,
Interventionparticipants (Number)
Any eventDrug hypersensitivityBone density decreasedRashDizzinessHypersensitivityAbnormal dreamsDrug eruptionDepression
ABC/3TC FDC33110213310
TDF/FTC FDC2818330012

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Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48

An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 48

,
Interventionparticipants (Number)
Any eventDrug hypersensitivityBone density decreasedRashDizzinessHypersensitivityDrug eruption
ABC/3TC FDC291102131
TDF/FTC FDC21123301

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Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24

An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 24

,
Interventionparticipants (Number)
Any eventDrug hypersensitivityRashDizzinessHypersensitivityDrug eruption
ABC/3TC FDC26112031
TDF/FTC FDC1413201

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Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96

Viral resistance was measured using blood samples collected from participants throughout the study. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor. Virological failure was defined as any one of: participant does not achieve a 1 log10 copies (cop)/mL decrease in plasma HIV-1 RNA by Week (Wk) 4, or has two consecutive plasma HIV-1 RNA measures >=400 cop/mL separated by at least 2-4 wk after being previously <=400 cop/mL on/after Wk 4, or has two consecutive plasma HIV-1 RNA measures >400 cop/mL separated by at least 2-4 wk on/after Wk 24. (NCT00549198)
Timeframe: Week 96

,
Interventionparticipants (Number)
Any treatment-emergent mutationNRTINNRTI
ABC/3TC FDC442
TDF/FTC FDC000

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"Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized"

Participants were asked at each visit whether or not they utilized unplanned healthcare resources. (NCT00549198)
Timeframe: Baseline to Week 96

,
Interventionparticipants (Number)
Week 4, Yes, n=178, 183Week 4, No, n=178, 183Week 12, Yes, n=162, 177Week 12, No, n=162, 177Week 24, Yes, n=156, 173Week 24, No, n=156, 173Week 36, Yes, n=148, 169Week 36, No, n=148, 169Week 48, Yes, n=137, 161Week 48, No, n=137, 161Week 60, Yes, n=129, 148Week 60, No, n=129, 148Week 72, Yes, n=126, 139Week 72, No, n=126, 139Week 84, Yes, n=121, 136Week 84, No, n=121, 136Week 96, Yes, n=113, 135Week 96, No, n=113, 135
ABC/3TC FDC601185610670864810044934782487834873083
TDF/FTC FDC49134471305911450119361254410440992410817118

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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionpercent change (Mean)
ABC/3TC FDC-0.87
TDF/FTC FDC-1.70

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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 48

Interventionpercent change (Mean)
ABC/3TC FDC-1.59
TDF/FTC FDC-2.41

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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24

BMD is a measure (grams [g] per centimeters cubed [cm^3]) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 24

Interventionpercent change (Mean)
ABC/3TC FDC-2.12
TDF/FTC FDC-3.30

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Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionpercent change (Mean)
ABC/3TC FDC-2.17
TDF/FTC FDC-3.55

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Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 48

Interventionpercent change (Mean)
ABC/3TC FDC-1.90
TDF/FTC FDC-3.56

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Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 24

Interventionpercent change (Mean)
ABC/3TC FDC-1.19
TDF/FTC FDC-2.73

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Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96

Change from baseline was calculated as the Week 96 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^s, meters squared; Scr, serum creatinine. (NCT00549198)
Timeframe: Baseline, Week 96

InterventionmL/min/1.73m^2 (Mean)
ABC/3TC FDC1.48
TDF/FTC FDC-1.15

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Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48

Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine; BMI, body mass index. (NCT00549198)
Timeframe: Baseline, Week 48

Interventionmilliliters per minute (mL/min)/1.73 m^2 (Mean)
ABC/3TC FDC0.22
TDF/FTC FDC1.18

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Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24

Change from baseline was calculated as the Week 24 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. (NCT00549198)
Timeframe: Baseline, Week 24

InterventionmL/min/1.73m^2 (Mean)
ABC/3TC FDC2.78
TDF/FTC FDC0.43

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Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48

Change from baseline was calculated as the Week 48 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram. (NCT00549198)
Timeframe: Baseline, Week 48

InterventionmL/min (Mean)
ABC/3TC FDC2.66
TDF/FTC FDC3.80

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Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24

Change from baseline was calculated as the Week 24 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram; CG, Cockcroft-Gault. (NCT00549198)
Timeframe: Baseline, Week 24

InterventionmL/min (Mean)
ABC/3TC FDC4.27
TDF/FTC FDC2.54

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Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline RBP value by the urine creatinine value. RBP, retinol binding protein (measured in micrograms per millimole [ug/mmol]). (NCT00549198)
Timeframe: Baseline, Week 96

Interventionratio (Geometric Mean)
ABC/3TC FDC1.099
TDF/FTC FDC1.550

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Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24

HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 24

,
Interventionparticipants (Number)
<50 copies/mL<400 copies/mL
ABC/3TC FDC126147
TDF/FTC FDC144168

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Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48

HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 48

,
Interventionparticipants (Number)
<50 copies/mL<400 copies/mL
ABC/3TC FDC121130
TDF/FTC FDC145151

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Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96

HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 96

,
Interventionparticipants (Number)
<50 copies/mL<400 copies/mL
ABC/3TC FDC98110
TDF/FTC FDC113126

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Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24

Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
NormalStage 1Stage 2Stage 3Stage 4Stage 5
ABC/3TC FDC97115100
TDF/FTC FDC114155100

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Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48

Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
MissingNormalStage 1Stage 2Stage 3Stage 4Stage 5
ABC/3TC FDC129073000
TDF/FTC FDC1910653000

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Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96

Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
MissingNormalStage 1Stage 2Stage 3Stage 4Stage 5
ABC/3TC FDC117534000
TDF/FTC FDC188344000

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
Low to lowLow to normalLow to highNormal to lowNormal to normalNormal to highHigh to lowHigh to normalHigh to high
ABC/3TC FDC197210012260010
TDF/FTC FDC3666913012035

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
Low to lowLow to normalLow to highNormal to lowNormal to normalNormal to highHigh to lowHigh to normalHigh to high
ABC/3TC FDC176718011270010
TDF/FTC FDC28731002320035

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
Low to lowLow to normalLow to highNormal to lowNormal to normalNormal to highHigh to lowHigh to normalHigh to high
ABC/3TC FDC11662508300010
TDF/FTC FDC23751301727017

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
Desirable to desirableDesirable to borderline highDesirable to highBorderline high to desirableBorderline high to borderline highBorderline high to highHigh to desirableHigh to borderline highHigh to high
ABC/3TC FDC5447321210003
TDF/FTC FDC104299396002

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
Desirable to desirableDesirable to borderline highDesirable to highBorderline high to desirableBorderline high to borderline highBorderline high to highHigh to desirableHigh to borderline highHigh to high
ABC/3TC FDC3949461210003
TDF/FTC FDC864710198002

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
Normal to normalNormal to borderline highNormal to highNormal to very highBorderline high to normalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to normalHigh to borderline highHigh to highHigh to very highVery high to normalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC63212305590251230001
TDF/FTC FDC781990710150631500010

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
Normal to normalNormal to borderline highNormal to highNormal to very highBorderline high to normalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to normalHigh to borderline highHigh to highHigh to very highVery high to normalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC552230045110241240001
TDF/FTC FDC702312167190531500010

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150->200 mg/dL, borderline high; 200-<500 mg/dL, high;>= 500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
Normal to normalNormal to borderline highNormal to highNormal to very highBorderline high to normalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to normalHigh to borderline highHigh to highHigh to very highVery high to normalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC472534144111241150001
TDF/FTC FDC553120158190521600010

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
Optimal to optimalOptimal to near or above optimalOptimal to borderline highOptimal to highOptimal to very highNear or above optimal to optimalNear or above optimal to near or above optimalNear or above optimal to borderline highNear or above optimal to highNear or above optimal to very highBorderline high to optimalBorderline high to near or above optimalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to optimalHigh to near or above optimalHigh to borderline highHigh to highHigh to very highVery high to optimalVery high to near or above optimalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC224122610617124012430001000101
TDF/FTC FDC464311105221151063320001000001

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
Optimal to optimalOptimal to near or above optimalOptimal to borderline highOptimal to highOptimal to very highNear or above optimal to optimalNear or above optimal to near or above optimalNear or above optimal to borderline highNear or above optimal to highNear or above optimal to very highBorderline high to optimalBorderline high to near or above optimalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to optimalHigh to near or above optimalHigh to borderline highHigh to highHigh to very highVery high to optimalVery high to near or above optimalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC203827810419124012340001000101
TDF/FTC FDC424612103211361035420001000001

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
Optimal to optimalOptimal to near or above optimalOptimal to borderline highOptimal to highOptimal to very highNear or above optimal to optimalNear or above optimal to near or above optimalNear or above optimal to borderline highNear or above optimal to highNear or above optimal to very highBorderline high to optimalBorderline high to near or above optimalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to optimalHigh to near or above optimalHigh to borderline highHigh to highHigh to very highVery high to optimalVery high to near or above optimalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC183529930417126012340001000101
TDF/FTC FDC374617101191672035330001000001

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Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24

The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment. (NCT00549198)
Timeframe: Week 24

,
Interventionparticipants (Number)
Cholesterol, Grade 3Cholesterol, Grade 4LDL cholesterol, Grade 3LDL cholesterol, Grade 4Non-HDL cholesterol, Grade 3Non-HDL cholesterol, Grade 4Triglycerides, Grade 3Triglycerides, Grade 4Alanine aminotransferase, Grade 3Alanine aminotransferase, Grade 4Aspartate aminotransferase, Grade 3Aspartate aminotransferase, Grade 4Alkaline phosphatase, Grade 3Alkaline phosphatase, Grade 4Creatinine kinase, Grade 3Creatinine kinase, Grade 4Phosphorus inorganic, Grade 3Phosphorus inorganic, Grade 4Lipase, Grade 3Lipase, Grade 4Hyperkalaemia, Grade 3Hyperkalaemia, Grade 4Glomerular filtration rate, MDRD, Grade 3Glomerular filtration rate, MDRD, Grade 4Total neutrophils, Grade 3Total neutrophils, Grade 4Thrombocytopenia, Grade 3Thrombocytopenia, Grade 4
ABC/3TC FDC60801902011110001103201101110
TDF/FTC FDC1030500031021011101001100200

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Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48

The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment. (NCT00549198)
Timeframe: Week 48

,
Interventionparticipants (Number)
Cholesterol, Grade 3Cholesterol, Grade 4LDL cholesterol, Grade 3LDL cholesterol, Grade 4Non-HDL cholesterol, Grade 3Non-HDL cholesterol, Grade 4Triglycerides, Grade 3Triglycerides, Grade 4Alanine aminotransferase, Grade 3Alanine aminotransferase, Grade 4Aspartate aminotransferase, Grade 3Aspartate aminotransferase, Grade 4Alkaline phosphatase, Grade 3Alkaline phosphatase, Grade 4Total bilirubin Grade 3Total bilirubin, Grade 4Creatinine kinase, Grade 3Creatinine kinase, Grade 4Phosphorus inorganic, Grade 3Phosphorus inorganic, Grade 4Lipase, Grade 3Lipase, Grade 4Hyperkalaemia, Grade 3Hyperkalaemia, Grade 4Glomerular filtration rate, MDRD, Grade 3Glomerular filtration rate, MDRD, Grade 4Total neutrophils, Grade 3Total neutrophils, Grade 4Thrombocytopenia, Grade 4
ABC/3TC FDC7090200302222001001305202102310
TDF/FTC FDC103060004102100021101002100200

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Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96

The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug therapy. (NCT00549198)
Timeframe: Week 96

,
Interventionparticipants (Number)
Cholesterol, Grade 3Cholesterol, Grade 4LDL cholesterol, Grade 3LDL cholesterol, Grade 4Non-HDL cholesterol, Grade 3Non-HDL cholesterol, Grade 4Triglycerides, Grade 3Triglycerides, Grade 4Alanine aminotransferase, Grade 3Alanine aminotransferase, Grade 4Aspartate aminotransferase, Grade 3Aspartate aminotransferase, Grade 4Alkaline phosphatase, Grade 3Alkaline phosphatase, Grade 4Total bilirubin, Grade 3Total bilirubin, Grade 4Creatinine kinase, Grade 3Creatinine kinase, Grade 4Phosphorus inorganic, Grade 3Phosphorus inorganic, Grade 4Lipase, Grade 3Lipase, Grade 4Hyperkalaemia, Grade 3Hyperkalaemia, Grade 4Glomerular filtration rate, MDRD, Grade 3Glomerular filtration rate, MDRD, Grade 4Total neutrophils, Grade 3Total neutrophils, Grade 4Thrombocytopenia, Grade 3Thrombocytopenia, Grade 4
ABC/3TC FDC90130220212222001001406402103510
TDF/FTC FDC105050004112100022302200101300

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Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96

Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionnanograms per Liter (ng/L) (Geometric Mean)
ABC/3TC FDC89.9
TDF/FTC FDC203.6

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Proportion of Patients Reporting CNS Side Effects of Any Severity

(NCT00552240)
Timeframe: baseline to week 52

Interventionparticipants (Number)
Nevirapine (NVP) Plus Truvada25
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada23

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Change in Framingham Score

Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient's gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%. (NCT00552240)
Timeframe: baseline to week 48

Interventionpercent 10-year risk (Mean)
Nevirapine (NVP) Plus Truvada-0.09
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada0.14

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Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio

(NCT00552240)
Timeframe: baseline to week 48

Interventionratio (Mean)
Nevirapine (NVP) Plus Truvada-0.38
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada-0.02

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Change in Fasting Plasma Triglycerides Level

(NCT00552240)
Timeframe: baseline to week 48

Interventionmg/dl (Mean)
Nevirapine (NVP) Plus Truvada-4.7
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada8.4

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Change in Fasting Plasma Total Cholesterol Level

(NCT00552240)
Timeframe: baseline to week 48

Interventionmg/dl (Mean)
Nevirapine (NVP) Plus Truvada18.2
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada13.8

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Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level

(NCT00552240)
Timeframe: baseline to week 48

Interventionmg/dl (Mean)
Nevirapine (NVP) Plus Truvada8.7
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada6.9

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Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level

(NCT00552240)
Timeframe: baseline to week 48

Interventionmg/dl (Mean)
Nevirapine (NVP) Plus Truvada9.6
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada3.5

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Change in CD4+ Cell Count From Baseline to Week 8.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 8

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada111.9
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada90.5

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Change in CD4+ Cell Count From Baseline to Week 6.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 6

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada87.2
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada78.4

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Change in CD4+ Cell Count From Baseline to Week 48.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 48

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada155.1
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada160.4

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Change in CD4+ Cell Count From Baseline to Week 4.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 4

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada76.4
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada63.0

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Change in CD4+ Cell Count From Baseline to Week 36.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 36

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada147.6
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada120.5

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Change in CD4+ Cell Count From Baseline to Week 24.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 24

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada131.8
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada132.5

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Change in CD4+ Cell Count From Baseline to Week 2.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 2

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada62.6
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada61.0

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Change in CD4+ Cell Count From Baseline to Week 12.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 12

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada123.1
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada102.2

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AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death

"AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi's sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting.~Number of cases (no time-to analysis was performed due to small numbers)." (NCT00552240)
Timeframe: baseline to week 48

InterventionParticipants (Number)
Nevirapine (NVP) Plus Truvada1
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada3

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Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48

using 4-variable Modification of Diet in Renal Disease (MDRD) formula (NCT00552240)
Timeframe: baseline to week 48

Interventionml/min/1.73m^2 (Mean)
Nevirapine (NVP) Plus Truvada-0.06
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada-12.81

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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 4

,
InterventionParticipants (Number)
HIV viral load < 50 copies/mlHIV viral load ≥ 50 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada10625
Nevirapine (NVP) Plus Truvada125310

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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 4

,
InterventionParticipants (Number)
HIV viral load < 400 copies/mlHIV viral load ≥ 400 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada31415
Nevirapine (NVP) Plus Truvada382710

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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 48

,
InterventionParticipants (Number)
HIV viral load < 400 copies/mlHIV viral load ≥ 400 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada54221
Nevirapine (NVP) Plus Truvada43131

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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 6

,
InterventionParticipants (Number)
HIV viral load < 400 copies/mlHIV viral load ≥ 400 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada442310
Nevirapine (NVP) Plus Truvada402114

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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 8

,
InterventionParticipants (Number)
HIV viral load < 400 copies/mlHIV viral load ≥ 400 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada58154
Nevirapine (NVP) Plus Truvada481116

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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 12

,
InterventionParticipants (Number)
HIV viral load < 50 copies/mlHIV viral load ≥ 50 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada43277
Nevirapine (NVP) Plus Truvada422013

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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 2

,
InterventionParticipants (Number)
HIV viral load < 50 copies/mlHIV viral load ≥ 50 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada5639
Nevirapine (NVP) Plus Truvada6627

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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48

HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment. (NCT00552240)
Timeframe: baseline to week 48

,
InterventionParticipants (Number)
RespondersNonresponders
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada488
Nevirapine (NVP) Plus Truvada422

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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 48

,
InterventionParticipants (Number)
HIV viral load < 50 copies/mlHIV viral load ≥ 50 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada48821
Nevirapine (NVP) Plus Truvada42231

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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 6

,
InterventionParticipants (Number)
HIV viral load < 50 copies/mlHIV viral load ≥ 50 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada145310
Nevirapine (NVP) Plus Truvada233814

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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 8

,
InterventionParticipants (Number)
HIV viral load < 50 copies/mlHIV viral load ≥ 50 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada23504
Nevirapine (NVP) Plus Truvada342516

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Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response

HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml) (NCT00552240)
Timeframe: baseline to week 24 and week 48

,
InterventionParticipants (Number)
At week 24At week 48
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada49
Nevirapine (NVP) Plus Truvada12

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Number of Participants With Virologic Response (VR)

VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48. (NCT00552240)
Timeframe: baseline to week 48

,
Interventionparticipants (Number)
RespondersNonresponders
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada5027
Nevirapine (NVP) Plus Truvada4629

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Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm

HIV viral load <50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48. (NCT00552240)
Timeframe: baseline to week 48

,
InterventionParticipants (Number)
RespondersNonresponders
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada5126
Nevirapine (NVP) Plus Truvada4827

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Number of Participants With Virologic Success (FDA Definition)

HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS). (NCT00552240)
Timeframe: baseline to week 48

,
InterventionParticipants (Number)
RespondersNonresponders
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada4829
Nevirapine (NVP) Plus Truvada4233

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Number of Patients With Virologic Rebound to >400 Copies/ml

HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml) (NCT00552240)
Timeframe: baseline to week 48

,
InterventionParticipants (Number)
Rebound following responseNo rebound following response
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada663
Nevirapine (NVP) Plus Truvada255

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Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities

(NCT00552240)
Timeframe: baseline to week 52

,
Interventionparticipants (Number)
Grade 2 moderateGrade 3 severeGrade 4 potential lifethreatening
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada3173
Nevirapine (NVP) Plus Truvada2587

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Percentage Adherence by Pill Count

Number of pills not returned / number of treatment days in percent (%) (NCT00552240)
Timeframe: baseline to week 48

Interventionpercentage adherence (Mean)
Nevirapine (NVP) Plus Truvada94.3
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada97.0

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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 24

,
InterventionParticipants (Number)
HIV viral load < 400 copies/mlHIV viral load ≥ 400 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada63311
Nevirapine (NVP) Plus Truvada51618

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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 36

,
InterventionParticipants (Number)
HIV viral load < 400 copies/mlHIV viral load ≥ 400 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada59117
Nevirapine (NVP) Plus Truvada54318

[back to top]

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 36

,
InterventionParticipants (Number)
HIV viral load < 50 copies/mlHIV viral load ≥ 50 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada55517
Nevirapine (NVP) Plus Truvada53418

[back to top]

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 2

,
InterventionParticipants (Number)
HIV viral load < 400 copies/mlHIV viral load ≥ 400 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada17519
Nevirapine (NVP) Plus Truvada24447

[back to top]

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 12

,
InterventionParticipants (Number)
HIV viral load < 400 copies/mlHIV viral load ≥ 400 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada6377
Nevirapine (NVP) Plus Truvada56613

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Incidence of Patients With AIDS Progression at Each Visit

Cumulative incidence of patients with AIDS progression are shown (NCT00552240)
Timeframe: baseline to week 52

,
Interventionparticipants (Number)
week 0week 2week 4week 6week 8week 12week 24week 36week 48week 50End of Study Visit
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada00011233333
Nevirapine (NVP) Plus Truvada00000000112

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Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml

(NCT00552240)
Timeframe: baseline to week 48

Interventiondays (Median)
Nevirapine (NVP) Plus Truvada55
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada84

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Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants

Time to response whereby patients withdrawing early were censored after their withdrawal (NCT00552240)
Timeframe: baseline to week 48

Interventiondays (Median)
Nevirapine (NVP) Plus Truvada57
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada84

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Proportion of Patients Reporting Rash of Any Severity

(NCT00552240)
Timeframe: baseline to week 52

Interventionparticipants (Number)
Nevirapine (NVP) Plus Truvada21
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada19

[back to top]

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 24

,
InterventionParticipants (Number)
HIV viral load < 50 copies/mlHIV viral load ≥ 50 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada61511
Nevirapine (NVP) Plus Truvada48918

[back to top]

Proportion of Patients Reporting Hepatic Events of Any Severity

(NCT00552240)
Timeframe: baseline to week 52

Interventionparticipants (Number)
Nevirapine (NVP) Plus Truvada5
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada24

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Head Circumference Among Infants Born to Female Participants Taking Study Drug

The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month. (NCT00557245)
Timeframe: up to 12 months

Interventionz-score difference per study month (Number)
Tenofovir Disoproxil Fumarate (TDF)-0.057
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)-0.005
Placebo-0.079

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Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants

The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms. (NCT00557245)
Timeframe: Up to 36 months

Interventionevents per 100 person years (Number)
Tenofovir Disoproxil Fumarate (TDF)0.65
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0.50
Placebo1.99

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Length Among Infants Born to Female Participants Taking Study Drug

The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month. (NCT00557245)
Timeframe: up to 12 months

Interventionz-score difference per study month (Number)
Tenofovir Disoproxil Fumarate (TDF)-0.006
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0.036
Placebo-0.033

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Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up

"Prevalence of STIs measured as the number of participants with a positive test result for N. gonorrhoeae, C. trachomatis, or T. vaginalis during follow-up. Participants were tested for STIs at annual follow-up visits and at intervening visits at which the participant presented with symptoms of an STI. Assessment for symptomatic sexually transmitted infections was conducted quarterly.~N. gonorrhoeae and C. trachomatis testing were by APTIMA Combo 2 (Gen-Probe) or COBAS Amplicor (Roche Diagnostics). T. vaginalis testing was by APTIMA TV TMA (Gen-Probe) or In Pouch TV (Biomed Diagnostics)." (NCT00557245)
Timeframe: Up to 36 months

Interventionparticipants (Number)
Tenofovir Disoproxil Fumarate (TDF)102
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)76
Placebo85

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Study Drug Adherence: Self-reported Missed Doses of Study Drug

Adherence to study drug measured as the percentage of visits when participants reported missing 1) any dose of study drug in the prior month and 2) 2 or more consecutive doses of study drug. (NCT00557245)
Timeframe: Up to 36 months

,,
Interventionpercentage of visits (Number)
Missed any dosesMissed 2+ consecutive doses
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)154
Placebo154
Tenofovir Disoproxil Fumarate (TDF)154

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Weight Among Infants Born to Female Participants Taking Study Drug

The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month. (NCT00557245)
Timeframe: up to 12 months

Interventionz-score difference per study month (Number)
Tenofovir Disoproxil Fumarate (TDF)-0.021
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0.009
Placebo-0.056

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Prevalence of Unprotected Sex During Follow-up

Sexual risk behavior of participants, measured as the percentage of visits when participants reported having unprotected sex during follow-up. (NCT00557245)
Timeframe: Up to 36 months

Interventionpercentage of visits (Number)
Tenofovir Disoproxil Fumarate (TDF)14
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)13
Placebo13

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Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.

Infant outcomes measured as the number of live-born infants born to female participants taking study drug that had any congenital anomalies. (NCT00557245)
Timeframe: Up to 36 months

InterventionNumber of live-born infants (Number)
Tenofovir Disoproxil Fumarate (TDF)4
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)4
Placebo5

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Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC

"HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. These mutation types were pre-defined. Plasma samples for resistance testing were collected at the visit seroconversion was first detected and again at a visit within 1 month of seroconversion. Mutations detected at either of those visits are reported.~Both seroconverters found to have a resistance mutation had been HIV infected at enrollment (TDF arm: n=1; FTC-TDF arm: n=1)." (NCT00557245)
Timeframe: Up to 36 months

InterventionParticipants (Number)
Tenofovir Disoproxil Fumarate (TDF)1
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)1
Placebo0

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Number of Participants With Serious Adverse Events (SAEs)

Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF compared to those randomized to placebo measured as the number of participants with Serious Adverse Events (SAEs) during follow-up. (NCT00557245)
Timeframe: Up to 36 months

InterventionParticipants (Number)
Tenofovir Disoproxil Fumarate (TDF)118
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)115
Placebo118

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Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.

Adherence to study medication as assessed by pill count at follow-up visits. We assessed the total number of doses taken of the total dispensed doses. (NCT00557245)
Timeframe: Up to 36 months

Interventionpercentage of doses taken of dispensed (Number)
Tenofovir Disoproxil Fumarate (TDF)97
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)97
Placebo97

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Length of Time Vaginal Sexual Intercourse Took Place After Using Gel.

Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used before the encounter). (NCT00592124)
Timeframe: Measured through Week 21

Interventionminutes (Median)
Vaginal and Oral Tenofovir60.0
Vaginal Tenofovir60.0

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Number of Days Product Missed

This represents the longest number of days in a row during the past 3 weeks that a participant missed using the study product. (NCT00592124)
Timeframe: Measured through Week 21

Interventiondays (Mean)
Vaginal and Oral Tenofovir0.9
Oral Tenofovir0.9
Vaginal Tenofovir0.9

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Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol

(NCT00592124)
Timeframe: Measured through Week 21

InterventionParticipants (Count of Participants)
Vaginal and Oral Tenofovir5
Oral Tenofovir5
Vaginal Tenofovir3

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Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use)

PK measures, including maximum concentrations (Cmax) in serum, tissue, and cervicovaginal lavage. (NCT00592124)
Timeframe: Measured through Week 21

,,
Interventionng/mL, ng/mg, ng/mL (Median)
Serum TFV CmaxTissue TFVCervicovaginal lavage
Oral Tenofovir3320.155380
Vaginal and Oral Tenofovir3371041600000
Vaginal Tenofovir3.91133100000

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Self-reported Adherence to Each Regimen

Participant self-reported product use. For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of doses expect if she were fully adherent. (NCT00592124)
Timeframe: Measured through Week 21

Interventionpercentage of expected doses (Mean)
Vaginal and Oral Tenofovir94
Oral Tenofovir93.8
Vaginal Tenofovir93.9

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Reported Sharing of Product

Number and percentage of participants who had a product sharing event during the 6-week product use period, where a sharing event includes 1) being asked for the study product, or 2) selling, trading, or giving away study product, or 3) having someone take the study product from the participant. (NCT00592124)
Timeframe: Measured through Week 21

InterventionParticipants (Count of Participants)
Vaginal and Oral Tenofovir2
Oral Tenofovir0
Vaginal Tenofovir3

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Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet.

Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used after the encounter). (NCT00592124)
Timeframe: Measured through Week 21

Interventionminutes (Median)
Vaginal and Oral Tenofovir90.0
Oral Tenofovir120.0

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Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel.

Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used after the encounter). (NCT00592124)
Timeframe: Measured through Week 21

Interventionminutes (Median)
Vaginal and Oral Tenofovir75.0
Vaginal Tenofovir120.0

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Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet.

Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used before the encounter). (NCT00592124)
Timeframe: Measured through Week 21

Interventionminutes (Median)
Vaginal and Oral Tenofovir60.0
Oral Tenofovir90.0

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Number of HIV-1 Infected Participants

Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected (NCT00594646)
Timeframe: 90 days

Interventionparticipants (Number)
Group 10

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Medication Regimen Completion Rates

Pill counts performed at 14 and 28 days (NCT00594646)
Timeframe: 28 days

Interventionparticipants (Number)
Completed as prescribedStopped or Modified regimenLost to follow-up
Group 1572815

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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs or Laboratory Abnormalities

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event. (NCT00605384)
Timeframe: Day 1 through end of treatment (Week 100 +/- 5 days)

,
Interventionparticipants (Number)
AEsSAEsDeathsDiscontinuations due to AEsDiscontinuations due to Laboratory Abnormalities
Adefovir + Continuing Lamivudine10000
Entecavir + Tenofovir10000

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Time to First Grade 3 or 4 Lab Event

5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab event (NCT00608569)
Timeframe: 52 weeks since randomization

,
Interventionweeks (Number)
5th percentile10th percentile
mDOT Arm24NA
Non-mDOT ArmNANA

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Time to First Grade 3 or 4 Lab or Sign/Symptom Event

5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab or sign/ symptom event (NCT00608569)
Timeframe: 52 weeks since randomization

,
Interventionweeks (Number)
5th percentile10th percentile
mDOT Arm6.424
Non-mDOT Arm2432.6

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Adherence to Second Line HAART Regimen

Number of participants with self-reported 100% adherence over the week prior to study visit (NCT00608569)
Timeframe: At weeks 4, 8, 12, 24, 36, 48 and 52

,
Interventionparticipants (Number)
Week 4Week 8Week 12Week 24Week 48Week 52
mDOT Arm105108114107103104
Non-mDOT Arm117115116116109109

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Time to First Grade 3 or 4 Sign or Symptom

5th and 10th percentiles in weeks from randomization to first grade 3 or 4 sign or symptom (NCT00608569)
Timeframe: 52 weeks since randomization

,
Interventionweeks (Number)
5th percentile10th percentile
mDOT Arm13.7NA
Non-mDOT Arm26.748.9

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CD4 Count at Follow-up Visits

CD4 cell count (median, inter-quartile range) (NCT00608569)
Timeframe: At Weeks 4, 12, 24, 36, and 48

,
Interventioncells/mm3 (Median)
Week 4Week 12Week 24Week 36Week 48
mDOT Arm212225268281301
Non-mDOT Arm219235266294347

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CD8 Count at Follow-up Visits

CD8 cell count (median, inter-quartile range) (NCT00608569)
Timeframe: At week 4, 12, 24, 36, and 48

,
Interventioncells/mm3 (Median)
Week 4Week 12Week 24Week 36Week 48
mDOT Arm776895816787815
Non-mDOT Arm859916818833823

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Confirmed Virologic Failure at or Prior to Week 24

Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤30 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 24 was reported. (NCT00608569)
Timeframe: At or prior to Week 24

,
Interventionparticipants (Number)
No FailureExperienced Failure
mDOT Arm10524
Non-mDOT Arm11117

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Confirmed Virologic Failure at or Prior to Week 48

Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤50 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 48 was reported. (NCT00608569)
Timeframe: At or prior to Week 48

,
Interventionparticipants (Number)
No FailureExperienced Failure
mDOT Arm9534
Non-mDOT Arm10523

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Participant Report of Change in Number of Sexual Partners

Difference in mean number of reported sexual partners between final study visit and enrollment visit (NCT00625404)
Timeframe: Up to 52 weeks

Interventionmean number of sexual partners (Mean)
Truvada Arm-0.14
Placebo Arm-0.13

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HIV Infection

HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens. (NCT00625404)
Timeframe: Cumulative HIV infection between enrollment and 52 weeks

Interventionparticipants (Number)
Truvada Arm33
Placebo Arm35

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FTC and/or Tenofovir Resistance

"Genotypic resistance to FTC and/or tenofovir at the time of HIV diagnosis and 4 weeks later. If resistance was present, testing was repeated at weeks 12, 24, 36 and 52 as necessary (resistance testing will stop if no resistance is detected).~participants were classified as having resistance if they had one or more visits in which resistance was detected, even if the resistance became undetectable over time." (NCT00625404)
Timeframe: up to 52 weeks

Interventionparticipants (Number)
Truvada Arm3
Placebo Arm1

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Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration

The total number of adverse events in the placebo and Truvada arms during and within 4 weeks after study product administration. (NCT00625404)
Timeframe: 10-26 months per site

InterventionNumber of adverse events (Number)
Truvada Arm2257
Placebo Arm2384

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Confirmed Grade 3 or Higher AST Elevation

Grade 3 or higher AST elevation was defined as ≥ 2.6 times the upper limit of normal (NCT00625404)
Timeframe: Through 52 weeks on product and 4 weeks post-product

Interventionparticipants (Number)
Truvada Arm3
Placebo Arm1

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Confirmed Grade 3 or Higher ALT Elevation

Grade 3 or higher ALT elevation was defined as ≥ 2.6 times the upper limit of normal (NCT00625404)
Timeframe: Through 52 weeks on product and 4 weeks post-product

Interventionparticipants (Number)
Truvada Arm6
Placebo Arm8

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CD4+ T-cell Count

CD4+ T-cell Count at the Time of HIV Seroconversion through 16 weeks (NCT00625404)
Timeframe: Up to 16 weeks

Interventioncells/mL (Mean)
Truvada Arm579.3
Placebo Arm601.4

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Confirmed Grade 3 or Higher Reduction in Phosphorus

Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL (NCT00625404)
Timeframe: Through 52 weeks on product and 4 weeks post-product

Interventionparticipants (Number)
Truvada Arm45
Placebo Arm40

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Confirmed Grade 2 or Higher Serum Creatinine Toxicity

Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal (NCT00625404)
Timeframe: cumulative toxicity through 52 weeks of product use and 4 weeks post product

Interventionparticipants (Number)
Truvada Arm4
Placebo Arm2

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Pregnancy Complications

Reported complications during pregnancy, including spontaneous abortion, vaginal or uterine bleeding, emergency c-section and other complications (NCT00625404)
Timeframe: up to 60 weeks

Interventionparticipants (Number)
Truvada Arm20
Placebo Arm10

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Pill Counts and Participant Report of Adherence to Once-daily Pill Taking

Pill counts and participant report of adherence to once-daily pill taking reported as mean days study product could have been used according to pill counts (NCT00625404)
Timeframe: Up to 52 weeks

Interventionpercentage of days (Mean)
Truvada Arm87
Placebo Arm89

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Plasma HIV RNA Level (HIV-1 Viral Load)

Viral load at the time of HIV detection, HIV conversion and through 16 weeks (NCT00625404)
Timeframe: up to 16 weeks

Interventionlog copies/mL (Log Mean)
Truvada Arm4.40
Placebo Arm4.37

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Absolute Change in CD4 Cell Counts

(NCT00632970)
Timeframe: 24 and 48 weeks

Interventioncells/mm^3 (Mean)
Raltegravir50
Lopinavir/Ritonavir50

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Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)

change was calculated as the mean of 12 assessments minus the baseline value (NCT00641641)
Timeframe: 12 times within 48 weeks.

Interventionlog copies/mL plasma (Mean)
Drug Intervention5.4

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Time to Virologic Failure

time to virologic failure at week 24 (up to 48 weeks) (NCT00654147)
Timeframe: week 24 (up to 48 weeks)

Interventionweeks (Median)
Raltegravir & Lopinavir/Ritonavir3.2296
Raltegravir & Emtricitabine/Tenofovir2.9952

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Time to Confirmed Virologic Failure

time to confirmed viologic failure at 24 weeks (up to 48 weeks) (NCT00654147)
Timeframe: weeks

Interventionweeks (Median)
Raltegravir & Lopinavir/Ritonavir28
Raltegravir & Emtricitabine/Tenofovir29

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Study Medication Tolerability

study treatment tolerability as measured by number of subjects receiving study treatment who either discontinued or changed any component of study treatment (NCT00654147)
Timeframe: date started study treatment to first week documented change study treatment up to week 48

Interventionparticipants (Number)
Raltegravir & Lopinavir/Ritonavir1
Raltegravir & Emtricitabine/Tenofovir0

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Weeks to HIV-1 RNA <200 Copies/ml

time to viral suppression noted as week on study treatment to attain HIV-1 RNA < 200 copies/ml (NCT00654147)
Timeframe: from date of treatment start to first week documented viral suppression

,
Interventionweek to viral supresssion (Median)
week to <200 Copies/mlweek to <50 Copies/ml
Raltegravir & Emtricitabine/Tenofovir2856
Raltegravir & Lopinavir/Ritonavir2856

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Change From Baseline CD4+ and CD8+ Cell Counts

mean change in CD4+ and CD8+ T-lymphocytes counts from baseline (defined as the average of pre-entry and entry values) at weeks 16 and 24 in the two treatment arms (NCT00654147)
Timeframe: Baseline, Weeks 16 and 24

,
Interventioncells/mm3 (Mean)
week 16 CD4 cellsweek 24 CD4 cells
Raltegravir & Emtricitabine/Tenofovir452.11482.36
Raltegravir & Lopinavir/Ritonavir516.34521.31

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HIV RNA < 75 Copies/ml

(NCT00662545)
Timeframe: entry, week 12, and week 24

Interventionparticipants (Number)
Entecavir Intensification5
Standard of Care5

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Hepatitis B Virus (HBV) DNA

"HBV DNA carries the genetic blueprint of the virus. How many HBV DNA particles or copies are found in the blood indicates how rapidly the virus is reproducing in the liver." (NCT00662545)
Timeframe: week 24

Interventionlog 10 IU/ml (Median)
Entecavir Intensification2.4
Standard of Care0.8

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Incidence of Permanent Discontinuation Due to Toxicity

(NCT00662545)
Timeframe: 24 weeks

Interventionparticipants (Number)
Entecavir Intensification0
Standard of Care0

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Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)

(NCT00662545)
Timeframe: every 4 weeks for 24 weeks

Interventionparticipants (Number)
Entecavir Intensification0
Standard of Care0

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Incidence of ALT Flares

ALT flare: sudden increase in blood level of alanine transaminase (ALT) (NCT00662545)
Timeframe: every 4 weeks for 24 weeks

Interventionparticipants (Number)
Entecavir Intensification0
Standard of Care0

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Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms

This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years). (NCT00705679)
Timeframe: For up to 30 months of follow-up

Interventioncases per 100 person-years (Number)
Oral TDF-FTC4.7
Oral Placebo4.6

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Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms

This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years). (NCT00705679)
Timeframe: For up to 30 months of follow-up

Interventioncases per 100 person-years (Number)
TFV Gel6.0
Placebo Gel6.8

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Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms

Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB). (NCT00705679)
Timeframe: For up to 30 months of follow-up

Interventionparticipants (Number)
Oral TDF52
Oral Placebo35

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Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms

Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB). (NCT00705679)
Timeframe: For up to 30 months of follow-up

Interventionparticipants (Number)
Oral TDF-FTC61
Oral Placebo60

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Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms

Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB). (NCT00705679)
Timeframe: For up to 30 months of follow-up

Interventionparticipants (Number)
TFV Gel61
Placebo Gel70

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Person-years of Follow-up of Oral TDF and Oral Placebo Arms

Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. Note that the data for both of these arms were censored on the date when sites were asked to discontinue treatment in the oral TDF group. (NCT00705679)
Timeframe: For up to 30 months of follow-up

Interventionperson-years (Number)
Oral TDF823
Oral Placebo838

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Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms

Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. (NCT00705679)
Timeframe: For up to 30 months of follow-up

Interventionperson-years (Number)
Oral TDF-FTC1284
Oral Placebo1308

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Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms

Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. (NCT00705679)
Timeframe: For up to 30 months of follow-up

Interventionperson-years (Number)
TFV Gel1024
Placebo Gel1030

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Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product

The primary resistance mutations for the study were pre-defined as K65R and K70E (which confer resistance to TDF), and M184I and M184V (which confer resistance to FTC), for their potential to cause a decrease in susceptibility to the study drug. K65R, K70E, and M184I were not detected in HIV-1 from any HIV-1 seroconverters while on study product. The number of HIV-1 seroconverters while on study with the M184V resistance mutation are reported for this outcome measure. (NCT00705679)
Timeframe: Throughout study, up to 2.5 years

,,,,
Interventionparticipants (Number)
M184V mutationNo M184V mutation
Gel Placebo068
Oral Placebo060
Oral TDF058
Oral TDF-FTC154
TFV Gel060

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Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events

This measure describes the number of participants with elevated serum creatinine levels, the only safety outcome of concern where a significant difference was detected between an active arm and the corresponding placebo arm. (NCT00705679)
Timeframe: Throughout study, up to 2.5 years

Interventionparticipants (Number)
Oral TDF4
Oral TDF-FTC13
Oral Placebo2
TFV Gel9
Gel Placebo3

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Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms

This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years). (NCT00705679)
Timeframe: For up to 30 months of follow-up

Interventioncases per 100 person-years (Number)
Oral TDF6.3
Oral Placebo4.2

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Mean Change From Baseline in Eosinophils (x 10^9/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^9/liter (Mean)
LPV/r + FTC/TDF-0.012
LPV/r + RAL0.015

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Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionmillimoles/liter (Mean)
LPV/r + FTC/TDF-0.011
LPV/r + RAL0.109

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Mean Change From Baseline in Hematocrit (Fraction)

Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples. (NCT00711009)
Timeframe: Baseline to Week 96

Intervention% by volume of packed RBCs in blood (Mean)
LPV/r + FTC/TDF0.038
LPV/r + RAL0.036

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Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF-0.046
LPV/r + RAL-0.028

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Mean Change From Baseline in Hips Measurement (cm)

Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96

Interventioncm (Mean)
LPV/r + FTC/TDF2.45
LPV/r + RAL4.70

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Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.257
LPV/r + RAL0.346

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Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionunits/liter (Mean)
LPV/r + FTC/TDF-0.8
LPV/r + RAL-9.6

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Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey

The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement. (NCT00711009)
Timeframe: Baseline to Week 96

InterventionScores on a scale (Mean)
LPV/r + FTC/TDF-1.0
LPV/r + RAL-1.1

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Mean Change From Baseline in Basophils (x 10^9/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^9/liter (Mean)
LPV/r + FTC/TDF0.005
LPV/r + RAL0.003

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Mean Change From Baseline in Bicarbonate (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF-0.5
LPV/r + RAL-0.8

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Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.00
LPV/r + RAL0.37

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF13.75
LPV/r + RAL27.01

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF1.67
LPV/r + RAL2.56

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF3.48
LPV/r + RAL6.34

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF7.28
LPV/r + RAL21.53

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF-1.49
LPV/r + RAL-1.25

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Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey

The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement. (NCT00711009)
Timeframe: Baseline to Week 96

InterventionScores on a scale (Mean)
LPV/r + FTC/TDF1.3
LPV/r + RAL1.3

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Mean Change From Baseline in Calcium (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF-0.040
LPV/r + RAL-0.016

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Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmilliliters/second (Mean)
LPV/r + FTC/TDF-0.122
LPV/r + RAL-0.024

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Mean Change From Baseline in Chest Measurement (cm)

Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant's chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96

Interventioncm (Mean)
LPV/r + FTC/TDF1.13
LPV/r + RAL4.06

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Mean Change From Baseline in Chloride (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF-0.4
LPV/r + RAL0.2

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Mean Change From Baseline in Cholesterol (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.808
LPV/r + RAL1.113

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Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionunits/liter (Mean)
LPV/r + FTC/TDF398.9
LPV/r + RAL157.2

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Mean Change From Baseline in Creatinine (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF5.7
LPV/r + RAL1.6

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Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicrograms/milliliter (Mean)
LPV/r + FTC/TDF2.112
LPV/r + RAL2.064

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Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionunits/liter (Mean)
LPV/r + FTC/TDF-6.1
LPV/r + RAL-13.4

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF-0.33
LPV/r + RAL1.52

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Mean Change From Baseline in Albumin (Grams/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams/liter (Mean)
LPV/r + FTC/TDF1.4
LPV/r + RAL1.3

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Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values

Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented. (NCT00711009)
Timeframe: Baseline to Week 96

,
InterventionPercentage of participants (Number)
Alananine aminotransferase >5x upper limit normalAspartate aminotransferase >5x upper limit normalCreatinine phosphokinase >4x upper limit of normalCalcium <1.75 millimoles/literCholesterol >7.77 millimoles/literTriglycerides >8.475 millimoles/literCalc. creatinine clearance <50 milliliters/minuteLipase >2x upper limit of normalNeutrophils < 0.75 x 10^9/literMagnesium < 0.5 millimoles/liter
LPV/r + FTC/TDF2.92.98.7013.54.83.87.73.80
LPV/r + RAL5.05.019.82.016.89.91.04.002.0

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Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm

A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died. (NCT00711009)
Timeframe: Baseline to Week 96

,
InterventionPercentage of Participants (Number)
Week 2Week 4Week 8Week 16Week 24Week 32Week 40Week 48Week 60Week 72Week 84Week 96
LPV/r + FTC/TDF7.617.136.267.680.085.784.884.882.978.174.368.6
LPV/r + RAL33.763.475.281.283.285.187.183.275.271.370.366.3

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Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionunits/liter (Mean)
LPV/r + FTC/TDF14.5
LPV/r + RAL1.7

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Mean Change From Baseline in Hemoglobin (Grams/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams/liter (Mean)
LPV/r + FTC/TDF5.4
LPV/r + RAL5.1

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Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF1.97
LPV/r + RAL2.27

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)

The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF-3.69
LPV/r + RAL0.52

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)

The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams/cm^2 (Mean)
LPV/r + FTC/TDF-2.48
LPV/r + RAL0.68

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)

The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF15.32
LPV/r + RAL28.82

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Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.

Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred. (NCT00711009)
Timeframe: Baseline to Week 96

,
InterventionParticipants (Number)
Lopinavir resistanceEmtricitabine resistanceTenofovir resistanceRaltegravir resistance
LPV/r + FTC/TDF010NA
LPV/r + RAL0003

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Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit

(NCT00711009)
Timeframe: Baseline to Week 96

,
Interventioncells/microliter (Mean)
Week 4Week 8Week 16Week 24Week 32Week 40Week 48Week 60Week 72Week 84Week 96
LPV/r + FTC/TDF97.2107.9158.7154.9180.0204.6245.0243.4277.4309.6296.4
LPV/r + RAL113.4124.5141.6174.5188.2223.0241.9250.6269.9280.2281.0

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Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672

Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL. (NCT00711009)
Timeframe: Baseline to Week 96

InterventionPercentage of Participants (Number)
LPV/r + FTC/TDF79.1
LPV/r + RAL77.8

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Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication

The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction. (NCT00711009)
Timeframe: Week 96

InterventionScores on a scale (Mean)
LPV/r + FTC/TDF84.6
LPV/r + RAL86.2

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Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication

The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction. (NCT00711009)
Timeframe: Week 96

InterventionScores on a scale (Mean)
LPV/r + FTC/TDF82.5
LPV/r + RAL85.5

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Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)

The Effectiveness Scale of the TSQM evaluates the participant's satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction. (NCT00711009)
Timeframe: Week 96

InterventionScores on a scale (Mean)
LPV/r + FTC/TDF75.5
LPV/r + RAL76.0

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Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm

A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died. (NCT00711009)
Timeframe: Baseline to Week 48

InterventionPercentage of Participants (Number)
LPV/r + FTC/TDF84.8
LPV/r + RAL83.2

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Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir

Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S. (NCT00711009)
Timeframe: Baseline to Week 96

InterventionParticipants (Number)
LPV/r + FTC/TDF0
LPV/r + RAL1

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Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^9/liter (Mean)
LPV/r + FTC/TDF0.90
LPV/r + RAL1.20

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Mean Change From Baseline in Weight (kg)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionkg (Mean)
LPV/r + FTC/TDF1.83
LPV/r + RAL3.77

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Mean Change From Baseline in Waist Measurement (cm)

Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant's waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96

Interventioncm (Mean)
LPV/r + FTC/TDF1.88
LPV/r + RAL4.93

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Mean Change From Baseline in Urine Specific Gravity

Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density. (NCT00711009)
Timeframe: Baseline to Week 96

Interventionratio of urine density to water density (Mean)
LPV/r + FTC/TDF0.0042
LPV/r + RAL0.0052

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Mean Change From Baseline in Urine pH

(NCT00711009)
Timeframe: Baseline to Week 96

InterventionpH (Mean)
LPV/r + FTC/TDF0.00
LPV/r + RAL0.03

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Mean Change From Baseline in Uric Acid (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF-29.0
LPV/r + RAL-6.1

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Mean Change From Baseline in Triglycerides (Micromoles/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.846
LPV/r + RAL1.103

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Mean Change From Baseline in Total Protein (Grams/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams/liter (Mean)
LPV/r + FTC/TDF-6.3
LPV/r + RAL-7.2

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Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.9
LPV/r + RAL1.9

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Mean Change From Baseline in Temperature (°F)

(NCT00711009)
Timeframe: Baseline to Week 96

Intervention°F (Mean)
LPV/r + FTC/TDF-0.152
LPV/r + RAL-0.183

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Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionpicograms/milliliter (Mean)
LPV/r + FTC/TDF-1257.9
LPV/r + RAL-1594.7

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Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionpicograms/milliliter (Mean)
LPV/r + FTC/TDF-138.602
LPV/r + RAL-166.403

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Mean Change From Baseline in Sodium (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.1
LPV/r + RAL0.7

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Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmm Hg (Mean)
LPV/r + FTC/TDF-0.7
LPV/r + RAL-2.4

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Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionbeats per minute (Mean)
LPV/r + FTC/TDF-4.6
LPV/r + RAL-6.3

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Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmm Hg (Mean)
LPV/r + FTC/TDF-2.4
LPV/r + RAL-1.8

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Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^12/liter (Mean)
LPV/r + FTC/TDF0.12
LPV/r + RAL0.16

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Mean Change From Baseline in Potassium (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.13
LPV/r + RAL0.03

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Mean Change From Baseline in Platelet Count (x 10^9/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^9/liter (Mean)
LPV/r + FTC/TDF46.8
LPV/r + RAL34.2

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF4.32
LPV/r + RAL6.96

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF12.71
LPV/r + RAL25.31

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF1.08
LPV/r + RAL1.56

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF2.9
LPV/r + RAL5.4

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Mean Change From Baseline in Neutrophils (x 10^9/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^9/liter (Mean)
LPV/r + FTC/TDF0.509
LPV/r + RAL0.705

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Mean Change From Baseline in Monocytes (x 10^9/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^9/liter (Mean)
LPV/r + FTC/TDF0.065
LPV/r + RAL0.112

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Mean Change From Baseline in Mid-Thigh Measurement (cm)

Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96

Interventioncm (Mean)
LPV/r + FTC/TDF2.09
LPV/r + RAL5.13

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Mean Change From Baseline in Mid-Arm Measurement (cm)

Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96

Interventioncm (Mean)
LPV/r + FTC/TDF1.76
LPV/r + RAL4.71

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Mean Change From Baseline in Magnesium (Millimoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmillimoles/liter (Mean)
LPV/r + FTC/TDF0.019
LPV/r + RAL-0.009

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Mean Change From Baseline in Lymphocytes (x 10^9/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^9/liter (Mean)
LPV/r + FTC/TDF0.332
LPV/r + RAL0.368

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Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionratio (Mean)
LPV/r + FTC/TDF-0.056
LPV/r + RAL-0.040

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Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.535
LPV/r + RAL0.715

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Mean Change From Baseline in Lipase (Units/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionunits/liter (Mean)
LPV/r + FTC/TDF4.674
LPV/r + RAL-1.898

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Mean Change From Baseline in Leptin (Nanograms/Milliliter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionnanograms/milliliter (Mean)
LPV/r + FTC/TDF3.623
LPV/r + RAL2.927

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Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionunits/liter (Mean)
LPV/r + FTC/TDF-21.157
LPV/r + RAL-28.926

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Mean Change From Baseline in Lactate (Millimoles/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionmillimoles/liter (Mean)
LPV/r + FTC/TDF0.281
LPV/r + RAL0.444

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Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionnanograms/liter (Mean)
LPV/r + FTC/TDF-1.584
LPV/r + RAL-53.286

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Mean Change From Baseline in Insulin (Picomoles/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionpicomoles/liter (Mean)
LPV/r + FTC/TDF-6.724
LPV/r + RAL4.441

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Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48

The percentage of participants with HIV-1 RNA < 200 copies/mL at Week 48 was summarized. (NCT00724711)
Timeframe: 48 weeks

,
Interventionpercentage of participants (Number)
On-Treatment Response Analysis (Missing = Failure)Snapshot Responder Analysis (Virologic Success)
ABC/3TC + PI/r82.182.1
TVD + PI/r84.484.4

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Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

,
Interventionpg/mL (Mean)
IL-10IL-6TNF-alpha
ABC/3TC + PI/r-0.2-0.64.7
TVD + PI/r0.0-0.20.0

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Change From Baseline Fasting Lipid Parameters at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

,
Interventionmg/dL (Mean)
Total CholesterolLDL (low-density lipoprotein)HDL (high-density lipoprotein)Triglycerides
ABC/3TC + PI/r-420-23
TVD + PI/r-21-6-2-51

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Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48

The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 50 copies/mL or the last HIV-1 RNA value >= 50 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionpercentage of participants (Number)
TVD + PI/r93.0
ABC/3TC + PI/r91.1

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Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48

The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionpercentage of participants (Number)
TVD + PI/r99.2
ABC/3TC + PI/r97.2

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Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm

The percentage of participants with HIV-1 RNA < 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionpercentage of participants (Number)
TVD + PI/r86.4
ABC/3TC + PI/r83.3

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Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventioncells/microliter (Mean)
TVD + PI/r8
ABC/3TC + PI/r34

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Change From Baseline Fasting Glucose at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionmg/dL (Mean)
TVD + PI/r1
ABC/3TC + PI/r1

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Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

InterventionmL/min/1.73m^2 (Mean)
TVD + PI/r-9.0
ABC/3TC + PI/r-3.7

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Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

InterventionRatio (Mean)
TVD + PI/r-0.1
ABC/3TC + PI/r-0.1

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Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

InterventionmL/min (Mean)
TVD + PI/r-8.4
ABC/3TC + PI/r-4.1

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Change From Baseline C-Reactive Protein at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionmg/dL (Mean)
TVD + PI/r-0.026
ABC/3TC + PI/r0.225

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Change From Baseline Fibrinogen at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionmg/dL (Mean)
TVD + PI/r-4
ABC/3TC + PI/r14

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was summarized. (NCT00724711)
Timeframe: 48 weeks

,
Interventionpercentage of participants (Number)
TLOVR Responder AnalysisOn-Treatment Response Analysis (Missing = Failure)Snapshot Responder Analysis (Virologic Success)
ABC/3TC + PI/r76.377.677.6
TVD + PI/r77.979.979.9

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Change From Baseline in Z-score for Whole Body BMD at Week 192

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 192

Interventionz-score (Mean)
TDF 12-14 Years-0.34
TDF 15-17 Years-0.11
Placebo 12-14 Years-0.21
Placebo 15-17 Years-0.19
Total TDF 12-17 Years-0.16
Total Placebo 12-17 Years-0.19

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Percentage of Participants With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL and Normalized ALT at Weeks 48, 72, 96, 144, and 192

Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192

,,,,,
Interventionpercentage of participants (Number)
Week 48Week 72Week 96Week 144Week 192
Placebo 12-14 Years0055.666.777.8
Placebo 15-17 Years0054.569.757.6
TDF 12-14 Years85.785.785.757.185.7
TDF 15-17 Years71.471.478.671.467.9
Total Placebo 12-17 Years0054.869.061.9
Total TDF 12-17 Years74.374.380.068.671.4

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Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192

Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192

,,,,,
Interventionpercentage of participants (Number)
Week 48Week 72Week 96Week 144Week 192
Placebo 12-14 Years11.122.266.766.777.8
Placebo 15-17 Years21.233.363.672.769.7
TDF 12-14 Years85.785.785.757.185.7
TDF 15-17 Years71.471.478.671.475.0
Total Placebo 12-17 Years19.031.064.371.471.4
Total TDF 12-17 Years74.374.380.068.677.1

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Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192

The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Weeks 48, 96, 144, and 192

,,,,,
Interventionpercentage of participants (Number)
Week 48Week 96Week 144Week 192
Placebo 12-14 Years0000
Placebo 15-17 Years0004.9
TDF 12-14 Years0000
TDF 15-17 Years02.42.44.8
Total Placebo 12-17 Years0003.7
Total TDF 12-17 Years01.91.93.8

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Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192

HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192

,,,,,
Interventionpercentage of participants (Number)
Week 48Week 72Week 96Week 144Week 192
Placebo 12-14 Years00000
Placebo 15-17 Years00000
TDF 12-14 Years00000
TDF 15-17 Years02.42.42.40
Total Placebo 12-17 Years00000
Total TDF 12-17 Years01.91.91.90

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Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192

Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Weeks 48, 72, 96, 144, and 192

,,,,,
Interventionpercentage of participants (Number)
Week 48Week 72Week 96Week 144Week 192
Placebo 12-14 Years0053.869.276.9
Placebo 15-17 Years0063.482.973.2
TDF 12-14 Years80.090.090.090.090.0
TDF 15-17 Years81.083.388.188.183.3
Total Placebo 12-17 Years0061.179.674.1
Total TDF 12-17 Years80.884.688.588.584.6

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Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72

"The percentage of participants with HBV DNA < 400 copies/mL at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the missing = failure (M = F) analysis with the double-blind efficacy evaluation (DBEE) algorithm.~In the M = F analysis method, all missing data were considered as failure to meet the outcome measure threshold. This method was combined with the DBEE algorithm, which included all available data for the double-blind period, and any data for the open-label period were not included; data generated during treatment-free follow-up from subjects who achieved HBsAg loss and entered treatment-free follow-up during double-blind treatment period were included." (NCT00734162)
Timeframe: Week 72

Interventionpercentage of participants (Number)
TDF 12-14 Years90.0
TDF 15-17 Years88.1
Placebo 12-14 Years0
Placebo 15-17 Years0
Total TDF 12-17 Years88.5
Total Placebo 12-17 Years0

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Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72

"Data were summarized by treatment and age group (grouped by baseline age for analysis).~In contrast with what was previously reported in the interim results posting, 1 participant met the primary safety endpoint of at least a 6% decrease from baseline in spine BMD at Week 72, based on the final BMD data analysis. The apparent discrepancy was due to the correction factor applied to the subject-specific BMD calculations performed at the time of the Interim Week 72 clinical study report that could not take into account the actual Week 72 phantom data (ie, calibration test used in longitudinal clinical trials to monitor and adjust for shifts in the dual-energy x-ray absorptiometry (DXA) scanner calibration over time), which were not provided by the site at that time. The correction factor applied to the final analysis has been properly based on all phantom data through the end of Week 72, as well as through the end of Week 192." (NCT00734162)
Timeframe: Baseline to Week 72

Interventionpercentage of participants (Number)
TDF 12-14 Years0
TDF 15-17 Years2.4
Placebo 12-14 Years0
Placebo 15-17 Years0
Total TDF 12-17 Years1.9
Total Placebo 12-17 Years0

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Percent Change From Baseline in Whole Body BMD at Week 96

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 96

Interventionpercentage change (Mean)
TDF 12-14 Years8.034
TDF 15-17 Years3.023
Placebo 12-14 Years10.056
Placebo 15-17 Years4.291
Total TDF 12-17 Years3.943
Total Placebo 12-17 Years5.675

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Percent Change From Baseline in Whole Body BMD at Week 72

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 72

Interventionpercentage change (Mean)
TDF 12-14 Years7.282
TDF 15-17 Years2.141
Placebo 12-14 Years8.480
Placebo 15-17 Years4.335
Total TDF 12-17 Years3.067
Total Placebo 12-17 Years5.391

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Percent Change From Baseline in Whole Body BMD at Week 48

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
TDF 12-14 Years5.123
TDF 15-17 Years1.339
Placebo 12-14 Years5.470
Placebo 15-17 Years3.236
Total TDF 12-17 Years2.048
Total Placebo 12-17 Years3.817

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Percent Change From Baseline in Whole Body BMD at Week 192

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 192

Interventionpercentage change (Mean)
TDF 12-14 Years13.923
TDF 15-17 Years4.295
Placebo 12-14 Years14.797
Placebo 15-17 Years4.549
Total TDF 12-17 Years6.086
Total Placebo 12-17 Years7.223

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Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192

Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Weeks 48, 72, 96, 144, and 192

,,,,,
Interventionpercentage of participants (Number)
Week 48Week 72Week 96Week 144Week 192
Placebo 12-14 Years0046.253.869.2
Placebo 15-17 Years0051.268.363.4
TDF 12-14 Years70.080.080.060.080.0
TDF 15-17 Years69.069.073.869.064.3
Total Placebo 12-17 Years0050.064.864.8
Total TDF 12-17 Years69.271.275.067.367.3

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Percent Change From Baseline in Whole Body BMD at Week 144

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 144

Interventionpercentage change (Mean)
TDF 12-14 Years10.940
TDF 15-17 Years3.529
Placebo 12-14 Years12.638
Placebo 15-17 Years4.730
Total TDF 12-17 Years4.949
Total Placebo 12-17 Years6.505

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Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
TDF 12-14 Years9.234
TDF 15-17 Years2.114
Placebo 12-14 Years9.038
Placebo 15-17 Years4.435
Total TDF 12-17 Years3.510
Total Placebo 12-17 Years5.562

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Percent Change From Baseline in Spine BMD at Week 96

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 96

Interventionpercentage change (Mean)
TDF 12-14 Years13.811
TDF 15-17 Years4.196
Placebo 12-14 Years16.687
Placebo 15-17 Years4.272
Total TDF 12-17 Years6.119
Total Placebo 12-17 Years7.003

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Percent Change From Baseline in Spine BMD at Week 72

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 72

Interventionpercentage change (Mean)
TDF 12-14 Years11.516
TDF 15-17 Years3.589
Placebo 12-14 Years14.131
Placebo 15-17 Years6.117
Total TDF 12-17 Years5.144
Total Placebo 12-17 Years8.080

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Percent Change From Baseline in Spine BMD at Week 192

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 192

Interventionpercentage change (Mean)
TDF 12-14 Years23.933
TDF 15-17 Years6.673
Placebo 12-14 Years25.036
Placebo 15-17 Years6.867
Total TDF 12-17 Years10.050
Total Placebo 12-17 Years11.212

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Percent Change From Baseline in Spine BMD at Week 144

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 144

Interventionpercentage change (Mean)
TDF 12-14 Years19.224
TDF 15-17 Years5.289
Placebo 12-14 Years21.346
Placebo 15-17 Years6.144
Total TDF 12-17 Years8.133
Total Placebo 12-17 Years9.311

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Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192

Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Weeks 48, 96, 144, and 192

,,,,,
Interventionpercentage of participants (Number)
Week 48Week 96Week 144Week 192
Placebo 12-14 Years053.869.276.9
Placebo 15-17 Years068.385.473.2
TDF 12-14 Years90.090.0100.090.0
TDF 15-17 Years85.788.190.585.7
Total Placebo 12-17 Years064.881.574.1
Total TDF 12-17 Years86.588.592.386.5

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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192

Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192

,,,,,
Interventionpercentage of participants (Number)
Week 48Week 72Week 96Week 144Week 192
Placebo 12-14 Years00000
Placebo 15-17 Years00000
TDF 12-14 Years00000
TDF 15-17 Years02.42.42.42.4
Total Placebo 12-17 Years00000
Total TDF 12-17 Years01.91.91.91.9

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Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192

Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Weeks 48, 72, 96, 144, and 192

,,,,,
Interventionpercentage of participants (Number)
Week 48Week 72Week 96Week 144Week 192
Placebo 12-14 Years30.830.869.269.284.6
Placebo 15-17 Years26.841.565.975.675.6
TDF 12-14 Years70.080.080.060.080.0
TDF 15-17 Years76.276.276.271.471.4
Total Placebo 12-17 Years27.838.966.774.177.8
Total TDF 12-17 Years75.076.976.969.273.1

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Change From Baseline in Z-score for Whole Body BMD at Week 96

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 96

Interventionz-score (Mean)
TDF 12-14 Years-0.12
TDF 15-17 Years-0.19
Placebo 12-14 Years0.09
Placebo 15-17 Years-0.06
Total TDF 12-17 Years-0.18
Total Placebo 12-17 Years-0.03

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Change From Baseline in Z-score for Whole Body BMD at Week 72

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 72

Interventionz-score (Mean)
TDF 12-14 Years0.02
TDF 15-17 Years-0.19
Placebo 12-14 Years0.20
Placebo 15-17 Years0.06
Total TDF 12-17 Years-0.16
Total Placebo 12-17 Years0.09

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Change From Baseline in Z-score for Whole Body BMD at Week 48

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 48

Interventionz-score (Mean)
TDF 12-14 Years0.02
TDF 15-17 Years-0.15
Placebo 12-14 Years0.10
Placebo 15-17 Years0.04
Total TDF 12-17 Years-0.12
Total Placebo 12-17 Years0.05

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Change From Baseline in Z-score for Whole Body BMD at Week 144

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 144

Interventionz-score (Mean)
TDF 12-14 Years-0.27
TDF 15-17 Years-0.21
Placebo 12-14 Years-0.06
Placebo 15-17 Years-0.16
Total TDF 12-17 Years-0.22
Total Placebo 12-17 Years-0.14

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Change From Baseline in Z-score for Spine BMD at Week 96

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 96

Interventionz-score (Mean)
TDF 12-14 Years-0.19
TDF 15-17 Years-0.07
Placebo 12-14 Years-0.02
Placebo 15-17 Years-0.13
Total TDF 12-17 Years-0.10
Total Placebo 12-17 Years-0.11

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Number of Participants With Changes in Drug-Resistant Mutations During the Study

The number of participants with changes in drug-resistant mutations during the study was summarized. (NCT00734162)
Timeframe: Baseline through Week 192

,
Interventionparticipants (Number)
New TDF Drug-Resistant MutationsEnrichment of TDF Drug-Resistant Mutations
Total Placebo 12-17 Years00
Total TDF 12-17 Years00

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Change From Baseline in Z-score for Spine BMD at Week 72

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 72

Interventionz-score (Mean)
TDF 12-14 Years-0.10
TDF 15-17 Years-0.05
Placebo 12-14 Years0.09
Placebo 15-17 Years0.10
Total TDF 12-17 Years-0.06
Total Placebo 12-17 Years0.10

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Change From Baseline in Z-score for Spine BMD at Week 48

To assess any effect of treatment on growth, Z-scores were used to express the deviation from a reference population for lumbar spine BMD. A Z-score of 0 indicated that a subject was typical of the population for their age, ethnicity, and gender. A negative Z-score indicated that the subject's recorded value was lower than typical for their age, ethnicity, and gender. A positive Z-score indicates that the subject's recorded value was higher than typical for their age, ethnicity, and gender. Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 48

Interventionz-score (Mean)
TDF 12-14 Years0.02
TDF 15-17 Years-0.10
Placebo 12-14 Years0.04
Placebo 15-17 Years0.05
Total TDF 12-17 Years-0.08
Total Placebo 12-17 Years0.05

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Change From Baseline in Z-score for Spine BMD at Week 192

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 192

Interventionz-score (Mean)
TDF 12-14 Years-0.24
TDF 15-17 Years0.08
Placebo 12-14 Years-0.26
Placebo 15-17 Years-0.05
Total TDF 12-17 Years0.02
Total Placebo 12-17 Years-0.10

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Change From Baseline in Z-score for Spine BMD at Week 144

Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 144

Interventionz-score (Mean)
TDF 12-14 Years-0.20
TDF 15-17 Years-0.05
Placebo 12-14 Years-0.16
Placebo 15-17 Years-0.04
Total TDF 12-17 Years-0.08
Total Placebo 12-17 Years-0.06

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Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192

The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192

,,,,,
Interventionpercentage of participants (Number)
Week 48Week 72Week 96Week 144Week 192
Placebo 12-14 Years00000
Placebo 15-17 Years0002.42.4
TDF 12-14 Years00000
TDF 15-17 Years00000
Total Placebo 12-17 Years0001.91.9
Total TDF 12-17 Years00000

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Percentage of Participants Who Were HBeAg-Positive With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL, Normalized ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192

Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192

,,,,,
Interventionpercentage of participants (Number)
Week 48Week 72Week 96Week 144Week 192
Placebo 12-14 Years0033.355.655.6
Placebo 15-17 Years0024.227.327.3
TDF 12-14 Years16.716.750.033.350.0
TDF 15-17 Years18.522.233.329.629.6
Total Placebo 12-17 Years0026.233.333.3
Total TDF 12-17 Years18.221.236.430.333.3

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Percentage of Participants Who Were HBeAg-Positive at Baseline Who Had HBV DNA < 400 Copies/mL, Normal ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192

Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192

,,,,,
Interventionpercentage of participants (Number)
Week 48Week 72Week 96Week 144Week 192
Placebo 12-14 Years0030.846.246.2
Placebo 15-17 Years0022.925.725.7
TDF 12-14 Years11.111.144.422.233.3
TDF 15-17 Years12.815.428.230.828.2
Total Placebo 12-17 Years0025.031.331.3
Total TDF 12-17 Years12.514.631.329.229.2

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Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192

Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192

,,,,,
Interventionpercentage of participants (Number)
Week 48Week 72Week 96Week 144Week 192
Placebo 12-14 Years7.723.138.553.853.8
Placebo 15-17 Years8.611.425.734.337.1
TDF 12-14 Years11.111.144.433.333.3
TDF 15-17 Years15.423.130.838.538.5
Total Placebo 12-17 Years8.314.629.239.641.7
Total TDF 12-17 Years14.620.833.337.537.5

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Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192

Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192

,,,,,
Interventionpercentage of participants (Number)
Week 48Week 72Week 96Week 144Week 192
Placebo 12-14 Years7.723.138.553.853.8
Placebo 15-17 Years8.611.428.634.337.1
TDF 12-14 Years11.111.144.444.433.3
TDF 15-17 Years17.923.130.838.543.6
Total Placebo 12-17 Years8.314.631.339.641.7
Total TDF 12-17 Years16.720.833.339.641.7

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Mean Hematocrit Between Treatment Groups at 2 Months

Mean hematocrit of all subjects at 2 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 2 months after baseline

Interventionpercentage (Mean)
Raltegravir Plus Truvada41.5
Efavirenz Plus Truvada41.8

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Mean CD4 Count Between Treatment Groups at 4 Months

Mean CD4 count between groups 4 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 4 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada617.2
Efavirenz Plus Truvada646.5

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Mean CD4 Count Between Treatment Groups at 5 Months

Mean CD4 count between groups 5 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 5 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada805.7
Efavirenz Plus Truvada539.6

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Mean Hematocrit Between Treatment Groups at 4 Months

Mean hematocrit of all subjects at 4 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 4 months after baseline

Interventionpercentage (Mean)
Raltegravir Plus Truvada41.4
Efavirenz Plus Truvada43

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Mean CD4 Count Between Treatment Groups at 6 Months

Mean CD4 count between groups 6 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 6 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada652.2
Efavirenz Plus Truvada673.5

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Mean CD4 Count Between Treatment Groups at 7 Months

Mean CD4 count between groups 7 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 7 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada504
Efavirenz Plus Truvada552.5

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Mean Hematocrit Between Treatment Groups at 6 Months

Mean hematocrit of all subjects at 6 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 6 months after baseline

Interventionpercentage (Mean)
Raltegravir Plus Truvada42.1
Efavirenz Plus Truvada39.8

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Mean White Blood Cell Count Between Treatment Groups at 8 Months

Mean WBC count of all subjects as determined by standard lab procedures at 8 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 8 months after baseline

Interventionwhite blood cells per microliter (mcL). (Mean)
Raltegravir Plus Truvada6240
Efavirenz Plus Truvada4607

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Mean White Blood Cell Count Between Treatment Groups at 6 Months

Mean WBC count of all subjects as determined by standard lab procedures at 6 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 6 months after baseline

Interventionwhite blood cells per microliter (mcL). (Mean)
Raltegravir Plus Truvada5219
Efavirenz Plus Truvada4522

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Mean CD4 Count Between Treatment Groups at 8 Months

Mean CD4 count between groups 8 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 8 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada464.5
Efavirenz Plus Truvada586.5

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Mean White Blood Cell Count Between Treatment Groups at 4 Months

Mean WBC count of all subjects as determined by standard lab procedures at 4 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 4 months post baseline

Interventionwhite blood cells per microliter (mcL). (Mean)
Raltegravir Plus Truvada5850
Efavirenz Plus Truvada4948

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Mean CD4 Count Between Treatment Groups at 2 Months

Mean CD4 count between groups 2 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 2 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada703.1
Efavirenz Plus Truvada527.2

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Mean White Blood Cell Count Between Treatment Groups at 14 Months

Mean WBC count of all subjects as determined by standard lab procedures at 14 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 14 months after baseline

Interventionwhite blood cells per microliter (mcL). (Mean)
Raltegravir Plus Truvada3180
Efavirenz Plus Truvada4903

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Mean CD4 Count Between Treatment Groups at 9 Months

Mean CD4 count between groups 9 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 9 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada306
Efavirenz Plus Truvada571

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Mean Hematocrit Between Treatment Groups at 10 Months

Mean hematocrit of all subjects at 10 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 10 months after baseline

Interventionpercentage (Mean)
Raltegravir Plus Truvada45
Efavirenz Plus Truvada38

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Mean CD4 Count Between Treatment Groups at 11 Months

Mean CD4 count between groups 11 months after of starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 11 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada495

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Mean CD4 Count Between Treatment Groups at 10 Months

Mean CD4 count between groups 10 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 10 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada469
Efavirenz Plus Truvada571.5

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Mean CD4 Count Between Treatment Groups at 1 Months

Mean CD4 count between groups 1 month after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 1 month after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada629.1
Efavirenz Plus Truvada535

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Mean Platelet Count Between Treatment Groups at 10 Months

The mean platelet count between treatment groups at 10 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 10 months after baseline

Interventioncount per microliter (Mean)
Raltegravir Plus Truvada193500
Efavirenz Plus Truvada243300

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Mean Platelet Count Between Treatment Groups at 12 Months

The mean platelet count between treatment groups at 12 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 12 months after baseline

Interventioncount per microliter (Mean)
Raltegravir Plus Truvada255600
Efavirenz Plus Truvada185500

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Mean Platelet Count Between Treatment Groups at 14 Months

The mean platelet count between treatment groups at 14 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 4 months after baseline

Interventioncount per microliter (Mean)
Raltegravir Plus Truvada217400
Efavirenz Plus Truvada216800

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Mean CD4 Count Between Treatment Groups at 3 Months

Mean CD4 count between groups 3 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 3 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada716.4
Efavirenz Plus Truvada671.7

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Mean Platelet Count Between Treatment Groups at 2 Months

The mean platelet count between treament groups at 2 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 100 per liter). (NCT00734344)
Timeframe: 2 months after baseline

Interventioncount per microliter (Mean)
Raltegravir Plus Truvada232600
Efavirenz Plus Truvada225600

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Mean Hematocrit Between Treatment Groups at 8 Months

Mean hematocrit of all subjects at 8 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 8 months after baseline

Interventionpercentage (Mean)
Raltegravir Plus Truvada40.3
Efavirenz Plus Truvada41.2

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Mean Platelet Count Between Treatment Groups at 4 Months

The mean platelet count between treatment groups at 4 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 4 months after baseline

Interventioncount per microliter (Mean)
Raltegravir Plus Truvada210800
Efavirenz Plus Truvada197300

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Mean Platelet Count Between Treatment Groups at 6 Months

The mean platelet count between treatment groups at 6 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 6 months after baseline

Interventioncount per microliter (Mean)
Raltegravir Plus Truvada230000
Efavirenz Plus Truvada224800

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Mean Platelet Count Between Treatment Groups at 8 Months

The mean platelet count between treatment groups at 8 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 8 months after baseline

Interventioncount per microliter (Mean)
Raltegravir Plus Truvada215700
Efavirenz Plus Truvada208100

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Mean White Blood Cell Count Between Treatment Groups at 10 Months

Mean WBC count of all subjects as determined by standard lab procedures at 10 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 10 months after baseline

Interventionwhite blood cells per microliter (mcL). (Mean)
Raltegravir Plus Truvada5230
Efavirenz Plus Truvada4615

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Mean White Blood Cell Count Between Treatment Groups at 12 Months

Mean WBC count of all subjects as determined by standard lab procedures at 12 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 12 months after baseline

Interventionwhite blood cells per microliter (mcL). (Mean)
Raltegravir Plus Truvada6320
Efavirenz Plus Truvada4868

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Mean Hematocrit Between Treatment Groups at 12 Months

Mean hematocrit of all subjects at 12 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 12 months after baseline

Interventionpercentage (Mean)
Raltegravir Plus Truvada41
Efavirenz Plus Truvada43.5

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Mean Hematocrit Between Treatment Groups at 14 Months

Mean hematocrit of all subjects at 14 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 14 months after baseline

Interventionpercentage (Mean)
Raltegravir Plus Truvada36
Efavirenz Plus Truvada39.7

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Mean White Blood Cell Count Between Treatment Groups at 2 Months

Mean WBC count for all subjects as determined by standard lab procedures at 2 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: baseline to 2 months

Interventionwhite blood cells per microliter (mcL). (Mean)
Raltegravir Plus Truvada5904
Efavirenz Plus Truvada4918

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Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48

Blood samples from study participants were collected for measuring HBV DNA via PCR method. (NCT00736190)
Timeframe: Week 48

InterventionParticipants (Number)
Tenofovir DF73

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Summary of Resistance Surveillance for Participants Without Virologic Breakthrough

Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples. (NCT00736190)
Timeframe: Week 48

InterventionParticipants (Number)
No changes in HBV pol/RTChanges at polymorphic sitesChanges at conserved sitesUnable to genotype
Tenofovir DF6121

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Summary of Resistance Surveillance for Participants With Virologic Breakthrough

Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples. (NCT00736190)
Timeframe: Week 48

InterventionParticipants (Number)
No changes in HBV pol/RTChanges at polymorphic sitesChanges at conserved sitesUnable to genotype
Tenofovir DF2000

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Summary of Resistance Surveillance for Participants Who Discontinued the Study Early

Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples. (NCT00736190)
Timeframe: Week 48

InterventionParticipants (Number)
No changes in HBV pol/RTChanges at polymorphic sitesChanges at conserved sitesUnable to genotype
Tenofovir DF1001

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Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion

HBeAg/HBsAg loss is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- at Week 48. HBeAg/HBsAg serocoversion is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- and anti-HBe+/antibody to hepatitis B surface antigen+ (anti-HBs+) at Week 48. (NCT00736190)
Timeframe: Week 48

InterventionParticipants (Number)
HBsAg+ at baselineHBsAg- at baselineHBsAg+ at Week 48HBsAg data missing at Week 48HBeAg+ at baselineHBeAg- at baselineHBeAg loss by Week 48Anti-HBe+ seroconversion by Week 48
Tenofovir DF900882533766

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Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL)

Blood samples were collected from study participants for measuring HBV DNA via polymerase chain reaction (PCR) method. (NCT00736190)
Timeframe: Week 48

InterventionParticipants (Number)
Tenofovir DF74

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Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48

Blood samples were collected for evaluating serum chemistry, including determination of ALT, and for measuring HBV DNA via PCR method. Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost hepatitis B e antigen (HBeAg) or developed antibody to hepatitis B e antigen (anti-HBe), only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed. (NCT00736190)
Timeframe: Week 48

InterventionParticipants (Number)
Tenofovir DF55

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Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48

A normal value at Week 48 after having elevated ALT at baseline; normal ALT is defined as being at or below the ULN for the central laboratory (34 U/L) (NCT00736190)
Timeframe: Week 48

Interventionparticipants (Number)
Tenofovir DF40

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Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48

Number of participants with normal ALT (at or below the upper limit of normal [ULN] for the central laboratory [34 U/L])at Week 48 (NCT00736190)
Timeframe: Week 48

InterventionParticipants (Number)
Tenofovir DF59

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Change From Baseline in FibroTest Value

The FibroTest score is used to assess liver fibrosis and is calculated based on a formula including the participant's age and sex and 5 laboratory parameters: alpha 2 macroglobulin, haptoglobin, gamma-glutamyl transferase (GGT), bilirubin, and apolipoprotein A1. Scores can range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. (NCT00736190)
Timeframe: Baseline and Week 48

InterventionScores on a scale (Mean)
Tenofovir DF-0.006

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To Compare the Phase 1 Viral Decay Rates Between LPV/r + RAL vs. EFV/TDF/FTC Treatment Combinations.

Repeated HIV RNA measured at different time points (baseline, days 2, 7, 10, 14) will be treated as the outcome variable in a linear mixed-effects model. The primary fixed effects will include time, treatment group, treatment group-by-time interaction; random effects will include both intercept and slope allowing each subject to have individual baseline viral load and viral decay (rate of decrease in viral load following initiation of antiretroviral therapy). The treatment group-by- time interaction term in the model will indicate the difference in viral decay rates between the two treatment groups. Baseline covariate adjustment will be included if necessary. (NCT00752856)
Timeframe: Baseline, days 2, 7, 10, 14

Interventionlog(10)/day (Median)
1 - Kaletra + Isentress Taken Twice Daily0.47
2 - Atripla Taken Once Daily0.55

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Compare Late Activated CD4+ T-cell Recovery Rates Between Treatment Regimens From Baseline to Week 48

To compare late (baseline to Week 48) activated CD4+ T-cell recovery rates between treatment regimens. (NCT00752856)
Timeframe: 48 weeks

Interventioncells/mm^3 (Mean)
1 - Kaletra + Isentress Taken Twice Daily-2.24
2 - Atripla Taken Once Daily-5.65

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Compare Early Activated CD4+ T-cell Recovery Rates From Baseline to Week 4.

To compare early (baseline to Week 4) activated CD4+ T-cell recovery rates between treatment regimens. (NCT00752856)
Timeframe: Baseline to Week 4

Interventioncells/mm^3 (Mean)
1 - Kaletra + Isentress Taken Twice Daily-3.81
2 - Atripla Taken Once Daily-1.18

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Viral Suppression Efficacy at 48 Weeks

To determine the antiviral efficacy of LPV/r + RAL compared to EFV/TDF/FTC after 48 weeks of treatment by achieving undetectable viral load (NCT00752856)
Timeframe: 48 weeks

Interventionpercentage of participants (Number)
1 - Kaletra + Isentress Taken Twice Daily86
2 - Atripla Taken Once Daily87.5

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Change From Baseline in Glucose at Week 12 and 48.

Participants glucose level was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was reported. (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
Interventionmg/dL (Mean)
Baseline (n=33,30)Change at Week 12 (n=30,29)Change at Week 48 (n=28,24)
Atazanavir89.75.86.4
Darunavir88.51.52.8

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Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48

Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
Interventionmg/dL (Mean)
Baseline (n= 28, 27)Change at Week 12 (n= 27, 27)Change at Week 48 (n= 26, 22)
Atazanavir165.14.611.8
Darunavir141.820.322.3

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Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48.

Participants homeostasis model assessment-insulin resistance (HOMA-IR) were observed and change from Baseline were reported. HOMA-IR score was calculated as: (fasting plasma glucose*fasting serum insulin)/22.5. Low HOMA IR values indicate high insulin sensitivity and high HOMA IR values indicate low insulin sensitivity (insulin resistance). (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
InterventionHOMA-IR score (Mean)
Baseline (n=27,22)Change at Week 12 (n=20,21)Change at Week 48 (n=19,14)
Atazanavir2.9430.105-1.236
Darunavir1.624-0.4830.035

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Change From Baseline in Insulin at Week 12 and 48.

Participants insulin was analyzed at Baseline and Week 12 and 48 and change from Baseline at Week 12 and 48 were reported. (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
InterventionIU/mL (Mean)
Baseline (n=33,30)Change at Week 12 (n=30,29)Change at Week 48 (n=28,24)
Atazanavir8.590.70-2.88
Darunavir5.96-1.070.95

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Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).

Participants' Cluster of Differentiation (CD) 4 Cell Count were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF. (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
Interventioncells/uL (Mean)
Baseline (n=34,31)Change at Week 12 (n=34,31)Change at Week 48 (n=34,31)
Atazanavir326.774.6187.7
Darunavir268.3103.4194.9

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Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.

the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values. (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
InterventionLog10 HIV RNA (Mean)
Baseline (n=34,31)Change at Week 12 (n=32,30)Change at Week 48 (n=29,24)
Atazanavir4.562-2.605-2.902
Darunavir5.016-2.955-3.269

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Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.

Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
Interventionmg/dL (Mean)
Baseline (n=28,27)Change at Week 12 (n=27,27)Change at Week 48 (n=26,22)
Atazanavir45.02.23.7
Darunavir37.96.66.0

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Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12

Observed values. (NCT00757783)
Timeframe: Baseline, Week 12

,
Interventionmilligram per deciliters (mg/dL) (Mean)
Baseline (n=28,27)Change at Week 12 (n=27,27)
Atazanavir114.28.1
Darunavir113.722.0

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Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.

Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed. (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
Interventioncells/micro L (Mean)
Baseline (n=34,31)Change at Week 12 (n=32,29)Change at Week 48 (n=29,25)
Atazanavir326.768.3205.3
Darunavir268.3111.1217.4

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Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.

Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
Interventiong/L (Mean)
Baseline (n=28,27)Change at Week 12 (n=27,27)Change at Week 48 (n=26,22)
Atazanavir0.8-0.050.0
Darunavir0.7-0.0040.0

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Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.

Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
Interventiongrams per liters (g/L) (Mean)
Baseline (n=28,27)Change at Week 12 (n=27,27)Change at Week 48 (n=26,22)
Atazanavir1.3-0.0070.0
Darunavir1.10.10.1

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Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.

Number of Participants with antiviral activity, human immunodeficiency virus Type 1 (HIV-1) RNA less than (<) 50 copies per milliliters (copies/mL) or < 400 copies/mL. (NCT00757783)
Timeframe: Week 12 and 48

,
Interventionnumber of participants (Number)
Week12: HIV-1 RNA Less Than (<) 50 copies/mLWeek 12: HIV-1 RNA < 400 copies/mLWeek 48: HIV-1 RNA < 50 copies/mLWeek 48: HIV-1 RNA < 400 copies/mL
Atazanavir19292224
Darunavir13282528

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Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.

Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
Interventionmg/dL (Mean)
Baseline (n=28, 27)Change at Week 12 (n=27, 27)Change at Week 48 (n=26, 22)
Atazanavir100.29.613.9
Darunavir84.613.614.7

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Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)

Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed. (NCT00757783)
Timeframe: Week 12 and 48

,
Interventionnumber of participants (Number)
Week 12: HIV-1 RNA Less Than (<) 50 copies/mLWeek 12: HIV-1 RNA < 400 copies/mLWeek 48: HIV-1 RNA < 50 copies/mLWeek 48: HIV-1 RNA < 400 copies/mL
Atazanavir19282224
Darunavir13282528

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Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).

Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF. (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
Interventionpercentage of CD4 cells (Mean)
Baseline (n=34,31)Change at Week 12 (n=32,30)Change at Week 48 (n=29,25)
Atazanavir21.44.58.5
Darunavir18.65.99.6

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Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.

Participants TC and HDL was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was calculated as ratio using observed values. (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
Interventionratio (Mean)
Baseline (n=28,27)Change at Week 12 (n=27,27)Change at Week 48 (n=26,22)
Atazanavir3.9-0.1-0.1
Darunavir4.1-0.10.1

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Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks

(NCT00762892)
Timeframe: Baseline and 48 weeks

Interventionpg/mL (Mean)
Raltegravir-2.71
Atazanavir-4.47

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Change From Baseline in Homocysteine at 6 Months

(NCT00762892)
Timeframe: Baseline and 48 weeks

Interventionumol/L (Mean)
Raltegravir0.53
Atazanavir0.10

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Change From Baseline in CD4 Count at 48 Weeks

(NCT00762892)
Timeframe: Baseline and 48 weeks

Interventioncells/uL (Mean)
Raltegravir192
Atazanavir205

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Change From Baseline in Lipids at 48 Weeks

(NCT00762892)
Timeframe: Baseline and 48 weeks

,
Interventionmg/dL (Mean)
Total cholesterolTriglyceridesHDL cholesterolLDL cholesterol
Atazanavir8.1316.88-1.385.88
Raltegravir-0.25-15.50-1.54.13

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Change From Baseline in Log HIV Viral Load at 48 Weeks

(NCT00762892)
Timeframe: Baseline and 48 weeks

Interventioncopies/mL (Mean)
Raltegravir-3.05
Atazanavir-3.29

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Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)

Hyperkalemia(meq/L) Gr 1: 5.6-6; Gr 2: 6.1-6.5; Gr 3: 6.6-7; Gr4: >7. Hypokalemia(meq/L) Gr 1: 3-3.4; Gr 2: 2.5-2.9; Gr 3: 2-2.4; Gr 4:<2. Hypernatremia (meq/L) Gr 1: 148-150; Gr 2: 151-157; Gr 3: 148-165; Gr 4: >165. Hyponatremia (meq/L) Gr 1: 130-132; Gr 2: 123-129; Gr 3: 116-122; Gr 4: >115.Hyperglycemia(mg/dL)Gr 1: 116-160; Gr 2: 161-250; Gr 3: 251-500; Gr 4: >500. Hypoglycemia(mg/dL)Gr 1: 55-64; Gr 2: 40-54; Gr 3:30-39;Gr 4:<30.Creatine kinase (IU/L) Gr 1: >ULN-1.5*ULN; Gr 2: 1.5-3*ULN; Gr 3: >3-6*ULN; Gr 4: >6.0*ULN. Albumin (g/dL) Gr 1: NCT00768989)
Timeframe: While on treatment from Baseline through Week 96

,
InterventionParticipants (Number)
HyperkalemiaHypokalemiaHypernatremiaHyponatremiaHyperclycemiaHypoglycemiaCreatine kinaseAlbumin
Atazanavir + Raltegravir210386213
Atazanavir + Ritonavir + Tenofovir/Emtricitabine11015472

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Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval

Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng/mL (Geometric Mean)
Atazanavir + Raltegravir3506.5

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Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants

ULN=upper limit of normal. Hematocrit(%) Grade (Gr) 1: ≥28.5-<31; Gr 2: ≥24-<28.5; Gr 3: ≥19.5-<24; Gr 4: <19.5. Hemoglobin (g/dL) Gr 1: 9.5-11; Gr 2: 8-9.4; Gr 3: 6.5-7.9; Gr 4: <6.5. Platelets (/mm^3) Gr 1: 75,000-99,000; Gr 2: 50,000-74,999; Gr 3: 20,000-49,999; Gr 4: <20,000. White Blood Cells (/mm^3) Gr 1: >2500-4000; Gr 2: >1000-<2500; Gr 3: >800-<1000; Gr 4: <800. . Prothrombin time (seconds) Gr 1: 1.01-1.25*ULN; Gr 2: 1.26-1.5*ULN; Gr 3: 1.51-3*ULN; Gr 4: >3*ULN. (NCT00768989)
Timeframe: While on treatment from Baseline through Week 96

,
InterventionParticipants (Number)
HematocritHemoglobinPlateletsProthrombin TimeWhite Blood Cells
Atazanavir + Raltegravir1211222
Atazanavir + Ritonavir + Tenofovir/Emtricitabine001714

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Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24

NC=F: noncompleter=failure; NC=M: noncompleter=missing; VR-OC: virologic response-observed (NCT00768989)
Timeframe: At Week 24 from Baseline

,
InterventionParticipants (Number)
NC=F (n= 63, 30)NC=M (n=58, 27)VR-OC (n=52, 25)
Atazanavir + Raltegravir525246
Atazanavir + Ritonavir + Tenofovir/Emtricitabine262624

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Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24

The number of HIV 1-infected treatment-naive participants with an HIV RNA level <50 copies/mL after 24 weeks of treatment. Confirmed virologic response noncompleter=failure (NC=F); noncompleter=missing (NC=M); virologic response-observed cases (VR-OC). (NCT00768989)
Timeframe: At Week 24 from Baseline

,
InterventionParticipants (Number)
NC=F (n=63, 30)NC=M (n=58, 27)VR-OC (n=52, 25)
Atazanavir + Raltegravir474741
Atazanavir + Ritonavir + Tenofovir/Emtricitabine191919

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Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose

(NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng•h/mL (Geometric Mean)
Atazanavir + Raltegravir687.1

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Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)

Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline

InterventionHours (Geometric Mean)
Atazanavir + Raltegravir3.0

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Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4

AST/SGOT=Aspartate aminotransferase/serum glutamate oxaloacetate transaminase; ALT/SGPT=Alanine transaminase/serum glutamic pyruvic transaminase. Bilirubin (mg/dL)Gr 1: 1.1-1.5*ULN;Gr 2:1.6-2.5*ULN;Gr3:2.6-5*ULN;Gr4:>5*ULN.AST/SGOT(U/L)Gr 1:1.25-2.5*ULN;Gr 2: 2.6-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.ALT/SGPT (U/L)Gr 1:1.25-2.5*ULN;Gr 2:1.4-2.09*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. Lipase(U/L)Gr 1:1.1-1.39*ULN;Gr 2:>1.5-2*ULN;Gr 3:2.5-5;Gr 4:5*ULN.Proteinuria(g/24 hr loss)Gr 1:1+or <1;Gr 2:2-3+or>1-2; Gr 3:4+or>2-3.5;Gr4:>3.5.Creatine kinase(IU/L)Gr1:2-3*ULN;Gr 2:3.1-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. (NCT00768989)
Timeframe: While on treatment from Baseline through Week 96

,
InterventionParticipants (Number)
Total BilirubinAST/SGOTALT/ SGPTLipaseProteinureaCreatine kinase
Atazanavir + Raltegravir621110111421
Atazanavir + Ritonavir + Tenofovir/Emtricitabine288813117

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Atazanavir Terminal Elimination Half Life

(NCT00768989)
Timeframe: At Week 2 from Baseline

InterventionHours (Mean)
Atazanavir + Raltegravir5.0

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Atazanavir Individual Inhibitory Quotient (IQ)

Individual IQ was defined at Cmin at Week 2 divided by the protein binding adjusted EC90 (ie, the drug concentration observed to inhibit virion production by 90% in a cell-based assay) values for Atazanavir that were derived from individual participant clinical isolates. (NCT00768989)
Timeframe: At Week 2 from Baseline

InterventionUnits on a Scale (Geometric Mean)
Atazanavir + Raltegravir23.47

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Raltegravir Cmin 12 Hours Postdose

(NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng•h/mL (Geometric Mean)
Atazanavir + Raltegravir76.2

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Raltegravir Cmax in 1 Dosing Interval

Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng/mL (Geometric Mean)
Atazanavir + Raltegravir1577.0

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Raltegravir AUC (0-12h) in 1 Dosing Interval

(NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng•h/mL (Geometric Mean)
Atazanavir + Raltegravir6446.4

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Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96

Participant HIV RNA level was determined at Weeks 48 and 96 using the Roche Amplicor® Ultrasensitive Assay Version 1. VR-OC=Virologic response-observed cases. (NCT00768989)
Timeframe: At Weeks 48 and 96 from Baseline

InterventionParticipants (Number)
Atazanavir + Raltegravir37
Atazanavir + Ritonavir + Tenofovir/Emtricitabine19

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Atazanavir Cmin Prior to the Morning Dose

(NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng*h / mL (Geometric Mean)
Atazanavir + Raltegravir879.25

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Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval

AUC (0-24h) was estimated by multiplying AUC (0-12h) by 2. (NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng•h/mL (Geometric Mean)
Atazanavir + Raltegravir39806.7

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Raltegravir Cmin Prior to the Morning Dose

(NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng•h/mL (Geometric Mean)
Atazanavir + Raltegravir445.42

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Raltegravir Terminal Elimination Half Life

(NCT00768989)
Timeframe: At Week 2 from Baseline

InterventionHours (Mean)
Atazanavir + Raltegravir2.9

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Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval

(NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng•h/mL (Geometric Mean)
Atazanavir + Raltegravir19903.4

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Raltegravir Tmax

Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline

InterventionHours (Geometric Mean)
Atazanavir + Raltegravir2.08

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Baseline and Mean Change From Baseline in Total Cholesterol Levels

The mean change from baseline in participant fasting lipids was determined using fasting serum samples. (NCT00768989)
Timeframe: From Baseline to Week 24 and Week 48

,
Interventionmg/dL (Mean)
Baseline (n=56, 26)Mean change from Baseline at Week 24 (n=51, 20)Mean change from Baseline at Week 48 (n=38, 20)
Atazanavir + Raltegravir164.614.718.0
Atazanavir + Ritonavir + Tenofovir/Emtricitabine169.615.117.1

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Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4

Blood urea nitrogen Gr 1:1.25-2.5*ULN;Gr 2:2.6-5.0*ULN; Gr 3:5.1-10*ULN; Gr 4:>10*ULN. Creatinine (mg/dL) Gr 1: 1.1-1.5 *ULN; Gr 2: 1.6-3*ULN: Gr 3: 3.1-6*ULN; Gr 4: >6*ULN. Hypercarbia (meq/L)Gr 1: 33-36; Gr 2:37-40; Gr 3: 41-45; Gr 4:>45. Hypocarbia (meq/L)Gr 1:19-21; Gr 2: 15-18; Gr 3: 10-14; Gr 4:<10. Hypercalcemia (mg/dL)Gr 1:10.6-11.5;Gr 2:11.6-12.5; Gr 3:12.6-13.5;Gr 4: >13.5. Hypocalcemia (mg/dL)Gr 1: 8.4-7.8;Gr 2:7.7-7; Gr 3:6.9-6.1; Gr 4: <6.1.Hyperchloremia(meq/L)Gr 1:113-116; Gr 2:117-120; Gr 3:121-125; Gr 4: >125.Hypochloremia(meq/L)Gr 1: 90-93; Gr 2: 85-89; Gr 3:80-84; Gr 4:<80. (NCT00768989)
Timeframe: While on treatment from Baseline through Week 96

,
InterventionParticipants (Number)
Blood urea nitrogenCreatinineHypercarbiaHypocarbiaHypercalcemiaHypocalcemiaHyperchloremiaHypochloremiaHyperkalemiaHypokalemiaHypernatremiaHyponatremiaHyperclycemiaHypoglycemia
Atazanavir + Raltegravir031152101260386
Atazanavir + Ritonavir + Tenofovir/Emtricitabine12171101050154

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Mean Change From Baseline in Electrocardiogram Findings

The incidence of QRS wave widening and QT and PR prolongation on participant electrocardiogram findings were evaluated at study Week 24. (NCT00768989)
Timeframe: From Baseline to Week 24

,
Interventionmsec (Mean)
QRS IntervalQTc Friderica IntervalPR Interval
Atazanavir + Raltegravir8.9-2.717.6
Atazanavir + Ritonavir + Tenofovir/Emtricitabine3.66.04.9

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Mean Change From Baseline in Total Bilirubin Level

(NCT00768989)
Timeframe: From Baseline to Week 24 and Week 48

,
Interventionmg/dL (Mean)
Mean change from Baseline at Week 24Mean change from Baseline at Week 48
Atazanavir + Raltegravir2.152.08
Atazanavir + Ritonavir + Tenofovir/Emtricitabine1.711.52

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Number of Nonresponders at Week 8

Participants were classified as nonresponders if they had an HIV RNA level ≥400 copies/mL and a decrease from baseline <2 log10 copies/mL. (NCT00768989)
Timeframe: At Week 8 from Baseline

InterventionParticipants (Number)
Atazanavir + Raltegravir0
Atazanavir + Ritonavir + Tenofovir/Emtricitabine1

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Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48

(NCT00768989)
Timeframe: At Week 48 from Baseline

InterventionParticipants (Number)
Atazanavir + Raltegravir45
Atazanavir + Ritonavir + Tenofovir/Emtricitabine25

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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation

AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event. (NCT00768989)
Timeframe: Week 1 to Week 96, continuously

,
InterventionParticipants (Number)
AEsSAEsDeathsAEs leading to discontinuationSAEs leading to discontinuation
Atazanavir + Raltegravir607041
Atazanavir + Ritonavir + Tenofovir/Emtricitabine292010

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Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count

(NCT00768989)
Timeframe: From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24

,
Interventioncells/mm^3 (Mean)
Mean change from Baseline at Week 2 (n=59, 26)Mean change from Baseline at Week 4 (n=62, 27)Mean change from Baseline at Week 8 (n=60, 29)Mean change from Baseline at Week 12 (n=62, 28)Mean change from Baseline at Week 16 (n=58, 27)Mean change from Baseline at Week 20 (n=58, 24)Mean change from Baseline at Week 24 (n=55, 24)
Atazanavir + Raltegravir81.182.7111.5128.6143.6166.5166.0
Atazanavir + Ritonavir + Tenofovir/Emtricitabine63.1100.1111.9129.3127.6140.7127.0

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Percentage of Patients Who Are Polymerase Chain Reaction(PCR)Negative at Week 12

Polymerase Chain Reaction (PCR) Negative is defined as HBV DNA levels <25 copies/ml. (NCT00805675)
Timeframe: Week 12

InterventionPercentage of Participants (Number)
Telbivudine 600 mg Monotherapy0.0
Tenofovir Disproxil Fumarate 300 mg Monotherapy0.0
Telbivudine 600 mg and Tenofovir 300 mg0.0

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Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Weeks 2, 4 and 8.

Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA. Serum HBV DNA determinations were performed at a central laboratory through use of the COBAS TaqMan™ HBV DNA assay (Roche Molecular Systems, Pleasanton, CA, USA) which utilized the Real-time polymerase chain reaction (PCR) method and automated extraction by Cobas Ampliprep (threshold for detection 12 IU/mL). The Screening serum HBV DNA values must be ≥ 7 log10 copies/mL by COBAS TaqMan™ HBV DNA assay. (NCT00805675)
Timeframe: Baseline, Week 2, Week 4, Week 8

,,
Interventionlog10 copies/mL (Mean)
Week 2Week 4Week 8
Telbivudine 600 mg and Tenofovir 300 mg-2.689-3.225-3.845
Telbivudine 600 mg Monotherapy-2.657-2.985-3.474
Tenofovir Disproxil Fumarate 300 mg Monotherapy-2.541-3.060-3.621

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Characterization of Very Early Viral Kinetics Through Efficiency Factor of Blocking Virus Production.

"The underlying bi-phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t) I(t) (1 ) (T I(t))V(t) I(t) where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise allinfected and uninfected target cells, and δ the rate of infected cell loss" (NCT00805675)
Timeframe: Week 12

InterventionPercentage (Mean)
Telbivudine 600 mg Monotherapy98.8
Tenofovir Disproxil Fumarate 300 mg Monotherapy99.0
Telbivudine 600 mg and Tenofovir 300 mg99.1

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"Percentage of Patients Who Achieve Hepatitis B e Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 12"

"HBeAg loss is defined as the loss of detectable serum HBeAg in a patient who was HBeAg positive at baseline. HBeAg seroconversion is defined as HBeAg loss with detectable Hepatitis B 'e' antibody (HBeAb). HBeAg stands for hepatitis B e antigen. This antigen is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the person is infectious and is able to spread the virus to other people." (NCT00805675)
Timeframe: Week 12

InterventionPercentage of Participants (Number)
Telbivudine 600 mg Monotherapy0
Tenofovir Disproxil Fumarate 300 mg Monotherapy0
Telbivudine 600 mg and Tenofovir 300 mg0

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Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12.

Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA. Serum HBV DNA determinations were performed at a central laboratory through use of the COBAS TaqMan™ HBV DNA assay (Roche Molecular Systems, Pleasanton, CA, USA) which utilized the Real-time polymerase chain reaction (PCR) method and automated extraction by Cobas Ampliprep (threshold for detection 12 IU/mL). The Screening serum HBV DNA values must be ≥ 7 log10 copies/mL by COBAS TaqMan™ HBV DNA assay. (NCT00805675)
Timeframe: Baseline, Week 12

Interventionlog10 copies/mL (Mean)
Telbivudine 600 mg Monotherapy-3.852
Tenofovir Disproxil Fumarate 300 mg Monotherapy-4.175
Telbivudine 600 mg and Tenofovir 300 mg-4.374

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Characterization of Very Early Viral Kinetics Through Estimated Viral Load

"The underlying bi-phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss" (NCT00805675)
Timeframe: Week 12

Interventionlog10 copies/ml (Mean)
Telbivudine 600 mg Monotherapy8.9
Tenofovir Disproxil Fumarate 300 mg Monotherapy8.7
Telbivudine 600 mg and Tenofovir 300 mg8.7

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Characterization of Very Early Viral Kinetics Through Half-live of Free Virus

"The underlying bi-phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss" (NCT00805675)
Timeframe: Week 12

InterventionHours (Mean)
Telbivudine 600 mg Monotherapy18.1
Tenofovir Disproxil Fumarate 300 mg Monotherapy16.4
Telbivudine 600 mg and Tenofovir 300 mg18.9

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Characterization of Very Early Viral Kinetics Through Rate of Infected Cell Loss

"The underlying bi-phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss" (NCT00805675)
Timeframe: Week 12

Interventionday^-1 (Mean)
Telbivudine 600 mg Monotherapy0.04
Tenofovir Disproxil Fumarate 300 mg Monotherapy0.06
Telbivudine 600 mg and Tenofovir 300 mg0.05

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Characterization of Very Early Viral Kinetics Through Viral Clearance

"The underlying bi-phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss" (NCT00805675)
Timeframe: Week 12

Interventionday^-1 (Mean)
Telbivudine 600 mg Monotherapy0.98
Tenofovir Disproxil Fumarate 300 mg Monotherapy1.19
Telbivudine 600 mg and Tenofovir 300 mg1.08

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Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96

"The Kaplan-Meier estimate of the cumulative probability of TROVR by week 96.~A composite TLOVR endpoint defined in the CDER of the FDA document Guidance for Industry - Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical Consideration for Accelerated and Traditional Approval (Appendix B, pages 20) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf.~If participants never achieved a confirmed HIV-1 RNA≤200 cp/mL (on two consecutive visits) prior to death, permanent discontinuation of randomized treatment, or time of last available HIV-1 RNA evaluation, TLOVR was equal to 0; otherwise, TLOVR was the earliest time of permanent discontinuation of randomized treatment prior to study close-out period, time to confirmed levels >200 cp/mL, or time to death. If TLOVR is immediately preceded by a single missing scheduled visit or multiple consecutive missing scheduled visits, TLOVR is replaced by the first such missing visit." (NCT00811954)
Timeframe: From study entry to week 96

Interventioncumulative probability per 100 persons (Number)
Arm A: ATV/RTV + FTC/TDF31
Arm B: RAL + FTC/TDF16
Arm C: DRV/RTV + FTC/TDF24

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Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96

The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date. (NCT00811954)
Timeframe: From study entry to week 96

Interventioncumulative events per 100 persons (Number)
Arm A: ATV/RTV + FTC/TDF14
Arm B: RAL + FTC/TDF1
Arm C: DRV/RTV + FTC/TDF5

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Cumulative Incidence of First Adverse Event by Week 96

"The cumulative incidence of first adverse event (with and without total bilirubin and creatine kinase and measured from study entry) by week 96 was estimated using methods for competing risks. Discontinuation of randomized treatment prior to an adverse event was considered a competing event.~The time to the first of any post-entry Grade 2, 3, or 4 sign or symptom, or Grade 3 or 4 laboratory abnormality while on randomization. The protocol required reporting of signs and symptoms and laboratory values as follow: all signs and symptoms grade ≥2 post-entry to week 48, signs and symptoms grade >3 after week 48, and laboratory values grade >3 and all signs, symptoms, and laboratory values that led to a change in treatment, regardless of grade throughout out all post-entry follow-up." (NCT00811954)
Timeframe: From study entry to week 96

Interventioncumulative events per 100 persons (Number)
Arm A: ATV/RTV + FTC/TDF81
Arm B: RAL + FTC/TDF59
Arm C: DRV/RTV + FTC/TDF65

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Cumulative Probability of First Virologic Failure by Week 96

"The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96.~Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA >1000 copies/mL at or after week 16 and before week 24, or >200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry." (NCT00811954)
Timeframe: From study entry to week 96

Interventioncumulative probability per 100 persons (Number)
Arm A: ATV/RTV + FTC/TDF13
Arm B: RAL + FTC/TDF10
Arm C: DRV/RTV + FTC/TDF15

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Incidence of Death or AIDS Defining Events (CDC Category C)

The incidence of death or AIDS defining events (CDC category C) was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence. (NCT00811954)
Timeframe: Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable

Interventionevents per 100 person-years (Number)
Arm A: ATV/RTV + FTC/TDF1.55
Arm B: RAL + FTC/TDF1.64
Arm C: DRV/RTV + FTC/TDF2.14

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Incidence of Targeted Serious Non-AIDS Defining Events (Renal Failure, Liver Disease, Serious Metabolic Disorder, and CVD)

The incidence of targeted serious non-AIDS defining events was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence. (NCT00811954)
Timeframe: Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable

Interventionevents per 100 person-years (Number)
Arm A: ATV/RTV + FTC/TDF2.38
Arm B: RAL + FTC/TDF2.24
Arm C: DRV/RTV + FTC/TDF2.69

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Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance

The number of participants with ATV/RTV or DRV/RTV resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. (NCT00811954)
Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)

Interventionparticipants (Number)
Arm A: ATV/RTV + FTC/TDF0
Arm B: RAL + FTC/TDF0
Arm C: DRV/RTV + FTC/TDF0

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Presence of Mutations Associated With INI Resistance

The number of participants with INI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. (NCT00811954)
Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)

Interventionparticipants (Number)
Arm A: ATV/RTV + FTC/TDF1
Arm B: RAL + FTC/TDF1
Arm C: DRV/RTV + FTC/TDF1

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Presence of Mutations Associated With NRTI Resistance

The number of participants with NRTI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. (NCT00811954)
Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)

Interventionparticipants (Number)
Arm A: ATV/RTV + FTC/TDF8
Arm B: RAL + FTC/TDF7
Arm C: DRV/RTV + FTC/TDF3

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Change in Waist Circumference From Baseline

Change was calculated as the waist circumference (based on mid-waist circumference) at week (48, 96, and 144) minus the baseline waist circumference. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144

,,
Interventioncm (Mean)
week 48 (nA=555, nB=551, nC=547)week 96 (nA=512, nB=526, nC=517)week 144 (nA=425, nB=419, nC=409)
Arm A: ATV/RTV + FTC/TDF2.33.33.6
Arm B: RAL + FTC/TDF3.14.04.0
Arm C: DRV/RTV + FTC/TDF2.12.83.4

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Change in Framingham 10-year Risk of MI or Coronary Death From Baseline

"Only risk score estimated with fasting lipid results were included. Change was calculated as the Framingham 10-year risk of MI or coronary death at week (48, 96, and 144) minus the baseline Framingham 10-year risk of MI or coronary death. Framingham 10-year risk of MI or coronary death was calculated using Hear Coronary Heart Disease (10-year risk) found at https://www.framinghamheartstudy.org/risk-functions/coronary-heart-disease/hard-10-year-risk.php.~Framingham 10-year risk of MI or coronary death was calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, systolic blood pressure, and treatment for hypertension. The Framingham 10-year risk of MI or coronary death was calculated as: for males: <0 point (<1 percent risk) up to ≥17 points (≥30 percent risk); whereas for females: <9 points (<1 percent risk) up to ≥25 points (≥30 percent risk). Higher scores indicate high cardiovascular risk." (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144

,,
Interventionpercent risk (Mean)
week 48 (nA=509, nB=537, nC=492)week 96 (nA=479, nB=493, nC=470)week 144 (nA=347, nB=383, nC=349)
Arm A: ATV/RTV + FTC/TDF0.40.50.6
Arm B: RAL + FTC/TDF0.00.20.4
Arm C: DRV/RTV + FTC/TDF0.40.40.9

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Change in Fasting Triglycerides Level From Baseline

Only fasting results are included. Change was calculated as the fasting triglycerides at week (48, 96, and 144) minus the baseline fasting triglycerides. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144

,,
Interventionmg/dL (Mean)
week 48 (nA=522, nB=542, nC=507)week 96 (nA=490, nB=505, nC=490)week 144 (nA=364, nB=397, nC=363)
Arm A: ATV/RTV + FTC/TDF181912
Arm B: RAL + FTC/TDF-9-9-4
Arm C: DRV/RTV + FTC/TDF161620

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Change in Fasting Total Cholesterol Level From Baseline

Only fasting results are included. Change was calculated as the fasting total cholesterol at week (48, 96, and 144) minus the baseline fasting total cholesterol. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144

,,
Interventionmg/dL (Mean)
week 48 (nA=521, nB=542, nC=507)week 96 (nA=490, nB=505, nC=490)week 144 (nA=364, nB=397, nC=363)
Arm A: ATV/RTV + FTC/TDF131620
Arm B: RAL + FTC/TDF136
Arm C: DRV/RTV + FTC/TDF151419

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Change in Fasting Plasma Glucose Level From Baseline

Only fasting results are included. Change was calculated as the fasting plasma glucose at week (48, 96, and 144) minus the baseline fasting plasma glucose. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144

,,
Interventionmg/dL (Mean)
week 48 (nA=517, nB=535, nC=506)week 96 (nA=489, nB=499, nC=481)week 144 (nA=353, nB=392, nC=358)
Arm A: ATV/RTV + FTC/TDF2.23.02.2
Arm B: RAL + FTC/TDF1.30.90.9
Arm C: DRV/RTV + FTC/TDF2.12.53.6

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Change in Fasting HDL Cholesterol Level From Baseline

Only fasting results are included. Change was calculated as the fasting HDL cholesterol at week (48, 96, and 144) minus the baseline fasting HDL cholesterol. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144

,,
Interventionmg/dL (Mean)
week 48 (nA=522, nB=542, nC=506)week 96 (nA=490, nB=505, nC=488)week 144 (nA=364, nB=397, nC=363)
Arm A: ATV/RTV + FTC/TDF678
Arm B: RAL + FTC/TDF566
Arm C: DRV/RTV + FTC/TDF557

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CD4+ T-cell Count Changes From Baseline

Change was calculated as the CD4+ T-cell count at week (24, 48, 96, and 144) minus the baseline CD4+ T-cell count (NCT00811954)
Timeframe: Study entry to weeks 24, 48, 96, and 144

,,
Interventioncells/mm^3 (Mean)
week 24 (nA=582, nB=574, nC=579)week 48 (nA=564, nB=565, nC=559)week 96 (nA=523, nB=541, nC=525)week 144 (nA=395, nB=418, nC=394)
Arm A: ATV/RTV + FTC/TDF157218284324
Arm B: RAL + FTC/TDF153218288325
Arm C: DRV/RTV + FTC/TDF147201256288

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CD4+ T-cell Count

The absolute levels of CD4+ T-cell counts (cells/mm3) (NCT00811954)
Timeframe: At Weeks 24, 48, 96, and 144

,,
Interventioncells/mm^3 (Mean)
week 24 (nA=582, nB=574, nC=579)week 48 (nA=564, nB=565, nC=559)week 96 (nA=523, nB=541, nC=525)week 144 (nA=395, nB=418, nC=394)
Arm A: ATV/RTV + FTC/TDF462524587622
Arm B: RAL + FTC/TDF460526596631
Arm C: DRV/RTV + FTC/TDF457509564596

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Change in Waist:Height Ratio From Baseline

Change was calculated as the waist:height ratio at week (48, 96, and 144) minus the baseline waist:height ratio. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144

,,
Interventioncm:cm (Mean)
week 48 (nA=555, nB=551, nC=547)week 96 (nA=512, nB=526, nC=517)week 144 (nA=425, nB=419, nC=409)
Arm A: ATV/RTV + FTC/TDF0.010.020.02
Arm B: RAL + FTC/TDF0.020.020.02
Arm C: DRV/RTV + FTC/TDF0.010.020.02

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Self-reported Adherence

Self-reported percentage of anti-HIV medications participant had taken during the last month at weeks 4, 24, 48, 96, and 144. (NCT00811954)
Timeframe: At Weeks 4, 24, 48, 96, and 144

,,
Interventionpercentage of prescribed medication (Mean)
week 4 (nA=584, nB=590, nC=583)week 24 (nA=570, nB=568, nC=562)week 48 (nA=555, nB=547, nC=536)week 96 (nA=508, nB=525, nC=507)week 144 (nA=361, nB=376, nC=350)
Arm A: ATV/RTV + FTC/TDF9897969697
Arm B: RAL + FTC/TDF9797979697
Arm C: DRV/RTV + FTC/TDF9896969698

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Number of Participants With Phenotypic Resistance

Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96. (NCT00827112)
Timeframe: Week 96 or Time of treatment failure

InterventionParticipants (Number)
Maraviroc+ Atazanavir / Ritonavir0
Atazanavir / Ritonavir + Emtricitabine / Tenofovir0

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Time-Averaged Difference (TAD) in log10 Viral Load

TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL). (NCT00827112)
Timeframe: Week 16, Week 24, Week 48, Week 96

,
Interventionlog10 copies/mL (Mean)
Week 16Week 24Week 48Week 96
Atazanavir / Ritonavir + Emtricitabine / Tenofovir-2.402-2.626-2.868-3.001
Maraviroc+ Atazanavir / Ritonavir-2.459-2.663-2.897-2.998

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Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA

(NCT00827112)
Timeframe: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96

,
InterventionPercentage of participants (Number)
Week 2 (n= 55, 60)Week 4 (n= 57, 60)Week 8 (n= 57, 59)Week 12 (n= 55, 59)Week 16 (n= 54, 58)Week 20 (n= 56, 57)Week 24 (n= 56, 58)Week 32 (n= 55, 57)Week 40 (n= 54, 55)Week 48 (n= 53, 54)Week 60 (n= 52, 53)Week 72 (n= 52, 53)Week 84 (n= 50, 52)Week 96 (n= 49, 51)
Atazanavir / Ritonavir + Emtricitabine / Tenofovir6.6021.3042.6062.3073.8083.6188.5288.5288.5283.6185.2581.9783.6181.97
Maraviroc+ Atazanavir / Ritonavir08.5047.5061.0072.9071.2081.3679.6681.3674.5867.8074.5876.2767.80

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Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96

(NCT00827112)
Timeframe: Baseline, Week 16, Week 24, Week 48, Week 96

,
Interventioncells/microliter (cells/mcL) (Mean)
Baseline (n= 59, 61)Change at Week 16 (n= 54, 58)Change at Week 24 (n= 54, 57)Change at Week 48 (n= 52, 53)Change at Week 96 (n= 50, 51)
Atazanavir / Ritonavir + Emtricitabine / Tenofovir390.00139.80173.30226.60298.50
Maraviroc+ Atazanavir / Ritonavir357.70169.60188.90215.70287.50

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Number of Participants With Genotypic Resistance

Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96. (NCT00827112)
Timeframe: Week 96 or Time of treatment failure

InterventionParticipants (Number)
Maraviroc+ Atazanavir / Ritonavir0
Atazanavir / Ritonavir + Emtricitabine / Tenofovir0

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Average Observed Plasma Concentration (Cavg) of Maraviroc

Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24). (NCT00827112)
Timeframe: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)

Interventionng/mL (Mean)
Maraviroc+ Atazanavir / Ritonavir185.10

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HIV-1 RNA Levels at Baseline

(NCT00827112)
Timeframe: Baseline

Interventioncopies/mL (Mean)
Maraviroc+ Atazanavir / Ritonavir84982
Atazanavir / Ritonavir + Emtricitabine / Tenofovir114827

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Minimum Observed Plasma Concentration (Cmin) of Maraviroc

(NCT00827112)
Timeframe: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)

Interventionng/mL (Median)
Maraviroc+ Atazanavir / Ritonavir37.0

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Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA

(NCT00827112)
Timeframe: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96

,
InterventionPercentage of participants (Number)
Week 2 (n= 55, 60)Week 4 (n= 57, 60)Week 8 (n= 57, 59)Week 12 (n= 55, 59)Week 16 (n= 54, 58)Week 20 (n= 56, 57)Week 24 (n= 56, 58)Week 32 (n= 55, 57)Week 40 (n= 54, 55)Week 48 (n= 53, 54)Week 60 (n= 52, 53)Week 72 (n= 52, 53)Week 84 (n= 50, 52)Week 96 (n= 49, 51)
Atazanavir / Ritonavir + Emtricitabine / Tenofovir34.4352.4677.0588.5291.8093.4493.4493.4490.1686.8986.8985.2585.2583.61
Maraviroc+ Atazanavir / Ritonavir27.1250.8579.6689.8388.1489.8391.5389.8391.5389.8386.4486.4481.3677.97

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Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay

Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population. (NCT00827112)
Timeframe: Baseline to Week 96 or Time of treatment Failure

,
InterventionParticipants (Number)
BaselineWeek 96 or Time of treatment Failure
Atazanavir / Ritonavir + Emtricitabine / Tenofovir610
Maraviroc+ Atazanavir / Ritonavir600

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Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96

(NCT00827112)
Timeframe: Baseline, Week 16, Week 24, Week 48, Week 96

,
Interventionlog10 copies/ml (Mean)
Baseline (n= 59, 61)Change at Week 16 (n= 54, 58)Change at Week 24 (n= 56, 58)Change at Week 48 (n= 53, 54)Change at Week 96 (n= 49, 51)
Atazanavir / Ritonavir + Emtricitabine / Tenofovir114827-107684.6-110498.1-115582.9-99662.6
Maraviroc+ Atazanavir / Ritonavir84982-89859.1-87241.2-82343.4-80117.7

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Time to Loss of Virological Response (TLOVR)

TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm. (NCT00827112)
Timeframe: Baseline through Week 96

InterventionDays (Mean)
Maraviroc+ Atazanavir / Ritonavir436.2
Atazanavir / Ritonavir + Emtricitabine / Tenofovir463.8

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Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14

Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only. (NCT00827112)
Timeframe: Baseline , Days 4, 7, 10 and 14

,
Interventioncopies/mL (Mean)
Change at Day 4Change at Day 7Change at Day 10Change at Day 14
Atazanavir / Ritonavir + Emtricitabine / Tenofovir-46479.40-52137.10-54925.90-55449.90
Maraviroc+ Atazanavir / Ritonavir1800.00-36947.90-58595.80-47271.60

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Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)

(NCT00827112)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Maraviroc+ Atazanavir / Ritonavir74.60
Atazanavir / Ritonavir + Emtricitabine / Tenofovir83.60

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Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96

(NCT00827112)
Timeframe: Baseline, Week 16, Week 24, Week 48, Week 96

,
Interventioncells/mcL (Mean)
Baseline (n= 59, 61)Change at Week 16 (n= 54, 58)Change at Week 24 (n= 54, 57)Change at Week 48 (n= 52, 53)Change at Week 96 (n= 50, 51)
Atazanavir / Ritonavir + Emtricitabine / Tenofovir1125.60-153.80-178.00-267.60-231.40
Maraviroc+ Atazanavir / Ritonavir931.1063.706.20-76.80-63.00

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Maximum Observed Plasma Concentration (Cmax) of Maraviroc

(NCT00827112)
Timeframe: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)

Interventionnanogram (ng)/mL (Median)
Maraviroc+ Atazanavir / Ritonavir650

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Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96

Soluble CD14 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96

,,
InterventionFold change (Median)
Fold change from study entry to week 48Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF1.010.98
Cohort B: RAL + FTC/TDF0.910.90
Cohort C: DRV/RTV + FTC/TDF1.000.98

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Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96

Soluble CD163 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96

,,
InterventionFold change (Median)
Fold change from study entry to week 48Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0.540.51
Cohort B: RAL + FTC/TDF0.620.56
Cohort C: DRV/RTV + FTC/TDF0.610.58

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Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT)

"Right common carotid artery intima-media thickness was measured by ultrasound scan at study entry and weeks 48, 96 and 144.~The annual rate of change in right common carotid artery intima-media thickness (CIMT) was estimated over 144 weeks from study entry using mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors." (NCT00851799)
Timeframe: Study entry, week 144

Interventionmicron/year (Mean)
Cohort A: ATV/RTV + FTC/TDF8.2
Cohort B: RAL + FTC/TDF10.7
Cohort C: DRV/RTV + FTC/TDF12.9

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Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96

Bone mineral density (BMD) of the lumber spine was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF-4.0
Cohort B: RAL + FTC/TDF-1.6
Cohort C: DRV/RTV + FTC/TDF-3.1

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CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144

The absolute levels of CD4+ T-cell counts (cells/mm^3) measured at study entry and weeks 24, 48, 96 and 144. (NCT00851799)
Timeframe: Study entry, weeks 24, 48, 96 and 144

,,
Interventioncell/mm^3 (Median)
Study EntryWeek 24Week 48Week 96Week 144
Cohort A: ATV/RTV + FTC/TDF350509573634658
Cohort B: RAL + FTC/TDF343445496569613
Cohort C: DRV/RTV + FTC/TDF355464528567560

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Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96

Percent expression of CD38+HLADR+ on CD4+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value). (NCT00851799)
Timeframe: Study entry, weeks 24 and 96

,,
InterventionFold change (Median)
Fold change from study entry to week 24Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0.490.38
Cohort B: RAL + FTC/TDF0.510.34
Cohort C: DRV/RTV + FTC/TDF0.520.37

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Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24

"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to week 24 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter." (NCT00851799)
Timeframe: Study entry, week 24

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF-0.05
Cohort B: RAL + FTC/TDF-0.27
Cohort C: DRV/RTV + FTC/TDF0.15

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Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96

Bone mineral density (BMD) of the hip was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF-3.7
Cohort B: RAL + FTC/TDF-2.2
Cohort C: DRV/RTV + FTC/TDF-3.3

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Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96

IL-6 was measured at study entry and weeks 48 and 96 (unit of measure pg/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96

,,
InterventionFold change (Median)
Fold change from study entry to week 48Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0.620.89
Cohort B: RAL + FTC/TDF0.710.82
Cohort C: DRV/RTV + FTC/TDF0.750.89

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Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48

The change in absolute FMD was defined as the maximum absolute FMD from the RH 60 and 90 second measurements, from study entry to weeks 4, 24, and 48 (unit of measure millimeters). All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments. (NCT00851799)
Timeframe: Study entry, weeks 4, 24 and 48

,,
Interventionmm (Mean)
Change from study entry to week 4Change from study entry to week 24Change from study entry to week 48
Cohort A: ATV/RTV + FTC/TDF0.002-0.0020.002
Cohort B: RAL + FTC/TDF0.012-0.0040.005
Cohort C: DRV/RTV + FTC/TDF-0.0050.008-0.001

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Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48

"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to weeks 4 and 48 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter." (NCT00851799)
Timeframe: Study entry, weeks 4 and 48

,,
Interventionpercent (Mean)
Change from study entry to week 4Change from study entry to week 48
Cohort A: ATV/RTV + FTC/TDF-0.04-0.04
Cohort B: RAL + FTC/TDF0.22-0.08
Cohort C: DRV/RTV + FTC/TDF-0.15-0.11

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Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96

Subcutaneous abdominal fat (SAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF10.3
Cohort B: RAL + FTC/TDF11.8
Cohort C: DRV/RTV + FTC/TDF11.4

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Percent Change in Lean Mass From Study Entry to Week 96

Lean mass was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF1.8
Cohort B: RAL + FTC/TDF1.7
Cohort C: DRV/RTV + FTC/TDF0.1

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Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144

Change was calculated as (CD4+ T-cell count at week 24, 48, 96, or 144) - (CD4+ T-cell count at study entry). (NCT00851799)
Timeframe: Study entry to weeks 24, 48, 96, and 144

,,
Interventioncell/mm^3 (Median)
Change from study entry to week 24Change from study entry to week 48Change from study entry to week 96Change from study entry to week 144
Cohort A: ATV/RTV + FTC/TDF161209280305
Cohort B: RAL + FTC/TDF133191247279
Cohort C: DRV/RTV + FTC/TDF118194248227

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Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96

Calculated LDL-C (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in calculated LDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96

,,
Interventionmg/dL (Median)
Change from study entry to week 4Change from study entry to week 24Change from study entry to week 48Change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0212
Cohort B: RAL + FTC/TDF-3-2-1-1
Cohort C: DRV/RTV + FTC/TDF1356

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Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96

Glucose (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96

,,
Interventionmg/dL (Median)
Change from study entry to week 4Change from study entry to week 24Change from study entry to week 48Change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF3443
Cohort B: RAL + FTC/TDF3446
Cohort C: DRV/RTV + FTC/TDF2422

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Percent Change in Total Limb Fat From Study Entry to Week 96

Total limb fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF9.8
Cohort B: RAL + FTC/TDF6.3
Cohort C: DRV/RTV + FTC/TDF7.9

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Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96

Insulin (unit of measure uIU/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96

,,
InterventionuIU/dL (Median)
Change from study entry to week 4Change from study entry to week 24Change from study entry to week 48Change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF4.04.04.03.5
Cohort B: RAL + FTC/TDF3.03.03.03.0
Cohort C: DRV/RTV + FTC/TDF3.02.03.02.0

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Percent Change in Trunk Fat From Study Entry to Week 96

Trunk fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF10.8
Cohort B: RAL + FTC/TDF13.5
Cohort C: DRV/RTV + FTC/TDF9.7

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Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96

Total cholesterol (TC, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TC was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96

,,
Interventionmg/dL (Median)
Change from study entry to week 4Change from study entry to week 24Change from study entry to week 48Change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF49812
Cohort B: RAL + FTC/TDF-7-4-11
Cohort C: DRV/RTV + FTC/TDF371214

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Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96

Triglyceride (TG, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TG was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96

,,
Interventionmg/dL (Median)
Change from study entry to week 4Change from study entry to week 24Change from study entry to week 48Change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF146910
Cohort B: RAL + FTC/TDF-12-16-13-7
Cohort C: DRV/RTV + FTC/TDF15280

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Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96

Bone mineral density (BMD) of the total body was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF-1.9
Cohort B: RAL + FTC/TDF-0.9
Cohort C: DRV/RTV + FTC/TDF-1.0

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Fold Change in D-dimer From Study Entry to Weeks 48 and 96

D-dimer was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96

,,
InterventionFold change (Median)
Fold change from study entry to week 48Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0.570.52
Cohort B: RAL + FTC/TDF0.730.72
Cohort C: DRV/RTV + FTC/TDF0.650.65

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Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96

hsCRP was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96

,,
InterventionFold change (Median)
Fold change from study entry to week 48Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0.750.85
Cohort B: RAL + FTC/TDF0.880.78
Cohort C: DRV/RTV + FTC/TDF0.781.31

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Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96

HDL cholesterol (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in HDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96

,,
Interventionmg/dL (Median)
Change from study entry to week 4Change from study entry to week 24Change from study entry to week 48Change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF-1324
Cohort B: RAL + FTC/TDF-2324
Cohort C: DRV/RTV + FTC/TDF-3014

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Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96

Visceral abdominal fat (VAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF10.7
Cohort B: RAL + FTC/TDF16.2
Cohort C: DRV/RTV + FTC/TDF9.5

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Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96

Percent expression of CD38+HLADR+ on CD8+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value). (NCT00851799)
Timeframe: Study entry, weeks 24 and 96

,,
InterventionFold change (Median)
Fold change from study entry to week 24Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0.510.35
Cohort B: RAL + FTC/TDF0.560.36
Cohort C: DRV/RTV + FTC/TDF0.590.38

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Post-Exposure Prophylaxis Medication Adherence

Median medication adherence rate, defined as the proportion of pills taken relative to the number of pills prescribed (i.e., # of pills taken / # of pills prescribed). (NCT00856323)
Timeframe: 28-days

Interventionproportional medication adherence (Median)
PEP/CM0.96

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Description of Incident STI Infections.

Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia. (NCT00856323)
Timeframe: Baseline and 3-months

InterventionProportion of Participants (Mean)
PEP/CM.074

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Area Under the Concentration Time Curve for Tenofovir, Emtricitabine and Efavirenz

The area under the concentration time curve for tenofovir, emtricitabine and efavirenz (NCT00862823)
Timeframe: 17 days

,
Interventionmg*hr/mL (Geometric Mean)
Efavirenz AUCEmtricitabine AUCTenofovir AUC
Atripla Liquid56.710.82.2
Atripla Tablet58.710.91.8

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Maximum Concentration for Tenofovir, Emtricitabine and Efavirenz

The maximum concentration for tenofovir, emtricitabine and efavirenz (NCT00862823)
Timeframe: 17 days

,
Interventionmg/L (Geometric Mean)
Efavirenz CmaxEmtricitabine CmaxTenofovir Cmax
Atripla Liquid1.32.10.2
Atripla Tablet1.51.80.3

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Atazanavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration

Interventionmg*h/L (Mean)
Antiretroviral Therapy23.9

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Ritonavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration

Interventionmg*h/L (Mean)
Antiretroviral Therapy6.7

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Tenofovir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase). (NCT00869960)
Timeframe: between time of dosing to 24 hours after dose administered

Interventionmg*h/L (Mean)
Antiretroviral Therapy2.4

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Tenofovir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase). (NCT00869960)
Timeframe: between time of dosing tp 24 hours after dose administration

Interventionmg*h/L (Mean)
Antiretroviral Therapy2.2

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Ritonavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration

Interventionmg*h/L (Mean)
Antiretroviral Therapy7.2

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Emtricitabine Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration

Interventionmg*h/L (Mean)
Antiretroviral Therapy10.2

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Emtricitabine Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration

Interventionmg*h/L (Mean)
Antiretroviral Therapy11.2

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Atazanavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)

Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration

Interventionmg*h/L (Mean)
Antiretroviral Therapy22.4

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IL-10

Interleukin 10 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks

Interventionpg/mL (Median)
CD4<10021.32
CD4>/=10010.30

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IL-4

Interleukin-4 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks

Interventionpg/mL (Median)
CD4<1000.07
CD4>/=1000.07

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IL-6

Interleukin 6 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks

Interventionpg/mL (Median)
CD4<1004.41
CD4>/=1004.01

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IL-7

Interleukin 7 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks

Interventionpg/mL (Median)
CD4<10017.50
CD4>/=10010.53

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IL-8

Interleukin 8 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks

Interventionpg/mL (Median)
CD4<1007.58
CD4>/=1005.18

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INF Gamma

Interferon gamma measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks

Interventionpg/mL (Median)
CD4<1002.24
CD4>/=1001.06

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TNF Alpha

Tumor Necrosis Factor Alpha - measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks

Interventionpg/mL (Median)
CD4<10013.07
CD4>/=1009.07

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Symptom Score

AIDS Clinical Trials Group Symptom Summary Score (20 item scale with severity from 0-4); Severity scale, 0=absent, 1=is least severe and 4 is most severe. Minimum score = 0 units on scale. Maximum score = 80 units on scale. (NCT00885664)
Timeframe: Week 4

Interventionunits on a scale (Median)
CD4<10010
CD4>/=1008

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SF-12 Physical Capacity Score

Measure of physical function out of 100. Lower score means less physical capacity. (NCT00885664)
Timeframe: 4 weeks

Interventionunits on a scale (Median)
CD4<10043
CD4>/=10054

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SF-12 Mental Capacity Score

Measure of mental functioning where lower is better out of a scale of 100. (NCT00885664)
Timeframe: 4 weeks

Interventionscore on a scale (Median)
CD4<10046
CD4>/=10050

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IL-1 Beta

Cytokine IL-1 beta measurement by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks

Interventionpg/mL (Median)
CD4<1000.03
CD4>/=1000.03

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Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for AUC24hr)

The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)

Interventionng.h/mL (Mean)
ATV/Rtv 300/100 mg (Reference)74210
ATV/Rtv 300/100 mg (Test)72220

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Pharmacokinetic Results of Etravirine (ETR) (Results for AUC12hr)

The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the area under the plasma concentration-time curve from time of intake to 12 hours after dosing (AUC12hr). (NCT00896051)
Timeframe: Week 2

Interventionng.h/mL (Mean)
ATV/Rtv 300/100 mg (Treatment A)7629
ATV/Rtv 400/100 mg (Treatment B)5171

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Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for AUC24hr)

The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)

Interventionng.h/ml (Mean)
ATV/Rtv 300/100 mg (Reference)12560
ATV/Rtv 300/100 mg (Test)11120

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Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for AUC24hr)

The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)

Interventionng.h/ml (Mean)
ATV/Rtv 300/100 mg (Reference)13880
ATV/Rtv 300/100 mg (Test)13660

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Change From Pre-Baseline in Log10 Viral Load Over Time

The table below shows the mean change from prebaseline over time in log10 (Copies/mL) plasma viral load using the Non-Completing = Failure (NC=F) imputation method. (NCT00896051)
Timeframe: Pre-Baseline, Baseline, Weeks 4, 12, 24, 48

,
Interventionlog10 (Copies/mL) (Mean)
BaselineWeek 4Week 12Week 24Week 48
ATV/Rtv 300/100 mg (Treatment A)-1.4-1.9-1.7-1.8-1.4
ATV/Rtv 400/100 mg (Treatment B)-1.4-1.8-2.0-1.8-1.4

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Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax)

The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax). (NCT00896051)
Timeframe: Day -1 (Pretreatment); Week 2 (Test)

,
Interventionng/ml (Mean)
C0h, ng/ml (Reference, n=21; Test, n=19)Cmin, ng/ml (Reference, n=20; Test, n=18)Cmax, ng/ml (Reference, n=20; Test, n=19)
ATV/Rtv 300/100 mg (Reference)133911045652
ATV/Rtv 300/100 mg (Test)845.7758.65232

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Pharmacokinetic Results of Etravirine (ETR) (Results for C0h, Cmin, and Cmax)

The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin) and maximum plasma concentration (Cmax). (NCT00896051)
Timeframe: Week 2

,
Interventionng/ml (Mean)
C0h (Treatment B, n=19)Cmin (Treatment A, n=16; Treatment B, n=18)Cmax (Treatment A, n=18; Treatment B, n=18)
ATV/Rtv 300/100 mg (Treatment A)422.2425.1773.0
ATV/Rtv 400/100 mg (Treatment B)316.6286.5628.7

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Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for C0h, Cmin, and Cmax)

The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)

,
Interventionng/ml (Mean)
C0h, ng/ml (Reference, n=21; Test, n=19)Cmin, ng/ml (Reference, n=20; Test, n=18)Cmax, ng/ml (Reference, n=20; Test, n=19)
ATV/Rtv 300/100 mg (Reference)143.460.421834
ATV/Rtv 300/100 mg (Test)102.543.971740

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Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for C0h, Cmin, and Cmax)

The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)

,
Interventionng/ml (Mean)
C0h, ng/ml (Reference, n=22; Test, n=20)Cmin, ng/mlCmax, ng/ml (Reference, n=22)
ATV/Rtv 300/100 mg (Reference)109.264.701882
ATV/Rtv 400/100 mg (Test)163.475.681847

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The Percentage of Participants With a Virologic Response (Plasma Viral Load < 50 Copies/mL) at Week 48 Using the Snapshot Analysis Method

The table below provides the results from the snapshot analysis method that includes the percentage of participants with virologic response (<50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available at Week 48. (NCT00896051)
Timeframe: Week 48

,
InterventionPercentage of Participants (Number)
Virologic ResponseVirologic FailureNo VL Data Available
ATV/Rtv 300/100 mg (Treatment A)50.031.818.2
ATV/Rtv 400/100 mg (Treatment B)45.536.418.2

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The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method

The table below shows the percentage of participants per time point with a virologic response defined as having a plasma viral load (VL) <50 copies/mL, and with plasma VL <400 copies/mL using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their Baseline value, thus resulting in a 0 change). (NCT00896051)
Timeframe: Baseline, Weeks 4, 12, 24, 48

,
InterventionPercentage of Participants (Number)
<50 copies/mL, Baseline<50 copies/mL, Week 4<50 copies/mL, Week 12<50 copies/mL, Week 24<50 copies/mL, Week 48<400 copies/mL, Baseline<400 copies/mL, Week 4<400 copies/mL, Week 12<400 copies/mL, Week 24<400 copies/mL, Week 48
ATV/Rtv 300/100 mg (Treatment A)9.131.859.163.650.040.977.368.272.750.0
ATV/Rtv 400/100 mg (Treatment B)9.136.459.163.645.540.977.381.872.759.1

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The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method

The table below shows the percentage of participants with a virologic response defined as a viral load <50 Copies/mL and <400 Copies/mL per time point calculated using the time to loss of virologic response (TLOVR) imputation method. (NCT00896051)
Timeframe: Baseline, Weeks 4, 12, 24, 48

,
InterventionPercentage of Particpants (Number)
<50 copies/mL, Baseline<50 copies/mL, Week 4<50 copies/mL, Week 12<50 copies/mL, Week 24<50 copies/mL, Week 48<400 copies/mL, Baseline<400 copies/mL, Week 4<400 copies/mL, Week 12<400 copies/mL, Week 24<400 copies/mL, Week 48
ATV/Rtv 300/100 mg (Treatment A)9.131.859.163.645.536.477.368.268.259.1
ATV/Rtv 400/100 mg (Treatment A)4.536.454.559.150.040.977.386.468.254.5

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Time to Confirmed Virologic Response

The table below provides the time in days it took participants to reach a confirmed virologic response defined as a plasma viral load (VL) <50 copies/mL, and plasma VL <400 copies/mL analyzed according to the Time to Loss of Virologic Response (TLOVR) imputation method. (NCT00896051)
Timeframe: Prebaseline to Week 48

,
InterventionDays (Median)
Plasma VL < 50 copies/mLPlasma VL < 400 copies/mL
ATV/Rtv 300/100 mg (Treatment A)71.028.0
ATV/Rtv 400/100 mg (Treatment B)76.028.0

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Time to Virologic Failure

The table below shows the number of days to virologic failure defined as a plasma viral load (VL) > 50 copies/mL for participants who had been virologic responders (ie, having a plasma VL <50, and <400 copies/mL according to the time to loss of virologic response [TLOVR] imputation method). Time to virologic failure was the time to subsequent loss of virologic response, and the time was calculated from Prebaseline (Week -2). Participants who never achieved a virologic response were defined as nonresponders and counted as virologic failures on Day 1. (NCT00896051)
Timeframe: Prebaseline to Week 48

,
InterventionDays (Median)
Virologic Responders (Plasma VL < 50 copies/mL)Virologic Responders (Plasma VL < 400 copies/mL)
ATV/Rtv 300/100 mg (Treatment A)318.0NA
ATV/Rtv 400/100 mg (Treatment B)NANA

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Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for C0h, Cmin, and Cmax)

The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)

,
Interventionng/ml (Mean)
C0h, ng/ml (Reference, n=22; Test, n=20)Cmin, ng/ml (Reference, n=21;Test, n=18)Cmax, ng/ml (Reference, n=22; Test, n=20)
ATV/Rtv 300/100 mg (Reference)189816716419
ATV/Rtv 400/100 mg (Test)154511076950

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Change From Prebaseline in CD4+ Cell Count Over Time

The table below shows the mean change from prebaseline over time in CD4+ cell count using the Non-Completing = Failure (NC=F) imputation method. (NCT00896051)
Timeframe: Prebaseline, Baseline, Weeks 4, 12, 24, 48

,
InterventionCD4+ cell count (Mean)
BaselineWeek 4Week 12Week 24Week 48
ATV/Rtv 300/100 mg (Treatment A)16553154105
ATV/Rtv 400/100 mg (Treatment B)8467283132

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Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for AUC24hr)

The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Pretreatment); Week 2 (Test)

Interventionng.h/mL (Mean)
ATV/Rtv 300/100 mg (Reference)60030
ATV/Rtv 300/100 mg (Test)55070

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Percentage of Participants With Undetectable Plasma Viral Load (VL) Values (<50 Copies/mL) at Week 48

The table below shows the percentage of participants wih undetectable plasma viral load (VL) values (<50 copies/mL) at Week 48 using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their baseline value, thus resulting in a 0 change). (NCT00896051)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
ATV/Rtv 300/100 mg (Treatment A)50.0
ATV/Rtv 400/100 mg (Treatment B)45.5

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Number of Participants Without Virologic Failure at Week 48

HIV RNA level <50 copies/mL at week 48 (NCT00924898)
Timeframe: HIV RNA level at week 48 following enrollment

InterventionParticipants (Count of Participants)
Acute HIV Infection Treatment Group71

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Number of Participants Without Virologic Failure at Week 24

Number of participants with a HIV RNA level <200 copies/mL at week 24 (NCT00924898)
Timeframe: HIV RNA level prior to or at week 24 following enrollment

InterventionParticipants (Count of Participants)
Acute HIV Infection Treatment Group81

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Number of Participants With HIV RNA Suppression at Week 96

Number of participants wtih HIV RNA level <50 copies/mL at week 96 (NCT00924898)
Timeframe: HIV RNA level at 96 weeks following enrollment

InterventionParticipants (Count of Participants)
Acute HIV Infection Treatment Group65

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Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment

Baseline genotypic resistance defined as presence of any surveillance drug resistance mutation to any drug in the study treatment listed by the World Health Organization (NCT00924898)
Timeframe: At enrollment

InterventionParticipants (Count of Participants)
Acute HIV Infection Treatment Group71

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Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications

Prevalence of any of the surveillance drug resistance mutations associated with resistance to antiretroviral medications listed by the World Health Organization (NCT00924898)
Timeframe: At enrollment

InterventionParticipants (Count of Participants)
Acute HIV Infection Treatment Group17

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Time to HIV RNA Suppression <50 Copies/mL

Number of days from ART initiation to HIV RNA suppression <50 copies/mL (NCT00924898)
Timeframe: Number of days from start of study treatment until HIV RNA suppression, assessed through week 96

Interventiondays (Median)
Acute HIV Infection Treatment Group105

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Patients With Plasma HIV RNA < 200 Copies/ml

number of patients with plasma HIV RNA below 200 copies/ml (NCT00928187)
Timeframe: 48 weeks

Interventionparticipants (Number)
Arm A130
Arm B118
Arm C127

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Number of Patients With Resistance Mutations

number of patients with resistance mutations after second line treatment failure (HIV RNA> 1000 copies/ml) (NCT00928187)
Timeframe: between W12 and W48

Interventionparticipants (Number)
Arm A0
Arm B0
Arm C0

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Number of Patients With Plasma HIV RNA < 50 Copies/mL

(NCT00928187)
Timeframe: 48 weeks

Interventionparticipants (Number)
Arm A105
Arm B92
Arm C97

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Number of Patients With HIV Plasma Viral Load < 50 Copies/ml

Snapshot of patients with HIV viral load less then 50 copies/ml at week 24 (NCT00928187)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
Arm A90
Arm B81
Arm C97

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Number of Patients With HIV Plasma Viral Load < 200 Copies/ml

number of patients having a plasma viral load below 200 copies/ml at week 24 (NCT00928187)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
Arm A127
Arm B117
Arm C129

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Tolerance: Neuropathies (Grade 1 to 4)

any symptom of peripheral neuropathy (NCT00928187)
Timeframe: between baseline and W48

Interventionparticipants (Number)
Arm A5
Arm B11
Arm C8

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Adherence

number of patients in different categories of adherence as measured by questionnaire (NCT00928187)
Timeframe: between baseline and W48

,,
Interventionparticipants (Number)
Always above 95%At least once 80-95%At least once < 80%
Arm A508911
Arm B547214
Arm C67784

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Development of Metabolic Syndrome

number of patients developing metabolic syndrome over a period of 48 weeks (NCT00928187)
Timeframe: from baseline to week 48

InterventionParticipants (Count of Participants)
Arm A12
Arm B21
Arm C9

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Gain in CD4 Cells Between Baseline and W48

median gain in circulating CD4 cells between baseline and W48 (NCT00928187)
Timeframe: between baseline and 48 weeks

Interventioncell/mm3 (Median)
Arm A133
Arm B136
Arm C115

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Number of Patients Discontinuing Study Treatment

number of patients discounting treatment because of adverse events (NCT00928187)
Timeframe: between baseline and W48

Interventionparticipants (Number)
Arm A0
Arm B4
Arm C1

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Tolerance: Gastrointestinal Complains

Gastrointestinal complaints (grade 1 to 4) between baseline and W48. (NCT00928187)
Timeframe: between baseline and 48 weeks

Interventionparticipants (Number)
Arm A50
Arm B48
Arm C26

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Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)

evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value (NCT00928187)
Timeframe: between baseline and W48

Interventionparticipants (Number)
Arm A28
Arm B14
Arm C19

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Change in Quality of Life From Baseline to 48 Weeks of Study Treatment

Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment. (NCT00931801)
Timeframe: baseline and 48 weeks

,,,
Interventionunits on a scale (Mean)
Mean Quality of Life Score at BaselineMean Quality of Life Score at Week 48Change in Quality of Life
Control Arm92.990.5-2.5
Intervention Arm No.177.478.20.8
Intervention Arm No.282.581.3-1.3
Total84.283.3-0.9

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The Change in Adherence to Study Treatment Arm From Baseline to Week 48

Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits. (NCT00931801)
Timeframe: Baseline and Week 48

,,,
Interventionpercentage of prescribed doses (Mean)
3 Day Adherence Recall at Baseline3 Day Adherence Recall at Week 48Change in 3 Day Adherence Recall
Control Arm1001000
Intervention Arm No.197.597.50
Intervention Arm No.296.795.0-1.7
Total98.197.6-0.5

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The Difference in CD4 From Baseline to Week 48

Change in mean CD4 from Baseline to Week 48. (NCT00931801)
Timeframe: Baseline and Week 48

,,,
Interventioncells/mm3 (Mean)
CD4 at BaselineCD4 at Week 48CD4 Change
Control Arm535.8611.275.4
Intervention Arm No.1514.1526.312.1
Intervention Arm No.2539.1507.2-31.9
Total528.3549.321.0

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Maintenance of Virologic Suppression

To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL. (NCT00931801)
Timeframe: 48 weeks

,,
Interventionparticipants (Number)
Virologic ResponseConfirmed Virologic FailuresWithdrawal Due to AE; HIV RNA < 50 copies/mLOther Withdrawal; HIV RNA < 50 copies/mL
Control Arm13001
Intervention Arm No.114001
Intervention Arm No.210310

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Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

Changes from baseline to follow-up in limb fat, trunk fat, total body fat, and lean mass were calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 96 weeks

Interventionpercentage of body fat (Median)
Total body fatLimb fatTrunk fat
Etravirine 400 mg Once Daily1.440.821.93

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Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

Changes from baseline to follow-up in limb fat, trunk fat, total body fat, and lean mass were calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 24 weeks

Interventionpercentage of body fat (Median)
Total body fatLimb fatTrunk fat
Etravirine 400 mg Once Daily0.430.480.32

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The Proportion of Participants With HIV RNA <50 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 96 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 96 weeks

Interventionproportion of participants (Number)
Etravirine 400 mg Once Daily0.71

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The Proportion of Participants With HIV RNA <50 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 48 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 48 weeks

Interventionproportion of participants (Number)
Etravirine 400 mg Once Daily0.77

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Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. (NCT00959894)
Timeframe: Baseline to 96 weeks

Interventionmg/dL (Median)
Total cholesterolHDL-cholesterolLDL-cholesterolTriglyceridesFasting glucose
Etravirine 400 mg Once Daily64-532

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The Proportion of Participants With HIV RNA <200 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA 200 copies/ml at Week 96 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 96 weeks

Interventionproportion of participants (Number)
Etravirine 400 mg Once Daily0.77

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The Proportion of Participants With HIV RNA <200 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <200 copies/ml at Week 48 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 48 weeks

Interventionproportion of participants (Number)
Etravirine 400 mg Once Daily0.82

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The Proportion of Participants With HIV RNA <200 Copies/mL at Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <200 copies/ml at Week 24 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 24 weeks

Interventionproportion of participants (Number)
Etravirine 400 mg Once Daily0.89

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Probability of Remaining Free of a Safety/Tolerability Event at 96 Weeks

The Kaplan-Meier method was used to estimate the proportion of participants ever exposed to etravirine who remained event-free through Week 96, with a 95% CI using Greenwood's variance estimate and a log-log transformation. Time was handled as continuous (weeks from treatment start to event or censoring). (NCT00959894)
Timeframe: 96 weeks

Interventionproportion of participants (Number)
Etravirine 400 mg Once Daily0.69

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Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults

Population pharmacokinetics were calculated using sparse sampling. Plasma concentrations of etravirine measured in samples from participants who provided blood samples at multiple study visits, with variation in sampling times relative to dosing of etravirine used to cover the spectrum of the dosing schedule. Model simulations and fitting were performed with NONMEM ® 7.3. (ICON, plc) and model exploration was performed with Berkeley Madonna (Berkeley, CA, USA) (NCT00959894)
Timeframe: At or after 4 weeks

Interventionng/mL (Median)
Etravirine trough plasma concentrationEtravirine peak plasma concentration
Etravirine 400 mg Once Daily217.47480.99

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Resistance Mutations in the Subset of Patients With Confirmed Virologic Failure Who Have HIV RNA >500 Copies/mL and Genotype Resistance Results

Per-protocol, genotype testing was conducted at confirmation of virologic failure if the confirmatory HIV-1 RNA was above the laboratory-specified threshold of 500 copies/mL. HIV-1 genotype was determined using the TRUGENE® HIV-1 assay (Siemens Healthcare Diagnostics, Tarrytown, NY) (NCT00959894)
Timeframe: 96 weeks

Interventionparticipants (Number)
Y181CE138KE138K, Y181C, M230L, M184I, K219E, V75INo resistance-associated mutations detected
Etravirine 400 mg Once Daily1113

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Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults: Etravirine AUC-24 Hours at Steady State

Population pharmacokinetics were calculated using sparse sampling. Plasma concentrations of etravirine measured in samples from participants who provided blood samples at multiple study visits, with variation in sampling times relative to dosing of etravirine used to cover the spectrum of the dosing schedule. Model simulations and fitting were performed with NONMEM ® 7.3. (ICON, plc) and model exploration was performed with Berkeley Madonna (Berkeley, CA, USA) (NCT00959894)
Timeframe: At or after 4 weeks

Interventionng*hr/mL (Median)
Etravirine 400 mg Once Daily8024.40

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Tolerability of Etravirine in HIV-1 Infected Adults Initiating Antiretroviral Therapy

"The safety/tolerability endpoint was defined as the first grade 3 or higher sign, symptom or laboratory abnormality that was at least one grade higher than baseline among participants ever exposed to etravirine (regardless of treatment status), or permanent discontinuation of etravirine due to any toxicity (regardless of grade). Modification of tenofovir/emtricitabine was not a safety/tolerability event.~The Kaplan-Meier method was used to estimate the proportion of participants ever exposed to etravirine who remained event-free through Week 96, with a 95% CI using Greenwood's variance estimate and a log-log transformation. Time was handled as continuous (weeks from treatment start to event or censoring)." (NCT00959894)
Timeframe: 96 weeks

Interventionparticipants (Number)
At least one safety/tolerability eventSigns or SymptomsLaboratory Abnormalities
Etravirine 400 mg Once Daily231310

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Pharmacokinetics of Etravirine in Genital Secretions of up to 10 Men and up to 10 Women at Week 4 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

This secondary outcome measure assessed the ratio of semen:plasma concentration of etravirine in paired semen and plasma samples collected from 14 male participants at Week 4 of treatment with etravirine and fixed dose tenofovir/emtricitabine. (NCT00959894)
Timeframe: 4 weeks

Interventionratio of semen:plasma drug concentration (Median)
Etravirine 400 mg Once Daily0.192

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Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. (NCT00959894)
Timeframe: Baseline to 96 weeks

InterventionµU/ml*mmol/L (Median)
Etravirine 400 mg Once Daily0.23

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Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. (NCT00959894)
Timeframe: Baseline to 48 weeks

InterventionµU/ml*mmol/L (Median)
Etravirine 400 mg Once Daily0.71

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Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. (NCT00959894)
Timeframe: Baseline to 24 weeks

InterventionµU/ml*mmol/L (Median)
Etravirine 400 mg Once Daily-0.08

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Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

Change from baseline to follow-up in fat mass ratio was calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Fat mass ratio was calculated as the ratio of trunk fat percentage and lower limb fat percentage (% trunk fat mass / % lower limb fat mass). Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 96 weeks

Interventionratio of trunk fat % : lower limb fat % (Median)
Etravirine 400 mg Once Daily0.06

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Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

Change from baseline to follow-up in fat mass ratio was calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Fat mass ratio was calculated as the ratio of trunk fat percentage and lower limb fat percentage (% trunk fat mass / % lower limb fat mass). Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 24 weeks

Interventionratio of trunk fat % : lower limb fat % (Median)
Etravirine 400 mg Once Daily0.02

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Change in CD4+ Cell Count From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

The per-protocol intention-to-treat analysis of change in CD4+ cell count from baseline to Week 96 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 96 weeks

Interventioncells/uL (Median)
Etravirine 400 mg Once Daily224

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Change in CD4+ Cell Count From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

The per-protocol intention-to-treat analysis of change in CD4+ cell count from baseline to Week 48 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 48 weeks

Interventioncells/uL (Median)
Etravirine 400 mg Once Daily163

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The Antiretroviral Activity of Etravirine 400 mg Given Once Daily, With Fixed-dose Truvada Once Daily, Among Treatment-naïve HIV-1 Infected Adults as Measured by the Percentage of Participants With HIV RNA < 50 Copies/mL at Week 24

The primary study endpoint was the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 24 of study participation. The per-protocol primary analysis was conducted intention-to-treat, with missing evaluations counted as failures. Achievement of HIV-1 viral load below 50 copies/ml was defined as having HIV-1 RNA <50 copies/ml during the Week 24 analysis window (>18 and <30 weeks post-entry). (NCT00959894)
Timeframe: 24 weeks

Interventionproportion of participants (Number)
Etravirine 400 mg Once Daily0.87

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Change in CD4+ Cell Count From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

The per-protocol analysis of change in CD4+ cell count from baseline to Week 24 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% confidence interval (CI). (NCT00959894)
Timeframe: Baseline to 24 weeks

Interventioncells/uL (Median)
Etravirine 400 mg Once Daily156

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Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. (NCT00959894)
Timeframe: Baseline to 48 weeks

Interventionmg/dL (Median)
Total cholesterolHDL-cholesterolLDL-cholesterolTriglyceridesFasting glucose
Etravirine 400 mg Once Daily65-1-102

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Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine

Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. (NCT00959894)
Timeframe: Baseline to 24 weeks

Interventionmg/dL (Median)
Total cholesterolHDL-cholesterolLDL-cholesterolTriglyceridesFasting glucose
Etravirine 400 mg Once Daily-71-9-161

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Change in Peak Oxygen Uptake.

change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups. (NCT00960622)
Timeframe: baseline and 6 months

Interventionml/Kg/min (Mean)
Truvada 200/300 mg, Daily, by Mouth.2.2
Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.2.8

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Mean Change From Baseline in HBV-DNA log10

An acute virologic response was determined by change from baseline in HBV-DNA log10. (NCT00962871)
Timeframe: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)

,,,
InterventionIU/mL (Mean)
Day 2Day 3Day 5Day 8Day 10Day 14Week 3Week 4Week 5Week 6
Delayed Treatment0.080.04-0.06-0.07-0.09-0.26-1.80-2.17NANA
PEG-IFN Alfa-2a 360 μg-0.14-0.46-0.64-0.54-0.57-0.61-0.79-0.98-1.22-1.30
Tenofovir 300 mg-0.61-1.04-1.53-2.16-2.37-2.7-0.76-0.84NANA
Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg-0.46-0.75-1.45-1.93-2.11-2.46-2.88-1.49-1.37-1.73

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Mean Change From Baseline in Viral Quantitative e Antibody

An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data. (NCT00962871)
Timeframe: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)

,,,
InterventionCut-off index (C.O.I.) (Mean)
Day 1Day 3Day 5Day 8Day 10Day 14Week 3Week 4Week 6
Delayed Treatment0.03-0.100.070.040.03-0.00NA-0.40NA
PEG-IFN Alfa-2a 360 μg0.02-0.13-0.15-0.09-0.12-0.13-0.22-0.29-0.31
Tenofovir 300 mg0.070.00-0.02-0.05-0.13-0.02NA-0.04NA
Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg0.150.030.040.070.040.030.01-0.05-0.21

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Change in Small Artery Elasticity (mL/mmHg x100) From Baseline to Week 24

Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events. (NCT00998582)
Timeframe: Change from baseline to 24 weeks

Interventionml/mmHg x100 (Median)
Abacavir0.2
Tenofovir-1.3

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Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24

Large artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the large (and small) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease. (NCT00998582)
Timeframe: Change from baseline to 24 weeks

Interventionml/mmHg x10 (Median)
Abacavir-0.2
Tenofovir-0.4

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Mean Change in Estimated Ultrasensitive Plasma HIV RNA Levels Between Baseline and Week 24

The isothermal transcription mediated amplification (TMA) assay (Aptima, Gen-Probe/Hologic) was used to measure ultrasensitive plasma HIV RNA levels at weeks 0, 4, 12, and 24. This is a nucleic acid-amplification test that has been FDA-approved for the early detection of HIV infection in blood donors. It is a highly specific and sensitive assay, with a singlicate 50% detection limit of 3.6-14 copies/mL. The assay was performed in triplicate on 0.5 mL plasma (1.5 mL total plasma), improving the overall 50% detection limit to < 5 copies/mL. (NCT01025427)
Timeframe: 24 weeks

Interventionfold decrease in signal/cutoff ratio (Mean)
HIV Controller66

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Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex

(NCT01033942)
Timeframe: 24 weeks

,
Intervention% of participants in each category (Number)
NeverRarelySometimesOften
FTC/TDF as PrEP90.594.711.183.53
Placebo Pill Control96.770.002.151.08

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Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time

(NCT01033942)
Timeframe: 24 weeks

,
Intervention% of participants in each category (Number)
NeverRarelySometimesOften
FTC/TDF as PrEP68.2424.714.712.35
Placebo Pill Control86.026.454.303.23

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Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed

(NCT01033942)
Timeframe: 24 weeks

,
Intervention% of participants in each category (Number)
NeverRarelySometimesOften
FTC/TDF as PrEP83.5312.940.003.53
Placebo Pill Control92.472.153.232.15

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Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 12

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP73.3320.006.670.000.00
No Pill Control43.7518.7525.0012.500.00
Placebo Pill Control81.256.256.250.006.25

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Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been on this study." (NCT01033942)
Timeframe: Week 12

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP46.6713.3313.3313.3313.33
No Pill Control25.0025.0018.7518.7512.50
Placebo Pill Control68.756.2518.756.250.00

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Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 12

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP60.0033.336.670.000.00
No Pill Control68.7518.7512.500.000.00
Placebo Pill Control93.750.006.250.000.00

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Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 16

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP75.0025.000.000.000.00
No Pill Control42.8628.5714.297.147.14
Placebo Pill Control80.006.6713.330.000.00

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Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 16

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP53.8515.3823.087.690.00
No Pill Control42.8642.867.140.007.14
Placebo Pill Control93.330.006.670.000.00

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Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 16

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP58.3333.338.330.000.00
No Pill Control35.7121.4328.570.0014.29
Placebo Pill Control80.006.6713.330.000.00

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Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 16

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP46.1515.3815.387.6915.38
No Pill Control42.8614.297.1421.4314.29
Placebo Pill Control66.676.676.6720.000.00

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Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 12

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP64.290.0021.4314.290.00
No Pill Control43.7518.7518.7518.750.00
Placebo Pill Control68.7512.5012.506.250.00

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Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 16

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP66.6725.000.008.330.00
No Pill Control71.437.147.147.147.14
Placebo Pill Control93.336.670.000.000.00

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Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects

(NCT01033942)
Timeframe: 24 weeks

,
Intervention% of participants in each category (Number)
NeverRarelySometimesOften
FTC/TDF as PrEP82.359.410.008.24
Placebo Pill Control91.403.232.153.23

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Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 20

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP75.0016.670.008.330.00
No Pill Control61.5423.087.697.690.00
Placebo Pill Control92.867.140.000.000.00

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Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 20

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP75.0025.000.000.000.00
No Pill Control38.4615.3815.3823.087.69
Placebo Pill Control78.577.147.147.140.00

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Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 20

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP66.6725.008.330.000.00
No Pill Control53.8523.0815.387.690.00
Placebo Pill Control78.5714.297.140.000.00

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Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 20

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP75.008.338.330.008.33
No Pill Control61.5415.387.697.697.69
Placebo Pill Control71.4321.430.007.140.00

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Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 20

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP91.678.330.000.000.00
No Pill Control61.5430.777.690.000.00
Placebo Pill Control92.867.140.000.000.00

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Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 24

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP60.0040.000.000.000.00
No Pill Control46.1515.3823.087.697.69
Placebo Pill Control83.3316.670.000.000.00

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Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 24

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP50.0030.0010.000.0010.00
No Pill Control46.1515.3823.0815.380.00
Placebo Pill Control83.3316.670.000.000.00

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Actual Number of Study Visits Completed by 24 Weeks

This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time. (NCT01033942)
Timeframe: 24 weeks

InterventionVisits (Least Squares Mean)
FTC/TDF as PrEP3.5927
Placebo Pill Control4.6263
No Pill Control4.6374

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Number of Missed Doses Based on Medication Refill Dates-Overall

Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: 20 Weeks

InterventionMissed doses (Median)
FTC/TDF as PrEP0
Placebo Pill Control0

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Number of Missed Doses Based on Medication Refill Dates-Week 12

Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 12

InterventionMissed doses (Median)
FTC/TDF as PrEP0
Placebo Pill Control0

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Number of Missed Doses Based on Medication Refill Dates-Week 16

Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 16

InterventionMissed doses (Median)
FTC/TDF as PrEP0
Placebo Pill Control0

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Number of Missed Doses Based on Medication Refill Dates-Week 20

Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 20

InterventionMissed doses (Median)
FTC/TDF as PrEP0
Placebo Pill Control0

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Number of Missed Doses Based on Medication Refill Dates-Week 4

Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 4

InterventionMissed doses (Median)
FTC/TDF as PrEP0
Placebo Pill Control0

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Number of Missed Doses Based on Medication Refill Dates-Week 8

Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 8

InterventionMissed doses (Median)
FTC/TDF as PrEP0
Placebo Pill Control0

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Number of Missed Doses Based on Self-Report Calendar Data-Week 12

Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 12

InterventionMissed Doses (Median)
FTC/TDF as PrEP10
Placebo Pill Control6.5

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Number of Missed Doses Based on Self-Report Calendar Data-Week 16

Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 16

InterventionMissed Doses (Median)
FTC/TDF as PrEP5
Placebo Pill Control19

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Number of Missed Doses Based on Self-Report Calendar Data-Week 20

Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 20

InterventionMissed Doses (Median)
FTC/TDF as PrEP5
Placebo Pill Control10

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Number of Missed Doses Based on Self-Report Calendar Data-Week 24

Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 24

InterventionMissed Doses (Median)
FTC/TDF as PrEP17
Placebo Pill Control5.5

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Number of Missed Doses Based on Self-Report Calendar Data-Week 4

Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: 4 weeks

InterventionMissed Doses (Median)
FTC/TDF as PrEP10
Placebo Pill Control10

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Number of Missed Doses Based on Self-Report Calendar Data-Week 8

Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 8

InterventionMissed Doses (Median)
FTC/TDF as PrEP14
Placebo Pill Control8

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Number of Missed Doses Over Time Based on Self-Report Calendar Data

The outcome measure presents the least square means from the generalized linear model. The outcome here is a binary variable that determines whether the subject missed a dose or not. In a binomial model with logit link, the least squares means are predicted population margins of the logits. (NCT01033942)
Timeframe: 24 weeks

InterventionDoses (Least Squares Mean)
FTC/TDF as PrEP0.4752
Placebo Pill Control0.4021

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Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline

"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Baseline

Interventionparticipants (Number)
FTC/TDF as PrEP11
Placebo Pill Control11
No Pill Control12

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Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8

(NCT01033942)
Timeframe: Week 8

,
Interventionparticipants (Number)
PlaceboPrEPDon't KnowDon't Understand Question
FTC/TDF as PrEP8540
Placebo Pill Control9270

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Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12

"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 12

Interventionparticipants (Number)
FTC/TDF as PrEP13
Placebo Pill Control14
No Pill Control12

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Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16

"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 16

Interventionparticipants (Number)
FTC/TDF as PrEP11
Placebo Pill Control13
No Pill Control12

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Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20

"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 20

Interventionparticipants (Number)
FTC/TDF as PrEP9
Placebo Pill Control11
No Pill Control10

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Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24

"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 24

Interventionparticipants (Number)
FTC/TDF as PrEP9
Placebo Pill Control7
No Pill Control10

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Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4

"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 4

Interventionparticipants (Number)
FTC/TDF as PrEP15
Placebo Pill Control14
No Pill Control12

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Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8

"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 8

Interventionparticipants (Number)
FTC/TDF as PrEP10
Placebo Pill Control12
No Pill Control10

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Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline

Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Baseline

Interventionpercentage of participants (Number)
FTC/TDF as PrEP0
Placebo Pill Control0

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Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12

Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 12

Interventionpercentage of participants (Number)
FTC/TDF as PrEP60
Placebo Pill Control0
No Pill Control0

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Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16

Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 16

Interventionpercentage of participants (Number)
FTC/TDF as PrEP53.8
Placebo Pill Control0
No Pill Control0

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Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20

Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 20

Interventionpercentage of participants (Number)
FTC/TDF as PrEP41.7
Placebo Pill Control0

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Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24

Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 24

Interventionpercentage of participants (Number)
FTC/TDF as PrEP20

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Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4

Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 4

Interventionpercentage of participants (Number)
FTC/TDF as PrEP63.2
Placebo Pill Control0

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Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8

Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 8

Interventionpercentage of participants (Number)
FTC/TDF as PrEP47.1
Placebo Pill Control0
No Pill Control0

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Acceptability of Being Contacted by the Research Team in Between Visits

(NCT01033942)
Timeframe: Week 24

,,
Interventionparticipants (Number)
Did not likeLikedLiked a lotMissing response
FTC/TDF as PrEP04610
No Pill Control03106
Placebo Pill Control2548

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Acceptability of Being Randomly Assigned to a Group

(NCT01033942)
Timeframe: Week 24

,,
Interventionparticipants (Number)
Did not like it at allDid not likeLikedLiked a lotMissing response
FTC/TDF as PrEP134111
No Pill Control02566
Placebo Pill Control42427

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Acceptability of Having an HIV Test at Every Visit

(NCT01033942)
Timeframe: Week 24

,,
Interventionparticipants (Number)
Did not likeLikedLiked a lotMissing response
FTC/TDF as PrEP001010
No Pill Control01126
Placebo Pill Control1387

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Acceptability of Health Clinic for Study Visits

(NCT01033942)
Timeframe: Week 24

,,
Interventionparticipants (Number)
Did not likeLikedLiked a lotMissing response
FTC/TDF as PrEP04610
No Pill Control03106
Placebo Pill Control2467

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Acceptability of Participating in Group Sessions

(NCT01033942)
Timeframe: Week 24

,,
Interventionparticipants (Number)
Did not like it at allDid not likeLikedLiked a lotMissing response
FTC/TDF as PrEP010910
No Pill Control00496
Placebo Pill Control12277

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Acceptability of Physical Examination by a Doctor

(NCT01033942)
Timeframe: Week 24

,,
Interventionparticipants (Number)
Did not like it at allDid not likeLikedLiked a lotMissing response
FTC/TDF as PrEP012710
No Pill Control003106
Placebo Pill Control30367

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Frequency of Missing Study Pills Because Participant Felt Sick or Ill

(NCT01033942)
Timeframe: 24 weeks

,
Intervention% of participants in each category (Number)
NeverRarelySometimesOften
FTC/TDF as PrEP81.1811.764.712.35
Placebo Pill Control89.255.383.232.15

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Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine

(NCT01033942)
Timeframe: 24 weeks

,
Intervention% of participants in each category (Number)
NeverRarelySometimesOften
FTC/TDF as PrEP62.3525.537.067.06
Placebo Pill Control70.9715.0510.753.23

[back to top]

Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take

(NCT01033942)
Timeframe: 24 weeks

,
Intervention% of participants in each category (Number)
NeverRarelySometimesOften
FTC/TDF as PrEP92.947.060.000.00
Placebo Pill Control95.702.151.081.08

[back to top]

Frequency of Missing Study Pills Because Participant Ran Out of Study Pills

(NCT01033942)
Timeframe: 24 weeks

,
Intervention% of participants in each category (Number)
NeverRarelySometimesOften
FTC/TDF as PrEP94.124.710.001.18
Placebo Pill Control97.851.081.080.00

[back to top]

Frequency of Missing Study Pills Because Participant Simply Forgot

(NCT01033942)
Timeframe: 24 Weeks

,
Intervention% of participants in each category (Number)
NeverRarelySometimesOften
FTC/TDF as PrEP38.8240.009.4111.76
Placebo Pill Control60.2216.1315.058.60

[back to top]

Frequency of Missing Study Pills Because Participant Was Away From Home

(NCT01033942)
Timeframe: 24 Weeks

,
Intervention% of participants in each category (Number)
NeverRarelySometimesOften
FTC/TDF as PrEP31.7634.1216.4717.65
Placebo Pill Control48.3920.4326.884.30

[back to top]

Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things

(NCT01033942)
Timeframe: 24 Weeks

,
Intervention% of participants in each category (Number)
NeverRarelySometimesOften
FTC/TDF as PrEP47.0630.5915.297.06
Placebo Pill Control58.0616.1321.514.30

[back to top]

Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12

(NCT01033942)
Timeframe: Week 12

,
Interventionparticipants (Number)
PlaceboPrEPDon't KnowDon't Understand Question
FTC/TDF as PrEP6350
Placebo Pill Control6280

[back to top]

Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16

(NCT01033942)
Timeframe: Week 16

,
Interventionparticipants (Number)
PlaceboPrEPDon't KnowDon't Understand Question
FTC/TDF as PrEP6240
Placebo Pill Control5190

[back to top]

Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20

(NCT01033942)
Timeframe: Week 20

,
Interventionparticipants (Number)
PlaceboPrEPDon't KnowDon't Understand Question
FTC/TDF as PrEP4340
Placebo Pill Control6260

[back to top]

Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24

(NCT01033942)
Timeframe: Week 24

,
Interventionparticipants (Number)
PlaceboPrEPDon't KnowDon't Understand Question
FTC/TDF as PrEP2340
Placebo Pill Control8040

[back to top]

Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4

(NCT01033942)
Timeframe: Week 4

,
Interventionparticipants (Number)
PlaceboPrEPDon't KnowDon't Understand Question
FTC/TDF as PrEP9451
Placebo Pill Control10161

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Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 12

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP57.1428.577.147.140.00
No Pill Control50.0018.7525.006.250.00
Placebo Pill Control81.2512.506.250.000.00

[back to top]

Acceptability of Questions About Sexual Behavior at Every Visit

(NCT01033942)
Timeframe: Week 24

,,
Interventionparticipants (Number)
Did not like it at allDid not likeLikedLiked a lotMissing response
FTC/TDF as PrEP001910
No Pill Control00496
Placebo Pill Control11467

[back to top]

Acceptability of Risk Reduction Counseling at Every Visit

(NCT01033942)
Timeframe: Week 24

,,
Interventionparticipants (Number)
Did not like it at allLikedLiked a lotMissing response
FTC/TDF as PrEP01910
No Pill Control0496
Placebo Pill Control1567

[back to top]

Acceptability of Size of Pill

(NCT01033942)
Timeframe: Week 24

,
InterventionParticipants (Number)
Did not like it at allDid not likeLikedLiked a lotMissing response
FTC/TDF as PrEP333110
Placebo Pill Control33607

[back to top]

Acceptability of Taking Part in the Study

(NCT01033942)
Timeframe: Week 24

,,
Interventionparticipants (Number)
Did not like it at allDid not likeLikedLiked a lotMissing response
FTC/TDF as PrEP200810
No Pill Control001126
Placebo Pill Control01297

[back to top]

Acceptability of Taking the Pill Everyday

(NCT01033942)
Timeframe: Week 24

,
Interventionparticipants (Number)
Did not like it at allDid not likeLikedLiked a lotMissing response
FTC/TDF as PrEP332210
Placebo Pill Control17407

[back to top]

Acceptability of the Color of the Pill

(NCT01033942)
Timeframe: Week 24

,
Interventionparticipants (Number)
Did not like it at allDid not likeLikedLiked a lotMissing response
FTC/TDF as PrEP124310
Placebo Pill Control13537

[back to top]

Acceptability of the Taste of the Pill

(NCT01033942)
Timeframe: Week 24

,
Interventionparticipants (Number)
Did not like it at allDid not likeLikedLiked a lotMissing response
FTC/TDF as PrEP414110
Placebo Pill Control34507

[back to top]

Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful

(NCT01033942)
Timeframe: 24 weeks

,
Intervention% of participants in each category (Number)
NeverRarelySometimesOften
FTC/TDF as PrEP87.065.883.533.53
Placebo Pill Control95.702.150.002.15

[back to top]

Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications

(NCT01033942)
Timeframe: 24 weeks

,
Intervention% of participants in each category (Number)
NeverRarelySometimesOften
FTC/TDF as PrEP88.245.882.353.53
Placebo Pill Control92.474.300.003.23

[back to top]

Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 24

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP50.0030.0010.0010.000.00
No Pill Control53.8515.3815.3815.380.00
Placebo Pill Control83.338.338.330.000.00

[back to top]

Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 24

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP50.0010.0010.0010.0020.00
No Pill Control30.7715.3815.3830.777.69
Placebo Pill Control66.6716.678.338.330.00

[back to top]

Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 24

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP80.0020.000.000.000.00
No Pill Control53.8523.0823.080.000.00
Placebo Pill Control91.670.000.008.330.00

[back to top]

Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 4

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP57.8926.3215.790.000.00
No Pill Control50.0027.7816.670.005.56
Placebo Pill Control66.6722.225.565.560.00

[back to top]

Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 4

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP66.675.5611.1111.115.56
No Pill Control55.5611.1116.6716.670.00
Placebo Pill Control55.5627.785.565.565.56

[back to top]

Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 4

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP63.165.2610.5321.050.00
No Pill Control55.5627.785.565.565.56
Placebo Pill Control66.6716.675.5611.110.00

[back to top]

Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 4

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP63.165.2610.5321.050.00
No Pill Control44.445.5622.2222.225.56
Placebo Pill Control50.0016.670.0027.785.56

[back to top]

Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 4

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP84.215.2610.530.000.00
No Pill Control94.440.005.560.000.00
Placebo Pill Control83.335.560.005.565.56

[back to top]

Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 8

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP47.0623.5323.530.005.88
No Pill Control35.2941.1823.530.000.00
Placebo Pill Control83.3311.115.560.000.00

[back to top]

Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 8

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP47.0629.4117.655.880.00
No Pill Control35.2935.2911.7617.650.00
Placebo Pill Control66.675.5627.780.000.00

[back to top]

Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 8

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP58.8217.6517.650.005.88
No Pill Control35.2923.5311.7629.410.00
Placebo Pill Control66.6711.1116.675.560.00

[back to top]

Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 8

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP52.945.8817.655.8817.65
No Pill Control23.5317.6523.5317.6517.65
Placebo Pill Control61.1111.115.565.5616.67

[back to top]

Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 8

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP68.7525.006.250.000.00
No Pill Control64.7129.415.880.000.00
Placebo Pill Control100.000.000.000.000.00

[back to top]

Perceived Risk of Becoming HIV Positive at Week 12

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 12

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP40.0040.0020.000.000.00
No Pill Control31.2537.5012.506.2512.50
Placebo Pill Control75.006.256.2512.500.00

[back to top]

Perceived Risk of Becoming HIV Positive at Week 16

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 16

,,
Interventionpercentage of partcipants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP58.3316.678.338.338.33
No Pill Control42.8621.4321.430.0014.29
Placebo Pill Control80.0013.336.670.000.00

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Perceived Risk of Becoming HIV Positive at Week 20

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 20

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP66.6716.670.0016.670.00
No Pill Control30.7723.0823.087.6915.38
Placebo Pill Control78.5721.430.000.000.00

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Perceived Risk of Becoming HIV Positive at Week 24

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 24

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP60.0020.000.0010.0010.00
No Pill Control38.4623.0815.387.6915.38
Placebo Pill Control75.008.3316.670.000.00

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Perceived Risk of Becoming HIV Positive at Week 4

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 4

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP52.6321.0510.5315.790.00
No Pill Control33.3322.2227.780.0016.67
Placebo Pill Control38.8933.3311.1111.115.56

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Perceived Risk of Becoming HIV Positive at Week 8

"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 8

,,
Interventionpercentage of participants (Number)
Strongly DisagreeDisagreeNeutralAgreeStrongly Agree
FTC/TDF as PrEP29.4117.6523.5323.535.88
No Pill Control58.8211.7611.7611.765.88
Placebo Pill Control66.6727.780.005.560.00

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Patients Without HIV Re-bound

HIV Viral load blood test at week 24 (NCT01044771)
Timeframe: 24 weeks

Interventionparticipants (Number)
Viral Rebound2

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Patients With Reduced or Resolved Proteinuria

Measurement of Protein in Urine samples at end of study visit (NCT01044771)
Timeframe: 24 weeks

Interventionparticipants (Number)
Change From Tenofovir to Raltegravir20

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Maternal Health Component: Other Targeted Medical Conditions

Other (non-cardiologic) medical conditions of particular concern were included in this outcome. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Events included were metabolic events, hepatic events, renal events, infections such as pulmonary tuberculosis, malaria, or other serious bacterial infections, and others. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Interventionevents per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)4.0
Maternal Health Arm B (Discontinue Triple ARVs)4.6

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Maternal Health Component: Incidence Rate of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event

"This outcome included AIDS-defining illnesses or cardiovascular, hepatic, or renal adverse events of particular concern which were evaluated as serious. Serious outcomes were both those defined as serious according to the International Conference on Harmonization (ICH) definition, or outcomes with grades equal to or worse than 3 (Severe). A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy. Hepatic events considered were cirrhosis and idiopathic sclerosing cholangitis. Renal events considered were renal insufficiency, acute or chronic." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Interventionevents per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)0.5
Maternal Health Arm B (Discontinue Triple ARVs)0.9

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Maternal Health Component: Incidence Rate of Death or Any Condition of Particular Concern

Particular events were targeted as those of particular concern. This outcome considered all such events: death, events defining WHO stages II, III, or IV, targeted cardiovascular adverse events, other targeted adverse events, or cancers which were not AIDS-defining. A complete list can be found in Appendix IV of the Protocol. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Interventionevents per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)9.0
Maternal Health Arm B (Discontinue Triple ARVs)14.0

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Maternal Health Component: Incidence Rate of Cardiovascular or Other Metabolic Events

"Cardiovascular or metabolic events of particular concern were included in this analysis. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates.~Metabolic events considered were diabetes mellitus, lipodystrophy, or dyslipidemia. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Interventionevents per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)2.9
Maternal Health Arm B (Discontinue Triple ARVs)5.7

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Maternal Health Component: Incidence of Tuberculosis

Incidence of tuberculosis. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

InterventionNew cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)0.40
Maternal Health Arm B (Discontinue Triple ARVs)0.31

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Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death

AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses in Appendix IV of the protocol. These events were reviewed and confirmed by an Endpoint review group. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

InterventionNew cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)0.24
Maternal Health Arm B (Discontinue Triple ARVs)0.49

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Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results

The maternal safety endpoints summarized include grade 2, 3 or 4 hematologies (hemoglobin (Hb), White Blood Cells (WBC), Absolute Neutrophil Count (ANC), platelet count), chemistries (Alanine Aminotransferase (ALT or SGPT), serum creatinine), and grade 3 or 4 signs and symptoms that occurred post-randomization. These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

InterventionNew cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)15.3
Maternal Health Arm B (Discontinue Triple ARVs)13.9

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Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery

Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit, confirmed by HIV NAT positivity of a second specimen drawn at a different time point, or infant death. Analyses (Kaplan-Meier probabilities) were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event. (NCT01061151)
Timeframe: Measured through 24 months post-delivery

InterventionProbability (Number)
Postpartum Arm A (Maternal Prophylaxis)0.971
Postpartum Arm B (Infant Prophylaxis)0.977

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Maternal Health Component: Incidence of Death

Number of women who died during the maternal health component; that is, who had been randomized to either continue or discontinue ART after risk of HIV vertical transmission through breastfeeding was over. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

InterventionNew cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)0.24
Maternal Health Arm B (Discontinue Triple ARVs)0.43

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Maternal Health Component: Incidence of AIDS-defining Illness

"AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses listed in Appendix IV. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

InterventionNew cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)0.08
Maternal Health Arm B (Discontinue Triple ARVs)0.25

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Antepartum Component: Number of Infant HIV Infections

Detected by HIV NAT positivity (NCT01061151)
Timeframe: Measured at the birth (<= 3 days postpartum) visit

InterventionParticipants (Count of Participants)
Antepartum Arm A22
Antepartum Arm B4
Antepartum Arm C2

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Antepartum Component: Number of Confirmed Infant HIV Infections

Defined as HIV nucleic acid test (NAT) positivity of the specimen drawn at either the birth (Day 0-5) or Week 1 (Day 6-14) visit, confirmed by HIV NAT positivity of a second specimen collected at a different time point (NCT01061151)
Timeframe: Measured at birth or Week 1 study visit

InterventionParticipants (Count of Participants)
Antepartum Arm A25
Antepartum Arm B7
Antepartum Arm C2

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Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)

Composite outcome (NCT01061151)
Timeframe: Measured at birth

InterventionParticipants (Count of Participants)
Period 2
Antepartum Arm C111

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Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)

Composite outcome (NCT01061151)
Timeframe: Measured at birth

,
InterventionParticipants (Count of Participants)
Periods 1 and 2Period 2
Antepartum Arm A38991
Antepartum Arm B563123

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Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events

These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit

InterventionParticipants (Count of Participants)
Period 2
Antepartum Arm C60

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Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events

These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit

,
InterventionParticipants (Count of Participants)
Periods 1 and 2Period 2
Antepartum Arm A26159
Antepartum Arm B31861

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Antepartum Component: Number of Mothers With Obstetrical Complications

"Complications included deaths, diagnoses, signs/symptoms, chemistry lab tests, or hematological lab tests, with grades of 3 (Severe) or worse. Obstetrical complications were those classified by the MedDra coding system as Pregnancy, puerperium and perinatal conditions, except if the condition was the death of the fetus: Abortions not specified as induced or spontaneous, Abortions spontaneous, or Stillbirth and foetal death." (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit

InterventionParticipants (Count of Participants)
Period 2
Antepartum Arm C23

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Antepartum Component: Number of Mothers With Obstetrical Complications

"Complications included deaths, diagnoses, signs/symptoms, chemistry lab tests, or hematological lab tests, with grades of 3 (Severe) or worse. Obstetrical complications were those classified by the MedDra coding system as Pregnancy, puerperium and perinatal conditions, except if the condition was the death of the fetus: Abortions not specified as induced or spontaneous, Abortions spontaneous, or Stillbirth and foetal death." (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit

,
InterventionParticipants (Count of Participants)
Periods 1 and 2Period 2
Antepartum Arm A8920
Antepartum Arm B7512

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Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)

For overall survival, failure was defined to be death. For HIV-free survival, failure was defined to be either death or developing HIV. The probability of living, or living without HIV infection, at 104 weeks was calculated by Kaplan-Meier estimation of the survival function. (NCT01061151)
Timeframe: Measured from birth through 104 weeks of age

InterventionProportional probability (Number)
Overall survival, period 2 groupHIV-free survival, period 2 group
Antepartum Arm C0.9420.921

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Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures

"Adherence is by maternal report; adherence through hair analysis is not included here.~The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since adherence was not a focus of the study." (NCT01061151)
Timeframe: Week 6 visit (14 days - 9 weeks postpartum); Week 14 visit (10-19 weeks postpartum); Week 26 visit (20 to 31 weeks postpartum); Week 50 visit (44 to 55 weeks postpartum); and Week 74 visit (68 to 80 weeks postpartum).

InterventionParticipants (Count of Participants)
Week 6 visit72329524Week 6 visit72329525Week 14 visit72329524Week 14 visit72329525Week 26 visit72329524Week 26 visit72329525Week 50 visit72329524Week 50 visit72329525Week 74 visit72329524Week 74 visit72329525
Missed dose over 1 month agoNever missed a doseMissed dose 2-4 weeks agoMissed dose within last 2 weeks
Postpartum Arm A (Maternal Prophylaxis)1003
Postpartum Arm B (Infant Prophylaxis)1104
Postpartum Arm A (Maternal Prophylaxis)12
Postpartum Arm A (Maternal Prophylaxis)17
Postpartum Arm B (Infant Prophylaxis)4
Postpartum Arm A (Maternal Prophylaxis)140
Postpartum Arm B (Infant Prophylaxis)74
Postpartum Arm A (Maternal Prophylaxis)956
Postpartum Arm B (Infant Prophylaxis)1081
Postpartum Arm A (Maternal Prophylaxis)20
Postpartum Arm B (Infant Prophylaxis)0
Postpartum Arm A (Maternal Prophylaxis)35
Postpartum Arm A (Maternal Prophylaxis)112
Postpartum Arm B (Infant Prophylaxis)50
Postpartum Arm A (Maternal Prophylaxis)888
Postpartum Arm B (Infant Prophylaxis)1035
Postpartum Arm A (Maternal Prophylaxis)48
Postpartum Arm A (Maternal Prophylaxis)31
Postpartum Arm B (Infant Prophylaxis)8
Postpartum Arm A (Maternal Prophylaxis)103
Postpartum Arm B (Infant Prophylaxis)47
Postpartum Arm A (Maternal Prophylaxis)716
Postpartum Arm B (Infant Prophylaxis)841
Postpartum Arm A (Maternal Prophylaxis)37
Postpartum Arm A (Maternal Prophylaxis)34
Postpartum Arm B (Infant Prophylaxis)7
Postpartum Arm A (Maternal Prophylaxis)64
Postpartum Arm B (Infant Prophylaxis)30
Postpartum Arm A (Maternal Prophylaxis)311
Postpartum Arm B (Infant Prophylaxis)377
Postpartum Arm A (Maternal Prophylaxis)15
Postpartum Arm B (Infant Prophylaxis)2
Postpartum Arm B (Infant Prophylaxis)1
Postpartum Arm B (Infant Prophylaxis)9

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Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery

Analysis used the principle of intent to treat. (NCT01061151)
Timeframe: Measured at the time of delivery

InterventionParticipants (Count of Participants)Participants (Count of Participants)
Periods 1 and 272329519Periods 1 and 272329520Period 272329520Period 272329519Period 272329521
HIV RNA < 400 copies/mLHIV RNA >= 400 copies/mL
Antepartum Arm A415
Antepartum Arm B1092
Antepartum Arm A929
Antepartum Arm B275
Antepartum Arm A102
Antepartum Arm B259
Antepartum Arm C225
Antepartum Arm A210
Antepartum Arm B62
Antepartum Arm C79

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Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery

Analyses (Kaplan-Meier probabilities) conducted for all individual infants (rather than M-I pair) (NCT01061151)
Timeframe: Measured at 12 and 24 months post-delivery

,
InterventionProbability (Number)
12 months post delivery24 months post delivery
Postpartum Arm A (Maternal Prophylaxis)0.9880.978
Postpartum Arm B (Infant Prophylaxis)0.9890.987

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Postpartum Component: Incidence of Confirmed Infant HIV Infection

Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit (i.e., any visit after the Week 1 [Day 6-14] visit), confirmed by HIV NAT positivity of a second specimen drawn at a different time point. Analyses were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event. (NCT01061151)
Timeframe: Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first

InterventionNew cases per 100 person-years (Number)
Postpartum Arm A (Maternal Prophylaxis)0.56
Postpartum Arm B (Infant Prophylaxis)0.55

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Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)

For overall survival, failure was defined to be death. For HIV-free survival, failure was defined to be either death or developing HIV. The probability of living, or living without HIV infection, at 104 weeks was calculated by Kaplan-Meier estimation of the survival function. (NCT01061151)
Timeframe: Measured from birth through 104 weeks of age

,
InterventionProportional probability (Number)
Overall survival, Periods 1 & 2 group (arms A & B only)Overall survival, period 2 groupHIV-free survival, Periods 1&2 group (arms A&B only)HIV-free survival, period 2 group
Antepartum Arm A0.9590.9510.9370.936
Antepartum Arm B0.9670.9820.9470.940

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Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events

These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first

InterventionNew cases per 100 person-years (Number)
Postpartum Arm A (Maternal Prophylaxis)14.4
Postpartum Arm B (Infant Prophylaxis)14.1

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Percentage of Participants With a Virologic Response at Week 48 - Treated Population

Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 48 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay, in a central laboratory. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ. (NCT01063036)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Entecavir + Tenofovir76.1

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Change From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population

HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in log 10 IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ. Baseline was Day 1, prior to study drug administration. (NCT01063036)
Timeframe: Baseline to Weeks 12, 24, 48, 96

Interventionlog10 IU/mL (Mean)
Week 12 (n=89)Week 24 (n=89)Week 48 (n=88)Week 96 (n=84)
Entecavir + Tenofovir-2.230-2.581-2.829-2.965

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Number of Participants on Treatment With Study Drug With Laboratory Test Abnormalities Meeting Selected Criteria on Treatment - Treated Population

Selected criteria presented in each category. Upper limit of normal among all laboratory ranges (ULN); Baseline (BL); alanine transaminase (ALT); milligram per deciliter (mg/dL); milliliters per minute (mL/min); greater than (>);greater than, equal to (>=); less than (<). Creatinine data presented below were confirmed, ie, at least 2 consecutive values. On-treatment = after Day 1 through last dose of study therapy + 5 days. (NCT01063036)
Timeframe: Day 1 to last dose of study drug plus 5 days; up to Week 96

Interventionparticipants (Number)
ALT > 2*Baseline(N=90)ALT > 3*Baseline(N=90)Total bilirubin >2*Baseline (N=90)Total bilirubin >3*Baseline (N=90)Lipase > 3*Baseline (N=90)Creatinine increase from BL >= 20%(N=91)Creatinine >1.5 mg/dL (N=91)Creatinine clearance < 50 mL/min (N=91)Phosphate < 2.0 mg/dL (N=90)Phosphate < 2.3 mg/dL (N=90)
Entecavir + Tenofovir92113442128

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Number of Participants With Emergence of Genotypic Resistance to Study Drugs at Weeks 48 and 96- Treated Population

Testing of HBV genotype was performed at baseline for all treated patients and for participants at Weeks 48 and 96 with primary non-response or virologic breakthrough. Emergent genotypic resistance to study drugs was defined as follows: Emergent = not detected at baseline; entecavir (ETV) resistance (ETVr): participant's sample was to have rtM204V/I/S and any substitution at rtT184, rtS202, or rtM250; tenofovir (TDF) resistance (TDFr) which was based on adefovir (ADV)-mutations: participant's sample was to have rtA181T/V, rtN236T, or (rtA194T and rtM204V/I/S). Primary non-response was defined as < 1 log10 decrease in HBV DNA from baseline on treatment at or after Week 12. Virologic breakthrough was defined as ≥ 1 log10 increase in HBV DNA over nadir on treatment, either confirmed or last on-treatment followed by discontinuation of study therapy. (NCT01063036)
Timeframe: Baseline to Weeks 48, 96

Interventionparticipants (Number)
Week 48 (n=5)Week 96 (n=7)
Entecavir + Tenofovir00

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Percentage of Participants With a Virologic Response at Week 24 and at Week 96 - Treated Population

Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 24, Week 96 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ. (NCT01063036)
Timeframe: Week 24, Week 96

Interventionpercentage of participants (Number)
Week 24 (n=92)Week 96 (n=92)
Entecavir + Tenofovir64.184.8

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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBsAg-Positive at Baseline

HBsAg seroconversion was defined as being both HBsAg-negative and HBsAb-positive at Weeks 24, 48, and 96 in those participants who had been HBsAg-positive at baseline. Percentage was calculated as number of participants with HBs seroconversion at Weeks 24 and 48 divided by the number of treated participants who were HBsAg-positive at baseline. Positive result for HBsAg was one of the inclusion criteria. Treated participants (HBsAg positive at baseline) were evaluated using NC=F. The method used was an Immunoassay testing - ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma [potassium ethylenediaminetetraacetic acid (EDTA), lithium or sodium heparinized]. Baseline was Day 1, before start of study drug. (NCT01063036)
Timeframe: Baseline, Weeks 24, 48, and 96

Interventionpercentage of participants (Number)
Week 24 (n=92)Week 48 (n=92)Week 96 (n=92)
Entecavir + Tenofovir1.101.1

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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 24, 48, 96 - Treated Population Who Were HBsAg-Positive at Baseline

Loss of HBsAg was defined as being HBsAg-negative at Weeks 24, 48, 96 in those participants who had been HBsAg-positive at baseline. The method used: Immunoassay - ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma (potassium ethylene diamine tetraacetic acid, lithium or sodium heparinized). Percentage calculated as number of participants with a HBsAg loss at Weeks 24, 48, and 96 divided by the number of treated participants who were HBsAg-positive at baseline (participants were not enrolled into the study unless they were positive for HBsAg). Treated participants (HBsAg-positive at baseline) were evaluated using NC=F. Baseline was Day 1, before start of study drug. (NCT01063036)
Timeframe: Baseline, Weeks 24, 48, 96

Interventionpercentage of participants (Number)
Week 24 (n=92)Week 48 (n=92)Week 96 (n=92)
Entecavir + Tenofovir1.102.2

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Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline

Loss of HBeAg was defined as being HBeAg-negative at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline. Method used for HBeAg was DiaSorin - Anti HBe enzyme immunoassay kit - procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples. Percentage was calculated as number of participants with HBeAg loss at Weeks 24 and 48 divided by the number of treated participants who were HBeAg-positive at baseline. Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug. (NCT01063036)
Timeframe: Baseline to Weeks 24, 48, and 96

Interventionpercentage of participants (Number)
Week 24 (n=56)Week 48 (n=56)Week 96 (n=56)
Entecavir + Tenofovir3.65.48.9

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Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population

HBV DNA less than (<) LLD (6 IU/mL) was defined/measured by the COBAS(REGISTERED) TaqMan HPS assay at Weeks 24, 48, and 96. Percentage was calculated as number of participants with HBV DNA < LLD at Weeks 24, 48, 96 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). (NCT01063036)
Timeframe: Weeks 24, 48, 96

Interventionpercentage of participants (Number)
Week 24 (n=92)Week 48 (n=92)Week 96 (n=92)
Entecavir + Tenofovir12.018.516.3

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Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline

HBe seroconversion was defined as being both HBeAg-negative and HBeAb-positive at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline. Method used was DiaSorin - Anti HBe enzyme immunoassay kit - procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples. Percentage was calculated as number of participants with HBe seroconversion at Weeks 24, 48, and 96 divided by the number of treated participants who were HBeAg-positive at baseline. Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug. (NCT01063036)
Timeframe: Baseline, Weeks 24, 48, and 96

Interventionpercentage of participants (Number)
Week 24 (n=56)Week 48 (n=56)Week 96 (n=56)
Entecavir + Tenofovir3.63.61.8

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Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) on Treatment, and Discontinuation of Study Drug Due to Adverse Events (AE) - Treated Population

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. On-treatment = on Day 1 through last dose of study therapy + 5 days. (NCT01063036)
Timeframe: Day 1 to last dose of study drug plus 5 days; up to Week 96

Interventionparticipants (Number)
Treatment emergent SAEDiscontinuation of treatment due to AE
Entecavir + Tenofovir61

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Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)

Abstinence will be measured using thrice weekly urine drug screens and self-report (NCT01140880)
Timeframe: Thrice-weekly for 8 weeks

InterventionStimulant-free urinalyses (Mean)
Contingency Management8.9
Yoked Contingency Management6.0

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Course Completion

PEP course completion is a dichotomous variable (0 = Not completed; 1 = Completed) that indicates whether the participant maintained sufficient adherence to the Truvada regimen to receive all 28 doses of the medication. Note: Missing 3 Truvada doses in a row terminated the PEP-intervention and prevented Course Completion. (NCT01140880)
Timeframe: 28-days post initiation

Interventionparticipants (Number)
Contingency Management12
Yoked Contingency Management4

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Medication Adherence

Adherence to Truvada medication (if initiated) as assessed by self-report and pill count. (NCT01140880)
Timeframe: Daily throughout medication course

Interventionproportion (Number)
Contingency Management0.75
Yoked Contingency Management0.45

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Time From Exposure to Truvada Initiation

Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen. (NCT01140880)
Timeframe: 6-month follow-up

Interventionhours (Mean)
Contingency Management32.8
Yoked Contingency Management33.0

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Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART.

The level of HIV Provirus in CD4 T cells obtained from peripheral blood at 48 weeks compared to baseline. A quantitative HIV PCR assay was done. The mean/median values from the standard HAART group is compared to the intensive HAART treatment regimen. (NCT01154673)
Timeframe: Baseline to Week 48

InterventionHIV DNA copies/ million CD4 cells (Median)
Intensive HAART279
Placebo Arm244

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The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment

To assess the rate of neuropsychiatric and central nervous system (CNS) toxicity as measured from baseline to 4 weeks of raltegravir therapy as measured by sleep questionnaire & CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale) (NCT01195467)
Timeframe: 4 weeks

Interventionpercentage improvement in CNS score (Number)
Single Arm26

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The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment

"The rate of neuropsychiatric and central nervous system (CNS) toxicity as measured after 12 weeks of raltegravir therapy as measured by :~Sleep questionnaire~CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)" (NCT01195467)
Timeframe: baseline to week 12

Interventionpercentage of improvement in sleep score (Number)
Single Arm25

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Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study

(NCT01214759)
Timeframe: 28 days

Interventionparticipants (Number)
Truvada and Raltegravir85

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Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months

This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV. (NCT01214759)
Timeframe: 6 months

Interventionparticipants (Number)
Truvada and Raltegravir0

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Number of Participants With Abnormalities in Laboratory Test Results

PreRX=pretreatment; ULN=upper limit of normal. Neutrophils, (absolute), low (10*3 c/uL): <0.85*PreRx, if PreRx <1.5; <1.5 if PreRx ≥1.5. Alanine aminotransferase, high (U/L): >1.25*PreRx if PreRx >ULN; >1.25*ULN if PreRx ≤ULN. Bilirubin, direct (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN. Bilirubin, total (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN. (NCT01232127)
Timeframe: Days 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.

,,
InterventionParticipants (Number)
WBC differential count (low)Neutrophils (absolute) (low)Alanine aminotransferase (high)Aspartate aminotransferase (high)Bilirubin, direct (high)Bilirubin, total (high)
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI100013
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)011007
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)000105

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Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir

(NCT01232127)
Timeframe: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.

,,
InterventionHours (Median)
Atazanavir TmaxRitonavir Tmax
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI3.04.0
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)3.04.00
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)3.04.0

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Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest

An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT01232127)
Timeframe: Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.

,,
InterventionParticipants (Number)
DeathsSAEsAEs leading to discontinuationAEsAEs of clinical interest: NauseaAEs of clinical interest: Diarrhea
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI000600
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)000723
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)000500

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Number of Participants With Abnormalities in Vital Signs

Vital signs include temperature, respiratory rate, seated blood pressure, and heart rate. (NCT01232127)
Timeframe: Days 1, 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.

InterventionParticipants (Number)
Isolated decrease in heart rateSporadic respiration rate >16 bpm
All Treated211

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Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings

ECG findings include heart rate, ECG intervals (including PR, QRS, QT, and corrections to QT using both Bazett's and Fridericia's formulae), and Investigator-identified ECG abnormalities. (NCT01232127)
Timeframe: Days 1 and 25 (end of study) and at study discharge for those who discontinued prematurely.

InterventionParticipants (Number)
Nonspecific ST/T wave abnormalityShort PR interval
All Treated11

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Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir

(NCT01232127)
Timeframe: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.

,,
Interventionng/mL (Geometric Mean)
Atazanavir CmaxAtazanavir CtroughRitonavir CmaxRitonavir Ctrough
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI3512496114145.8
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)4131602114849.2
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)3322494109647.3

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Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir

(NCT01232127)
Timeframe: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.

,,
Interventionng*h/mL (Geometric Mean)
Atazanavir AUCRitonavir AUC
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI325627317
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)378947430
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)314817052

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Change in Flow-mediated Dilation (FMD) of the Brachial Artery

Change in FMD is a measure of change in endothelial function (NCT01270802)
Timeframe: Baseline and 24 weeks

Intervention% change from baseline (Mean)
Continued Tenofovir/Emtricitabine/Efavirenz-0.67
Switch to Tenofovir/Emtricitabine Plus Raltegravir-0.1

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Change in Serum Levels of Vitamin D

Change in serum levels of 24-OH-vitamin D provide a measure of the amount of change in vitamin D in the body (NCT01270802)
Timeframe: Baseline and 24 weeks

Interventionng/mL (Mean)
Continued Tenofovir/Emtricitabine/Efavirenz0.06
Switch to Tenofovir/Emtricitabine Plus Raltegravir0.14

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Number of Participants Reporting Suggestions Regarding Ease of Use or Comfort

"Participants were asked if they could suggest ways that would make each applicator easier or more comfortable to use. Response categories were yes and no. If yes, participants were asked to describe how they would make the applicator easier and/or more comfortable to use." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)

,
Interventionparticipants (Number)
YesNo
Prefilled Applicator520
User-Filled Applicator718

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Number of Participants Reporting Applicator Preference (User-filled or Prefilled) Across a Variety of Factors

"Participants were asked about their preference for either the user-filled or prefilled applicator with regard to several use factors as well as in relation to disposal, storage, and overall comfort and preference.~Response categories included user-filled, prefilled, and same." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)

,,
Interventionresponses (Number)
Ease of useEase of insertionEase of dispensing gelEase of disposalEase of storageOverall comfortOverall applicator preference
Prefilled Applicator111080161010
Same4396640
User-Filled Applicator101281931115

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Number of Participants Reporting Applicator Easy to Insert

"Participants were asked to describe the insertion of the applicator into the vagina for each applicator (user-filled and prefilled).~Response categories included easy, moderately difficult, and difficult." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)

,
Interventionparticipants (Number)
EasyModerately difficultDifficult
Prefilled Applicator2230
User-Filled Applicator2122

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Number of Participants Reporting Applicator Easy to Fill

"Participants were asked to describe the process of filling the user-filled applicator.~Response categories included easy, moderately difficult, and difficult.~Since ease of filling only applies to the user-filled applicator, this question was not applicable for the prefilled applicator." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)

Interventionparticipants (Number)
EasyModerately difficultDifficult
User-Filled Applicator2500

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Number of Participants Reporting That They Would Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention

"Participants were asked if they would use the user-filled applicator in the future if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)

Interventionparticipants (Number)
YesNoIn some circumstances
Entire Study Population2401

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Number of Colposcopic Findings (Baseline and After One Week of Product Use)

Comparison of colposcopic findings between baseline visits and after one week of twice-daily application of Tenofovir 1% gel with either a user-filled or prefilled applicator (NCT01283555)
Timeframe: 7 days

,
Interventioncolposcopic findings (Number)
PetechiaeLaceration external genitaliaPeeling cervic or vaginaPetechiae (iatrogenic)Ecchymosis left lateral vaginal wall (iatrogenic)
Baseline Colposcopic Findings32111
Colposcopic Findings After 7 Days of Product Use00310

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Number of Respondents Reporting Confidence With Filling the User-filled Applicator

"Participants were asked when using the user-filled applicator, how confident did they feel that they at inserted the correct amount of gel into the applicator.~Response categories included very confident, confident, and not confident.~(Note: this question does not apply to the prefilled applicator.)" (NCT01283555)
Timeframe: Final study visit (after completing both study arms)

Interventionparticipants (Number)
Very confidentConfidentNot confident
User-Filled Applicator4210

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Reasons Given by Participants for Knowing When the Applicator Was Filled Correctly

"Participants were asked how did they know when the applicator was filled correctly (that is, with the right amount of gel). More than one answer was allowed.~Response categories included plunger automatically stopped, the 'FULL' line was reached, and other.~Note: this question does not apply to the prefilled applicator." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)

Interventionparticipants (Number)
Plunger automatically stoppedThe fill line/arrow was reachedOther
User-Filled Applicator9182

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Number of Participants Reporting That Both Applicators Were Acceptable

"Participants were asked if both applicators were acceptable to them. Responses were either yes or no." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)

Interventionparticipants (Number)
YesNo
Entire Study Population241

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Filling Precision (5% Range)

A 5% range was calculated around the average filled volumes to determine how many applicators were filled within this range (+/-5% of average volume) (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use

Interventiondoses (Number)
User-Filled Applicator69
Prefilled Applicator75

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Filling Precision (10% Range)

A 10% range was calculated around the average filled volumes to determine how many applicators were filled within this range (+/-10% of average volume) (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use

Interventiondoses (Number)
User-Filled Applicator74
Prefilled Applicator75

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Number of Participants Reporting That the Instructions for Use Were Helpful

"For each applicator type, participants were asked if the instructions were helpful to you.~Response categories were yes and no." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)

,
Interventionparticipants (Number)
YesNo
Prefilled Applicator250
User-Filled Applicator250

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Filled Volume

At each dose delivery visit, the applicator was weighed, prior to vaginal insertion. For the user-filled applicator, the participant handed the applicator to the investigator after filling with gel from the multidose tube. The applicator was then weighed and returned to the participant for insertion. For the prefilled applicator, the participant inserted the plunger into the barrel, and then handed the applicator to the investigator for weighing. (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use

Interventionml (Mean)
User-Filled Applicator4.22
Prefilled Applicator4.11

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Dosing Volume (Expressed Volume)

At each dose delivery visit, the applicator was weighed prior to vaginal insertion and after use. The volume of gel expressed was measured using the following data: weight of filled applicator, weight of emptied applicator, the average weight of an empty applicator, and gel density. (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use

Interventionml (Mean)
User-Filled Applicator3.83
Prefilled ApplicatorNA

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Dosing Precision, 5% (Expressed Volume)

A 5% range was calculated around the average expressed volume of 3.83ml to determine how many applicators delivered a dose within this range (+/-5% of average volume) (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use

Interventiondoses (Number)
User-Filled Applicator48
Prefilled ApplicatorNA

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Dosing Precision, 10% (Expressed Volume)

A 10% range was calculated around the average expressed volume of 3.83ml to determine how many applicators delivered a dose within this range (+/-10% of average volume) (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use

Interventiondoses (Number)
User-Filled Applicator64
Prefilled ApplicatorNA

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Filling Accuracy (% of Target Dose)

The target dose for Tenofovir gel in this study was 4.0ml, which is the volume of Tenofovir being used in current microbicide clinical trials. The filled volume for each applicator was compared with the intended target dose of 4.0ml. (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use

Intervention% of target dose filled into applicator (Number)
User-Filled Applicator105.5
Prefilled Applicator102.8

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Dosing Accuracy (% of Target Dose Delivered)

The target dose for Tenofovir gel in this study was 4.0ml, which is the volume of Tenofovir being used in current microbicide clinical trials. The average dose delivered for each applicator was compared with the intended target dose of 4.0ml. (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use

Interventionpercent of target dose delivered (Number)
User-Filled Applicator96
Prefilled ApplicatorNA

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Number of Participants Reporting That the Gel Was Easy to Dispense

"Participants were asked to describe the dispensing of the gel into the vagina with each applicator (user-filled and prefilled).~Response categories included easy, moderately difficult, and difficult." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)

,
Interventionparticipants (Number)
EasyModerately difficultDifficult
Prefilled Applicator2320
User-Filled Applicator2410

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Number of Participants Reporting That They Would Not Want to Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention

"Participants were asked if there were any reasons that they would not want to use this user-filled applicator in the future if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)

Interventionparticipants (Number)
YesNoIn some circumstances
Entire Study Population2230

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Number of Participants Reporting That They Would Recommend the User-filled Applicator for HIV Prevention

"Participants were asked if they would recommend the user-filled applicator to other women if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)

Interventionparticipants (Number)
YesNoIn some circumstances
Entire Study Population2500

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Number of Participants Reporting That the Cost of the Applicator Would Influence Their Choice of Applicator

"Participants were asked if the cost of the applicator would influence their choice of applicator.~Response categories were yes, no, and maybe." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)

Interventionparticipants (Number)
YesNoMaybe
Entire Study Population6127

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Number of Participants Reporting That Applicator Was Comfortable to Use

"Participants were asked to describe the comfort of use for each applicator type(user-filled and prefilled).~Response categories included comfortable, neutral, and uncomfortable." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)

,
Interventionparticipants (Number)
ComfortableNeutralUncomfortable
Prefilled Applicator2050
User-Filled Applicator1960

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HCV RNA

HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg. (NCT01285050)
Timeframe: 48 hours after interferon administration

Interventionlog IU/ml (Median)
Pre ART HCV RNA Decline0.65
Post ART HCV Decline0.81

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Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240

HBsAg loss is defined as a negative HBsAg result for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240. (NCT01300234)
Timeframe: Weeks 24, 48, 96, 144, 192 and 240

,
InterventionParticipants (Number)
Week 24, HBsAg lossWeek 24, HBsAg seroconversionWeek 48, HBsAg lossWeek 48, HBsAg seroconversionWeek 96, HBsAg lossWeek 96, HBsAg seroconversionWeek 144, HBsAg lossWeek 144, HBsAg seroconversionWeek 192, HBsAg lossWeek 192, HBsAg seroconversionWeek 240, HBsAg lossWeek 240, HBsAg seroconversion
ADV-TDF000000110000
TDF-TDF000000000000

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Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2.

Histological improvement is defined as a reduction of >=2 points in the KNS with no increase in fibrosis at Week 48 and Week 240 in participants with Baseline KNS >=2 which was derived from the American Association for the Study of Liver Diseases Practice Guidelines for Management of Chronic Hepatitis B (2009) and the European Association for the Study of the Liver Clinical Practice Guidelines Management of chronic hepatitis B virus infection (2012). The Knodell scale consists of 5 domains: periportal +/- bridging necrosis (scored from best to worst: 0, 1, 3, 4, 5, 6, or 10); intralobular degeneration and focal necrosis (0 to 4); portal inflammation (0 to 4); and fibrosis (0 to 4). The necroinflammatory score (ranging from 0 [best] to 14 [worst]) is the combined score for necrosis (0 to 10) plus inflammation (0 to 4; the participant is scored for only one inflammatory condition). Liver biopsy slides within 6 months prior to randomization could be accepted as Baseline evaluation. (NCT01300234)
Timeframe: Baseline; Week 48 and Week 240

,
InterventionParticipants (Number)
Week 48, HBeAg-positive, n=38, 49Week 48, HBeAg-negative, n=45, 50Week 240, HBeAg-positive, n=38, 49Week 240, HBeAg-negative, n=45, 50
ADV-TDF393424
TDF-TDF313258

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Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48

"The number of participants with Hepatitis B Virus (HBV) deoxyribonucleic acid (DNA) <400 copies/milliliter (mL) at Week 48 in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed." (NCT01300234)
Timeframe: Week 48

,
InterventionParticipants (Number)
HBeAg-positive, n=103, 99HBeAg-negative, n=154, 153
ADV 10 mg18109
TDF 300 mg79149

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Number of Participants in the Indicated Category for Renal Laboratory Abnormalities

"The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was used for grading. Confirmed is defined as two consecutive visits. mg=milligrams. dL=deciliter, G= Grade." (NCT01300234)
Timeframe: Up to Week 240

,
InterventionParticipants (Number)
Creatinine increase of 0.5 mg/dL above BaselineConfirmed creatinine >=2.0 mg/dLConfirmed clearance <50 milliliters/minuteConfirmed phosphorus G 3/4 abnormality, <2.0 mg/dL
ADV-TDF0000
TDF-TDF1003

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Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs)

TE grade 3 or grade 4 LAs are defined as values that increase by >=1 grade from Baseline (Day 0) to Grade 3 (severe) or 4 (potentially life threatening) at any post-Baseline value. The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was referred for grading. Laboratory parameters assessed included Sodium for hyponatremia and hypernatremia; Potassium for hypokalemia and hyperkalemia; glucose for hypoglycemia and hyperglycemia non-fasting; Phosphate for hypophosphatemia; alanine aminotransferase/aspartate aminotransferase, bilirubin, creatinine kinase, hemoglobin, platelets, neutrophils, lymphocytes, prothrombin time and amylase. (NCT01300234)
Timeframe: Up to Week 240

,
Interventionparticipants (Number)
SodiumPhosphateAlanine aminotransferaseAspartate aminotransferaseBilirubinCreatine kinaseHemoglobinPlateletsNeutrophilsProthrombin timePotassiumGlucoseLymphocytesAmylase
ADV-TDF0314614534170232
TDF-TDF22191016446101121

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Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240

"The number of participants with HBV DNA <400 copies/mL in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. Week 96, 144, 192, and 240 data are not yet available, as this report includes data up to and including Week 48. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed." (NCT01300234)
Timeframe: Weeks 96, 144, 192, and 240

,
InterventionParticipants (Number)
Week 96, HBeAg-positive, n=103, 99Week 96, HBeAg-negative, n=154, 153Week 144, HBeAg-positive, n=103, 99Week 144, HBeAg-negative, n=154,153Week 192, HBeAg-positive, n=103,99Week 192,HBeAg-negative, n=154,153Week 240, HBeAg-positive, n=103,99Week 240, HBeAg-negative, n=154,153
ADV-TDF92143951459314187137
TDF-TDF95144971449414487138

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Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is Grade 4 (life threatening or disabling). Participants with any non-serious AEs and SAEs has been reported. (NCT01300234)
Timeframe: Up to Week 240 treatment period and 24 weeks follow-up visit off treatment

,
InterventionParticipants (Number)
Non-serious AESAE
ADV-TDF12120
TDF-TDF14012

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Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus

The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was referred for grading. Serum creatinine: Grade 1, > 133 to 177 micromoles per Liter (µmoles/Liter), Grade 2, >177 to 265 µmoles/Liter, Grade 3, >265 to 530 µmoles/Liter, Grade 4, >530 µmoles/Liter. Serum phosphorus: Grade 2, 0.63 to <0.80 millimoles per Liter (mmoles/L), Grade 3, 0.31 to <0.63 mmoles/L, Grade 4, <0.31 mmoles/L. The normal range for serum phosphorus was 0.8 to 1.45 mmoles/L; the upper limit for a Grade 2 abnormality is 0.80 mmoles/L. Therefore, no Grade 1 abnormalities could be attributed, as values were contained within the normal range. NA indicates the value was not available for the indicated time point. (NCT01300234)
Timeframe: Up to Week 240

,
InterventionParticipants (Number)
Serum creatinine, Grade 1Serum creatinine, Grade 2Serum creatinine, Grade 3Serum creatinine, Grade 4Serum phosphorus, Grade 1Serum phosphorus, Grade 2Serum phosphorus, Grade 3Serum phosphorus, Grade 4
ADV-TDF1000NA5530
TDF-TDF0000NA4220

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Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240

"The number of HBeAg-positive and HBeAg-negative participants who had virological breakthrough at Weeks 48, 96, 144, 192 and 240 were assessed. Virological breakthrough is defined by >= one log increase in HBV DNA from NADIR (as determined by two sequential HBV DNA measurements at least one month apart or last on treatment measurement). A non-completers equal failures approach was used for the analysis in ITT population." (NCT01300234)
Timeframe: Weeks 48, 96, 144, 192 and 240

,
InterventionParticipants (Number)
Week 48,HBeAg-Positive, n=103, 99Week 48, HBeAg-Negative, n=154, 153Week 96, HBeAg-positive, n=103, 99Week 96, HBeAg-negative, n=154, 153Week 144, HBeAg-positive, n=103, 99Week 144, HBeAg-negative, n=154, 153Week 192, HBeAg-positive, n=103, 99Week 192, HBeAg-negative, n=154, 153Week 240, HBeAg-positive, n=103, 99Week 240, HBeAg-negative, n=154, 153
ADV-TDF42437475118
TDF-TDF0002030343

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Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240

"Change from Baseline of log 10 copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 in the HBeAg-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually a negative result indicates that the participant has lower levels of virus in the blood and less infectious. Values at Day 0 were considered as Baseline values. Change from Baseline was calculated as post Baseline values minus Baseline values. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed." (NCT01300234)
Timeframe: Baseline, Weeks 48, 96, 144, 192 and 240

,
Interventionlog10 copies/mL (Mean)
Week 48,HBeAg-positive, n=102, 97Week 48,HBeAg-negative, n=151, 148Week 96, HBeAg-positive, n=101, 97Week 96, HBeAg-negative, n=147,148Week 144, HBeAg-postive, n=100, 96Week 144, HBeAg-negative, n=145, 146Week 192, HBeAg-positive, n=97,93Week 192, HBeAg-negative, n=145,145Week 240, HBeAg-positive, n=91,90Week 240, HBeAg-negative, n=138,138
ADV-TDF-4.4-4.3-6.5-4.8-6.5-4.9-6.6-4.8-6.5-4.9
TDF-TDF-6.4-4.9-6.5-4.9-6.6-4.9-6.6-4.9-6.6-4.9

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Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline

"Participants who had abnormal ALT at Baseline and had normalized ALT at Weeks 48, 96, 144, 192 and 240 were assessed. This report includes data up to and including Weeks 48, 96, 144, 192 and 240. An increased level of ALT is referred to as abnormal ALT (the normal range is 0 to 48 units per liter [U/L]). Values at Day 0 were considered as Baseline values. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed." (NCT01300234)
Timeframe: Baseline; Weeks 48, 96, 144, 192 and 240

,
InterventionParticipants (Number)
Week 48, HBeAg-positive, n=102, 97Week 48, HBeAg-negative, n=136, 132Week 96, HBeAg-positive, n=102, 97Week 96, HBeAg-negative, n=136,132Week 144, HBeAg-positive, n=102, 97Week 144, HBeAg-negative, n=136, 132Week 192, HBeAg-positive, n=102, 97Week 192, HBeAg-negative, n=136,132Week 240, HBeAg-positive, n=102, 97Week 240, HBeAg-negative, n=136,132
ADV-TDF8311688118871197911880111
TDF-TDF8812093126921238912582119

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Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240

"Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart from Week 96 to 240. This report includes data up to and including Week 240. A non-completers equal failures approach was used for the analysis in ITT population." (NCT01300234)
Timeframe: Week 96 to Week 240

,
InterventionParticipants (Number)
HBeAg-positive, n= 88, 90HBeAg-negative, n = 132, 137
ADV-TDF01
TDF-TDF10

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Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48

"Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart. This report includes data up to and including Week 48. A non-completers equal failures approach was used for the analysis in ITT population." (NCT01300234)
Timeframe: Week 24 to Week 48

,
InterventionParticipants (Number)
HBeAg-positive, n =100, 97HBeAg-negative, n=150, 147
ADV 10 mg00
TDF 300 mg00

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Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240

HBsAg loss is defined as negative HBsAg results for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240. (NCT01300234)
Timeframe: Weeks 24, 48, 96, 144, 192 and 240

,
InterventionParticipants (Number)
Week 24, HBsAg lossWeek 24, HBsAg seroconversionWeek 48, HBsAg lossWeek 48, HBsAg seroconversionWeek 96, HBsAg lossWeek 96, HBsAg seroconversionWeek 144, HBsAg lossWeek 144, HBaAg seroconversionWeek 192, HBsAg, lossWeek 192, HBsAg, seroconversionWeek 240, HBsAg lossWeek 240 HBsAg seroconversion
ADV-TDF000000000000
TDF-TDF000000101010

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Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240.

HBeAg loss is defined as a negative HBeAg result for those participants who were HBeAg positive at Baseline. Seroconversion to anti-HBe is defined as HBeAg loss and a positive anti-HBe result. This report includes data up to and including Weeks 24, 48, 96, 144, 192 and 240. (NCT01300234)
Timeframe: Weeks 24, 48, 96, 144, 192 and 240

,
InterventionParticipants (Number)
Week 24, HBeAg lossWeek 24, HBeAg seroconversionWeek 48, HBeAg lossWeek 48, HBeAg seroconversionWeek 96, HBeAg lossWeek 96, HBeAg seroconversionWeek 144, HBeAg lossWeek 144, HBeAg seroconversionWeek 192, HBeAg lossWeek 192, HBeAg seroconversionWeek 240, HBeAg lossWeek 240, HBeAg seroconversion
ADV-TDF441092118242031243628
TDF-TDF151418163732373343334333

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A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm

Only the listing of adverse events (AEs) by grade and arm are presented here. See outcome measure 10 for the listing of AE by relationship to study product (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)

InterventionParticipants (Count of Participants)
Blood and lymphatic system disorders : Mild72291137Blood and lymphatic system disorders : Mild72291143Blood and lymphatic system disorders : Mild72291138Blood and lymphatic system disorders : Mild72291139Blood and lymphatic system disorders : Mild72291140Blood and lymphatic system disorders : Mild72291141Blood and lymphatic system disorders : Mild72291142Blood and lymphatic system disorders : Mild72291144Blood and lymphatic system disorders : Mild72291145Cardiac disorders72291137Cardiac disorders72291143Cardiac disorders72291138Cardiac disorders72291139Cardiac disorders72291140Cardiac disorders72291141Cardiac disorders72291142Cardiac disorders72291144Cardiac disorders72291145Ear and labyrinth disorders72291137Ear and labyrinth disorders72291143Ear and labyrinth disorders72291144Ear and labyrinth disorders72291142Ear and labyrinth disorders72291138Ear and labyrinth disorders72291139Ear and labyrinth disorders72291140Ear and labyrinth disorders72291141Ear and labyrinth disorders72291145Eye disorders72291137Eye disorders72291143Eye disorders72291138Eye disorders72291139Eye disorders72291140Eye disorders72291141Eye disorders72291142Eye disorders72291144Eye disorders72291145Gastrointestinal disorders72291137Gastrointestinal disorders72291143Gastrointestinal disorders72291142Gastrointestinal disorders72291138Gastrointestinal disorders72291139Gastrointestinal disorders72291140Gastrointestinal disorders72291141Gastrointestinal disorders72291144Gastrointestinal disorders72291145General disorders and administration site conditio72291137General disorders and administration site conditio72291142General disorders and administration site conditio72291143General disorders and administration site conditio72291140General disorders and administration site conditio72291138General disorders and administration site conditio72291139General disorders and administration site conditio72291141General disorders and administration site conditio72291144General disorders and administration site conditio72291145Hepatobiliary disorders72291137Hepatobiliary disorders72291142Hepatobiliary disorders72291143Hepatobiliary disorders72291138Hepatobiliary disorders72291139Hepatobiliary disorders72291140Hepatobiliary disorders72291141Hepatobiliary disorders72291144Hepatobiliary disorders72291145Immune system disorders72291137Immune system disorders72291142Immune system disorders72291143Immune system disorders72291138Immune system disorders72291139Immune system disorders72291140Immune system disorders72291141Immune system disorders72291144Immune system disorders72291145Infections and infestations72291137Infections and infestations72291142Infections and infestations72291143Infections and infestations72291138Infections and infestations72291139Infections and infestations72291140Infections and infestations72291141Infections and infestations72291144Infections and infestations72291145Injury, poisoning and procedural complications72291137Injury, poisoning and procedural complications72291142Injury, poisoning and procedural complications72291138Injury, poisoning and procedural complications72291139Injury, poisoning and procedural complications72291140Injury, poisoning and procedural complications72291141Injury, poisoning and procedural complications72291143Injury, poisoning and procedural complications72291144Injury, poisoning and procedural complications72291145Investigations72291137Investigations72291142Investigations72291138Investigations72291139Investigations72291140Investigations72291141Investigations72291143Investigations72291144Investigations72291145Metabolism and nutrition disorders72291137Metabolism and nutrition disorders72291142Metabolism and nutrition disorders72291141Metabolism and nutrition disorders72291138Metabolism and nutrition disorders72291139Metabolism and nutrition disorders72291140Metabolism and nutrition disorders72291143Metabolism and nutrition disorders72291144Metabolism and nutrition disorders72291145Musculoskeletal and connective tissue disorders72291137Musculoskeletal and connective tissue disorders72291142Musculoskeletal and connective tissue disorders72291138Musculoskeletal and connective tissue disorders72291139Musculoskeletal and connective tissue disorders72291140Musculoskeletal and connective tissue disorders72291141Musculoskeletal and connective tissue disorders72291143Musculoskeletal and connective tissue disorders72291144Musculoskeletal and connective tissue disorders72291145Nervous system disorders72291137Nervous system disorders72291142Nervous system disorders72291141Nervous system disorders72291138Nervous system disorders72291139Nervous system disorders72291140Nervous system disorders72291143Nervous system disorders72291144Nervous system disorders72291145Pregnancy, puerperium and perinatal conditions72291137Pregnancy, puerperium and perinatal conditions72291142Pregnancy, puerperium and perinatal conditions72291140Pregnancy, puerperium and perinatal conditions72291144Pregnancy, puerperium and perinatal conditions72291141Pregnancy, puerperium and perinatal conditions72291138Pregnancy, puerperium and perinatal conditions72291139Pregnancy, puerperium and perinatal conditions72291143Pregnancy, puerperium and perinatal conditions72291145Psychiatric disorders72291141Psychiatric disorders72291142Psychiatric disorders72291137Psychiatric disorders72291144Psychiatric disorders72291143Psychiatric disorders72291138Psychiatric disorders72291139Psychiatric disorders72291140Psychiatric disorders72291145Renal and urinary disorders72291137Renal and urinary disorders72291142Renal and urinary disorders72291139Renal and urinary disorders72291138Renal and urinary disorders72291140Renal and urinary disorders72291141Renal and urinary disorders72291143Renal and urinary disorders72291144Renal and urinary disorders72291145Reproductive system and breast disorders72291137Reproductive system and breast disorders72291140Reproductive system and breast disorders72291142Reproductive system and breast disorders72291138Reproductive system and breast disorders72291139Reproductive system and breast disorders72291143Reproductive system and breast disorders72291145Reproductive system and breast disorders72291141Reproductive system and breast disorders72291144Respiratory, thoracic and mediastinal disorders72291137Respiratory, thoracic and mediastinal disorders72291142Respiratory, thoracic and mediastinal disorders72291145Respiratory, thoracic and mediastinal disorders72291140Respiratory, thoracic and mediastinal disorders72291138Respiratory, thoracic and mediastinal disorders72291139Respiratory, thoracic and mediastinal disorders72291141Respiratory, thoracic and mediastinal disorders72291143Respiratory, thoracic and mediastinal disorders72291144Skin and subcutaneous tissue disorders72291137Skin and subcutaneous tissue disorders72291138Skin and subcutaneous tissue disorders72291142Skin and subcutaneous tissue disorders72291140Skin and subcutaneous tissue disorders72291139Skin and subcutaneous tissue disorders72291141Skin and subcutaneous tissue disorders72291143Skin and subcutaneous tissue disorders72291144Skin and subcutaneous tissue disorders72291145Social circumstances72291142Social circumstances72291145Social circumstances72291137Social circumstances72291138Social circumstances72291139Social circumstances72291140Social circumstances72291141Social circumstances72291143Social circumstances72291144Vascular disorders72291142Vascular disorders72291137Vascular disorders72291141Vascular disorders72291140Vascular disorders72291144Vascular disorders72291138Vascular disorders72291139Vascular disorders72291143Vascular disorders72291145Neoplasms benign, malignant, and unspecified72291144Neoplasms benign, malignant, and unspecified72291139Neoplasms benign, malignant, and unspecified72291141Neoplasms benign, malignant, and unspecified72291138Neoplasms benign, malignant, and unspecified72291140Neoplasms benign, malignant, and unspecified72291143Neoplasms benign, malignant, and unspecified72291137Neoplasms benign, malignant, and unspecified72291142Neoplasms benign, malignant, and unspecified72291145
SeverePotentically Life ThreateningDeathNoneMildModerate
Daily Dosing, Cape Town1
Time-driven Dosing, Harlem2
Daily Dosing, Cape Town0
Daily Dosing, Cape Town57
Time-driven Dosing, Harlem58
Daily Dosing, Cape Town59
Daily Dosing, Bangkok58
Time-driven Dosing, Harlem60
Time-driven Dosing, Harlem0
Daily Dosing, Cape Town58
Daily Dosing, Cape Town2
Daily Dosing, Cape Town55
Time-driven Dosing, Cape Town57
Event-driven Dosing, Harlem58
Daily Dosing, Cape Town18
Event-driven Dosing, Cape Town18
Time-driven Dosing, Bangkok22
Event-driven Dosing, Bangkok23
Daily Dosing, Harlem28
Time-driven Dosing, Harlem27
Event-driven Dosing, Harlem28
Daily Dosing, Cape Town8
Time-driven Dosing, Cape Town9
Daily Dosing, Bangkok6
Event-driven Dosing, Bangkok0
Daily Dosing, Cape Town33
Time-driven Dosing, Cape Town32
Event-driven Dosing, Cape Town32
Daily Dosing, Bangkok30
Time-driven Dosing, Bangkok35
Event-driven Dosing, Bangkok32
Daily Dosing, Harlem30
Time-driven Dosing, Harlem31
Event-driven Dosing, Harlem31
Daily Dosing, Cape Town9
Daily Dosing, Bangkok10
Time-driven Dosing, Bangkok16
Event-driven Dosing, Bangkok11
Event-driven Dosing, Harlem8
Event-driven Dosing, Cape Town5
Event-driven Dosing, Bangkok1
Daily Dosing, Cape Town50
Time-driven Dosing, Bangkok43
Event-driven Dosing, Bangkok47
Time-driven Dosing, Cape Town58
Time-driven Dosing, Bangkok58
Event-driven Dosing, Bangkok59
Event-driven Dosing, Cape Town58
Time-driven Dosing, Bangkok59
Time-driven Dosing, Harlem59
Event-driven Dosing, Harlem59
Daily Dosing, Cape Town11
Time-driven Dosing, Cape Town10
Event-driven Dosing, Cape Town15
Daily Dosing, Bangkok22
Time-driven Dosing, Bangkok33
Event-driven Dosing, Bangkok28
Daily Dosing, Harlem22
Time-driven Dosing, Harlem21
Event-driven Dosing, Harlem21
Daily Dosing, Cape Town25
Time-driven Dosing, Cape Town25
Event-driven Dosing, Cape Town21
Time-driven Dosing, Bangkok6
Event-driven Dosing, Bangkok10
Event-driven Dosing, Bangkok2
Daily Dosing, Cape Town23
Time-driven Dosing, Cape Town24
Event-driven Dosing, Cape Town24
Daily Dosing, Bangkok27
Time-driven Dosing, Bangkok19
Event-driven Dosing, Bangkok19
Daily Dosing, Harlem37
Time-driven Dosing, Harlem39
Event-driven Dosing, Harlem37
Daily Dosing, Cape Town7
Daily Dosing, Bangkok16
Time-driven Dosing, Bangkok15
Event-driven Dosing, Bangkok14
Daily Dosing, Harlem17
Time-driven Dosing, Harlem18
Event-driven Dosing, Harlem14
Daily Dosing, Cape Town3
Daily Dosing, Cape Town48
Daily Dosing, Bangkok44
Time-driven Dosing, Bangkok41
Event-driven Dosing, Bangkok44
Daily Dosing, Harlem38
Event-driven Dosing, Harlem45
Daily Dosing, Cape Town13
Time-driven Dosing, Cape Town15
Event-driven Dosing, Cape Town13
Daily Dosing, Bangkok18
Time-driven Dosing, Bangkok9
Event-driven Dosing, Bangkok7
Event-driven Dosing, Harlem6
Daily Dosing, Cape Town5
Time-driven Dosing, Cape Town6
Daily Dosing, Bangkok5
Time-driven Dosing, Bangkok2
Event-driven Dosing, Bangkok3
Event-driven Dosing, Harlem2
Daily Dosing, Cape Town41
Time-driven Dosing, Cape Town38
Daily Dosing, Bangkok35
Time-driven Dosing, Bangkok47
Event-driven Dosing, Bangkok48
Daily Dosing, Harlem50
Event-driven Dosing, Cape Town7
Time-driven Dosing, Bangkok1
Daily Dosing, Harlem3
Daily Dosing, Cape Town6
Event-driven Dosing, Cape Town10
Time-driven Dosing, Harlem3
Event-driven Dosing, Harlem4
Time-driven Dosing, Bangkok0
Time-driven Dosing, Cape Town49
Event-driven Dosing, Cape Town43
Event-driven Dosing, Bangkok58
Daily Dosing, Harlem52
Time-driven Dosing, Harlem53
Daily Dosing, Bangkok13
Event-driven Dosing, Bangkok13
Daily Dosing, Harlem13
Time-driven Dosing, Harlem11
Event-driven Dosing, Harlem9
Daily Dosing, Bangkok4
Time-driven Dosing, Cape Town51
Daily Dosing, Bangkok43
Time-driven Dosing, Harlem49
Event-driven Dosing, Harlem51
Daily Dosing, Cape Town17
Time-driven Dosing, Cape Town14
Event-driven Dosing, Cape Town19
Daily Dosing, Bangkok17
Time-driven Dosing, Bangkok18
Event-driven Dosing, Bangkok22
Daily Dosing, Harlem16
Time-driven Dosing, Harlem10
Event-driven Dosing, Harlem17
Daily Dosing, Cape Town15
Event-driven Dosing, Cape Town12
Daily Dosing, Bangkok3
Daily Dosing, Cape Town27
Event-driven Dosing, Cape Town29
Daily Dosing, Bangkok39
Event-driven Dosing, Bangkok36
Daily Dosing, Harlem42
Time-driven Dosing, Harlem47
Event-driven Dosing, Harlem43
Time-driven Dosing, Bangkok10
Event-driven Dosing, Bangkok8
Daily Dosing, Harlem10
Time-driven Dosing, Harlem9
Event-driven Dosing, Cape Town2
Time-driven Dosing, Harlem1
Time-driven Dosing, Cape Town56
Event-driven Dosing, Cape Town56
Daily Dosing, Bangkok52
Time-driven Dosing, Bangkok49
Event-driven Dosing, Bangkok51
Daily Dosing, Harlem46
Time-driven Dosing, Harlem48
Daily Dosing, Cape Town10
Time-driven Dosing, Cape Town11
Event-driven Dosing, Cape Town11
Daily Dosing, Bangkok1
Time-driven Dosing, Bangkok3
Daily Dosing, Harlem12
Time-driven Dosing, Harlem6
Event-driven Dosing, Harlem7
Daily Dosing, Cape Town4
Event-driven Dosing, Cape Town3
Time-driven Dosing, Harlem4
Event-driven Dosing, Harlem1
Daily Dosing, Cape Town45
Time-driven Dosing, Cape Town46
Event-driven Dosing, Cape Town46
Daily Dosing, Bangkok59
Time-driven Dosing, Bangkok55
Event-driven Dosing, Bangkok56
Daily Dosing, Harlem47
Time-driven Dosing, Harlem50
Event-driven Dosing, Harlem52
Time-driven Dosing, Cape Town17
Event-driven Dosing, Cape Town17
Daily Dosing, Harlem1
Event-driven Dosing, Harlem3
Daily Dosing, Cape Town39
Time-driven Dosing, Cape Town34
Event-driven Dosing, Cape Town34
Event-driven Dosing, Bangkok57
Daily Dosing, Harlem58
Event-driven Dosing, Harlem57
Time-driven Dosing, Cape Town5
Event-driven Dosing, Cape Town9
Daily Dosing, Bangkok36
Time-driven Dosing, Bangkok23
Event-driven Dosing, Bangkok29
Daily Dosing, Harlem18
Time-driven Dosing, Harlem19
Event-driven Dosing, Harlem18
Time-driven Dosing, Cape Town2
Daily Dosing, Cape Town49
Time-driven Dosing, Cape Town52
Event-driven Dosing, Cape Town50
Daily Dosing, Bangkok24
Time-driven Dosing, Bangkok36
Daily Dosing, Harlem41
Time-driven Dosing, Harlem41
Event-driven Dosing, Harlem42
Time-driven Dosing, Cape Town8
Event-driven Dosing, Cape Town8
Daily Dosing, Bangkok8
Daily Dosing, Harlem8
Time-driven Dosing, Harlem5
Event-driven Dosing, Harlem5
Event-driven Dosing, Cape Town4
Daily Dosing, Bangkok2
Time-driven Dosing, Cape Town48
Event-driven Dosing, Cape Town48
Daily Dosing, Bangkok50
Time-driven Dosing, Bangkok44
Event-driven Dosing, Bangkok46
Daily Dosing, Harlem51
Time-driven Dosing, Harlem55
Event-driven Dosing, Harlem55
Time-driven Dosing, Cape Town59
Event-driven Dosing, Cape Town60
Daily Dosing, Harlem59
Time-driven Dosing, Cape Town3
Event-driven Dosing, Cape Town1
Daily Dosing, Harlem2
Time-driven Dosing, Cape Town1
Daily Dosing, Bangkok0
Time-driven Dosing, Cape Town0
Event-driven Dosing, Cape Town0
Daily Dosing, Harlem0
Event-driven Dosing, Harlem0
Daily Dosing, Cape Town56
Time-driven Dosing, Cape Town55
Event-driven Dosing, Cape Town59
Daily Dosing, Bangkok60
Daily Dosing, Harlem57
Event-driven Dosing, Harlem60

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Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)

Below we presented the percentages of total cohort with TFV-DP concentrations consistent with >=2 pills/week in women who also report sex in the last 7 day for each arm. For Cape Town and Bangkok, TFV-DP in PBMC was analyzed, for Harlem site, the TFV-DP in DBS (dried blood spot) was analyzed. Note: PBMC >5.2 fmol/10^6 cells is considered as participants taken >=2 tablets per week; DBS >=326 fmol/punch is considered as participants taken >=2 tablets per week (NCT01327651)
Timeframe: week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomization

,,,,,,,,
InterventionParticipants (Count of Participants)
Week 10Week 18Week 30
Daily Dosing, Bangkok312822
Daily Dosing, Cape Town332919
Daily Dosing, Harlem13119
Event-driven Dosing, Bangkok302413
Event-driven Dosing, Cape Town251012
Event-driven Dosing, Harlem533
Time-driven Dosing, Bangkok293018
Time-driven Dosing, Cape Town161613
Time-driven Dosing, Harlem8103

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Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing

"Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as covered if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm." (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)

,,,,,,,,
Interventionpercentage of sexual exposures (Number)
% completely covered% pre-exposure coverage% post-exposure coverage% uncovered
Daily Dosing, Bangkok851113
Daily Dosing, Cape Town752113
Daily Dosing, Harlem662428
Event-driven Dosing, Bangkok741953
Event-driven Dosing, Cape Town523387
Event-driven Dosing, Harlem5229613
Time-driven Dosing, Bangkok841231
Time-driven Dosing, Cape Town563095
Time-driven Dosing, Harlem4730815

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Self-reported Side Effect or Symptom Scores

The self-reported symptom/side effect scores for common symptoms/side effects including headache, dizziness, cramping, abdominal pain, and flatulence. Collected during clinic visits. All the presented numbers are the percent of visits with each side effects (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)

,,,,,,,,
Interventionpercent of visits between week 6 to 30 (Number)
Neurologic side effectGastrointestinal side effects
Daily Dosing, Bangkok14.213.1
Daily Dosing, Cape Town12.410.6
Daily Dosing, Harlem6.18
Event-driven Dosing, Bangkok13.310.5
Event-driven Dosing, Cape Town7.85.4
Event-driven Dosing, Harlem4.57.1
Time-driven Dosing, Bangkok14.38.5
Time-driven Dosing, Cape Town6.08.8
Time-driven Dosing, Harlem3.35.8

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the cross table between drug resistance by arm are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels, and outcome measure 12 for the listing of drug resistance test by arm among all participants who seroconvert while on study. (NCT01327651)
Timeframe: From enrollment to week 30 (end of self-administered dosing)

InterventionParticipants (Count of Participants)
Before Randomization72291147Before Randomization72291146Before Randomization72291148After Randomization (Daily dosing)72291146After Randomization (Daily dosing)72291147After Randomization (Daily dosing)72291148After Randomization (Time-driven dosing)72291147After Randomization (Time-driven dosing)72291146After Randomization (Time-driven dosing)72291148After Randomization (Event-driven dosing)72291147After Randomization (Event-driven dosing)72291146After Randomization (Event-driven dosing)72291148
Drug ResistanceNo Drug Resistance
Cape Town, South Africa1
Bangkok, Thailand0
Harlem, United States1
Cape Town, South Africa190
Bangkok, Thailand193
Harlem, United States237
Harlem, United States0
Cape Town, South Africa59
Bangkok, Thailand60
Harlem, United States59
Cape Town, South Africa58
Harlem, United States60
Cape Town, South Africa0
Cape Town, South Africa60
Bangkok, Thailand59

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

,
Interventionviral load (Number)
EnrollmentWeek 4Week 5Week 6Week 10Week 14Week 18
Harlem, United States, Seroconverted Participant #20000000
Cape Town, South Africa, Seroconverted Participant #60000001

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

,
Interventionviral load (Number)
EnrollmentWeek 4
Cape Town, South Africa, Seroconverted Participant #101
Harlem, United States, Seroconverted Participant #101

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

,,
Interventionviral load (Number)
EnrollmentWeek 4Week 5Week 6Week 10Week 14Week 18Week 22
Cape Town, South Africa, Seroconverted Participant #400000000
Cape Town, South Africa, Seroconverted Participant #500000000
Cape Town, South Africa, Seroconverted Participant #700000000

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
EnrollmentWeek 4Week 5Week 6Week 10Week 14Week 18Week 22Week 26Week 30
Cape Town, South Africa, Seroconverted Participant #80000000000

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
Day 3Week 4Week 6Week 10Week 14Week 18Week 22Week 26Week 30
Bangkok, Thailand, Seroconverted Participant #1407495909296017999501197201273301780709618036140

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
Day 3Week 4Week 5Week 10Week 14Week 18Week 22Week 26Week 30
Cape Town, South Africa, Seroconverted Participant #24003667690393867093040936601145201782108997035210

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
Week 6Week 10Week 14Week 18Week 22
Cape Town, South Africa, Seroconverted Participant #4400400400650400

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
Week 14Week 18Week 22Week 26Week 30
Cape Town, South Africa, Seroconverted Participant #621003710127480220830193130

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
EnrollmentDay 3Week 4Week 5Week 10
Cape Town, South Africa, Seroconverted Participant #12040034605732050416070

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A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm

Only the listing of AE related to study product are presented here. See outcome measure 6 for the listing of adverse events (AEs) by grade and arm. (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)

,,,,,,,,
InterventionParticipants (Count of Participants)
Blood and lymphatic system disordersCardiac disordersEar and labyrinth disordersEye disordersGastrointestinal disordersGeneral disorders and administration site conditioHepatobiliary disordersImmune system disordersInfections and infestationsInjury, poisoning and procedural complicationsInvestigationsMetabolism and nutrition disordersMusculoskeletal and connective tissue disordersNeoplasms benign, malignant, and unspecifiedNervous system disordersPregnancy, puerperium and perinatal conditionsPsychiatric disordersRenal and urinary disordersReproductive system and breast disordersRespiratory, thoracic and mediastinal disordersSkin and subcutaneous tissue disordersSocial circumstancesVascular disorders
Daily Dosing, Bangkok0101910001023020301000200
Daily Dosing, Cape Town000018400131021017031012400
Daily Dosing, Harlem0000133000139400702802101
Event-driven Dosing, Bangkok0000200011010100100200200
Event-driven Dosing, Cape Town000024601271260021011012300
Event-driven Dosing, Harlem1000164000107530503400000
Time-driven Dosing, Bangkok000011100712100200100000
Time-driven Dosing, Cape Town20001710004135001701501500
Time-driven Dosing, Harlem2000139000169500402900200

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
Day 3Week 4Week 5Week 6
Bangkok, Thailand, Seroconverted Participant #27845071015705070

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
Day 3Week 4Week 6
Harlem, United States, Seroconverted Participant #14004090083260

[back to top]

A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

,
Interventionviral load (Number)
Week 26Week 30
Cape Town, South Africa, Seroconverted Participant #350395010910
Cape Town, South Africa, Seroconverted Participant #8400400

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
Week 14Week 18
Harlem, United States, Seroconverted Participant #2156704073030

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
Week 22
Cape Town, South Africa, Seroconverted Participant #55887760

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
EnrollmentWeek 4Week 5Week 6Week 10Week 14Week 18Week 22Week 26
Cape Town, South Africa, Seroconverted Participant #3000000000

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The Total Pills Actually Used Over the Follow-up Period

The total pills actually used over the follow-up period was calculated based on the adjusted electronic and self-reported pill-use data. It could be more or less than required by study design (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)

InterventionNumber of pills actually used (Number)
Daily Dosing, Cape Town7349
Time-driven Dosing, Cape Town2852
Event-driven Dosing, Cape Town2000
Daily Dosing, Bangkok8285
Time-driven Dosing, Bangkok3713
Event-driven Dosing, Bangkok2157
Daily Dosing, Harlem5507
Time-driven Dosing, Harlem2468
Event-driven Dosing, Harlem2356

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
EnrollmentWeek 4Week 5
Bangkok, Thailand, Seroconverted Participant #2000

[back to top]

A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
EnrollmentWeek 4Week 6
Bangkok, Thailand, Seroconverted Participant #1000

[back to top]

A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
EnrollmentWeek 4Week 5Week 6
Cape Town, South Africa, Seroconverted Participant #20000

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The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)

"Below I reported the number of sex acts as reported based on the adjusted electronic and self-reported sexual activity data, also the number of pills needed for 100% coverage. 100% coverage means all sex events (excluding oral sex) are covered; Note: sex act is considered as covered if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity (same coverage definition for all three arms)" (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)

InterventionNumber of pills needed for 100% coverage (Number)
Daily Dosing, Cape Town2097
Time-driven Dosing, Cape Town1552
Event-driven Dosing, Cape Town1906
Daily Dosing, Bangkok1746
Time-driven Dosing, Bangkok1573
Event-driven Dosing, Bangkok1268
Daily Dosing, Harlem1244
Time-driven Dosing, Harlem1390
Event-driven Dosing, Harlem1582

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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study

Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)

Interventionviral load (Number)
Week 18Week 22Week 26Week 30
Cape Town, South Africa, Seroconverted Participant #7830101363102502029390

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Mean Changes in Fasting Lipid Levels From Baseline to Week 48

LD=low-density lipoprotein; HDL=high-density lipoprotein. (NCT01332227)
Timeframe: From Baseline to Week 48

,
Interventionmg/dL (Mean)
Fasting total cholesterolFasting LDL cholesterolFasting HDL cholesterolFasting non-HDL cholesterolFasting triglycerides
Atazanavir/Ritonavir + Raltegravir11.77.72.79.014.7
Atazanavir/Ritonavir + Tenofovir/Emtricitabine-10.2-5.4-0.3-9.8-17.6

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Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24

HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus. (NCT01332227)
Timeframe: From Day 1 to Week 24

InterventionPercentage of participants (Number)
Atazanavir/Ritonavir + Raltegravir80.6
Atazanavir/Ritonavir + Tenofovir/Emtricitabine94.6

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Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48

Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals. (NCT01332227)
Timeframe: From Day 1 to Week 48

InterventionPercentage of participants (Number)
Atazanavir/Ritonavir + Raltegravir69.4
Atazanavir/Ritonavir + Tenofovir/Emtricitabine86.5

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Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48

Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients (NCT01332227)
Timeframe: Day 1 to Week 48

,
InterventionParticipants (Number)
Genotypable (GI)/phenotypable isolates (PI)Emergent genotypic substitutions in GI pts (n=5,0)Phenotypic resistance in PI pts (n=5,0)
Atazanavir/Ritonavir + Raltegravir551
Atazanavir/Ritonavir + Tenofovir/Emtricitabine000

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Number of Participants With Virologic Rebound at Weeks 24 and 48

Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. (NCT01332227)
Timeframe: Day 1 to Weeks 28 and 48

,
InterventionParticipants (Number)
Week 24: Virologic reboundWeek 48: Virologic rebound
Atazanavir/Ritonavir + Raltegravir79
Atazanavir/Ritonavir + Tenofovir/Emtricitabine11

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Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24

Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients (NCT01332227)
Timeframe: Day 1 to Week 24

,
InterventionParticipants (Number)
Genotypable (GI)/phenotypable isolates (PI)Emergent genotypic substitutions in GI pts (n=4,0)Phenotypic resistance in PI pts (n=4,0)
Atazanavir/Ritonavir + Raltegravir441
Atazanavir/Ritonavir + Tenofovir/Emtricitabine000

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Cerebral Function; Changes in Global Cognitive Z-score

"Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir.~Mean Scores from the eight tasks (NPZ-8) assessed were used to derive a global composite measure of neurocognitive function. The result shows the change before and after switch, an increase in z-score represents an improvement in cognitive function assessed by CogState battery, required approximately 10-15 min for completion." (NCT01335620)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Truvada Plus Raltegravir0.91

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Drug Levels in Blood

rategravir concentration (NCT01335620)
Timeframe: Day 28

Interventionng/ml (Geometric Mean)
Truvada Plus Raltegravir1732

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Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22

Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state. (NCT01340196)
Timeframe: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22

Interventionng/mL (Geometric Mean)
Tenofovir/Faldaprevir31000
Faldaprevir40000

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Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15

Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state. (NCT01340196)
Timeframe: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15

Interventionng*h/mL (Geometric Mean)
Tenofovir2700
Tenofovir/Faldaprevir3290

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Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22

Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-12 hours, at steady state. (NCT01340196)
Timeframe: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22

Interventionng*h/mL (Geometric Mean)
Tenofovir/Faldaprevir418000
Faldaprevir523000

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Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG

"Clinical relevant abnormalities for physical examination, vital signs, safety laboratory tests and 12-lead ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.~Preferred term of relevant AE: Presyncope" (NCT01340196)
Timeframe: From drug administration up to 32 days.

Interventionparticipants (Number)
Tenofovir1
Tenofovir/Faldaprevir0
Faldaprevir0

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Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22

Maximum measured concentration of analyte in plasma (Cmax), at steady state. (NCT01340196)
Timeframe: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22

Interventionng/mL (Geometric Mean)
Tenofovir/Faldaprevir41700
Faldaprevir50400

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Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15

Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state. (NCT01340196)
Timeframe: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15

Interventionng/mL (Geometric Mean)
Tenofovir54.0
Tenofovir/Faldaprevir79.4

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Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15

Maximum measured concentration of analyte in plasma (Cmax), at steady state. (NCT01340196)
Timeframe: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00. 192:00 hours on day 15

Interventionng/mL (Geometric Mean)
Tenofovir300
Tenofovir/Faldaprevir284

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The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA).

The relationship of the proportion of participants achieving HIV-1 RNA <50 copies/mL at Week 48 with the screening tropism test for the MVC containing regimen was analyzed. Virologic response for a participant at Week 48 was derived using the FDA's Snapshot MSDF algorithm. Difference in proportions of patients with plasma HIV-1 RNA <50 copies/mL at week 48 between the maraviroc and the emtricitabine/tenofovir treatment arms, with two-sided 95% confidence interval, among patients who are R5 by genotype (including some who were originally randomized to ESTA and are R5 by genotype upon retesting), were calculated via the Maximum Likelihood method. The estimate was adjusted for the screening plasma HIV RNA level (<100,000 vs. ≥100,000) copies/mL via the Mantel Haenszel (MH) method. (NCT01345630)
Timeframe: Week 48

Interventionproportion of participants (Number)
MVC+DRV/r0.8047
FTC/TDF+DRV/r0.8797

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Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria.

For participants meeting the PDTF criteria, viral resistance to maraviroc for maraviroc treated participants was assessed in patients with R5 virus at failure. The resistance level is calculated by reference to a laboratory strain of virus that is analyzed in parallel with the clinical isolate to identify 50% inhibitory concentrations (IC50). The maximal percent inhibition is the percent inhibition that is achieved in a titration of the drug at high concentrations when the addition of more drug does not result in increased inhibition. Maximal percent inhibition is obtained in the same way as the titration for IC50, but the key measure is of the plateau height of percent inhibition, where increased concentration of maraviroc does not result in additional inhibition. This is consistent with the virus developing some ability to use maraviroc-bound CCR5 for entry. A significant change in IC50 is not required for this mechanism. (NCT01345630)
Timeframe: Week 48

,
Interventionparticipants (Number)
Not eligible for analysis (failed tropism test)Not eligible for analysis (non-R5 tropism)Eligible for analysis (R5 virus using ESTA)Results reportedMaximal percent inhibition <95%IC50 FC ≥3.0
FTC/TDF+DRV/r111100
MVC+DRV/r41121200

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Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin

Bone turnover marker, osteocalcin, was collected in the subset of participants participating in the DEXA scan sub-study. (NCT01345630)
Timeframe: Week 48

Interventionng/mL (Mean)
MVC+DRV/r5.61
FTC/TDF+DRV/r6.77

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Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF).

Per the protocol participants who meet the following criteria were regarded as PDTFs requiring a confirmatory plasma HIV-1 RNA determination: • Decrease in plasma HIV-1 RNA <1 log10 from baseline after Week 4 unless plasma HIV-1 RNA is <50 copies/mL, or • Plasma HIV-1 RNA >1.0 log10 above the nadir value after Week 4 where the nadir is the lowest plasma HIV-1 RNA concentration, or • Plasma HIV-1 RNA ≥50 copies/mL at any time after Week 24, or • Plasma HIV-1 RNA ≥50 copies/mL after suppression to <50 copies/mL on two consecutive visits, or • Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <400 copies/mL. Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <50 copies/mL (before August 30 2012) or <400 copies/mL (after August 30 2012). (NCT01345630)
Timeframe: Week 48

,
InterventionNumber of participants (Number)
Confirmed PDTFEvaluable PDTF
FTC/TDF+DRV/r133
MVC+DRV/r4017

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Tropism Change Between Screening or Baseline and PDTF

For participants meeting the PDTF criteria, tropism was assessed using the original randomized and alternate assays (ie, both genotype testing and ESTA). Data reported here corresponds to the timepoint at or after PDTF. (NCT01345630)
Timeframe: Week 48

,,,
Interventionparticipants (Number)
R5 (Randomized Assay)NON R5 (Randomized Assay)NR (Randomized Assay)R5 (Alternate Assay)NON R5 (Alternate Assay)NR (Alternate Assay)
FTC/TDF+DRV/r - Baseline201300
FTC/TDF+DRV/r - Failure102210
MVC+DRV/r - Baseline14121025
MVC+DRV/r - Failure13131034

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Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)

Bone turnover marker, C-telopeptide of type 1 collagen (CTx), was collected in the subset of participants participating in the DEXA scan sub-study. (NCT01345630)
Timeframe: Week 48

Interventionpg/mL (Mean)
MVC+DRV/r121.13
FTC/TDF+DRV/r223.52

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Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD

Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4) as measured by the DEXA scan. (NCT01345630)
Timeframe: Week 48

Interventiong/cm^2 (Least Squares Mean)
MVC+DRV/r-0.020
FTC/TDF+DRV/r-0.025

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Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD

Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from Baseline bone mineral density femoral neck as measured by the DEXA scan. (NCT01345630)
Timeframe: Week 48

Interventiong/cm^2 (Least Squares Mean)
MVC+DRV/r-0.021
FTC/TDF+DRV/r-0.029

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Severity of Abnormal Laboratory Values

Number of participants who had clinically significant laboratory abnormalities of Grade 3 and Grade 4 according to DAIDS. Abnormality incidence of highest grade was reported for a labcode for each individual participant. (NCT01345630)
Timeframe: Week 96

,
Interventionparticipants (Number)
Alanine Aminotransferase (ALT) (n=396, 400)Alkaline Phosphatase (n=396, 400)Amylase (n=396, 400)Aspartate Aminotransferase (AST) (n=396, 400)Blood Urea Nitrogen (BUN) (n=396, 400)Calcium (n=396, 400)Creatine Kinase (n=396, 400)Hemoglobin (n=396, 400)LDL Cholesterol (n=396, 400)Lipase (n=116, 122)Lymphocytes (Abs) (n=396, 400)Phosphate (n=396, 400)Platelets (n=396, 400)Potassium (n=396, 400)Sodium (n=396, 400)Total Bilirubin (n=396, 400)Total Neutrophils (Abs) (n=396, 400)Triglycerides (n=396, 400)Uric Acid (n=396, 400)White Blood Cell Count (n=396, 400)Creatinine (n=396, 400)
FTC/TDF+DRV/r601375102222410212120126201
MVC+DRV/r915113718450325532364010

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Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%)

The differences in the magnitude of changes in CD8+ cell counts from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48

,
InterventionPercentage of lymphocytes (Mean)
Baseline (n=396, 401)Week 48 (n=394, 396)Change from Baseline at Week 48 (n=394, 396)
FTC/TDF+DRV/r55.843.0-12.6
MVC+DRV/r57.046.0-10.9

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Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%)

The differences in the magnitude of changes in CD4+ from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48

,
InterventionPercentage of lymphocytes (Mean)
Baseline (n=396, 401)Week 48 (n=394, 396)Change from Baseline at Week 48 (n=394, 396)
FTC/TDF+DRV/r24.533.79.2
MVC+DRV/r24.231.37.0

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Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria

For participants meeting the PDTF criteria, viral resistance (both genotypic and phenotypic) to NRTI, NNRTI, and PI's were assessed at Baseline and on-treatment. The assessment was performed using the overall (i.e. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15/17 for the MVC+DRV/r arm and 3/3 for the FTC/TDF+DRV/r arm. (NCT01345630)
Timeframe: Week 48

,
Interventionparticipants (Number)
NRTI - All (Baseline, n=15, 3)NNRTI Delavirdine (Baseline, n=15, 3)NNRTI Nevirapine (Baseline, n=15, 3)NNRTI Efavirenz (Baseline, n=15, 3)PRI - All (Baseline, n=15, 3)NRTI - All (PDTF, n=15, 3)NNRTI Delavirdine (PDTF, n=15, 3)NNRTI Nevirapine (PDTF, n=15, 3)NNRTI Efavirenz (PDTF, n=15, 3)PRI - All (PDTF, n=15, 3)
FTC/TDF+DRV/r0000000000
MVC+DRV/r0111001110

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Number of Participants With Abnormal Laboratory Values

Number of participants with laboratory abnormalities are reported (NCT01345630)
Timeframe: Week 96

,
Interventionparticipants (Number)
Normal BaselineAbnormal Baseline
FTC/TDF+DRV/r205101
MVC+DRV/r210111

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Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48.

A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline. (NCT01345630)
Timeframe: Week 48

Interventiongram (Least Squares Mean)
MVC+DRV/r-181.6
FTC/TDF+DRV/r-257.5

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Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48

The differences in the magnitude of changes in CD4+/CD8+ ratio from Baseline through Weeks 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48

,
InterventionRatio (Mean)
Baseline (n=396, 401)Week 48 (n=394, 396)Change from Baseline at Week 48 (n=394, 396)
FTC/TDF+DRV/r0.480.870.39
MVC+DRV/r0.470.750.28

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Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3)

The differences in the magnitude of changes in CD8+ cell counts from baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48

,
Interventioncell/mm^3 (Mean)
Baseline (n=396, 401)Week 48 (n=394, 396)Change from Baseline at Week 48 (n=394, 396)
FTC/TDF+DRV/r914.5751.1-157.9
MVC+DRV/r954.4900.0-49.9

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Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3)

The differences in the magnitude of changes in CD4+ at Baseline and at Week 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48

,
Interventioncell/mm^3 (Mean)
Baseline (n=396, 401)Week 48 (n=394, 396)Change from Baseline at Week 48 (n=394, 396)
FTC/TDF+DRV/r379.5574.6194.2
MVC+DRV/r382.0576.9194.9

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Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48

A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline. (NCT01345630)
Timeframe: Week 48

Interventionratio (Least Squares Mean)
MVC+DRV/r0.017
FTC/TDF+DRV/r-0.014

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Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD

Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4), left total hip and femoral neck as measured by the DEXA scan. (NCT01345630)
Timeframe: Week 48

Interventiong/cm^2 (Least Squares Mean)
MVC+DRV/r-0.014
FTC/TDF+DRV/r-0.028

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL.

"The proportion of participants who achieved HIV-1 RNA <50 copies/mL at week 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm used the plasma HIV-1 RNA in the Week 48 visit window, followed the virology-first principle and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure." (NCT01345630)
Timeframe: Week 48

InterventionPercentage of participants (Number)
MVC+DRV/r77.3
FTC/TDF+DRV/r86.8

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Number of Participants With Treatment-emergent Serious Adverse Events

Total number of participants with treatment-emergent serious adverse events are reported (NCT01345630)
Timeframe: Week 96

Interventionparticipants (Number)
MVC+DRV/r41
FTC/TDF+DRV/r40

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Number of Participants With Grade 3 or 4 AEs

Number of participants with grade 3 or 4 AEs are presented here. (NCT01345630)
Timeframe: Week 96

Interventionparticipants (Number)
MVC+DRV/r65
FTC/TDF+DRV/r71

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Number of Participants Who Discontinued Due to AEs

Number of participants who discontinued due to AEs are reported here. Three participants (two from the MVC+DRV/r arm and one from the FTC/TDF+DRV/r arm) were not considered as discontinued due to AE because other reasons for discontinuation were prioritized for these participants. (NCT01345630)
Timeframe: Week 96

Interventionparticipants (Number)
MVC+DRV/r22
FTC/TDF+DRV/r23

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Frequency of Adverse Events (AE).

Number of participants with treatment-emergent non serious AEs (NCT01345630)
Timeframe: Week 96

Interventionparticipants (Number)
MVC+DRV/r360
FTC/TDF+DRV/r365

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Percentage of Participants With Etoposide Dose Modification

Etoposide (ET) was administered for a maximum of 8 cycles (16 weeks) from study entry (Arm B) or from Step 2 entry (Arm A). Dose modifications were reported as temporarily held, resumed at a different dose, deferred, prematurely discontinued and underdosed. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category. (NCT01352117)
Timeframe: From ET dispensation to ET discontinuation (total duration of ET was up to 16 weeks)

,
Interventionpercentage of participants (Number)
Temporarily heldResumed at a different doseDeferredDiscontinuedUnderdosed
Arm A: ART With Delayed ET (Step 2)015.637.56.30
Arm B: ART With Immediate ET5.29.424.010.41.0

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Percentage of Participants With ARV Dose Modification

ARV dose modifications were reported as temporarily held, prematurely discontinued and increased. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category. (NCT01352117)
Timeframe: From treatment dispensation to Week 96

,
Interventionpercentage of participants (Number)
Temporarily heldPrematurely discontinuedIncreased
Arm A: ART Alone or With Delayed ET7.426.61.1
Arm B: ART With Immediate ET11.521.90

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Change in Peripheral Blood CD4+ Lymphocyte Cell Count

Absolute change in CD4+ cell count was calculated as value at a given visit minus the value at study screening in Step 1, and as value at a given visit minus Step 2 entry in Step 2. Only participants in Arm A could enter Step 2 to initiate delayed ET. (NCT01352117)
Timeframe: Screening and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.

Interventioncells/mm^3 (Median)
Week 12: CD4 changeWeek 24: CD4 changeWeek 32: CD4 changeWeek 48: CD4 changeWeek 72: CD4 changeWeek 96: CD4 change
Arm B: ART With Immediate ET67121119121125206

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Change in Peripheral Blood CD4+ Lymphocyte Cell Count

Absolute change in CD4+ cell count was calculated as value at a given visit minus the value at study screening in Step 1, and as value at a given visit minus Step 2 entry in Step 2. Only participants in Arm A could enter Step 2 to initiate delayed ET. (NCT01352117)
Timeframe: Screening and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.

Interventioncells/mm^3 (Median)
Week 12: CD4 changeWeek 24: CD4 changeWeek 32: CD4 changeWeek 48: CD4 changeWeek 72: CD4 changeWeek 96: CD4 changeStep 2 Week 12: CD4 changeStep 2 Week 24: CD4 changeStep 2 Week 32: CD4 changeStep 2 Week 48: CD4 changeStep 2 Week 72: CD4 change
Arm A: ART Alone or With Delayed ET405790125143149-13-1528251

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Number of Participants With Grade 3 or Higher Adverse Events

Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. (NCT01352117)
Timeframe: From study treatment dispensation through up to Week 96, until long-term follow-up began in Step 3 or until study discontinuation.

InterventionParticipants (Count of Participants)
Arm A: ART Alone or With Delayed ET47
Arm B: ART With Immediate ET42

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Cumulative Incidence of KS-IRIS

KS-IRIS was defined as KS progressive disease that occurs within 12 weeks of initiation of ART that is associated with an increase in peripheral blood CD4+ lymphocyte cell count of at least 50 cells/mm^3 above the study screening value and/or a decrease in the HIV RNA level by at least 0.5 log10 below the study entry value prior to, or at the time of, documented KS progressive disease. Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored (1) when lost to follow-up, (2) at the study visit following Week 12 or (3) on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. Time of KS-IRIS was defined as the time of the initial KS progressive disease. (NCT01352117)
Timeframe: From study entry to Week 12

Interventioncumulative events per 100 participants (Number)
Arm A: ART Alone or With Delayed ET23.14
Arm B: ART With Immediate ET7.40

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Cumulative Incidence of KS Response After Initiation of Delayed Etoposide in Arm A

KS response, partial or complete (PR or CR) compared to Step 2 entry (prior to initiation of delayed ET) based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. (NCT01352117)
Timeframe: From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)

Interventioncumulative events per 100 participants (Number)
Arm A: ART With Delayed ET Period (Step 2)62.57

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Cumulative Incidence of KS Progressive Disease After Initiation of Delayed Etoposide in Arm A

KS progressive disease (PD) compared to Step 2 entry (prior to initiation of delayed ET) or Step 2 best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. (NCT01352117)
Timeframe: From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)

Interventioncumulative events per 100 participants (Number)
Arm A: ART With Delayed ET Period (Step 2)35.78

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Cumulative Incidence of Initial KS Progressive Disease by Week 96

KS progressive disease (PD) compared to study entry or best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. (NCT01352117)
Timeframe: From entry through 96 weeks

Interventioncumulative events per 100 participants (Number)
Arm A: ART Alone Period (Step 1)60.61
Arm B: ART With Immediate ET52.73

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Cumulative Incidence of Initial KS Partial or Complete Response by Week 96

KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of delayed KS treatment (alternate KS treatment or delayed ET in Arm A) as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. (NCT01352117)
Timeframe: From entry through 96 weeks

Interventioncumulative events per 100 participants (Number)
Arm A: ART Alone Period (Step 1)39.89
Arm B: ART With Immediate ET64.08

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Percentage of Participants With HIV-1 RNA Suppression

HIV-1 RNA suppression was defined as plasma HIV-1 RNA <400 copies/mL. Only Arm A participants could enter Step 2 to initiate delayed ET. (NCT01352117)
Timeframe: Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.

Interventionpercentage of participants (Number)
Entry: HIV-1 RNA suppressionWeek 12: HIV-1 RNA suppressionWeek 24: HIV-1 RNA suppressionWeek 32: HIV-1 RNA suppressionWeek 48: HIV-1 RNA suppressionWeek 72: HIV-1 RNA suppressionWeek 96: HIV-1 RNA suppression
Arm B: ART With Immediate ET4.290.697.594.798.696.693.8

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Percentage of Participants With HIV-1 RNA Suppression

HIV-1 RNA suppression was defined as plasma HIV-1 RNA <400 copies/mL. Only Arm A participants could enter Step 2 to initiate delayed ET. (NCT01352117)
Timeframe: Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.

Interventionpercentage of participants (Number)
Entry: HIV-1 RNA suppressionWeek 12: HIV-1 RNA suppressionWeek 24: HIV-1 RNA suppressionWeek 32: HIV-1 RNA suppressionWeek 48: HIV-1 RNA suppressionWeek 72: HIV-1 RNA suppressionWeek 96: HIV-1 RNA suppressionStep 2 entry: HIV-1 RNA suppressionStep 2 Week 12: HIV-1 RNA suppressionStep 2 Week 24: HIV-1 RNA suppressionStep 2 Week 32: HIV-1 RNA suppressionStep 2 Week 48: HIV-1 RNA suppressionStep 2 Week 72: HIV-1 RNA suppression
Arm A: ART Alone or With Delayed ET4.390.394.592.095.391.292.993.3100.095.896.0100.0100.0

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Number of Participants With a New AIDS-defining Events or Death

AIDS-defining events were those recognized by the Centers for Disease Control (CDC) and World Health Organization (WHO) (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)

Interventionparticipants (Number)
Arm A: LPV/r Plus RAL15
Arm B: LPV/r Plus Best Available NRTIs17

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Number of Participants Discontinuing Randomized Treatment for Toxicity

Discontinuation of randomized treatment for toxicity included participant decision to discontinue for low grade toxicity. Within class NRTI changes were not considered discontinuations. (NCT01352715)
Timeframe: From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks)

Interventionparticipants (Number)
Arm A: LPV/r Plus RAL3
Arm B: LPV/r Plus Best Available NRTIs3

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Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure

Mutations were defined as major IAS mutations in the IAS-USA July 2014 list. New mutations were those detected at virologic failure but not at baseline. (NCT01352715)
Timeframe: From study entry through to week 96

,
Interventionparticipants (Number)
No new IAS mutations1-2 new IAS mutations3 new IAS mutations
Arm A: LPV/r Plus RAL2991
Arm B: LPV/r Plus Best Available NRTIs32130

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Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline

Fasting was for 8 hours and the metabolic panel was drawn locally. (NCT01352715)
Timeframe: Study entry and week 48

,
Interventionmg/dL (Mean)
total cholesterol changehigh-density lipoprotein (HDL) cholesterol changelow-density lipoprotein (LDL) cholesterol changetriglycerides changeglucose change
Arm A: LPV/r Plus RAL31417802
Arm B: LPV/r Plus Best Available NRTIs15210313

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Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline

The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. (NCT01352715)
Timeframe: From start of randomized treatment to off randomized treatment (up to 96 weeks)

Interventionparticipants (Number)
Arm A: LPV/r Plus RAL62
Arm B: LPV/r Plus Best Available NRTIs81

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Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death

Serious non-AIDS diagnoses were based on ACTG Appendix 60 Diagnosis Codes (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)

Interventionparticipants (Number)
Arm A: LPV/r Plus RAL7
Arm B: LPV/r Plus Best Available NRTIs7

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Change in CD4+ Cell Count From Baseline to Week 48

Change in CD4+ cell count was calculated as CD4+ cell count at week 48 minus CD4+ cell count at study entry. (NCT01352715)
Timeframe: Study entry and week 48

Interventioncells/mm^3 (Mean)
Arm A: LPV/r Plus RAL199
Arm B: LPV/r Plus Best Available NRTIs190

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Cumulative Probability of Virologic Failure by Week 48

The primary endpoint was time to virologic failure. Virologic failure was defined as confirmed viral load >400 copies/mL at or after week 24. The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 48 was used. (NCT01352715)
Timeframe: From study entry to week 48

Interventioncumulative probability per 100 persons (Number)
Arm A: LPV/r Plus RAL10.3
Arm B: LPV/r Plus Best Available NRTIs12.4

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Percentage of Time Spent in Hospital

The percentage of total study time that participants were in hospital. (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)

Interventionpercentage of time spent in hospital (Number)
Arm A: LPV/r Plus RAL0.08
Arm B: LPV/r Plus Best Available NRTIs0.12

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Number of Participants With HBV DNA<1000 IU/mL at Week 192

Number of participants with HBV DNA <1000 IU/mL at week 192 (NCT01369212)
Timeframe: week 192

InterventionParticipants (Count of Participants)
Tenofovir95
Peginterferon-alfa 2a and Tenofovir90

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Number of Participants With HBsAg Seroconversion at Week 240

Number of participants who became HBsAg negative and developed anti-HBs at week 240 (NCT01369212)
Timeframe: week 240

InterventionParticipants (Count of Participants)
Tenofovir2
Peginterferon-alfa 2a and Tenofovir4

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Number of Participants With HBsAg Seroconversion at Week 192

Number of participants who became with HBsAg negative and developed anti-HBs at week 192 (NCT01369212)
Timeframe: week 192

InterventionParticipants (Count of Participants)
Tenofovir1
Peginterferon-alfa 2a and Tenofovir4

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Number of Participants With HBeAg Seroconversion at Week 240

Number of participants who became HBeAg negative and developed anti-HBe at week 240 among HBeAg positive participants at baseline (NCT01369212)
Timeframe: week 240

InterventionParticipants (Count of Participants)
Tenofovir14
Peginterferon-alfa 2a and Tenofovir15

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Number of Participants With HBeAg Seroconversion at Week 192

Number of participants who became HBeAg negative and developed anti-HBe at week 192 among HBeAg positive participants at baseline (NCT01369212)
Timeframe: week 192

InterventionParticipants (Count of Participants)
Tenofovir8
Peginterferon-alfa 2a and Tenofovir16

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Number of Participants With HBeAg Loss at Week 240

Number of participants who became HBeAg negative at week 240 among HBeAg positive participants at baseline (NCT01369212)
Timeframe: week 240

InterventionParticipants (Count of Participants)
Tenofovir19
Peginterferon-alfa 2a and Tenofovir28

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Number of Participants With Alanine Transaminase(ALT) Levels <= 38 U/L for Males and <=25 for Females at Week 192

Number of participants with alanine transaminase(ALT) levels <= 38 U/L for males and <=25 for females at week 192. The cut-offs 38 and 25 are approximately 1.25 times the upper limit of normal (30 U/L for males and 20 U/L for females) respectively. (NCT01369212)
Timeframe: week 192

InterventionParticipants (Count of Participants)
Tenofovir58
Peginterferon-alfa 2a and Tenofovir72

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Cumulative Percent of Participants With HBsAg Loss at Week 192

Cumulative percentage of participants with HBsAg loss at week 192 estimated using Kaplan-Meier method (NCT01369212)
Timeframe: Week 192

InterventionCumulative percentage of participants (Number)
Tenofovir1.0
Peginterferon-alfa 2a and Tenofovir5.2

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Number of Participants With Adverse Events

Number of participants with at least one adverse event between randomization and week 240 (NCT01369212)
Timeframe: up to 240 weeks

InterventionParticipants (Count of Participants)
Tenofovir50
Peginterferon-alfa 2a and Tenofovir60

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Cumulative Percent of Participants With HBsAg Loss at Week 240

Cumulative percent of participants with HBsAg loss at week 240 estimated using Kaplan-Meier method (NCT01369212)
Timeframe: Week 240

Interventionpercentage of participants (Number)
Tenofovir4.1
Peginterferon-alfa 2a and Tenofovir5.2

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Number of Participants With Serious Adverse Events

Number of participants with at least one serious adverse event between randomization and week 240 (NCT01369212)
Timeframe: Up to 240 weeks

InterventionParticipants (Count of Participants)
Tenofovir11
Peginterferon-alfa 2a and Tenofovir7

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Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240

Estimated percent of participants who became HBsAg negative by week 240 from randomization (NCT01369212)
Timeframe: Week 240

InterventionPercentage of participants (Number)
Tenofovir4.1
Peginterferon-alfa 2a and Tenofovir5.2

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Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 240

Number of participants with normal alanine transaminase (ALT) levels [males ≤30 U/L, for females ≤20 U/L] at week 240 (NCT01369212)
Timeframe: week 240

InterventionParticipants (Count of Participants)
Tenofovir38
Peginterferon-alfa 2a and Tenofovir41

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Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 192

Number of participants with normal alanine transaminase (ALT) levels at week 192 (Normal ALT for males ≤30 U/L, for females ≤20 U/L) (NCT01369212)
Timeframe: week 192

InterventionParticipants (Count of Participants)
Tenofovir37
Peginterferon-alfa 2a and Tenofovir51

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Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 192

Number of participants who became Hepatitis B e antigen (HBeAg) negative at week 192 among HBeAg positive participants at randomization (baseline) (NCT01369212)
Timeframe: week 192

InterventionParticipants (Count of Participants)
Tenofovir14
Peginterferon-alfa 2a and Tenofovir29

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Number of Participants With HBV DNA<20 IU/mL at Week 240

Number of participants with HBV DNA<20 IU/mL at week 240 (NCT01369212)
Timeframe: week 240

InterventionParticipants (Count of Participants)
Tenofovir46
Peginterferon-alfa 2a and Tenofovir48

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Number of Participants With HBV DNA<20 IU/mL at Week 192

Number of participants with HBV DNA<20 IU/mL at week 192 (NCT01369212)
Timeframe: week 192

InterventionParticipants (Count of Participants)
Tenofovir82
Peginterferon-alfa 2a and Tenofovir87

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Number of Participants With HBV DNA<1000 IU/mL at Week 240

Number of participants with HBV DNA <1000 IU/mL at week 240 (NCT01369212)
Timeframe: week 240

InterventionParticipants (Count of Participants)
Tenofovir66
Peginterferon-alfa 2a and Tenofovir65

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eGFR Change From Baseline in Telbivudine Arm vs Tenofovir Arm Over the Course of the Study

eGFR changes were calculated using the Modification of Diet in Renal Disease (MDRD) formula: GFR = 186 x (sCr)^(-1.154) x (age)^-0.203 with Female: Multiply GFR by 0.742; Black: Multiply GFR by 1.210. sCr is Serum Creatinine in mg/dl (measured at each scheduled visit). Age in years at visit (=[sCr sample collection date -Date of birth]/365.25). Weight in kilograms, as measured at the visit or the closest previous visit Safety population. (NCT01379508)
Timeframe: Baseline, 24 weeks, 52 weeks, 104 weeks, 156 weeks

,,,,,
InterventionmL/min/1.73 m2 (Mean)
Week 24 change (97,22,119,108,11,119)Week 52 change(97,22,119,108,11,119)Week 104 change(97,22,119,108,11,119)Week 156 change(62,17,79,79,10,89)Baseline actual(98,22,120,109,11,120)Week 24 actual(97,22,119,108,11,119)Week 52 actual(97,22,119,108,11,119)Week 104 actual (97,22,119,108,11,119)Week 156 actual(62,17,79,79,10,89)
LdT Mono at Week 241.435.185.198.0794.7196.43100.18100.20101.33
LdT Overall-1.072.963.163.9997.4796.67100.70100.90101.20
LdT+TDF at Week 24-12.06-6.80-5.77-10.89109.7997.73102.99104.02100.70
TDF + LdT at Week 24-7.17-8.39-8.69-6.6794.5087.3386.1285.8187.93
TDF Mono at Week 24-2.41-2.70-3.83-5.3495.9193.6193.3292.1988.83
TDF Overall-2.85-3.22-4.28-5.4995.7893.0392.6691.6088.73

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Percentage of Participants Achieving HBV DNA < 300 Copies/mL (51 IU/mL) at Week 52 (rITT Population) -

"The primary objective of the study is to compare the efficacy of Roadmap-Concept-based telbivudine treatment versus Roadmap-Concept-based tenofovir treatment in HBeAg-negative CHB patients. The rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 will be used for the comparison of the efficacy. The hypothesis is that the aggregated rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 of Telbivudine (ARM 1) is non-inferior to Tenofovir (ARM 2). For the treating missing as failure analysis, patients who came for their primary endpoint Week 52 visit within the ± 7-day window but not on the exact designated day of the visit were treated as missing data." (NCT01379508)
Timeframe: week 52

,
Interventionpercentage of participants (Number)
Missing DNA data at Wk 52=failureImputing +/- 7 days DNA for Wk 52Imputing LOCF DNA for Wk 52Imputing within +28d DNA for Wk 52
LdT Overall91.091.995.492.7
TDF Overall95.095.099.295.0

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Percentage of Participants Achieving Secondary Efficacy Endpoints at Week 156 (mITT)

To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL) at Week156, ALT normalization, HBsAg loss, development of HBsAg conversion , cumulative tx emergent resistance, HBV DNA <300 copies/mL with HBV DNA <7 log at Baseline (NCT01379508)
Timeframe: 156 weeks

,,,,,
Interventionpercentage of participants (Number)
HBV DNA < 300 Week 156HBV DNA < 300 Wk156 LOCFALT normalization Wk 156ALT normalization Wk 156 LOCFHBSAg loss/ seroconversionCum VB Wk104-156 LOCFCum VB BL to Wk 156 LOCFCum tx emerg resist Week 156 LOCFHBV DNA < 300 Wk156 <7 log at BLHBV DNA <300 Wk156 <7 log LOCFCum tx-emerg resist Wk156 <7log LOCF
LdT Mono at Week 2417.788.714.385.7016.121.014.017.688.28.7
LdT Overall16.591.112.088.0012.716.510.816.788.98.2
LdT+TDF at Week 2411.8100.06.793.300000100.00.0
TDF + LdT at Week 2420.0100.028.685.7000050.0100.00.0
TDF Mono at Week 2413.9100.010.586.801.31.3011.7100.00.0
TDF Overall14.6100.0013.386.701.11.1012.9100.00.0

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Percentage of Patients Achieving Secondary Efficacy Endpoints (rITT)

To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL), ALT normalization, HBsAg loss, HBsAg conversion, virologic breakthrough (VB) at study visit, cumulative VB by study defined study period, cumulative treatment-emergent resistance (NCT01379508)
Timeframe: week 24, 52, 104

,,,,,
Interventionpercentage of particiipants (Number)
HBV DNA <300 Week 24HBV DNA <300 Week 104HBV DNA <300 Week 24 LOCFHBV DNA <300 Wk104 LOCFALT Normalization Wk 52ALT Normalization Week 104ALT Normalization Wk 52 LOCFALT Normalization Wk 104 LOCFHBsAg loss Week 52HBsAg loss Week 104HBsAg conversion Week 52HBsAg conversion Week 104Cum virol break BaseL to Wk 24Cum virol break Wk 24 to Wk 52Cum virol break Wk 52 to Wk 104Cum virol break BaseLto Wk 104Cum vir break BL to Wk24 LOCFCum virol break Wk 24 to Wk 52 LOCFCum virol break Wk52-Wk104 LOCFCum virol break BLto Wk 104 LOCFCum tx emergent resistance Wk 52Ccum tx emergent resistance Wk 104Cum tx emergent resist Wk52 LOCFCum tx emergent resist Wk 104 LOCF<7 log at BL HBV DNA <300 Wk52<7 log HBV DNA <300 Wk104<7 log HBV DNA <300 Wk 52 LOCF<7 log HBV DNA <300 Wk 104 LOCF
LdT Mono at Week 2498.969.6100.092.484.070.088.092.0000003.312.014.103.312.014.13.39.23.39.293.468.497.492.1
LdT Overall80.570.881.493.883.870.686.889.700000.92.79.712.40.92.79.712.42.77.42.77.492.567.597.592.5
LdT+TDF at Week 240.076.20100.083.372.283.383.300004.8004.84.8004.8000075.050.0100.0100.0
TDF + LdT at Week 24081.80100.085.785.785.785.70000000000000000100.066.7100.0100.0
TDF Mono at Week 2499.174.5100.099.182.561.487.786.00000001.91.9001.91.9000095.076.3100.098.8
TDF Overall89.775.290.699.182.864.187.585.90000001.71.7001.71.7000095.275.9100.098.8

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Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy

Blood was collected and CD4+ and CD8+ cell count assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and Day 8

,,,
Interventioncells per cubic millimeter (Mean)
CD4+CD8+
FTR 1200 mg QD/RAL/TDF63.467.6
FTR 400 mg BID/RAL/TDF58.4134.2
FTR 600 mg QD/RAL/TDF71.8188.0
FTR 800 mg BID/RAL/TDF134.8216.3

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Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period

Change from monotherapy Baseline in log10 HIV RNA to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. ITT-E Monotherapy Population comprised of participants that were randomized and participated in the monotherapy sub-study and received at least one dose of FTR Monotherapy. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). (NCT01384734)
Timeframe: Baseline and up to Day 8 of the monotherapy period

,,,
Interventionlog10 c/mL (Mean)
Day 2, n=7, 5, 10, 9Day 5, n=7, 4, 10, 10Day 6, n=7, 5, 10, 10Day 7, n=6, 5, 10, 10Day 8, n=6, 4, 9, 9
FTR 1200 mg QD/RAL/TDF0.126-0.767-1.053-1.198-1.470
FTR 400 mg BID/RAL/TDF0.220-0.340-0.530-0.556-0.691
FTR 600 mg QD/RAL/TDF0.126-0.593-0.822-1.086-1.218
FTR 800 mg BID/RAL/TDF0.149-0.811-1.082-1.443-1.372

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Number of Participants With Newly-emergent Genotypic Substitutions at Week 24

Participants who administered antiretroviral (ARV) with virologic failure (VF) were assessed. Genotypic substitution included assessment of Reverse Transcriptase (RT) substitution, Protease Inhibitor (PI) substitution and Integrase RAL substitution as per International Acquired Immune Deficiency Syndrome (AIDS) Society-USA (IAS-USA) list. ITT-E Resistance Tested through Week 24 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 24 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or met the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. (NCT01384734)
Timeframe: Up to Week 24

,,,,
InterventionParticipants (Count of Participants)
PI substitutionRT substitutionIntegrase substitution
ATV/r/RAL/TDF000
FTR 1200 mg QD/RAL/TDF011
FTR 400 mg BID/RAL/TDF000
FTR 600 mg QD/RAL/TDF001
FTR 800 mg BID/RAL/TDF000

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Number of Participants With Newly-emergent Genotypic Substitutions at Week 96

Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 96 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 96 Snapshot analysis window. The criteria for resistance tested was participants with virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. (NCT01384734)
Timeframe: Up to Week 96

,,,,
InterventionParticipants (Count of Participants)
PI substitutionRT substitutionIntegrase RAL substitution
ATV/r/RAL/TDF010
FTR 1200 mg QD/RAL/TDF223
FTR 400 mg BID/RAL/TDF322
FTR 600 mg QD/RAL/TDF221
FTR 800 mg BID/RAL/TDF112

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Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. (NCT01384734)
Timeframe: Up to Day 8 of the monotherapy period

,,,
InterventionParticipants (Count of Participants)
SAEAEs leading to discontinuation
FTR 1200 mg QD/RAL/TDF00
FTR 400 mg BID/RAL/TDF00
FTR 600 mg QD/RAL/TDF00
FTR 800 mg BID/RAL/TDF00

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Number of Participants With SAE and Discontinuation Due to AEs During Primary Study

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety Population comprised of participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week X (where X = 48 or 96) included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 48 and 96 visit snapshot window. (NCT01384734)
Timeframe: Weeks 48 and 96

,,,,
InterventionParticipants (Count of Participants)
SAE, Week 48SAE, Week 96AEs leading to discontinuation, Week 48AEs leading to discontinuation, Week 96
ATV/r/RAL/TDF5735
FTR 1200 mg QD/RAL/TDF2412
FTR 400 mg BID/RAL/TDF3511
FTR 600 mg QD/RAL/TDF4600
FTR 800 mg BID/RAL/TDF5722

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Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety population included all participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week 24 included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 24 visit snapshot window. (NCT01384734)
Timeframe: Up to Week 24

,,,,
InterventionParticipants (Count of Participants)
SAEAEs leading to discontinuation
ATV/r/RAL/TDF52
FTR 1200 mg QD/RAL/TDF21
FTR 400 mg BID/RAL/TDF31
FTR 600 mg QD/RAL/TDF40
FTR 800 mg BID/RAL/TDF42

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Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage CI. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. (NCT01384734)
Timeframe: Weeks 48 and 96

,,,,
InterventionPercentage of Participants (Number)
Week 48Week 96
ATV/r/RAL/TDF7157
FTR 1200 mg QD/RAL/TDF6858
FTR 400 mg BID/RAL/TDF8278
FTR 600 mg QD/RAL/TDF6963
FTR 800 mg BID/RAL/TDF6149

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Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Baseline of combination therapy was assessed to evaluate the antiviral activity of four doses of FTR. Baseline of combination therapy was the Day 1 of the combination therapy. Virologic success or failure was determined using the non-missing viral load value at Baseline of combination therapy. The assessment closest to the window target Study Day was used for the analysis. Only those participants with data available at the specified time points were analyzed. (NCT01384734)
Timeframe: Up to Day 8 of the monotherapy period

InterventionPercentage of Participants (Number)
FTR 400 mg BID/RAL/TDF0
FTR 800 mg BID/RAL/TDF0
FTR 600 mg QD/RAL/TDF0
FTR 1200 mg QD/RAL/TDF11

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Number of Participants With Newly-emergent Genotypic Substitutions at Week 48

Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 48 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 48 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. (NCT01384734)
Timeframe: Up to Week 48

,,,,
InterventionParticipants (Count of Participants)
PI substitutionRT substitutionIntegrase substitution
ATV/r/RAL/TDF000
FTR 1200 mg QD/RAL/TDF122
FTR 400 mg BID/RAL/TDF101
FTR 600 mg QD/RAL/TDF001
FTR 800 mg BID/RAL/TDF001

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Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and up to Week 48

InterventionIC50 Fold Change (Mean)
FTR 400 mg BID/RAL/TDF-2.624
FTR 800 mg BID/RAL/TDF586.776
FTR 600 mg QD/RAL/TDF81.729
FTR 1200 mg QD/RAL/TDF449.092

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Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and up to Week 96

InterventionIC50 Fold Change (Mean)
FTR 400 mg BID/RAL/TDF25.480
FTR 800 mg BID/RAL/TDF419.901
FTR 600 mg QD/RAL/TDF46.351
FTR 1200 mg QD/RAL/TDF777.818

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Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL . The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and up to Week 24

InterventionIC50 Fold Change (Mean)
FTR 400 mg BID/RAL/TDF-2.350
FTR 800 mg BID/RAL/TDF1014.748
FTR 600 mg QD/RAL/TDF101.627
FTR 1200 mg QD/RAL/TDF39.030

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Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA

Maximum decrease from monotherapy Baseline in log10 plasma HIV-1 RNA during monotherapy to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. The data for monotherapy nadir has been presented where nadir represents the maximum decrease from Baseline. (NCT01384734)
Timeframe: Baseline and up to Day 8 of the monotherapy period

Interventionlog10 c/mL (Mean)
FTR 400 mg BID/RAL/TDF-0.770
FTR 800 mg BID/RAL/TDF-1.524
FTR 600 mg QD/RAL/TDF-1.250
FTR 1200 mg QD/RAL/TDF-1.399

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Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage confidence intervals (CI). Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. Intent-To-Treat-Exposed (ITT-E) Population includes all randomized participants who received at least one dose of study treatment. (NCT01384734)
Timeframe: Week 24

InterventionPercentage of Participants (Number)
FTR 400 mg BID/RAL/TDF80
FTR 800 mg BID/RAL/TDF69
FTR 600 mg QD/RAL/TDF76
FTR 1200 mg QD/RAL/TDF72
ATV/r/RAL/TDF75

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Change From Baseline in CD4+ T-cell Count

Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Weeks 24, 48 and 96 to evaluate the immunological activity of multiple doses of BMS-663068/GSK3684934. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). (NCT01384734)
Timeframe: Baseline and Weeks 24, 48 and 96

,,,,
InterventionCells per cubic millimeter (Mean)
Week 24, n=41, 38, 48, 42, 40Week 48, n=43, 34, 43, 41, 41Week 96, n=42, 28, 35, 28, 31
ATV/r/RAL/TDF119.4178.7250.1
FTR 1200 mg QD/RAL/TDF124.5155.4211.7
FTR 400 mg BID/RAL/TDF134.3199.1264.6
FTR 600 mg QD/RAL/TDF109.5140.5175.7
FTR 800 mg BID/RAL/TDF111.0158.7210.8

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Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy

Blood was collected and CD4+ and CD8+ proportion assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and Day 8

,,,
Interventioncells per cubic millimeter (Mean)
CD4+CD8+
FTR 1200 mg QD/RAL/TDF0.014-0.021
FTR 400 mg BID/RAL/TDF-0.005-0.003
FTR 600 mg QD/RAL/TDF0.008-0.009
FTR 800 mg BID/RAL/TDF0.023-0.040

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Change in CD4+ Cell Count From Randomisation to 12 Months Post-randomisation

Difference between 12 months and randomisation CD4+ count was calculated and then summarised (NCT01387022)
Timeframe: Measured at 12 months post ART initiation

Interventioncells/uL (Median)
Tenofovir-containing Regimen217
Tenofovir-sparing Regimen174

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Reported Adverse Events With Severity Grades 3 and 4 Based on the DAIDS Toxicity Grading Tables

(NCT01387022)
Timeframe: From randomisation until either time of termination or time of death

InterventionParticipants (Count of Participants)
Tenofovir-containing Regimen7
Tenofovir-sparing Regimen12

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Tenofovir Resistance, Defined as Presence of K65R, K70E or Any of the TAMS Mutations

(NCT01387022)
Timeframe: From randomisation until either time of termination or time of death

InterventionParticipants (Count of Participants)
Tenofovir-containing Regimen1
Tenofovir-sparing Regimen1

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The Antiretroviral Treatment Failure Rate at 12 Months.

Treatment failure is defined as viral load > 50 copies/ml, antiretroviral regimen changes for treatment failure or death (NCT01387022)
Timeframe: 12 months post ART intiation or until time of death

Interventionparticipants (Number)
Tenofovir-containing Regimen4
Tenofovir-sparing Regimen5

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Percentage Change in Expression of CD38+/HLA-DR+ on CD8+ T Cells From Baseline to Week 48

percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48

Interventionpercentage change (Median)
MVC Arm: DRV/r + MVC + FTC + TDF Placebo-59.5
TDF Arm: DRV/r + TDF + FTC + MVC Placebo-60.9

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Percentage Change in Expression of CD38+/HLA-DR+ on CD4+ T Cells From Baseline to Week 48

percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48

Interventionpercentage change (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)-52.1
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)-48.6

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Percent Change in Lumbar Spine Bone Mineral Density (BMD)

The percent change in bone mineral density (BMD) at lumbar spine (as measured by DXA scan) from baseline (week 0) to week 48. (NCT01400412)
Timeframe: Week 0, week 48

Interventionpercentage change (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)-0.88
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)-2.35

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Percent Change in Expression of RANKL+ on CD8+ T Cells From Baseline to Week 48

percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48

Interventionpercentage change (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)-20.7
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)-17.0

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Percent Change in Expression of CD57+ on CD8+ T Cells From Baseline to Week 48

percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48

Interventionpercentage change (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)-3.5
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)-4.6

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Percent Change in Expression of CD28+ on CD8+ T Cells From Baseline to Week 48

percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48

Interventionpercentage change (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)11.9
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)14.0

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Percent Change From Baseline in Total Hip Bone Mineral Density (BMD)

The primary endpoint is the percent change in bone mineral density (BMD) at total hip (as measured by DXA scan) from baseline (week 0) to week 48. (NCT01400412)
Timeframe: Week 0, week 48

Interventionpercentage change (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)-1.51
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)-2.40

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Number of Participants Who Died During the Study

Number of participants who died during the study (NCT01400412)
Timeframe: From study treatment initiation to week 48

Interventionparticipants (Number)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)0
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)0

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Number of Participants Who Developed Grade 3 or 4 Primary Adverse Events

"Grade 3 or 4 primary adverse events includes primary signs/symptoms, primary laboratory abnormalities, or primary diagnoses.~See DAIDS AE Grading Table Version 1.0, Dec 2004 (Clarification, Aug 2009)" (NCT01400412)
Timeframe: From study treatment initiation to week 48

Interventionparticipants (Number)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)16
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)22

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Change in CD4 Count From Baseline to Week 24

Change in CD4 count from baseline (week 0) to week 24 (NCT01400412)
Timeframe: Week 0, week 24

Interventioncells/mm^3 (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)165
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)127

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Percent Change in Expression of CD28+/CD57+ on CD8+ T Cells From Baseline to Week 48

percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48

Interventionpercentage change (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)-9.1
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)-11.2

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CD8+ T-cell Change From Baseline to Week 48

CD8+ T-cell change from baseline to week 48 (NCT01400412)
Timeframe: At weeks 0 and 48

Interventioncell/mm^3 (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)-6
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)-109

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Change in Level of IP-10 From Baseline to Week 48

Change in level of Interferon gamma-induced protein 10 (IP-10) from baseline to week 48 (NCT01400412)
Timeframe: At weeks 0 and 48

Interventionpg/ml (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)-198
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)-170

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Change in Levels of D-dimer From Baseline

Change in levels of D-dimer from baseline (NCT01400412)
Timeframe: At weeks 0 and 48

Interventionng/ml (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)-82
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)-61

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Change in Levels of IL-6 From Baseline to Week 48

Change in levels of Interleukin 6 (IL-6) from baseline to week 48 (NCT01400412)
Timeframe: At weeks 0 and 48

Interventionpg/ml (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)-0.21
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)-0.12

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Change in Levels of sCD14 From Baseline

Change in levels of soluble CD14 from baseline (NCT01400412)
Timeframe: At weeks 0 and 48

Interventionng/ml (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)-103
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)-10

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Number of Participants Who Experienced Bone Fractures

Number of participants who experienced bone fractures during the study (NCT01400412)
Timeframe: From study treatment initiation to week 48

Interventionparticipants (Number)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)2
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)2

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Change in Levels of sCD163 From Baseline to Week 48

Change in levels of soluble CD163 from baseline to week 48 (NCT01400412)
Timeframe: At weeks 0 and 48

Interventionng/ml (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)-250
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)-258

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Cumulative Probability of Virologic Failure by Week 48

"Confirmed virologic failure is defined as confirmed plasma HIV-1 RNA levels > 1000 copies/mL at or after week 16 and before week 24, or confirmed HIV-1 RNA levels> 200 copies/mL at or after week 24. Participants who discontinued the study with an unconfirmed virologic failure (HIV-1 RNA > 1000 copies at 16 weeks or HIV-1 RNA level > 200 copies/mL at or after week 24) are considered as virologic failures at the study visit week of the unconfirmed value. Time to virologic failure is defined as the time from study entry to the planned visit week of the initial failure.~Product-limit estimates for the survival function were used to estimate the cumulative probability of virologic failure over time and its corresponding 95% confidence interval for each treatment group." (NCT01400412)
Timeframe: From study treatment initiation to week 48

Interventioncumulative probability per 100 persons (Number)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)6
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)5

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Change in CD4 Count From Baseline to Week 48

Change in CD4 count from baseline (week 0) to week 48 (NCT01400412)
Timeframe: Week 0, week 48

Interventioncells/mm^3 (Median)
MVC Arm (DRV/r + MVC + FTC + TDF Placebo)234
TDF Arm (DRV/r + TDF + FTC + MVC Placebo)188

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Self-reported Adherence to ART Therapy

ART adherence is based on participant's recall of the number of missed ART doses for the past month. Perfect adherence is defined as having zero missed ART doses. (NCT01435018)
Timeframe: At Weeks 6, 12, 18, 30 and 48

,,
InterventionParticipants (Count of Participants)
Week 6 Perfect AdherenceWeek 12 Perfect AdherenceWeek 18 Perfect adherenceWeek 30 Perfect adherenceWeek 48 Perfect adherence
BV+ART101101856613
ET+ART433629130
PTX+ART106103978520

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Number of Participants With Symptomatic Peripheral Neuropathy (SPN)

"SPN consists of three assessments: (1) pain, aching or burning in feet, legs, (2) pins and needles in feet, legs, and (3) numbness (lack of feeling) in feet, legs. SPN is graded on a severity scale from 0 (not present), 1 (mild) to 10 (severe). Presence of SPN is defined as having grade >=1 in at least one of the three assessments." (NCT01435018)
Timeframe: Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of SPN for ET+ART was only done at screening, weeks 9 and 21.

,,
InterventionParticipants (Count of Participants)
ScreeningWeek 3Week 6Week 9Week 12Week 15Week 18Week 21
BV+ART7662464036262530
ET+ART2400140004
PTX+ART5934322723161520

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Number of Participants With Peripheral Neuropathy (PN)

Presence of PN is defined as having all of the following results: presence of symptomatic PN, abnormal perception of vibrations, and absent or hypoactive deep tendon reflexes. (NCT01435018)
Timeframe: Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of PN for ET+ART was only done at screening, weeks 9 and 21.

,,
InterventionParticipants (Count of Participants)
ScreeningWeek 3Week 6Week 9Week 12Week 15Week 18Week 21
BV+ART71133265
ET+ART10000000
PTX+ART00224312

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Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4

IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 4 treatment arm. (NCT01435018)
Timeframe: From Step 4 study entry to Step 4 discontinuation, up to 96 weeks

,
InterventionParticipants (Count of Participants)
With IERC-confirmed KS progressionWith dose-limiting toxicityDiedWith AIDS-defining eventsWith virologic failureWith objective response
BV+ART203013
PTX+ART302003

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Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3

IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 3 treatment arm. (NCT01435018)
Timeframe: From Step 3 study entry to Step 3 discontinuation, up to 144 weeks

,,
InterventionParticipants (Count of Participants)
With IERC-confirmed KS progressionWith dose-limiting toxicityDiedWith AIDS-defining eventsWith virologic failureWith objective response
BV+ART6035218
ET+ART200025
PTX+ART8077129

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Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2

IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 2 treatment arm. (NCT01435018)
Timeframe: From Step 2 study entry to Step 2 discontinuation, up to 144 weeks

,,
InterventionParticipants (Count of Participants)
With IERC-confirmed KS progressionWith dose-limiting toxicityDiedWith AIDS-defining eventsWith virologic failureWith objective response
BV+ART101127
ET+ART100010
PTX+ART105015

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Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART

Baseline CD4 lymphocyte cell count is the mean of screening and Step 1 entry CD4 values. Absolute change in CD4+ lymphocyte cell count was calculated as value at a given visit minus the baseline CD4 lymphocyte cell count. (NCT01435018)
Timeframe: Baseline, weeks 12, 24, 48

,
Interventioncells/mm^3 (Median)
Week 12 CD4 changeWeek 24 CD4 changeWeek 48 CD4 change
ET+ART3710669
PTX+ART4795157

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Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART

Baseline CD4 lymphocyte cell count is the mean of screening and Step 1 entry CD4 values. Absolute change in CD4+ lymphocyte cell count was calculated as value at a given visit minus the baseline CD4 lymphocyte cell count. (NCT01435018)
Timeframe: Baseline, weeks 12, 24, 48

,
Interventioncells/mm^3 (Median)
Week 12 CD4 changeWeek 24 CD4 changeWeek 48 CD4 change
BV+ART2143112
PTX+ART3765105

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Time to IERC-confirmed KS Progression or Death for ET+ART vs. PTX+ART

Time to IERC-confirmed KS progression or death was computed as the number of weeks between study entry and the earlier between date of IERC-confirmed KS progression or date of death. For participants who did not have the event, event time was censored at the week of last contact with the participant or the participant's off study week, whichever is later. The 25-th percentile and hazard ratio are presented. (NCT01435018)
Timeframe: From study entry to week 240

Interventionweeks (Number)
ET+ART17.9
PTX+ART30.0

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Time to IERC-confirmed KS Progression or Death for BV+ART vs. PTX+ART

Time to IERC-confirmed KS progression or death was computed as the number of weeks between study entry and the earlier between date of IERC-confirmed KS progression or date of death. For participants who did not have the event, event time was censored at the week of last contact with the participant or at the participant's off study week, whichever is later.The 25-th percentile and hazard ratio are presented. (NCT01435018)
Timeframe: From study entry to week 240

Interventionweeks (Number)
BV+ART24.7
PTX+ART38.6

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Number of Participants With Objective Response for ET+ART vs. PTX+ART

The number of participants with objective response (complete response or partial response) as best overall KS response in Step 1. Overall KS response status (complete response, partial response, stable, disease progression) was based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry up to week 144

InterventionParticipants (Count of Participants)
ET+ART18
PTX+ART34

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Number of Participants With Objective Response for BV+ART vs. PTX+ART

The number of participants with objective response (complete response or partial response) as best overall KS response in Step 1. Overall KS response status (complete response, partial response, stable, disease progression) was based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry up to week 144

InterventionParticipants (Count of Participants)
BV+ART80
PTX+ART91

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Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for ET+ART vs. PTX+ART

KS-IRIS is defined as any IERC-confirmed KS-progression that occurs within 12 weeks of ART-initiation that is associated with an increase in CD4 cell count of at least 50 cells/mm^3 above the study entry value and/or a decrease in the HIV-1 RNA level by at least 0.5 log below the study entry value prior to or at the time of documented KS progression. (NCT01435018)
Timeframe: From study entry to week 12

InterventionParticipants (Count of Participants)
ET+ART6
PTX+ART0

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Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for BV+ART vs. PTX+ART

KS-IRIS is defined as any IERC-confirmed KS-progression that occurs within 12 weeks of ART-initiation that is associated with an increase in CD4 cell count of at least 50 cells/mm^3 above the study entry value and/or a decrease in the HIV-1 RNA level by at least 0.5 log below the study entry value prior to or at the time of documented KS progression. (NCT01435018)
Timeframe: From study entry to week 12

InterventionParticipants (Count of Participants)
BV+ART2
PTX+ART0

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Duration of Objective Response for ET+ART vs. PTX+ART

Duration of objective response is the number of weeks from first complete or partial response to the earliest among progression, death or off study week. The 25th percentile duration is presented. (NCT01435018)
Timeframe: From study entry up to week 144

Interventionweeks (Number)
ET+ART10.1
PTX+ART19.9

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Duration of Objective Response for BV+ART vs. PTX+ART

Duration of objective response is the number of weeks from first complete or partial response to the earliest among progression, death or off study week. The 25th percentile duration is presented. (NCT01435018)
Timeframe: From study entry up to week 144

Interventionweeks (Number)
ET+ART21.0
PTX+ART45.7

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Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART

Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART19.7
PTX+ART49.8

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Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART

Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART44.1
PTX+ART64.2

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Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48 (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART72.4
PTX+ART54.6

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Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48 (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART56.7
PTX+ART42.1

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Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART57.6
PTX+ART33.9

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Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART54.5
PTX+ART36.2

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Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48 (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART77.5
PTX+ART54.6

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Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48 (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART60.9
PTX+ART42.0

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Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of IERC-confirmed KS progression by week 48. IERC-confirmed KS progression was defined as KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART69.8
PTX+ART41.2

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Cumulative Rate of IERC-confirmed KS Progression by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of IERC-confirmed KS progression by week 48. IERC-confirmed KS progression was defined as KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART43.9
PTX+ART25.7

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Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for ET+ART vs. PTX+ART

Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART7.8
PTX+ART0.0

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Cumulative Rate of Death for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of death. Time to death was computed as the number of weeks between study entry and date of death. For participants who did not have the event, time to death was censored at the week of last contact with the participant or at the participant's off study week, whichever is later. (NCT01435018)
Timeframe: From study entry to week 240

InterventionCumulative events per 100 persons (Number)
ET+ART25.6
PTX+ART10.7

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Cumulative Rate of Death for BV+ART vs PTX+ART

The Kaplan-Meier estimate of the cumulative rate of death. Time to death was computed as the number of weeks between study entry and date of death. For participants who did not have the event, time to death was censored at the week of last contact with the participant or at the participant's off study week, whichever is later. (NCT01435018)
Timeframe: From study entry to week 240

InterventionCumulative events per 100 persons (Number)
BV+ART18.5
PTX+ART10.3

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Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of death by week 48. Time to death was computed as the number of weeks from study entry to date of death. For participants who did have the event, time to death was censored at the week of last contact with the participant. Time to death above 48 were censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART25.6
PTX+ART10.7

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Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of death by week 48. Time to death was computed as the number of weeks from study entry to the death date. For participants who did have the event, time to death was censored at the week of last contact with the participant. Time to death above 48 were censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART18.5
PTX+ART10.3

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Cumulative Rate of Change in KS Treatment by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of change in KS treatment by week 48. Change in KS treatment was defined as stopping Step 1 randomized chemotherapy and initiating a different chemotherapy. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART59.5
PTX+ART26.0

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Cumulative Rate of Change in KS Treatment by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of change in KS treatment by week 48. Change in KS treatment was defined as stopping Step 1 randomized chemotherapy and initiating a different chemotherapy. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART32.5
PTX+ART18.9

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Cumulative Rate of AIDS-defining Event by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of AIDS-defining events by week 48. AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Time to event was computed as the number of weeks from study entry to the first AIDS-defining event. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
ET+ART15.2
PTX+ART28.6

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Cumulative Rate of AIDS-defining Event by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of AIDS-defining events by week 48. AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Time to event was computed as the number of weeks from study entry to the first AIDS-defining event. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART17.9
PTX+ART19.6

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Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for BV+ART vs. PTX+ART

Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. (NCT01435018)
Timeframe: From study entry to week 48

InterventionCumulative events per 100 persons (Number)
BV+ART7.4
PTX+ART1.8

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HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo

The within-person changes in rate of HSV shedding during study drug administration (treatment phase) compared with the rate of HSV shedding during lead-in observation phase in the same participants. We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment. This is analyzed separately for each treatment arm and not compared between arms. (NCT01448616)
Timeframe: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase

,,
Interventionpercentage of swabs positive (%) (Number)
Lead-in PhaseTreatment Phase
Oral Placebo + Vaginal Placebo21.320.4
Oral Placebo + Vaginal TFV Gel13.812.0
Oral TDF + Vaginal Placebo Gel22.919.5

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Within-person Changes in Log-copy Numbers of HSV

"The within-person changes in mean log-copy numbers of HSV shed during treatment phase (oral TDF, vaginal TFV, or double placebo) compared with the lead-in (observation) phase in the same participants. Each treatment arm is analyzed separately without comparison between arms.~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment." (NCT01448616)
Timeframe: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase

,,
Interventionlog-copy number of HSV DNA shed (Mean)
Lead-in PhaseTreatment Phase
Oral Placebo + Vaginal Tenofovir 1% Gel4.474.40
Oral TDF + Vaginal Placebo Gel4.024.11
Placebo Oral + Placebo Vaginal Gel3.714.22

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Genital Lesion Rate

"The within person change in proportion of days with lesions between the lead-in (observational) and study drug (treatment) phase for each arm separately. No between arm comparisons were performed. We include intent to treat with all randomized participants as well as per protocol (persons receiving study drug for at least 30 days with 90% or better reported compliance per returned product counts).~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment." (NCT01448616)
Timeframe: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase

,,
Interventionpercentage of days with lesions (%) (Number)
Lead-in PhaseTreatment Phase
Oral Placebo + Vaginal Tenofovir 1% Gel8.77.1
Oral TDF + Vaginal Placebo Gel11.811.6
Placebo Oral + Placebo Vaginal Gel13.614.7

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Asymptomatic Shedding (Shedding on Days Without Genital Lesions)

"Within person changes in shedding on days without lesions between the lead-in (observational) phase and the study drug (treatment) phase. Each arm is evaluated separately and no inter arm comparisons are made.~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment." (NCT01448616)
Timeframe: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase

,,
Intervention% days with asymptomatic shedding (Number)
Lead-in PhaseTreatment Phase
Oral Placebo + Vaginal Tenofovir 1% Gel7.68.2
Oral TDF + Vaginal Placebo Gel17.513.7
Placebo Oral + Placebo Vaginal Gel14.412.1

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Cumulative Incidence Herpes Simplex Virus Type 2

cumulative incidence of herpes simplex virus type 2, assessed at 52 weeks. Persons with baseline positivity were excluded. (NCT01450189)
Timeframe: 52 weeks

InterventionProportion of participants (Number)
Standard Counseling Arm0.5
Behavioral Intervention Arm Only1.0
Behavioral Intervention Plus ARV0.3

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Number of Adverse Events

Mean number of adverse events per group (NCT01450189)
Timeframe: one year

Interventionnumber of events (Mean)
Standard Counseling Arm0.78
Behavioral Intervention Arm Only1.3
Behavioral Intervention Plus ARV1.3

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Number of Partners Reporting for HIV Testing

Number of partners per index reporting for HIV testing at any time during follow-up (NCT01450189)
Timeframe: 52 weeks

Interventionpartners per index participant (Mean)
Standard Counseling Arm0.4
Behavioral Intervention Arm Only0.4
Behavioral Intervention Plus ARV0.4

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Proportion of Participants Completing Full Course of ARVs in Arm BIA

Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that (NCT01450189)
Timeframe: 1 year

Interventionproportion of BIA participants (Number)
Behavioral Intervention Plus Antiretrovirals (BIA)0.917

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Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.

In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms. (NCT01450189)
Timeframe: 1 year

Interventionproportion of participants (Number)
Combined Behavioral Intervention Arms0.216

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Proportion of Partners Reporting for HIV Testing

Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants (NCT01450189)
Timeframe: 52 weeks

Interventionproportion of sex partners (Number)
Standard Counseling Arm0.1
Behavioral Intervention Arm Only0.1
Behavioral Intervention Plus ARV0.1

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Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening

(NCT01450189)
Timeframe: 1 year

Interventionproportion of participants screened (Number)
Overall0.622

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Proportion of Persons Completing All Scheduled Visits in Each Study Arm

(NCT01450189)
Timeframe: 1 year

InterventionProportion of participants (Number)
Standard Counseling Arm0.44
Behavioral Intervention Arm0.44
Behavioral Intervention Plus Antiretrovirals (BIA)0.37

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Prevalence of AHI Among Persons Screened

Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization. (NCT01450189)
Timeframe: 1 year

Interventionproportion of participants (Number)
Overall0.0073

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Genital HIV RNA Concentration - Week 26, Women

median HIV RNA concentration in cervical lavage fluid (NCT01450189)
Timeframe: 26 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm11.5
Behavioral Intervention Arm Only0
Behavioral Intervention Plus ARV164

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Proportion of Persons With AHI Successfully Recruited Into the Study

This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization. (NCT01450189)
Timeframe: 1 year

InterventionProportion of persons with AHI recruited (Number)
Overall0.69

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Suppression of HIV RNA to <1000c/ml at 12 Weeks

Proportion of persons in each arm with viral load <1000copies/ml at 12 weeks (NCT01450189)
Timeframe: 12 weeks

InterventionProportion of participants (Number)
Standard Counseling Arm0.5
Behavioral Intervention Arm Only0.25
Behavioral Intervention Plus ARV0.72

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Genital HIV RNA Concentration - Week 52, Women

median HIV RNA concentration in cervical lavage fluid (NCT01450189)
Timeframe: 52 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm0
Behavioral Intervention Arm Only219
Behavioral Intervention Plus ARV2111

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Genital HIV RNA Concentration - Week 52, Men

median HIV RNA concentration as measured in semen (NCT01450189)
Timeframe: 52 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm13088
Behavioral Intervention Arm Only66
Behavioral Intervention Plus ARV0

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Genital HIV RNA Concentration - Week 26, Men

median HIV RNA concentration as measured in semen (NCT01450189)
Timeframe: 26 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm9456
Behavioral Intervention Arm Only292
Behavioral Intervention Plus ARV0

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Genital HIV RNA Concentration - Week 12, Women

median HIV RNA concentration in cervical lavage fluid (NCT01450189)
Timeframe: 12 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm82.5
Behavioral Intervention Arm Only0
Behavioral Intervention Plus ARV38.5

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Genital HIV RNA Concentration - Week 12, Men

median HIV RNA concentration as measured in semen (NCT01450189)
Timeframe: 12 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm25364
Behavioral Intervention Arm Only446
Behavioral Intervention Plus ARV0

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Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)

Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis (NCT01450189)
Timeframe: 26 weeks

Interventionproportion of participants (Number)
Standard Counseling Arm0.14
Behavioral Intervention Arm Only0.33
Behavioral Intervention Plus ARV0.12

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Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)

At least one incident infection with either gonorrhea, chlamydia or trichomoniasis (NCT01450189)
Timeframe: 52 weeks

Interventionproportion of participants (Number)
Standard Counseling Arm0.14
Behavioral Intervention Arm Only0.42
Behavioral Intervention Plus ARV0.15

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Cumulative Incidence Herpes Simplex Virus Type 2

cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded. (NCT01450189)
Timeframe: 26 weeks

InterventionProportion of participants (Number)
Standard Counseling Arm0.5
Behavioral Intervention Arm Only0.5
Behavioral Intervention Plus ARV0.25

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Blood HIV RNA Concentration at Week 52

(NCT01450189)
Timeframe: 52 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm3248.5
Behavioral Intervention Arm Only6467.5
Behavioral Intervention Plus ARV10876

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Blood HIV RNA Concentration at Week 26

(NCT01450189)
Timeframe: 26 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm8661
Behavioral Intervention Arm Only58504
Behavioral Intervention Plus ARV6788

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Blood HIV RNA Concentration at Week 12

(NCT01450189)
Timeframe: 12 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm19411
Behavioral Intervention Arm Only22734
Behavioral Intervention Plus ARV20

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Time to HIV RNA Suppression <1000 c/ml

median time to viral load suppression (<1000 c/ml) (NCT01450189)
Timeframe: From date of randomization until viral load suppression, up to 52 weeks

Interventionweeks (Median)
Standard Counseling Arm39
Behavioral Intervention Arm Only26
Behavioral Intervention Plus ARV16

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Occurrence of Grade 3 or Higher Adverse Events (AEs)

participants had Occurrence of Grade 3 or higher adverse events (AEs) (NCT01505114)
Timeframe: Through Week 48

InterventionParticipants (Count of Participants)
Arm 118
Arm 224
Arm 320
Arm 428

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AUC 0-6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol*h/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA6180015000
Group B243009880027600

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AUC 0-6hr of Deleobuvir Reduction Metabolite CD 6168

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol*h/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA4170019300
Group B133006220039100

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Cmax of Deleobuvir (BI 207127)

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA2700010100
Group B109003140016000

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Cmax of 1-OH-Midazolam (1-hydroxy-midazolam)

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=15, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group A5.576.506.465.05
Group B6.686.525.024.67

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AUC 0-6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol*h/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA29801620
Group B89357003510

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Cmax of Tolbutamide

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=15, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group A152000146000130000110000
Group B170000158000126000127000

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Cmax of Midazolam

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=15, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group A21.129.931.921.3
Group B23.829.828.823.2

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Cmax of Faldaprevir (BI 201335)

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionng/mL (Geometric Mean)
Day 9 (N=15,0)Day 17 (N=14,14)Day 66 (N=13,15)
Group A352087804410
Group BNA99506690

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Cmax of Deleobuvir Reduction Metabolite CD 6168

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA85204510
Group B3040124008880

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Cmax of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA596386
Group B2031130806

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Cmax of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA127003790
Group B5620202006550

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C6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)

Concentration of an analyte in plasma at 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 14)
Group ANA112002740
Group B4330175005780

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C6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)

Concentration of an analyte in plasma at 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 14)
Group ANA508295
Group B159962712

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C6hr of Deleobuvir Reduction Metabolite CD 6168

Concentration of an analyte in plasma at 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 14)
Group ANA69803360
Group B2250102007460

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Cmax of Caffeine

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionng/mL (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=15, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group A5170489048305590
Group B5340722065306450

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C6hr of Deleobuvir (BI 207127)

Concentration of an analyte in plasma at 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 14)
Group ANA179005080
Group B58002080010100

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C24hr of Faldaprevir (BI 201335)

Concentration of an analyte in plasma at 24 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionng/mL (Geometric Mean)
Day 9 (N=15,0)Day 17 (N=14,19)Day 66 (N=13,14)
Group A98336701140
Group BNA54102580

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AUC 0-infinity of Tolbutamide

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionnmol*h/L (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=13, 17)Day 17 (N=14, 18)Day 66 (N=12, 15)
Group A1940000180000015200001330000
Group B2220000194000014100001390000

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AUC 0-infinity of Midazolam

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionnmol*h/L (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=15, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group A79.711712775.5
Group B10713014095.6

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AUC 0-infinity of Caffeine

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionng*h/mL (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=15, 15)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group A549004210071900120000
Group B77500142000170000159000

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AUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionnmol*h/L (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=15, 17)Day 17 (N=14, 19)Day 66 (N=13, 13)
Group A23.624.223.518.3
Group B26.028.522.820.8

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AUC 0-6hr of Deleobuvir (BI 207127)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol*h/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA11900036200
Group B4110013500059200

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Area Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionng*h/mL (Geometric Mean)
Day 9 (N=15,0)Day 17 (N=14,19)Day 66 (N=13,15)
Group A4560013800056200
Group BNA17300097300

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Number of Participants With Sustained Virological Response (SVR12)

Sustained virologic response (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) undetectable at 12 weeks after the end of treatment. SVR12 was analyzed in a descriptive manner using frequency of participants who achieved SVR12. (NCT01525628)
Timeframe: 12 weeks post treatment

InterventionParticipants (Number)
Group A13
Group B13
Group C11
Group D10
Group E3

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Number of Participants With Treatment Switch or Discontinuation

Overall (regardless of the molecule) (NCT01605890)
Timeframe: from Week 0 to Week 48

InterventionParticipants (Count of Participants)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate4

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Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48

(NCT01605890)
Timeframe: at Week 48

InterventionParticipants (Count of Participants)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate3

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Median Change of CD4 Lymphocytes at Week 48

(NCT01605890)
Timeframe: between Week 0 and Week 48

Interventioncells/µL (Median)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate87

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Percentage of Participants in Therapeutic Success

"The participants will be considered in therapeutic success at Week 48 if they did not present any of the following events:~Plasma HIV-2 RNA load over or equal to 100 copies/mL, starting from Week 24 and confirmed within the next 4 weeks,~CD4 lymphocytes gain below 100/mm3 at Week 48 compared to the CD4 lymphocytes counts average between Week-4 and Week 0,~Raltegravir permanent discontinuation,~Death from any cause,~New B or C events confirmed by an endpoint review committee" (NCT01605890)
Timeframe: at Week 48

Interventionpercentage of participants (Number)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate40

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Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24

(NCT01605890)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate5

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Number of Clinical and Biological Events

(NCT01605890)
Timeframe: from Week 0 to Week 48

Interventionclinical and biological events (Number)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate61

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Median Change in CD4 Lymphocytes Count at Week 12

(NCT01605890)
Timeframe: between Week 0 and Week 12

Interventioncells/µL (Median)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate73

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Number of Participants With Clinical Progression

"Clinical progression is defined as the switch:~from category A to B, C or death.~from category B to C or death." (NCT01605890)
Timeframe: from Week 0 to Week 48

InterventionParticipants (Count of Participants)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate0

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Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL

(NCT01605890)
Timeframe: between Week 0 and Week 48

Interventionpercentage of participants (Number)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate96.4

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Number of Virological Failure Participants With Resistance Mutations

Virological failure is defined as plasma HIV-2 RNA load over or equal to 100 copies/mL after plasma HIV-2 RNA load below 100copies/mL, confirmed with a retest within the 4 following weeks. The number and type of mutations in the RT and integrase genes compared to week 0 is being reported. (NCT01605890)
Timeframe: from Week 0 to Week 48

InterventionParticipants (Count of Participants)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate1

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Minimal Median of the Lower Dimension Out of the 4 Dimensions of the Quality of Life Questionnaire

"The quality of life questionnaire is the Professional Quality of Life (PROQOL) questionnaire, including 4 dimensions:~Physical health and symptoms, Relationship with others, Mental and cognitive functioning and Treatment impact For each scale, a score ranging from 0 (the worst answer) to 100 (the best answer) is calculated." (NCT01605890)
Timeframe: from Week 0 to Week 48

InterventionScore on a scale (Median)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate45

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Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence

(NCT01605890)
Timeframe: from Week 4 to Week 48

Interventionpercentage of participants (Number)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate76

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Change in log10(Pf Gametocyte Density) From Entry to Day 30

"Change in log10(Pf gametocyte density) as evaluated using a Hodges-Lehmann estimate from entry to day 30 is evaluated in two groups:~Randomized to nNRTI-based ART with continued Pf SCP at day 15~Randomized to LPV/r-based ART with continued Pf SCP at day 15~Analysis was not conducted in either group with clearance at day 15 due to the small sample size and high number of undetectable samples in both clearance groups at entry and day 30." (NCT01632891)
Timeframe: Entry, Day 30

Interventionlog10(gametocyte/µL) (Number)
nNRTI-based ART, Not Cleared-0.46
LPV/R-based ART, Not Cleared0.17

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Number of Participants With Detectable Pf Gametocyte Density

Number of participants with detectable Pf gametocyte density as determined by PCR. Due to the large number of undetectable results, this outcome was measured as dichotomous. (NCT01632891)
Timeframe: Entry, days 3, 6, 9, 12, 15, 20, 25, 30

,
InterventionParticipants (Count of Participants)
EntryDay 3Day 6Day 9Day 12Day 15Day 20Day 25Day 30
LPV/R-based ART1110911610111211
nNRTI-based ART121512131114141613

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Proportion of Participants With Plasmodium Falciparum (Pf) Subclinical Parasitemia (SCP) Clearance

"Pf SCP clearance defined by polymerase chain reaction (PCR) < 10 parasites/µL on three consecutive occasions within a 24-hour period.~If a participant had missing data on day 15, they were considered as not having clearance." (NCT01632891)
Timeframe: Day 15 (3 samples collected, separated by at least 5 hours and all three collected within 24-hours)

,
InterventionProportion of participants (Number)
Proportion ClearedProportion Not Cleared
LPV/R-based ART0.230.77
nNRTI-based ART0.270.73

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Change in log10(Pf Parasite Density) From Entry to Day 30

"Change is evaluated as log10(Pf parasite density) at day 30 minus log10(Pf parasite density) at entry.~Change is evaluated in four groups:~Randomized to nNRTI-based ART with continued Pf SCP at day 15~Randomized to nNRTI-based ART with clearance of Pf SCP at day 15~Randomized to LPV/r-based ART with continued Pf SCP at day 15~Randomized to LPV/r-based ART with clearance of Pf SCP at day 15" (NCT01632891)
Timeframe: Entry, Day 30

Interventionlog10(parasites/µL) (Median)
nNRTI-based ART, Not Cleared-2.26
nNRTI-based ART, Cleared-1.65
LPV/R-based ART, Not Cleared-1.82
LPV/R-based ART, Cleared-3.61

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Number of Participants With Uncomplicated Clinical Malaria

Uncomplicated clinical malaria is defined as the presence of non-severe fever/symptoms and parasitemia without organ complication. (NCT01632891)
Timeframe: From study entry to day 30

InterventionParticipants (Count of Participants)
LPV/R-based ART2
nNRTI-based ART1

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Time to First Pf SCP Clearance

Time to clearance is defined by time to first measurement with PCR < 10 parasites/µL, and is evaluated as the point estimate and 95% CI for the day when 50% of participants cleared parasite. (NCT01632891)
Timeframe: From study entry up to day 30

InterventionDays (Median)
LPV/R-based ART12
nNRTI-based ART14

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Log10(Pf Parasite Density)

Pf parasite density was determined by PCR. If parasite density equals 0, the value is set to 0.01 before log10 transformation. The value 0.01 was chosen based on the smallest observed parasite density value of 0.017. (NCT01632891)
Timeframe: Entry, days 3, 6, 9, 12, 15, 20, 25, 30

,
Interventionlog10(parasites/µL) (Mean)
EntryDay 3Day 6Day 9Day 12Day 15Day 20Day 25Day 30
LPV/R-based ART2.481.921.771.651.591.590.650.280.14
nNRTI-based ART2.091.571.491.631.561.430.670.490.30

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Change From Baseline in Fasting Values of Total Cholesterol

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72

,,,,,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Experimental: Cohort A5.74.47.6
Experimental: Cohort C16.520.022.1
Experimental: Cohort D7.919.124.5
Experimental: Sub-cohort B116.719.722.6
Experimental: Sub-cohort B232.540.440.4
Experimental: Sub-cohort B312.49.928.2

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Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC]

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72

,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Cell Phone Intervention (CPI) + Standard of Care (SOC)2.95.66.0
Standard of Care (SOC)3.63.76.6

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Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)] (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72

,,,,,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Experimental: Cohort A2.83.54.7
Experimental: Cohort C1.02.35.8
Experimental: Cohort D-2.21.83.4
Experimental: Sub-cohort B13.25.34.4
Experimental: Sub-cohort B211.413.415.7
Experimental: Sub-cohort B32.13.84.6

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Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC]

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72

,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Cell Phone Intervention (CPI) + Standard of Care (SOC)3.73.63.6
Standard of Care (SOC)3.75.11.5

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Change From Baseline in Fasting Values of Glucose

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72

,,,,,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Experimental: Cohort A1.92.13.0
Experimental: Cohort C2.13.0-0.9
Experimental: Cohort D3.24.27.8
Experimental: Sub-cohort B18.89.36.8
Experimental: Sub-cohort B26.16.2-5.2
Experimental: Sub-cohort B36.61.74.3

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Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC]

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72

,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Cell Phone Intervention (CPI) + Standard of Care (SOC)5.512.011.9
Standard of Care (SOC)9.510.112.8

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Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72

,,,,,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Experimental: Cohort A1.33.43.9
Experimental: Cohort C12.215.313.6
Experimental: Cohort D9.914.419.7
Experimental: Sub-cohort B113.316.322.4
Experimental: Sub-cohort B221.528.227.8
Experimental: Sub-cohort B3-0.50.316.6

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Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC]

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72

,
Interventioncells/mm^3 (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Cell Phone Intervention (CPI) + Standard of Care (SOC)72112145
Standard of Care (SOC)74107134

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Change From Baseline in CD4+ T-cell Count

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72

,,,,,
Interventioncells/mm^3 (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Experimental: Cohort A396587
Experimental: Cohort C100160185
Experimental: Cohort D90135165
Experimental: Sub-cohort B1109157182
Experimental: Sub-cohort B2116158197
Experimental: Sub-cohort B314286238

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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks [CPI+SOC v SOC]

"The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive).~The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 72 weeks after the date of entry

Interventionproportion of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)0.69
Standard of Care (SOC)0.62

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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks

"The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive).~The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 72. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 72 weeks after the date of entry

Interventionproportion of participants (Number)
Overall Study0.64
Experimental: Cohort A0.44
Experimental: Sub-cohort B10.92
Experimental: Sub-cohort B20.87
Experimental: Sub-cohort B31.00
Experimental: Cohort C0.85
Experimental: Cohort D0.77

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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks [CPI+SOC v SOC]

"The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA >200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 48 weeks after the date of entry

Interventionproportion of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)0.66
Standard of Care (SOC)0.62

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Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

InterventionParticipants (Count of Participants)
Experimental: Cohort A145
Experimental: Sub-cohort B16
Experimental: Sub-cohort B24
Experimental: Sub-cohort B30
Experimental: Cohort C5
Experimental: Cohort D6

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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks

"The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA >200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 48. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 48 weeks after the date of entry

Interventionproportion of participants (Number)
Overall Study0.64
Experimental: Cohort A0.44
Experimental: Sub-cohort B10.88
Experimental: Sub-cohort B20.88
Experimental: Sub-cohort B31.00
Experimental: Cohort C0.90
Experimental: Cohort D0.74

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Time to First Dose Modification Due to Grade 3 or 4 Toxicity

Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile
Experimental: Cohort A45.7NA
Experimental: Cohort CNANA
Experimental: Cohort DNANA
Experimental: Sub-cohort B163.3NA
Experimental: Sub-cohort B2NANA
Experimental: Sub-cohort B3NANA

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Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)2424NANA
Standard of Care (SOC)242448NA

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Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile
Experimental: Cohort A242424144
Experimental: Cohort C48NANANA
Experimental: Cohort D242424NA
Experimental: Sub-cohort B124NANANA
Experimental: Sub-cohort B224NANANA
Experimental: Sub-cohort B3NANANANA

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Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile50th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)24242460NA
Standard of Care (SOC)24242424NA

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Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile50th percentile
Experimental: Cohort A2424242460
Experimental: Cohort C2448120NANA
Experimental: Cohort D242424NANA
Experimental: Sub-cohort B12448NANANA
Experimental: Sub-cohort B22472144NANA
Experimental: Sub-cohort B3NANANANANA

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Time From Study Entry/Randomization to Treatment Modification or Discontinuation.

Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile50th percentile
Experimental: Cohort A1.08.425.358.6NA
Experimental: Cohort C0.14.129.7NANA
Experimental: Cohort D2.45.147.698.9NA
Experimental: Sub-cohort B13.133.459.0NANA
Experimental: Sub-cohort B24.436.038.6165.6NA
Experimental: Sub-cohort B34.44.44.4NANA

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Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC]

Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)3.1NA
Standard of Care (SOC)9.0NA

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Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC]

Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)1.05.123.684.0
Standard of Care (SOC)2.422.338.9111.1

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Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC]

Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)4.027.660.6NA
Standard of Care (SOC)4.042.377.9NA

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Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event

Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile
Experimental: Cohort A4.027.657.9NA
Experimental: Cohort C3.336.077.9142.4
Experimental: Cohort D2.424.048.496.3
Experimental: Sub-cohort B13.136.084.0NA
Experimental: Sub-cohort B216.350.3120.0NA
Experimental: Sub-cohort B3NANANANA

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Time From Study Entry/Randomization to the First of Death or Hospitalization.

Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile50th percentile
Experimental: Cohort A2.413.432.6120.1168.9
Experimental: Cohort C2.07.777.9NANA
Experimental: Cohort D2.35.696.1NANA
Experimental: Sub-cohort B12.320.380.7NANA
Experimental: Sub-cohort B23.028.049.7NANA
Experimental: Sub-cohort B316.416.416.4NANA

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Number of Weeks of Follow-up [CPI+SOC v SOC]

All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up

Interventionweeks (Median)
Cell Phone Intervention (CPI) + Standard of Care (SOC)72
Standard of Care (SOC)72

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Number of Weeks of Follow-up

All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up

Interventionweeks (Median)
Experimental: Cohort A72
Experimental: Sub-cohort B196
Experimental: Sub-cohort B284
Experimental: Sub-cohort B396
Experimental: Cohort C72
Experimental: Cohort D96

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Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

InterventionParticipants (Count of Participants)
Cell Phone Intervention (CPI) + Standard of Care (SOC)20
Standard of Care (SOC)32

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Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

InterventionParticipants (Count of Participants)
Experimental: Cohort A48
Experimental: Sub-cohort B11
Experimental: Sub-cohort B22
Experimental: Sub-cohort B30
Experimental: Cohort C1
Experimental: Cohort D5

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Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

InterventionParticipants (Count of Participants)
Cell Phone Intervention (CPI) + Standard of Care (SOC)66
Standard of Care (SOC)89

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Percent of Participants With Confirmed Virologic Failure by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. (NCT01641367)
Timeframe: From week 24 to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)24.9
Standard of Care (SOC)32.2

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Percent of Participants With Confirmed Virologic Failure by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 to Week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A48.9
Experimental: Sub-cohort B18.2
Experimental: Sub-cohort B22.9
Experimental: Sub-cohort B30
Experimental: Cohort C5.8
Experimental: Cohort D18.6

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Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)1.2
Standard of Care (SOC)0

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Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A1.0
Experimental: Sub-cohort B10
Experimental: Sub-cohort B20
Experimental: Sub-cohort B30
Experimental: Cohort C0
Experimental: Cohort D0

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Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)0.4
Standard of Care (SOC)1.1

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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks [CPI+SOC v SOC]

"The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 24 weeks after the date of entry

Interventionproportion of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)0.68
Standard of Care (SOC)0.61

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Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A3.2
Experimental: Sub-cohort B12.7
Experimental: Sub-cohort B21.4
Experimental: Sub-cohort B30
Experimental: Cohort C4.3
Experimental: Cohort D0

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Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity

Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile10th percentile
Experimental: Cohort A2.1106.1NA
Experimental: Cohort C0.1NANA
Experimental: Cohort DNANANA
Experimental: Sub-cohort B115.0NANA
Experimental: Sub-cohort B26.4134.0NA
Experimental: Sub-cohort B3NANANA

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Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)7.8
Standard of Care (SOC)12.1

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Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.Length of follow-up varied by Cohort.A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 to Week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A16.6
Experimental: Sub-cohort B11.4
Experimental: Sub-cohort B21.4
Experimental: Sub-cohort B30
Experimental: Cohort C1.5
Experimental: Cohort D15.4

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Percent of Participants With Death or Hospitalization by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A12.3
Experimental: Sub-cohort B18.1
Experimental: Sub-cohort B29.7
Experimental: Sub-cohort B312.5
Experimental: Cohort C5.7
Experimental: Cohort D5.9

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Percent of Participants With Death or Hospitalization by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)10.6
Standard of Care (SOC)10.6

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Percent of Participants With Treatment Modification or Discontinuation by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A19.9
Experimental: Sub-cohort B16.8
Experimental: Sub-cohort B219.4
Experimental: Sub-cohort B312.5
Experimental: Cohort C14.3
Experimental: Cohort D11.8

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Percent of Participants With Treatment Modification or Discontinuation by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)19.1
Standard of Care (SOC)13.6

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Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)2.8
Standard of Care (SOC)2.3

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Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC]

Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)45.7NA
Standard of Care (SOC)NANA

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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks

"The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 24. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 24 weeks after the date of entry

Interventionproportion of participants (Number)
Overall Study0.64
Experimental: Cohort A0.43
Experimental: Sub-cohort B10.89
Experimental: Sub-cohort B20.88
Experimental: Sub-cohort B31.00
Experimental: Cohort C0.90
Experimental: Cohort D0.74

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Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC]

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72

,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Cell Phone Intervention (CPI) + Standard of Care (SOC)10.115.117.4
Standard of Care (SOC)14.414.118.7

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Change From Baseline in Fasting Values of Triglycerides

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72

,,,,,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Experimental: Cohort A15.412.217.5
Experimental: Cohort C15.49.911.8
Experimental: Cohort D28.924.46.7
Experimental: Sub-cohort B1-3.6-11.5-31.3
Experimental: Sub-cohort B227.619.918.9
Experimental: Sub-cohort B336.022.220.7

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Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC]

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72

,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Cell Phone Intervention (CPI) + Standard of Care (SOC)15.32.213.7
Standard of Care (SOC)18.719.67.1

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Time From Study Entry/Randomization to Death

Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile10th percentile
Experimental: Cohort A11.362.4NA
Experimental: Cohort C77.9NANA
Experimental: Cohort D2.4NANA
Experimental: Sub-cohort B13.1NANA
Experimental: Sub-cohort B244.6NANA
Experimental: Sub-cohort B3NANANA

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Time From Study Entry/Randomization to Death [CPI+SOC v SOC]

Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)11.3NANA
Standard of Care (SOC)15.982.1NA

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Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS)

Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile
Experimental: Cohort ANANA
Experimental: Cohort CNANA
Experimental: Cohort D13.0NA
Experimental: Sub-cohort B1NANA
Experimental: Sub-cohort B225.0NA
Experimental: Sub-cohort B3NANA

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Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC]

Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)NANA
Standard of Care (SOC)25.0NA

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Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC]

Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)2.311.344.6168.9
Standard of Care (SOC)2.320.345.3NA

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Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A0.7
Experimental: Sub-cohort B10
Experimental: Sub-cohort B21.4
Experimental: Sub-cohort B30
Experimental: Cohort C0
Experimental: Cohort D3.0

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Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)8.2
Standard of Care (SOC)6.5

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Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A8.8
Experimental: Sub-cohort B15.4
Experimental: Sub-cohort B24.2
Experimental: Sub-cohort B30
Experimental: Cohort C5.8
Experimental: Cohort D5.9

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Percent of Participants Experiencing Death by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)3.9
Standard of Care (SOC)1.5

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Percent of Participants Experiencing Death by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A3.9
Experimental: Sub-cohort B11.4
Experimental: Sub-cohort B21.4
Experimental: Sub-cohort B30
Experimental: Cohort C0
Experimental: Cohort D2.9

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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264

InterventionMilliliters per minute (Mean)
Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 20; n=2, 0, 0, 1Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40Week 180; n=1, 0, 0, 0
GSK1265744 10 mg-3.0-1.45.52.28.0-2.7-2.62.21.0

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Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96

CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionCells per cubic millimeter (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=58, 56, 57, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=49, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=46, 46, 52, 41
Efavirenz 600 mg456.5487.0509.9531.4564.3594.4607.7599.5625.7635.7663.8651.5687.9732.6733.9722.5744.7747.8
GSK1265744 10 mg445.5544.0580.5576.6588.4608.3607.3614.6632.8652.2638.1638.7650.2677.3668.1683.2718.3726.2
GSK1265744 30 mg444.9525.1522.0555.2599.0595.8607.4626.5629.5635.9650.8658.6658.5687.2720.9651.3736.9722.9
GSK1265744 60 mg459.0549.3545.8544.3596.6599.7636.6658.0645.8653.3665.2720.3667.6713.8719.8710.9735.0743.1

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Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionInternational Units per Liter (Mean)
ALT; Baseline; n=60, 60, 61, 62ALT; Week 2; n=58, 56, 58, 58ALT; Week 4; n=58, 57, 59, 57ALT; Week 8; n=58, 55, 57, 54ALT; Week 12; n=58, 53, 57, 51ALT; Week 16; n=57, 54, 57, 52ALT; Week 20; n=56, 54, 55, 49ALT; Week 24; n=56, 53, 56, 47ALT; Week 26; n=48, 50, 53, 45ALT; Week 28; n=51, 52, 52, 45ALT; Week 32; n=52, 53, 55, 45ALT; Week 36; n=52, 52, 55, 45ALT; Week 40; n=52, 53, 55, 44ALT; Week 48; n=51, 53, 54, 44ALT; Week 60; n=48, 47, 53, 44ALT; Week 72; n=47, 47, 52, 42ALT; Week 84; n=46, 48, 52, 42ALT; Week 96; n=45, 48, 52, 40AST; Baseline; n=60, 60, 61, 62AST; Week 2; n=58, 56, 58, 58AST; Week 4; n=58, 57, 59, 57AST; Week 8; n=58, 55, 57, 54AST; Week 12; n=58, 53, 57, 51AST; Week 16; n=57, 54, 57, 52AST; Week 20; n=56, 54, 55, 49AST; Week 24; n=56, 53, 56, 47AST; Week 26; n=48, 50, 53, 45AST; Week 28; n=51, 52, 52, 45AST; Week 32; n=52, 53, 55, 45AST; Week 36; n=52, 52, 55, 45AST; Week 40; n=52, 53, 55, 44AST; Week 48; n=51, 53, 54, 44AST; Week 60; n=48, 47, 53, 44AST; Week 72; n=47, 47, 52, 42AST; Week 84; n=46, 48, 52, 42AST; Week 96; n=45, 48, 52, 40CK; Baseline; n=60, 60, 61, 62CK; Week 2; n=58, 56, 58, 58CK; Week 4; n=58, 57, 59, 57CK; Week 8; n=58, 55, 57, 54CK; Week 12; n=58, 53, 57, 51CK; Week 16; n=57, 54, 57, 52CK; Week 20; n=56, 54, 55, 49CK; Week 24; n=56, 53, 56, 47CK; Week 26; n=48, 50, 53, 45CK; Week 28; n=51, 52, 52, 45CK; Week 32; n=52, 53, 55, 45CK; Week 36; n=52, 52, 55, 45CK; Week 40; n=52, 53, 55, 44CK; Week 48; n=51, 53, 54, 44CK; Week 60; n=48, 47, 53, 44CK; Week 72; n=47, 47, 52, 42CK; Week 84; n=46, 48, 52, 42CK; Week 96; n=45, 48, 52, 40
Efavirenz 600 mg30.530.031.425.025.730.427.025.728.324.223.123.523.422.624.922.727.124.331.532.829.024.424.436.728.726.125.823.725.426.323.023.724.922.929.927.7349.8512.1236.2152.9161.2646.5528.2247.4163.5154.7254.7303.1150.2146.3168.0120.5258.6281.1
GSK1265744 10 mg23.924.023.125.425.026.022.320.924.220.419.523.422.718.421.419.920.122.025.025.624.028.726.324.226.023.328.422.621.929.224.721.423.421.822.323.6197.3237.9196.7413.3316.1195.1342.7226.0344.1213.4205.6528.4259.5203.5315.7182.5204.3542.7
GSK1265744 30 mg28.126.325.629.331.428.524.927.526.626.526.924.724.624.825.930.729.948.727.526.625.029.529.029.224.227.226.926.726.525.424.524.325.331.029.247.7295.9276.1221.8427.2314.7427.3202.1306.3267.7276.8248.8242.9225.4219.3215.5354.0329.2272.8
GSK1265744 60 mg28.527.230.335.926.626.930.328.623.524.823.224.225.824.828.126.325.325.528.126.828.332.825.526.531.728.624.525.525.626.426.524.230.426.425.225.9181.2184.8180.5451.7211.8213.3485.3243.0242.5290.4311.3255.2292.6219.8399.6247.7195.0199.7

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Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product. (NCT01641809)
Timeframe: Week 48

InterventionPercentage of participants (Number)
GSK1265744 10 mg80
GSK1265744 30 mg80
GSK1265744 60 mg87
Efavirenz 600 mg71

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Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase

AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Week 24 to Week 96

InterventionPercentage of participants (Number)
GSK1265744 10 mg2
GSK1265744 30 mg4
GSK1265744 60 mg2
Efavirenz 600 mg2

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Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase

AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Up to Week 24

InterventionPercentage of participants (Number)
GSK1265744 10 mg0
GSK1265744 30 mg2
GSK1265744 60 mg5
Efavirenz 600 mg13

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Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events

AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Up to Week 324

InterventionPercentage of participants (Number)
GSK1265744 10 mg7
GSK1265744 30 mg7
GSK1265744 60 mg7
Efavirenz 600 mg15

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Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings

Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented. (NCT01641809)
Timeframe: Up to Week 324

InterventionParticipants (Count of Participants)
GSK1265744 10 mg25
GSK1265744 30 mg19
GSK1265744 60 mg15
Efavirenz 600 mg10

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Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase

Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study. (NCT01641809)
Timeframe: Weeks 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionPercentage of participants (Number)
Week 24Week 26Week 28Week 32Week 36Week 40Week 48Week 60Week 72Week 84Week 96
Efavirenz 600 mg9687919194899489898983
GSK1265744 10 mg9690989698969290838379
GSK1265744 30 mg9485899192929183838585
GSK1265744 60 mg9695959695959695959593

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Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2

Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post dose at Week 2

InterventionMicrograms per milliliter (Geometric Mean)
GSK1265744 10 mg1.45
GSK1265744 30 mg4.34
GSK1265744 60 mg5.83

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Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2

Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2

InterventionHours*micrograms per milliliter (Geometric Mean)
GSK1265744 10 mg45.69
GSK1265744 30 mg133.74
GSK1265744 60 mg227.58

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Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit

Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionLog10 copies per milliliter (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 47, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=36, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=33, 39, 47, 0Week 228; n=32, 39, 47, 0Week 240; n=31, 39, 45, 0Week 252; n=31, 38, 47, 0Week 264; n=32, 38, 47, 0Week 276; n=31, 38, 45, 0Week 288; n=30, 38, 45, 0Week 300; n=31, 37, 44, 0Week 312; n=31, 33, 43, 0Week 324; n=3, 4, 3, 0
GSK1265744 10 mg4.4241.8831.7061.6951.6431.6191.6231.6151.5951.5911.6091.6041.6121.6861.6481.6251.6451.6811.6341.6381.6461.6821.6341.6651.6131.6891.6281.5911.5911.5961.5911.5911.5911.5911.6011.5971.591
GSK1265744 30 mg4.2701.9841.7311.6661.6181.6021.5961.5971.6021.6071.6201.6101.6181.6541.5981.6971.6431.6031.6091.5911.6311.6981.6031.6421.5911.5911.5951.5921.5911.6011.5991.5911.5911.5921.5911.6001.591
GSK1265744 60 mg4.4281.9391.7251.6661.6411.6161.5991.6031.5941.5911.6181.6061.6081.5981.5941.5911.5921.5961.5911.6181.5911.6301.6191.6031.6001.6991.6341.6341.6251.5911.5931.6171.6181.5911.6251.5911.591

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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264

InterventionMilliliters per minute (Mean)
Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 20; n=2, 0, 0, 1Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 60; n=0, 0, 0, 1Week 96; n=45, 48, 52, 40
Efavirenz 600 mg-0.7-0.10.03.44.04.80.416.05.1

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Number of Participants With AEs and SAEs Over Time

An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
Any AEAny SAE
Efavirenz 600 mg604
GSK1265744 10 mg5713
GSK1265744 30 mg5712
GSK1265744 60 mg6011

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Number of Participants With AEs and SAEs-Induction Phase

An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. (NCT01641809)
Timeframe: Up to Week 24

,,,
InterventionParticipants (Count of Participants)
Any AEAny SAE
Efavirenz 600 mg592
GSK1265744 10 mg542
GSK1265744 30 mg540
GSK1265744 60 mg552

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Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time

Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
ALT; Grade 1ALT; Grade 2ALT; Grade 3ALT; Grade 4Albumin; Grade 1Albumin; Grade 2Albumin; Grade 3Albumin; Grade 4ALP; Grade 1ALP; Grade 2ALP; Grade 3ALP; Grade 4AST; Grade 1AST; Grade 2AST; Grade 3AST; Grade 4CO2/bicarbonate; Grade 1CO2/bicarbonate; Grade 2CO2/bicarbonate; Grade 3CO2/bicarbonate; Grade 4Cholesterol; Grade 1Cholesterol; Grade 2Cholesterol; Grade 3Cholesterol; Grade 4CK; Grade 1CK; Grade 2CK; Grade 3CK; Grade 4Creatinine; Grade 1Creatinine; Grade 2Creatinine; Grade 3Creatinine; Grade 4Glucose; Grade 1Glucose; Grade 2Glucose; Grade 3Glucose; Grade 4LDL cholesterol; Grade 1LDL cholesterol; Grade 2LDL cholesterol; Grade 3LDL cholesterol; Grade 4Lipase; Grade 1Lipase; Grade 2Lipase; Grade 3Lipase; Grade 4Inorganic phosphorus; Grade 1Inorganic phosphorus; Grade 2Inorganic phosphorus; Grade 3Inorganic phosphorus; Grade 4Potassium; Grade 1Potassium; Grade 2Potassium; Grade 3Potassium; Grade 4Sodium; Grade 1Sodium; Grade 2Sodium; Grade 3Sodium; Grade 4Total bilirubin; Grade 1Total bilirubin; Grade 2Total bilirubin; Grade 3Total bilirubin; Grade 4Triglycerides; Grade 1Triglycerides; Grade 2Triglycerides; Grade 3Triglycerides; Grade 4
Efavirenz 600 mg84010000500072328100910605045110012601874010710892041001110000000111
GSK1265744 10 mg960100002000762261001773092371100191400147401195251120140001420072000110
GSK1265744 30 mg1261110001100138011400017120010426100018100017112098203111070001210013100400
GSK1265744 60 mg1950200004000155409000191530124452000211120131470911621065080001600084000331

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Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase

Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Week 24 to Week 96

,,,
InterventionParticipants (Count of Participants)
ALT; Grade 1ALT; Grade 2ALT; Grade 3ALT; Grade 4Albumin; Grade 1Albumin; Grade 2Albumin; Grade 3Albumin; Grade 4ALP; Grade 1ALP; Grade 2ALP; Grade 3ALP; Grade 4AST; Grade 1AST; Grade 2AST; Grade 3AST; Grade 4CO2/bicarbonate; Grade 1CO2/bicarbonate; Grade 2CO2/bicarbonate; Grade 3CO2/bicarbonate; Grade 4Cholesterol; Grade 1Cholesterol; Grade 2Cholesterol; Grade 3Cholesterol; Grade 4CK; Grade 1CK; Grade 2CK; Grade 3CK; Grade 4Creatinine; Grade 1Creatinine; Grade 2Creatinine; Grade 3Creatinine; Grade 4Glucose; Grade 1Glucose; Grade 2Glucose; Grade 3Glucose; Grade 4LDL cholesterol; Grade 1LDL cholesterol; Grade 2LDL cholesterol; Grade 3LDL cholesterol; Grade 4Lipase; Grade 1Lipase; Grade 2Lipase; Grade 3Lipase; Grade 4Inorganic phosphorus; Grade 1Inorganic phosphorus; Grade 2Inorganic phosphorus; Grade 3Inorganic phosphorus; Grade 4Potassium; Grade 1Potassium; Grade 2Potassium; Grade 3Potassium; Grade 4Sodium; Grade 1Sodium; Grade 2Sodium; Grade 3Sodium; Grade 4Total bilirubin; Grade 1Total bilirubin; Grade 2Total bilirubin; Grade 3Total bilirubin; Grade 4Triglycerides; Grade 1Triglycerides; Grade 2Triglycerides; Grade 3Triglycerides; Grade 4
Efavirenz 600 mg630100004000523281009104050351000115008640970079204100710000000110
GSK1265744 10 mg96010000200055226100176308236110017140014640995251020120001420072000110
GSK1265744 30 mg126111000110013801140001712009426100017100016112098103111070001210013100400
GSK1265744 60 mg175000000400013520900019153011445200020112013147081162955080001600084000331

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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264

InterventionMilliliters per minute (Mean)
Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40Week 264; n=0, 0, 1, 0
GSK1265744 60 mg-4.97.0-2.7-5.8-4.5-9.0-143.0

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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264

InterventionMilliliters per minute (Mean)
Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 24; n=52, 53, 55, 46Week 26; n=0, 1, 0, 0Week 40; n=0, 1, 0, 0Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40Week 204; n=0, 1, 0, 0Week 252; n=0, 1, 0, 0
GSK1265744 30 mg-10.0-3.7-1.00.2-6.4-7.0-95.0-1.1-2.4-23.00.0

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Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit

Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionMicromoles per liter (Mean)
Creatinine; Week 2; n=58, 56, 58, 58Creatinine; Week 4; n=58, 57, 59, 57Creatinine; Week 8; n=58, 55, 57, 54Creatinine; Week 12; n=58, 53, 57, 51Creatinine; Week 16; n=57, 54, 57, 52Creatinine; Week 20; n=56, 54, 55, 49Creatinine; Week 24; n=56, 53, 56, 47Creatinine; Week 26; n=48, 50, 53, 45Creatinine; Week 28; n=51, 52, 52, 45Creatinine; Week 32; n=52, 53, 55, 45Creatinine; Week 36; n=52, 52, 55, 45Creatinine; Week 40; n=52, 53, 55, 44Creatinine; Week 48; n=51, 53, 54, 44Creatinine; Week 60; n=48, 47, 53, 44Creatinine; Week 72; n=47, 47, 52, 42Creatinine; Week 84; n=46, 48, 52, 42Creatinine; Week 96; n=45, 48, 52, 40Creatinine; Week 108; n=43, 46, 48, 0Creatinine; Week 120; n=40, 45, 48, 0Creatinine; Week 132; n=40, 46, 49, 0Creatinine; Week 144; n=37, 45, 47, 0Creatinine; Week 156; n=37, 42, 49, 0Creatinine; Week 168; n=35, 43, 47, 0Creatinine; Week 180; n=36, 41, 47, 0Creatinine; Week 192; n=36, 39, 47, 0Creatinine; Week 204; n=34, 39, 47, 0Creatinine; Week 216; n=33, 39, 46, 0Creatinine; Week 228; n=32, 39, 47, 0Creatinine; Week 240; n=30, 39, 46, 0Creatinine; Week 252; n=31, 38, 46, 0Creatinine; Week 264; n=32, 38, 47, 0Creatinine; Week 276; n=31, 38, 45, 0Creatinine; Week 288; n=31, 38, 45, 0Creatinine; Week 300; n=30, 37, 44, 0Creatinine; Week 312; n=31, 34, 43, 0Creatinine; Week 324; n=3, 4, 3, 0T. Bilirubin; Week 2; n=58, 56, 58, 58T. Bilirubin; Week 4; n=58, 57, 59, 57T. Bilirubin; Week 8; n=58, 55, 57, 54T. Bilirubin; Week 12; n=58, 53, 57, 51T. Bilirubin; Week 16; n=57, 54, 57, 52T. Bilirubin; Week 20; n=56, 54, 55, 49T. Bilirubin; Week 24; n=56, 53, 56, 47T. Bilirubin; Week 26; n=48, 50, 53, 45T. Bilirubin; Week 28; n=51, 52, 52, 45T. Bilirubin; Week 32; n=52, 53, 55, 45T. Bilirubin; Week 36; n=52, 52, 55, 45T. Bilirubin; Week 40; n=52, 53, 55, 44T. Bilirubin; Week 48; n=51, 53, 54, 44T. Bilirubin; Week 60; n=48, 47, 53, 44T. Bilirubin; Week 72; n=47, 47, 52, 42T. Bilirubin; Week 84; n=46, 48, 52, 42T. Bilirubin; Week 96; n=45, 48, 52, 40T. Bilirubin; Week 108; n=43, 46, 48, 0T. Bilirubin; Week 120; n=40, 45, 48, 0T. Bilirubin; Week 132; n=40, 46, 49, 0T. Bilirubin; Week 144; n=37, 45, 47, 0T. Bilirubin; Week 156; n=37, 42, 49, 0T. Bilirubin; Week 168; n=35, 43, 47, 0T. Bilirubin; Week 180; n=36, 41, 47, 0T. Bilirubin; Week 192; n=36, 39, 47, 0T. Bilirubin; Week 204; n=34, 39, 47, 0T. Bilirubin; Week 216; n=33, 39, 46, 0T. Bilirubin; Week 228; n=32, 39, 47, 0T. Bilirubin; Week 240; n=30, 39, 46, 0T. Bilirubin; Week 252; n=31, 38, 46, 0T. Bilirubin; Week 264; n=32, 38, 47, 0T. Bilirubin; Week 276; n=31, 38, 45, 0T. Bilirubin; Week 288; n=31, 38, 45, 0T. Bilirubin; Week 300; n=30, 37, 44, 0T. Bilirubin; Week 312; n=31, 34, 43, 0T. Bilirubin; Week 324; n=3, 4, 3, 0
GSK1265744 10 mg3.362.242.383.392.912.542.522.742.223.363.112.832.753.283.894.581.905.874.413.765.995.286.575.896.906.218.347.168.486.965.977.898.8110.497.9815.900.00.10.00.40.4-0.10.51.11.10.71.21.60.91.91.52.31.00.70.91.00.71.61.11.10.71.10.51.61.21.40.40.70.51.11.45.3
GSK1265744 30 mg2.582.502.061.591.100.852.441.802.801.693.412.362.182.304.713.805.345.184.154.025.806.365.625.087.916.469.317.197.337.527.105.847.849.167.869.75-0.3-0.3-0.5-0.9-1.2-0.70.20.50.70.20.61.70.10.00.10.10.01.41.12.01.11.00.80.00.30.70.80.50.92.02.92.81.91.71.15.5
GSK1265744 60 mg4.154.083.443.792.095.294.456.035.015.006.004.764.474.466.596.537.767.266.784.995.075.166.825.915.905.167.426.617.087.646.996.196.208.197.105.03-0.4-0.8-0.6-0.5-0.2-0.4-0.71.00.50.91.41.5-0.30.90.61.21.70.81.31.10.41.01.41.00.90.60.3-0.3-0.10.2-0.10.90.00.90.80.7

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Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit

Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionMicromoles per liter (Mean)
Creatinine; Week 2; n=58, 56, 58, 58Creatinine; Week 4; n=58, 57, 59, 57Creatinine; Week 8; n=58, 55, 57, 54Creatinine; Week 12; n=58, 53, 57, 51Creatinine; Week 16; n=57, 54, 57, 52Creatinine; Week 20; n=56, 54, 55, 49Creatinine; Week 24; n=56, 53, 56, 47Creatinine; Week 26; n=48, 50, 53, 45Creatinine; Week 28; n=51, 52, 52, 45Creatinine; Week 32; n=52, 53, 55, 45Creatinine; Week 36; n=52, 52, 55, 45Creatinine; Week 40; n=52, 53, 55, 44Creatinine; Week 48; n=51, 53, 54, 44Creatinine; Week 60; n=48, 47, 53, 44Creatinine; Week 72; n=47, 47, 52, 42Creatinine; Week 84; n=46, 48, 52, 42Creatinine; Week 96; n=45, 48, 52, 40T. Bilirubin; Week 2; n=58, 56, 58, 58T. Bilirubin; Week 4; n=58, 57, 59, 57T. Bilirubin; Week 8; n=58, 55, 57, 54T. Bilirubin; Week 12; n=58, 53, 57, 51T. Bilirubin; Week 16; n=57, 54, 57, 52T. Bilirubin; Week 20; n=56, 54, 55, 49T. Bilirubin; Week 24; n=56, 53, 56, 47T. Bilirubin; Week 26; n=48, 50, 53, 45T. Bilirubin; Week 28; n=51, 52, 52, 45T. Bilirubin; Week 32; n=52, 53, 55, 45T. Bilirubin; Week 36; n=52, 52, 55, 45T. Bilirubin; Week 40; n=52, 53, 55, 44T. Bilirubin; Week 48; n=51, 53, 54, 44T. Bilirubin; Week 60; n=48, 47, 53, 44T. Bilirubin; Week 72; n=47, 47, 52, 42T. Bilirubin; Week 84; n=46, 48, 52, 42T. Bilirubin; Week 96; n=45, 48, 52, 40
Efavirenz 600 mg0.65-0.32-0.92-1.42-2.92-3.26-2.03-2.67-3.42-3.50-3.26-2.83-2.73-3.87-4.48-2.48-2.28-3.0-3.4-3.4-2.4-2.4-2.6-2.9-2.7-2.8-2.6-2.7-2.9-2.6-2.2-2.7-2.6-2.5

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Change From Baseline in CD4+ Cell Count Over Time by Visit

CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionCells per cubic millimeter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=58, 56, 57, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=49, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=46, 46, 52, 41Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 46, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=35, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=33, 39, 47, 0Week 228; n=32, 39, 47, 0Week 240; n=32, 39, 47, 0Week 252; n=31, 38, 47, 0Week 264; n=32, 38, 47, 0Week 276; n=31, 38, 46, 0Week 288; n=30, 38, 45, 0Week 300; n=30, 37, 44, 0Week 312; n=30, 34, 43, 0Week 324; n=3, 4, 3, 0
GSK1265744 10 mg92.6136.4129.9140.5159.3165.2172.5186.4205.0191.4192.0203.6235.1217.7232.0261.5269.4296.2266.1297.1330.7334.5338.1338.0300.8369.5397.0331.8356.5400.3344.4398.3411.0437.7335.0402.0
GSK1265744 30 mg79.576.9117.8140.8142.2153.8180.9177.7188.1205.2213.0212.8241.6269.4201.4287.0267.5304.3279.3305.2308.9319.2332.4348.6351.0332.9373.4366.5395.9343.7365.0350.3383.5404.4433.0276.0
GSK1265744 60 mg91.788.290.5145.2148.3182.6204.0194.7193.3209.9265.0212.3259.0266.1254.0278.1286.2288.4307.2313.2322.4320.4361.3384.2342.3340.0357.8383.7408.4383.1391.8362.2337.1353.5407.0272.0

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Change From Baseline in CD4+ Cell Count Over Time by Visit

CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionCells per cubic millimeter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=58, 56, 57, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=49, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=46, 46, 52, 41
Efavirenz 600 mg24.846.065.6103.4135.5149.0143.4166.4178.2197.4185.2221.5262.5263.8257.1279.4281.7

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Change From Baseline in ALT, AST and CK Over Time by Visit

Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionInternational Units per Liter (Mean)
ALT; Week 2; n=58, 56, 58, 58ALT; Week 4; n=58, 57, 59, 57ALT; Week 8; n=58, 55, 57, 54ALT; Week 12; n=58, 53, 57, 51ALT; Week 16; n=57, 54, 57, 52ALT; Week 20; n=56, 54, 55, 49ALT; Week 24; n=56, 53, 56, 47ALT; Week 26; n=48, 50, 53, 45ALT; Week 28; n=51, 52, 52, 45ALT; Week 32; n=52, 53, 55, 45ALT; Week 36; n=52, 52, 55, 45ALT; Week 40; n=52, 53, 55, 44ALT; Week 48; n=51, 53, 54, 44ALT; Week 60; n=48, 47, 53, 44ALT; Week 72; n=47, 47, 52, 42ALT; Week 84; n=46, 48, 52, 42ALT; Week 96; n=45, 48, 52, 40AST; Week 2; n=58, 56, 58, 58AST; Week 4; n=58, 57, 59, 57AST; Week 8; n=58, 55, 57, 54AST; Week 12; n=58, 53, 57, 50AST; Week 16; n=57, 54, 57, 52AST; Week 20; n=56, 54, 55, 49AST; Week 24; n=56, 53, 56, 47AST; Week 26; n=48, 50, 53, 45AST; Week 28; n=51, 52, 52, 45AST; Week 32; n=52, 53, 55, 45AST; Week 36; n=52, 52, 55, 45AST; Week 40; n=52, 53, 55, 44AST; Week 48; n=51, 53, 54, 44AST; Week 60; n=48, 47, 53, 44AST; Week 72; n=47, 47, 52, 42AST; Week 84; n=46, 48, 52, 42AST; Week 96; n=45, 48, 52, 40CK; Week 2; n=58, 56, 58, 58CK; Week 4; n=58, 57, 59, 57CK; Week 8; n=58, 55, 57, 54CK; Week 12; n=58, 53, 57, 51CK; Week 16; n=57, 54, 57, 52CK; Week 20; n=56, 54, 55, 49CK; Week 24; n=56, 53, 56, 47CK; Week 26; n=48, 50, 53, 45CK; Week 28; n=51, 52, 52, 45CK; Week 32; n=52, 53, 55, 45CK; Week 36; n=52, 52, 55, 45CK; Week 40; n=52, 53, 55, 44CK; Week 48; n=51, 53, 54, 44CK; Week 60; n=48, 47, 53, 44CK; Week 72; n=47, 47, 52, 42CK; Week 84; n=46, 48, 52, 42CK; Week 96; n=45, 48, 52, 40
Efavirenz 600 mg-1.30.1-6.3-6.3-1.6-4.8-6.0-3.7-8.1-8.6-8.2-8.0-8.6-6.3-8.5-4.0-7.60.9-2.9-7.3-7.94.4-3.6-2.1-2.6-5.1-2.8-1.9-5.1-4.4-3.2-4.62.3-0.3159.8-120.3-212.8-220.1269.7135.3103.921.24.1110.3158.73.82.824.5-14.3123.9143.9

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Change From Baseline in ALT, AST and CK Over Time by Visit

Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionInternational Units per Liter (Mean)
ALT; Week 2; n=58, 56, 58, 58ALT; Week 4; n=58, 57, 59, 57ALT; Week 8; n=58, 55, 57, 54ALT; Week 12; n=58, 53, 57, 51ALT; Week 16; n=57, 54, 57, 52ALT; Week 20; n=56, 54, 55, 49ALT; Week 24; n=56, 53, 56, 47ALT; Week 26; n=48, 50, 53, 45ALT; Week 28; n=51, 52, 52, 45ALT; Week 32; n=52, 53, 55, 45ALT; Week 36; n=52, 52, 55, 45ALT; Week 40; n=52, 53, 55, 44ALT; Week 48; n=51, 53, 54, 44ALT; Week 60; n=48, 47, 53, 44ALT; Week 72; n=47, 47, 52, 42ALT; Week 84; n=46, 48, 52, 42ALT; Week 96; n=45, 48, 52, 40ALT; Week 108; n=43, 46, 48, 0ALT; Week 120; n=40, 45, 48, 0ALT; Week 132; n=40, 46, 49, 0ALT; Week 144; n=37, 45, 47, 0ALT; Week 156; n=37, 42, 49, 0ALT; Week 168; n=35, 43, 47, 0ALT; Week 180; n=36, 41, 47, 0ALT; Week 192; n=36, 39, 47, 0ALT; Week 204; n=34, 39, 47, 0ALT; Week 216; n=33, 39, 46, 0ALT; Week 228; n=32, 39, 47, 0ALT; Week 240; n=30, 39, 46, 0ALT; Week 252; n=31, 38, 46, 0ALT; Week 264; n=32, 38, 47, 0ALT; Week 276; n=31, 38, 45, 0ALT; Week 288; n=31, 38, 45, 0ALT; Week 300; n=30, 37, 44, 0ALT; Week 312; n=31, 34, 43, 0ALT; Week 324; n=3, 4, 3, 0AST; Week 2; n=58, 56, 58, 58AST; Week 4; n=58, 57, 59, 57AST; Week 8; n=58, 55, 57, 54AST; Week 12; n=58, 53, 57, 50AST; Week 16; n=57, 54, 57, 52AST; Week 20; n=56, 54, 55, 49AST; Week 24; n=56, 53, 56, 47AST; Week 26; n=48, 50, 53, 45AST; Week 28; n=51, 52, 52, 45AST; Week 32; n=52, 53, 55, 45AST; Week 36; n=52, 52, 55, 45AST; Week 40; n=52, 53, 55, 44AST; Week 48; n=51, 53, 54, 44AST; Week 60; n=48, 47, 53, 44AST; Week 72; n=47, 47, 52, 42AST; Week 84; n=46, 48, 52, 42AST; Week 96; n=45, 48, 52, 40AST; Week 108; n=43, 46, 48, 0AST; Week 120; n=40, 45, 48, 0AST; Week 132; n=40, 46, 49, 0AST; Week 144; n=37, 45, 47, 0AST; Week 156; n=37, 42, 49, 0AST; Week 168; n=35, 43, 47, 0AST; Week 180; n=36, 41, 47, 0AST; Week 192; n=36, 39, 47, 0AST; Week 204; n=34, 39, 47, 0AST; Week 216; n=33, 39, 46, 0AST; Week 228; n=32, 39, 47, 0AST; Week 240; n=30, 39, 46, 0AST; Week 252; n=31, 38, 46, 0AST; Week 264; n=32, 38, 47, 0AST; Week 276; n=31, 38, 45, 0AST; Week 288; n=31, 38, 45, 0AST; Week 300; n=30, 37, 44, 0AST; Week 312; n=31, 34, 43, 0AST; Week 324; n=3, 4, 3, 0CK; Week 2; n=58, 56, 58, 58CK; Week 4; n=58, 57, 59, 57CK; Week 8; n=58, 55, 57, 54CK; Week 12; n=58, 53, 57, 51CK; Week 16; n=57, 54, 57, 52CK; Week 20; n=56, 54, 55, 49CK; Week 24; n=56, 53, 56, 47CK; Week 26; n=48, 50, 53, 45CK; Week 28; n=51, 52, 52, 45CK; Week 32; n=52, 53, 55, 45CK; Week 36; n=52, 52, 55, 45CK; Week 40; n=52, 53, 55, 44CK; Week 48; n=51, 53, 54, 44CK; Week 60; n=48, 47, 53, 44CK; Week 72; n=47, 47, 52, 42CK; Week 84; n=46, 48, 52, 42CK; Week 96; n=45, 48, 52, 40CK; Week 108; n=43, 46, 48, 0CK; Week 120; n=40, 45, 48, 0CK; Week 132; n=40, 46, 49, 0CK; Week 144; n=37, 45, 47, 0CK; Week 156; n=37, 42, 49, 0CK; Week 168; n=35, 43, 47, 0CK; Week 180; n=36, 41, 47, 0CK; Week 192; n=36, 39, 47, 0CK; Week 204; n=34, 39, 47, 0CK; Week 216; n=33, 39, 46, 0CK; Week 228; n=32, 39, 47, 0CK; Week 240; n=30, 39, 46, 0CK; Week 252; n=31, 38, 46, 0CK; Week 264; n=32, 38, 47, 0CK; Week 276; n=31, 38, 45, 0CK; Week 288; n=31, 38, 45, 0CK; Week 300; n=30, 37, 44, 0CK; Week 312; n=31, 34, 43, 0CK; Week 324; n=3, 4, 3, 0
GSK1265744 10 mg0.1-0.72.21.22.1-0.7-2.11.1-2.3-3.10.80.1-4.1-1.0-2.8-2.4-0.40.54.44.30.1-0.52.31.74.91.91.736.85.32.03.33.36.64.85.517.70.7-1.04.21.3-0.71.3-1.43.3-2.0-2.74.60.1-3.3-0.9-2.7-2.2-0.8-1.00.1-0.2-3.4-3.0-0.8-1.9-1.5-1.7-2.713.5-1.0-2.2-1.6-1.5-1.4-2.011.72.740.0-2.3216.9120.6-2.0144.227.5133.79.83.1325.957.1-1.3115.4-19.8-0.7335.464.211.530.610.6-5.327.722.45.279.143.264.01.224.61.939.921.625.3727.5-1.3
GSK1265744 30 mg-2.1-2.60.52.70.1-3.6-1.2-2.6-2.3-1.7-4.2-4.1-3.8-2.62.71.920.6-2.7-2.6-3.0-3.4-1.8-1.1-2.8-3.3-1.7-3.0-1.1-0.12.80.72.91.2-1.47.61.3-1.3-2.81.51.61.9-3.1-0.3-0.9-0.2-1.0-2.1-2.9-3.2-2.03.72.020.5-4.0-2.5-3.9-4.3-3.2-3.4-4.2-5.3-4.8-4.9-5.9-5.3-2.1-4.3-3.3-3.6-5.3-2.3-5.3-32.2-82.0115.839.8156.3-68.932.4-16.374.1-25.1-33.6-48.6-54.7-80.153.833.6-22.8-88.5-48.9-41.3-72.4-87.9-60.7-16.4-98.5-101.8-74.4-129.0-108.1-110.1-31.3-126.5-98.5-100.7-141.3-195.0
GSK1265744 60 mg-1.51.78.0-0.6-0.33.01.4-1.7-2.9-4.0-3.0-1.4-2.40.5-0.9-2.0-1.7-0.7-3.7-3.8-1.8-2.2-3.6-1.21.3-3.4-2.70.5-0.7-1.62.01.11.9-1.80.01.0-1.60.15.3-1.7-0.64.61.5-1.7-1.9-1.4-0.6-0.5-3.03.0-0.5-1.8-1.00.6-2.40.7-3.9-4.1-3.8-2.90.1-4.5-4.3-2.8-3.4-3.9-2.9-1.4-2.2-4.1-0.3-6.70.4-2.9266.727.128.6298.955.954.496.8122.166.1103.528.6206.267.614.919.6100.361.4649.668.773.374.462.898.648.341.940.492.062.538.9146.443.456.0209.4102.7

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Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase

Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 24

,,,
InterventionParticipants (Count of Participants)
ALT; Grade 1ALT; Grade 2ALT; Grade 3ALT; Grade 4Albumin; Grade 1Albumin; Grade 2Albumin; Grade 3Albumin; Grade 4ALP; Grade 1ALP; Grade 2ALP; Grade 3ALP; Grade 4AST; Grade 1AST; Grade 2AST; Grade 3AST; Grade 4CO2/bicarbonate; Grade 1CO2/bicarbonate; Grade 2CO2/bicarbonate; Grade 3CO2/bicarbonate; Grade 4Chloride; Grade 1Chloride; Grade 2Chloride; Grade 3Chloride; Grade 4Cholesterol; Grade 1Cholesterol; Grade 2Cholesterol; Grade 3Cholesterol; Grade 4CK; Grade 1CK; Grade 2CK; Grade 3CK; Grade 4Creatinine; Grade 1Creatinine; Grade 2Creatinine; Grade 3Creatinine; Grade 4Glucose; Grade 1Glucose; Grade 2Glucose; Grade 3Glucose; Grade 4HDL cholesterol; Grade 1HDL cholesterol; Grade 2HDL cholesterol; Grade 3HDL cholesterol; Grade 4LDL cholesterol; Grade 1LDL cholesterol; Grade 2LDL cholesterol; Grade 3LDL cholesterol; Grade 4Lipase; Grade 1Lipase; Grade 2Lipase; Grade 3Lipase; Grade 4Inorganic phosphorus; Grade 1Inorganic phosphorus; Grade 2Inorganic phosphorus; Grade 3Inorganic phosphorus; Grade 4Potassium; Grade 1Potassium; Grade 2Potassium; Grade 3Potassium; Grade 4Sodium; Grade 1Sodium; Grade 2Sodium; Grade 3Sodium; Grade 4Total bilirubin; Grade 1Total bilirubin; Grade 2Total bilirubin; Grade 3Total bilirubin; Grade 4Triglycerides; Grade 1Triglycerides; Grade 2Triglycerides; Grade 3Triglycerides; Grade 4Urea/BUN; Grade 1Urea/BUN; Grade 2Urea/BUN; Grade 3Urea/BUN; Grade 4
Efavirenz 600 mg8400000030006120600000004960412411006501000048206510682021008100000002010000
GSK1265744 10 mg31000000000062101000000073007232010010500000054009620561070007000020000000000
GSK1265744 30 mg4500000011008500500000008200521400008300000091003110221010004000110001000000
GSK1265744 60 mg1300200004000713010000000123206312000013120000085305741722020007000410003100000

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Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionGiga cells per liter (Mean)
T. neutrophils; Baseline; n=60, 60, 61, 62T. neutrophils; Week 2; n=57, 56, 59, 59T. neutrophils; Week 4; n=57, 57, 59, 57T. neutrophils; Week 8; n=58, 56, 56, 55T. neutrophils; Week 12; n=58, 53, 57, 51T. neutrophils; Week 16; n=57, 54, 57, 52T. neutrophils; Week 20; n=56, 54, 55, 49T. neutrophils; Week 24; n=56, 53, 56, 47T. neutrophils; Week 26; n=48, 50, 53, 45T. neutrophils; Week 28; n=50, 52, 52, 45T. neutrophils; Week 32; n=51, 53, 55, 45T. neutrophils; Week 36; n=52, 53, 55, 44T. neutrophils; Week 40; n=51, 53, 55, 45T. neutrophils; Week 48; n=51, 53, 54, 44T. neutrophils; Week 60; n=48, 47, 52, 44T. neutrophils; Week 72; n=47, 48, 52, 42T. neutrophils; Week 84; n=46, 48, 51, 42T. neutrophils; Week 96; n=46, 46, 52, 41Platelet count; Baseline; n=60, 60, 61, 62Platelet count; Week 2; n=57, 56, 59, 59Platelet count; Week 4; n=57, 57, 59, 57Platelet count; Week 8; n=58, 56, 56, 55Platelet count; Week 12; n=58, 53, 57, 51Platelet count; Week 16; n=57, 54, 57, 52Platelet count; Week 20; n=56, 54, 55, 49Platelet count; Week 24; n=56, 53, 56, 47Platelet count; Week 26; n=48, 50, 53, 45Platelet count; Week 28; n=50, 52, 52, 45Platelet count; Week 32; n=51, 52, 55, 45Platelet count; Week 36; n=52, 53, 55, 44Platelet count; Week 40; n=51, 53, 54, 45Platelet count; Week 48; n=51, 52, 53, 44Platelet count; Week 60; n=48, 47, 51, 44Platelet count; Week 72; n=47, 48, 52, 42Platelet count; Week 84; n=46, 48, 51, 42Platelet count; Week 96; n=46, 45, 51, 41WBC count; Baseline; n=60, 60, 61, 62WBC count; Week 2; n=57, 56, 59, 59WBC count; Week 4; n=57, 57, 59, 57WBC count; Week 8; n=58, 56, 56, 55WBC count; Week 12; n=58, 53, 57, 51WBC count; Week 16; n=57, 54, 57, 52WBC count; Week 20; n=56, 54, 55, 49WBC count; Week 24; n=56, 53, 56, 47WBC count; Week 26; n=48, 50, 53, 45WBC count; Week 28; n=50, 52, 52, 45WBC count; Week 32; n=51, 53, 55, 45WBC count; Week 36; n=52, 53, 55, 44WBC count; Week 40; n=51, 53, 55, 45WBC count; Week 48; n=51, 53, 54, 44WBC count; Week 60; n=48, 47, 52, 44WBC count; Week 72; n=47, 48, 52, 42WBC count; Week 84; n=46, 48, 51, 42WBC count; Week 96; n=46, 46, 52, 41
Efavirenz 600 mg2.4413.2072.8482.7462.9792.8583.1873.1422.8862.9163.1742.9143.1873.1343.2693.3613.2593.297200.1216.2216.0209.8213.7211.4214.9220.9214.4215.4212.6209.8217.7220.3230.5225.9216.5214.04.705.455.025.025.275.135.505.345.085.145.485.175.515.535.755.845.785.75
GSK1265744 10 mg2.6432.7232.6852.8992.8123.0782.9583.1512.8853.1832.7973.1623.1553.1383.1643.1973.2453.466212.5225.0225.2224.5227.2230.0231.3226.1224.9223.3220.5220.0224.9225.6232.5234.0224.8237.15.065.325.245.445.415.565.465.575.305.715.305.645.635.515.735.805.916.14
GSK1265744 30 mg2.8912.7762.7712.8022.9332.7162.9042.9962.9583.0053.0362.9163.0653.1323.3333.1313.3853.540202.3222.0222.4228.4216.4212.4215.5219.7215.5217.0214.0212.1210.1221.2219.8224.4218.8221.85.195.305.175.305.505.205.415.535.505.535.635.485.615.725.935.716.116.15
GSK1265744 60 mg2.4872.5982.6492.7382.8222.6652.9892.8842.8302.9893.1673.0103.0503.0043.2003.1633.5123.494190.0204.8204.6211.5209.2209.5205.4210.9199.4209.8207.8204.2199.3209.9212.2212.2210.1210.64.725.025.025.045.344.975.395.285.295.385.575.565.455.415.635.736.056.01

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Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time

Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
APTT; Grade 1APTT; Grade 2APTT; Grade 3APTT; Grade 4Hemoglobin; Grade 1Hemoglobin; Grade 2Hemoglobin; Grade 3Hemoglobin; Grade 4INR; Grade 1INR; Grade 2INR; Grade 3INR; Grade 4Platelet count; Grade 1Platelet count; Grade 2Platelet count; Grade 3Platelet count; Grade 4PT; Grade 1PT; Grade 2PT; Grade 3PT; Grade 4Total neutrophils; Grade 1Total neutrophils; Grade 2Total neutrophils; Grade 3Total neutrophils; Grade 4WBC count; Grade 1WBC count; Grade 2WBC count; Grade 3WBC count; Grade 4
Efavirenz 600 mg5001000031001000310023113000
GSK1265744 10 mg5001010020104000100075112100
GSK1265744 30 mg5101000041010000301192015100
GSK1265744 60 mg50010000010041110010103132110

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Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase

Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 24

,,,
InterventionParticipants (Count of Participants)
APTT; Grade 1APTT; Grade 2APTT; Grade 3APTT; Grade 4Basophils; Grade 1Basophils; Grade 2Basophils; Grade 3Basophils; Grade 4Eosinophils; Grade 1Eosinophils; Grade 2Eosinophils; Grade 3Eosinophils; Grade 4Hematocrit; Grade 1Hematocrit; Grade 2Hematocrit; Grade 3Hematocrit; Grade 4Hemoglobin; Grade 1Hemoglobin; Grade 2Hemoglobin; Grade 3Hemoglobin; Grade 4INR; Grade 1INR; Grade 2INR; Grade 3INR; Grade 4Lymphocytes; Grade 1Lymphocytes; Grade 2Lymphocytes; Grade 3Lymphocytes; Grade 4MCV; Grade 1MCV; Grade 2MCV; Grade 3MCV; Grade 4Monocytes; Grade 1Monocytes; Grade 2Monocytes; Grade 3Monocytes; Grade 4Platelet count; Grade 1Platelet count; Grade 2Platelet count; Grade 3Platelet count; Grade 4PT; Grade 1PT; Grade 2PT; Grade 3PT; Grade 4RBC; Grade 1RBC; Grade 2RBC; Grade 3RBC; Grade 4Total neutrophils; Grade 1Total neutrophils; Grade 2Total neutrophils; Grade 3Total neutrophils; Grade 4WBC count; Grade 1WBC count; Grade 2WBC count; Grade 3WBC count; Grade 4
Efavirenz 600 mg30000000000000000000100000000000000010001000000022111000
GSK1265744 10 mg10000000000000000100000000000000000020000000000083000000
GSK1265744 30 mg00010000000000000000200100000000000000001001000062002100
GSK1265744 60 mg10010000000000000000000000000000000020000000000083012000

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionPercentage of participants (Number)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40
Efavirenz 600 mg0142655768791969396969893989510010098

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionPercentage of participants (Number)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 47, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=36, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=33, 39, 47, 0Week 228; n=32, 39, 47, 0Week 240; n=31, 39, 45, 0Week 252; n=31, 38, 47, 0Week 264; n=32, 38, 47, 0Week 276; n=31, 38, 45, 0Week 288; n=30, 38, 45, 0Week 300; n=31, 37, 44, 0Week 312; n=31, 33, 43, 0Week 324; n=3, 4, 3, 0
GSK1265744 10 mg0518392959591939810096989692949191899595959295949794971001009710010010010097100100
GSK1265744 30 mg05482898894989894949496969296929498961009693959510010097100100979710010010010097100
GSK1265744 60 mg0537393919398959810096959598981001009810098100989898989698989810098989610095100100

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312

,,,
InterventionPercentage of participants (Number)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 24Week 26Week 28Week 32Week 36Week 40Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312
Efavirenz 600 mg013244861747466696971687168686863000000000000000000
GSK1265744 10 mg048809088908778858385838078727268686562585857585755555350525352505252
GSK1265744 30 mg050788375838575788082828073737575727370676365676562636362626262626052
GSK1265744 60 mg051708782878785858785858785858584808080778075757475777574757570747070

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Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase

Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Week 24 to Week 96

,,,
InterventionParticipants (Count of Participants)
APTT; Grade 1APTT; Grade 2APTT; Grade 3APTT; Grade 4Hemoglobin; Grade 1Hemoglobin; Grade 2Hemoglobin; Grade 3Hemoglobin; Grade 4INR; Grade 1INR; Grade 2INR; Grade 3INR; Grade 4Platelet count; Grade 1Platelet count; Grade 2Platelet count; Grade 3Platelet count; Grade 4PT; Grade 1PT; Grade 2PT; Grade 3PT; Grade 4Total neutrophils; Grade 1Total neutrophils; Grade 2Total neutrophils; Grade 3Total neutrophils; Grade 4WBC count; Grade 1WBC count; Grade 2WBC count; Grade 3WBC count; Grade 4
Efavirenz 600 mg5001000031001000310023113000
GSK1265744 10 mg5001010020104000100075112100
GSK1265744 30 mg5101000041010000301192015100
GSK1265744 60 mg50010000010041110010103132110

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Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease

HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
CDC Class A to CDC Class CCDC Class B to CDC Class CCDC Class C to new CDC Class CCDC Class A, B or C to Death
Efavirenz 600 mg0000
GSK1265744 10 mg1000
GSK1265744 30 mg1001
GSK1265744 60 mg0001

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Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance

Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
Any INI mutationAny mutation to other classes
Efavirenz 600 mg00
GSK1265744 10 mg34
GSK1265744 30 mg00
GSK1265744 60 mg11

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Number of Participants With Treatment Emergent Phenotypic Resistance

Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/ritonavir [ATV/r], Darunavir (DRV)/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
INI, GSK1265744; Resistant; n=5, 1, 2, 2INI, GSK1265744; Sensitive; n=5, 1, 2, 2INI, RAL; Resistant; n=5, 1, 2, 2INI, RAL; Sensitive; n=5, 1, 2, 2NNRTI, DLV; Resistant; n=6, 2, 2, 5NNRTI, DLV; Sensitive; n=6, 2, 2, 5NNRTI, EFV; Resistant; n=6, 2, 2, 5NNRTI, EFV; Sensitive; n=6, 2, 2, 5NNRTI, ETR; Resistant; n=6, 2, 2, 5NNRTI, ETR; Partially sensitive; n=6, 2, 2, 5NNRTI, ETR; Sensitive; n=6, 2, 2, 5NNRTI, NVP; Resistant; n=6, 2, 2, 5NNRTI, NVP; Sensitive; n=6, 2, 2, 5NNRTI, RPV; Resistant; n=6, 2, 2, 5NNRTI, RPV; Sensitive; n=6, 2, 2, 5NRTI, 3TC; Resistant; n=6, 2, 2, 5NRTI, 3TC; Sensitive; n=6, 2, 2, 5NRTI, ABC; Resistant; n=6, 2, 2, 5NRTI, ABC; Partially sensitive; n=6, 2, 2, 5NRTI, ABC; Sensitive; n=6, 2, 2, 5NRTI, FTC; Resistant; n=6, 2, 2, 5NRTI, FTC; Sensitive; n=6, 2, 2, 5NRTI, TDF; Resistant; n=6, 2, 2, 5NRTI, TDF; Partially sensitive; n=6, 2, 2, 5NRTI, TDF; Sensitive; n=6, 2, 2, 5NRTI, ZDV; Resistant; n=6, 2, 2, 5NRTI, ZDV; Sensitive; n=6, 2, 2, 5NRTI, d4T; Resistant; n=6, 2, 2, 5NRTI, d4T; Sensitive; n=6, 2, 2, 5NRTI, ddI; Resistant; n=6, 2, 2, 5NRTI, ddI; Partially sensitive; n=6, 2, 2, 5NRTI, ddI; Sensitive; n=6, 2, 2, 5PI, ATV/r; Resistant; n=6, 2, 2, 5PI, ATV/r; Sensitive; n=6, 2, 2, 5PI, DRV/r; Resistant; n=6, 2, 2, 5PI, DRV/r; Partially sensitive; n=6, 2, 2, 5PI, DRV/r; Sensitive; n=6, 2, 2, 5PI, FPV/r; Resistant; n=6, 2, 2, 5PI, FPV/r; Partially sensitive; n=6, 2, 2, 5PI, FPV/r; Sensitive; n=6, 2, 2, 5PI, IDV/r; Resistant; n=6, 2, 2, 5PI, IDV/r; Sensitive; n=6, 2, 2, 5PI, LPV/r; Resistant; n=6, 2, 2, 5PI, LPV/r; Partially sensitive; n=6, 2, 2, 5PI, LPV/r; Sensitive; n=6, 2, 2, 5PI, NFV; Resistant; n=6, 2, 2, 5PI, NFV; Sensitive; n=6, 2, 2, 5PI, RTV; Resistant; n=6, 2, 2, 5PI, RTV; Sensitive; n=6, 2, 2, 5PI, SQV/r; Resistant; n=6, 2, 2, 5PI, SQV/r; Partially sensitive; n=6, 2, 2, 5PI, SQV/r; Sensitive; n=6, 2, 2, 5PI, TPV/r; Resistant; n=6, 2, 2, 5PI, TPV/r; Partially sensitive; n=6, 2, 2, 5PI, TPV/r; Sensitive; n=6, 2, 2, 5
Efavirenz 600 mg0202050500505050500505005050500505005005050050505005005
GSK1265744 10 mg2332333330333330600606015240600606006006060060606006006
GSK1265744 30 mg0101020200202020200202002020200202002002020020202002002
GSK1265744 60 mg1111020200202020200202002020200202002002020020202002002

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Week 16 and Week 24

,,,
InterventionPercentage of participants (Number)
Week 16Week 24
Efavirenz 600 mg7474
GSK1265744 10 mg9087
GSK1265744 30 mg8385
GSK1265744 60 mg8787

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase

An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product. (NCT01641809)
Timeframe: Week 24 to Week 96

,,,
InterventionParticipants (Count of Participants)
Any AEAny SAE
Efavirenz 600 mg352
GSK1265744 10 mg405
GSK1265744 30 mg505
GSK1265744 60 mg505

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Number of Participants With Adherence to Study Treatment

Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312

,
InterventionParticipants (Count of Participants)
Baseline; n=57, 55, 56, 52Week 4; n=54, 52, 53, 50Week 8; n=53, 50, 56, 48Week 12; n=55, 48, 53, 48Week 16; n=53, 51, 53, 44Week 20; n=51, 49, 55, 44Week 24; n=51, 46, 51, 43Week 28; n=49, 48, 53, 41Week 32; n=47, 48, 55, 41Week 36; n=46, 48, 50, 41Week 40; n=38, 35, 45, 39Week 48; n=33, 37, 45, 35Week 60; n=38, 38, 40, 37Week 72; n=35, 37, 44, 32Week 84; n=36, 39, 42, 33Week 96; n=31, 36, 33, 0Week 108; n=23, 23, 29, 0Week 120; n=30, 38, 41, 0Week 132; n=29, 32, 40, 0Week 144; n=33, 34, 43, 0Week 156; n=31, 28, 39, 0Week 168; n=29, 33, 41, 0Week 180; n=26, 29, 39, 0Week 192; n=30, 30, 39, 0Week 204; n=29, 32, 38, 0Week 216; n=29, 30, 37, 0Week 228; n=27, 34, 40, 0Week 240; n=28, 26, 41, 0Week 252; n=23, 26, 33, 0Week 264; n=15, 18, 24, 0Week 276; n=14, 14, 21, 0Week 288; n=12, 14, 18, 0Week 300; n=12, 13, 20, 0Week 312; n=1, 1, 0, 0
GSK1265744 10 mg5346494444454745464033323732342521282832302924282729252818121312111
GSK1265744 30 mg514945404540414642433033353536322036302925242427262728222116131071

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Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit

Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionLog10 copies per milliliter (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40
Efavirenz 600 mg4.2902.4152.2011.9501.7581.6971.6491.6101.6101.6001.6141.6071.6071.5961.6571.5921.5911.598

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Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionGrams per liter (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=57, 57, 59, 57Week 8; n=58, 56, 56, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 55, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=50, 52, 52, 45Week 32; n=51, 53, 55, 45Week 36; n=52, 53, 55, 44Week 40; n=51, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 52, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 51, 42Week 96; n=46, 46, 52, 41
Efavirenz 600 mg145.4146.4146.6148.1149.2147.6147.2148.5148.2145.9145.9145.0145.1145.4147.6147.7147.0147.0
GSK1265744 10 mg141.9142.0141.9144.9144.3143.5144.3144.8144.4143.7144.6142.3142.2142.9144.5143.9145.6144.9
GSK1265744 30 mg143.2142.8143.5147.7147.4146.5146.9147.8145.8146.8146.1145.9145.2145.7148.3148.1147.7147.1
GSK1265744 60 mg146.6145.9147.3148.6149.1148.7149.8150.4149.8149.3150.5149.8149.2146.5149.8149.6150.3150.8

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Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm

Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionPercentage of participants (Number)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 24Week 26Week 28Week 32Week 36Week 40Week 48Week 60Week 72Week 84Week 96
Efavirenz 600 mg068687973817971737373737371686865
GSK1265744 10 mg087939390939380858787878380777775
GSK1265744 30 mg080939285878780838585858577757777
GSK1265744 60 mg084939289939287858990908987858585

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Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionPercentage of participants (Number)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40
Efavirenz 600 mg0717491929610010010010010010010010098100100100
GSK1265744 10 mg0919795979810010010010010010010098969810096
GSK1265744 30 mg0869898100100100100100100100100100981009698100
GSK1265744 60 mg08697989810010010010010098100100100100100100100

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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96

InterventionMilliliters per minute (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 20; n=2, 0, 0, 1Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40
GSK1265744 10 mg131.096.0129.3125.0132.4137.0127.9127.0130.8

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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96

InterventionMilliliters per minute (Mean)
Baseline; n=60, 60, 61, 62Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40
GSK1265744 60 mg128.3122.4143.0123.9120.7122.3116.6

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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96

InterventionMilliliters per minute (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 24; n=52, 53, 55, 46Week 26; n=0, 1, 0, 0Week 40; n=0, 1, 0, 0Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40
GSK1265744 30 mg135.2106.0132.5124.0139.4132.8147.0180.0139.2137.7

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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96

InterventionMilliliters per minute (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 20; n=2, 0, 0, 1Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 60; n=0, 0, 0, 1Week 96; n=45, 48, 52, 40
Efavirenz 600 mg125.699.0127.0101.0132.3122.0135.1131.0144.0134.8

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Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionMicromoles per liter (Mean)
Creatinine; Baseline; n=60, 60, 61, 62Creatinine; Week 2; n=58, 56, 58, 58Creatinine; Week 4; n=58, 57, 59, 57Creatinine; Week 8; n=58, 55, 57, 54Creatinine; Week 12; n=58, 53, 57, 51Creatinine; Week 16; n=57, 54, 57, 52Creatinine; Week 20; n=56, 54, 55, 49Creatinine; Week 24; n=56, 53, 56, 47Creatinine; Week 26; n=48, 50, 53, 45Creatinine; Week 28; n=51, 52, 52, 45Creatinine; Week 32; n=52, 53, 55, 45Creatinine; Week 36; n=52, 52, 55, 45Creatinine; Week 40; n=52, 53, 55, 44Creatinine; Week 48; n=51, 53, 54, 44Creatinine; Week 60; n=48, 47, 53, 44Creatinine; Week 72; n=47, 47, 52, 42Creatinine; Week 84; n=46, 48, 52, 42Creatinine; Week 96; n=45, 48, 52, 40T. Bilirubin; Baseline; n=60, 60, 61, 62T. Bilirubin; Week 2; n=58, 56, 58, 58T. Bilirubin; Week 4; n=58, 57, 59, 57T. Bilirubin; Week 8; n=58, 55, 57, 54T. Bilirubin; Week 12; n=58, 53, 57, 51T. Bilirubin; Week 16; n=57, 54, 57, 52T. Bilirubin; Week 20; n=56, 54, 55, 49T. Bilirubin; Week 24; n=56, 53, 56, 47T. Bilirubin; Week 26; n=48, 50, 53, 45T. Bilirubin; Week 28; n=51, 52, 52, 45T. Bilirubin; Week 32; n=52, 53, 55, 45T. Bilirubin; Week 36; n=52, 52, 55, 45T. Bilirubin; Week 40; n=52, 53, 55, 44T. Bilirubin; Week 48; n=51, 53, 54, 44T. Bilirubin; Week 60; n=48, 47, 53, 44T. Bilirubin; Week 72; n=47, 47, 52, 42T. Bilirubin; Week 84; n=46, 48, 52, 42T. Bilirubin; Week 96; n=45, 48, 52, 40
Efavirenz 600 mg83.183.883.182.481.179.679.580.078.678.578.178.479.279.077.977.779.781.09.76.86.46.37.07.06.86.66.86.46.66.56.36.67.06.56.66.8
GSK1265744 10 mg80.483.882.982.983.883.483.283.283.483.083.883.583.383.483.984.585.082.09.29.29.49.39.59.69.09.610.610.39.810.310.810.011.210.811.710.3
GSK1265744 30 mg80.583.383.082.282.782.382.083.382.683.882.684.683.283.183.086.184.886.49.49.19.39.08.98.59.09.89.910.29.810.111.29.69.810.09.99.9
GSK1265744 60 mg79.984.684.283.584.182.486.185.287.085.685.786.785.485.085.287.387.388.510.510.09.810.110.210.410.410.012.011.411.712.212.310.411.611.412.012.5

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Number of Participants With Adherence to Study Treatment

Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312

InterventionParticipants (Count of Participants)
Baseline; n=57, 55, 56, 52Week 4; n=54, 52, 53, 50Week 8; n=53, 50, 56, 48Week 12; n=55, 48, 53, 48Week 16; n=53, 51, 53, 44Week 20; n=51, 49, 55, 44Week 24; n=51, 46, 51, 43Week 28; n=49, 48, 53, 41Week 32; n=47, 48, 55, 41Week 36; n=46, 48, 50, 41Week 40; n=38, 35, 45, 39Week 48; n=33, 37, 45, 35Week 60; n=38, 38, 40, 37Week 72; n=35, 37, 44, 32Week 84; n=36, 39, 42, 33Week 96; n=31, 36, 33, 0Week 108; n=23, 23, 29, 0Week 120; n=30, 38, 41, 0Week 132; n=29, 32, 40, 0Week 144; n=33, 34, 43, 0Week 156; n=31, 28, 39, 0Week 168; n=29, 33, 41, 0Week 180; n=26, 29, 39, 0Week 192; n=30, 30, 39, 0Week 204; n=29, 32, 38, 0Week 216; n=29, 30, 37, 0Week 228; n=27, 34, 40, 0Week 240; n=28, 26, 41, 0Week 252; n=23, 26, 33, 0Week 264; n=15, 18, 24, 0Week 276; n=14, 14, 21, 0Week 288; n=12, 14, 18, 0Week 300; n=12, 13, 20, 0
GSK1265744 60 mg555253465051484852484141374139302739354135353435333135352921181718

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Number of Participants With Adherence to Study Treatment

Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312

InterventionParticipants (Count of Participants)
Baseline; n=57, 55, 56, 52Week 4; n=54, 52, 53, 50Week 8; n=53, 50, 56, 48Week 12; n=55, 48, 53, 48Week 16; n=53, 51, 53, 44Week 20; n=51, 49, 55, 44Week 24; n=51, 46, 51, 43Week 28; n=49, 48, 53, 41Week 32; n=47, 48, 55, 41Week 36; n=46, 48, 50, 41Week 40; n=38, 35, 45, 39Week 48; n=33, 37, 45, 35Week 60; n=38, 38, 40, 37Week 72; n=35, 37, 44, 32Week 84; n=36, 39, 42, 33
Efavirenz 600 mg484447434241393537363433352729

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Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit

Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionGiga cells per liter (Mean)
T. neutrophils; Week 2; n=57, 56, 59, 59T. neutrophils; Week 4; n=57, 57, 59, 57T. neutrophils; Week 8; n=58, 56, 56, 55T. neutrophils; Week 12; n=58, 53, 57, 51T. neutrophils; Week 16; n=57, 54, 57, 52T. neutrophils; Week 20; n=56, 54, 55, 49T. neutrophils; Week 24; n=56, 53, 56, 47T. neutrophils; Week 26; n=48, 50, 53, 45T. neutrophils; Week 28; n=50, 52, 52, 45T. neutrophils; Week 32; n=51, 53, 55, 45T. neutrophils; Week 36; n=52, 53, 55, 44T. neutrophils; Week 40; n=51, 53, 55, 45T. neutrophils; Week 48; n=51, 53, 54, 44T. neutrophils; Week 60; n=48, 47, 52, 44T. neutrophils; Week 72; n=47, 48, 52, 42T. neutrophils; Week 84; n=46, 48, 51, 42T. neutrophils; Week 96; n=46, 46, 52, 41Platelet count; Week 2; n=57, 56, 59, 59Platelet count; Week 4; n=57, 57, 59, 57Platelet count; Week 8; n=58, 56, 56, 55Platelet count; Week 12; n=58, 53, 57, 51Platelet count; Week 16; n=57, 54, 57, 52Platelet count; Week 20; n=56, 54, 55, 49Platelet count; Week 24; n=56, 53, 56, 47Platelet count; Week 26; n=48, 50, 53, 45Platelet count; Week 28; n=50, 52, 52, 45Platelet count; Week 32; n=51, 52, 55, 45Platelet count; Week 36; n=52, 53, 55, 44Platelet count; Week 40; n=51, 53, 54, 45Platelet count; Week 48; n=51, 52, 53, 44Platelet count; Week 60; n=48, 47, 51, 44Platelet count; Week 72; n=47, 48, 52, 42Platelet count; Week 84; n=46, 48, 51, 42Platelet count; Week 96; n=46, 45, 51, 41WBC count; Week 2; n=57, 56, 59, 59WBC count; Week 4; n=57, 57, 59, 57WBC count; Week 8; n=58, 56, 56, 55WBC; Week 12; n=58, 53, 57, 51WBC count; Week 16; n=57, 54, 57, 52WBC count; Week 20; n=56, 54, 55, 49WBC count; Week 24; n=56, 53, 56, 47WBC count; Week 26; n=48, 50, 53, 45WBC count; Week 28; n=50, 52, 52, 45WBC count; Week 32; n=51, 53, 55, 45WBC count; Week 36; n=52, 53, 55, 44WBC count; Week 40; n=51, 53, 55, 45WBC count; Week 48; n=51, 53, 54, 44WBC count; Week 60; n=48, 47, 52, 44WBC count; Week 72; n=47, 48, 52, 42WBC count; Week 84; n=46, 48, 51, 42WBC count; Week 96; n=46, 46, 52, 41
Efavirenz 600 mg0.7160.3750.2730.5250.3670.7400.6370.4490.4460.7170.4140.7300.6650.8000.8920.7900.83117.115.610.311.29.317.123.917.517.213.812.318.920.630.828.318.917.50.690.290.270.540.360.780.550.350.390.710.360.750.730.951.020.950.92

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Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit

Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionGiga cells per liter (Mean)
T. neutrophils; Week 2; n=57, 56, 59, 59T. neutrophils; Week 4; n=57, 57, 59, 57T. neutrophils; Week 8; n=58, 56, 56, 55T. neutrophils; Week 12; n=58, 53, 57, 51T. neutrophils; Week 16; n=57, 54, 57, 52T. neutrophils; Week 20; n=56, 54, 55, 49T. neutrophils; Week 24; n=56, 53, 56, 47T. neutrophils; Week 26; n=48, 50, 53, 45T. neutrophils; Week 28; n=50, 52, 52, 45T. neutrophils; Week 32; n=51, 53, 55, 45T. neutrophils; Week 36; n=52, 53, 55, 44T. neutrophils; Week 40; n=51, 53, 55, 45T. neutrophils; Week 48; n=51, 53, 54, 44T. neutrophils; Week 60; n=48, 47, 52, 44T. neutrophils; Week 72; n=47, 48, 52, 42T. neutrophils; Week 84; n=46, 48, 51, 42T. neutrophils; Week 96; n=46, 46, 52, 41T. neutrophils; Week 108; n=43, 46, 49, 0T. neutrophils; Week 120; n=41, 46, 49, 0T. neutrophils; Week 132; n=40, 46, 49, 0T. neutrophils; Week 144; n=37, 45, 46, 0T. neutrophils; Week 156; n=37, 42, 49, 0T. neutrophils; Week 168; n=35, 43, 47, 0T. neutrophils; Week 180; n=36, 41, 47, 0T. neutrophils; Week 192; n=35, 40, 47, 0T. neutrophils; Week 204; n=34, 39, 47, 0T. neutrophils; Week 216; n=32, 39, 43, 0T. neutrophils; Week 228; n=30, 39, 47, 0T. neutrophils; Week 240; n=32, 39, 47, 0T. neutrophils; Week 252; n=31, 36, 45, 0T. neutrophils; Week 264; n=32, 38, 46, 0T. neutrophils; Week 276; n=31, 38, 45, 0T. neutrophils; Week 288; n=30, 38, 44, 0T. neutrophils; Week 300; n=30, 37, 43, 0T. neutrophils; Week 312; n=31, 33, 41, 0T. neutrophils; Week 324; n=3, 4, 2, 0Platelet count; Week 2; n=57, 56, 59, 59Platelet count; Week 4; n=57, 57, 59, 57Platelet count; Week 8; n=58, 56, 56, 55Platelet count; Week 12; n=58, 53, 57, 51Platelet count; Week 16; n=57, 54, 57, 52Platelet count; Week 20; n=56, 54, 55, 49Platelet count; Week 24; n=56, 53, 56, 47Platelet count; Week 26; n=48, 50, 53, 45Platelet count; Week 28; n=50, 52, 52, 45Platelet count; Week 32; n=51, 52, 55, 45Platelet count; Week 36; n=52, 53, 55, 44Platelet count; Week 40; n=51, 53, 54, 45Platelet count; Week 48; n=51, 52, 53, 44Platelet count; Week 60; n=48, 47, 51, 44Platelet count; Week 72; n=47, 48, 52, 42Platelet count; Week 84; n=46, 48, 51, 42Platelet count; Week 96; n=46, 45, 51, 41Platelet count; Week 108; n=43, 46, 49, 0Platelet count; Week 120; n=41, 46, 49, 0Platelet count; Week 132; n=40, 46, 48, 0Platelet count; Week 144; n=37, 45, 44, 0Platelet count; Week 156; n=37, 42, 47, 0Platelet count; Week 168; n=35, 43, 46, 0Platelet count; Week 180; n=36, 41, 46, 0Platelet count; Week 192; n=35, 40, 46, 0Platelet count; Week 204; n=34, 39, 45, 0Platelet count; Week 216; n=32, 39, 44, 0Platelet count; Week 228; n=31, 39, 46, 0Platelet count; Week 240; n=32, 39, 47, 0Platelet count; Week 252; n=31, 36, 44, 0Platelet count; Week 264; n=32, 38, 45, 0Platelet count; Week 276; n=31, 38, 45, 0Platelet count; Week 288; n=30, 38, 43, 0Platelet count; Week 300; n=30, 37, 40, 0Platelet count; Week 312; n=31, 33, 41, 0Platelet count; Week 324; n=3, 4, 2, 0WBC count; Week 2; n=57, 56, 59, 59WBC count; Week 4; n=57, 57, 59, 57WBC count; Week 8; n=58, 56, 56, 55WBC; Week 12; n=58, 53, 57, 51WBC count; Week 16; n=57, 54, 57, 52WBC count; Week 20; n=56, 54, 55, 49WBC count; Week 24; n=56, 53, 56, 47WBC count; Week 26; n=48, 50, 53, 45WBC count; Week 28; n=50, 52, 52, 45WBC count; Week 32; n=51, 53, 55, 45WBC count; Week 36; n=52, 53, 55, 44WBC count; Week 40; n=51, 53, 55, 45WBC count; Week 48; n=51, 53, 54, 44WBC count; Week 60; n=48, 47, 52, 44WBC count; Week 72; n=47, 48, 52, 42WBC count; Week 84; n=46, 48, 51, 42WBC count; Week 96; n=46, 46, 52, 41WBC count; Week 108; n=43, 46, 49, 0WBC count; Week 120; n=41, 46, 49, 0WBC count; Week 132; n=40, 46, 49, 0WBC count; Week 144; n=37, 45, 46, 0WBC count; Week 156; n=37, 42, 49, 0WBC count; Week 168; n=35, 43, 47, 0WBC count; Week 180; n=36, 41, 47, 0WBC count; Week 192; n=35, 40, 47, 0WBC count; Week 204; n=34, 39, 47, 0WBC count; Week 216; n=32, 39, 43, 0WBC count; Week 228; n=31, 39, 47, 0WBC count; Week 240; n=32, 39, 47, 0WBC count; Week 252; n=31, 36, 45, 0WBC count; Week 264; n=32, 38, 46, 0WBC count; Week 276; n=31, 38, 45, 0WBC count; Week 288; n=30, 38, 44, 0WBC count; Week 300; n=30, 37, 43, 0WBC count; Week 312; n=31, 33, 41, 0WBC count; Week 324; n=3, 4, 2, 0
GSK1265744 10 mg0.0420.0380.2510.1380.3880.2700.4620.1200.4960.0710.4200.4300.3860.3740.3830.4100.6310.6230.3720.7770.6720.7620.5880.7690.4900.6180.5430.7800.5080.2680.4750.4000.4560.1390.2430.86011.09.910.313.716.517.212.08.36.67.75.211.112.520.923.713.625.924.523.816.827.126.634.928.434.733.928.128.727.215.927.948.444.128.527.331.70.190.160.370.320.450.360.470.190.670.250.560.570.430.600.630.710.950.890.590.920.911.050.971.070.610.980.880.980.790.660.620.920.920.580.571.97
GSK1265744 30 mg-0.084-0.083-0.0660.040-0.1560.0320.1090.0520.2130.1490.0290.1780.2450.4580.2740.5280.6980.5700.6500.4050.4680.4180.5340.4050.5940.6480.5880.7890.8130.7610.7610.6270.6730.4550.4170.31516.620.125.914.611.314.518.411.215.811.610.88.920.018.722.817.220.824.626.921.023.230.636.427.624.626.425.227.126.215.423.234.535.526.830.98.30.130.020.150.280.020.230.340.260.420.450.300.420.530.760.560.961.010.901.010.710.820.750.970.690.890.951.011.131.151.101.211.041.130.770.700.53
GSK1265744 60 mg0.1040.1550.3410.3590.2030.5250.4060.3750.5020.6920.5350.5750.5340.7110.6661.0060.9971.0060.7690.6710.8311.0951.0110.8400.7220.8210.9140.8191.0830.8121.1761.1060.9130.6990.5640.96014.314.118.417.717.913.719.310.317.815.411.87.817.626.622.721.121.733.120.432.233.541.240.045.427.937.633.529.127.430.832.845.846.745.435.32.00.310.300.480.730.360.770.640.660.690.930.920.810.781.041.091.431.381.351.161.021.221.641.581.331.111.241.371.311.531.171.661.571.321.020.95-0.05

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Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit

Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionLog10 copies per milliliter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 47, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=36, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=33, 39, 47, 0Week 228; n=32, 39, 47, 0Week 240; n=31, 39, 45, 0Week 252; n=31, 38, 47, 0Week 264; n=32, 38, 47, 0Week 276; n=31, 38, 45, 0Week 288; n=30, 38, 45, 0Week 300; n=31, 37, 44, 0Week 312; n=31, 33, 43, 0Week 324; n=3, 4, 3, 0
GSK1265744 10 mg-2.534-2.731-2.733-2.793-2.823-2.823-2.831-2.788-2.784-2.763-2.768-2.760-2.682-2.729-2.745-2.722-2.670-2.723-2.712-2.705-2.690-2.737-2.680-2.747-2.671-2.750-2.787-2.770-2.798-2.787-2.780-2.786-2.768-2.776-2.780-2.488
GSK1265744 30 mg-2.306-2.550-2.611-2.634-2.659-2.665-2.659-2.662-2.663-2.636-2.646-2.638-2.602-2.613-2.514-2.568-2.608-2.632-2.650-2.610-2.555-2.645-2.592-2.628-2.641-2.632-2.636-2.636-2.627-2.601-2.659-2.659-2.659-2.664-2.569-2.215
GSK1265744 60 mg-2.504-2.718-2.741-2.790-2.815-2.834-2.830-2.792-2.791-2.781-2.792-2.790-2.799-2.787-2.783-2.782-2.778-2.743-2.717-2.743-2.703-2.716-2.700-2.767-2.667-2.718-2.718-2.726-2.736-2.758-2.734-2.764-2.775-2.730-2.789-2.438

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Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit

Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionLog10 copies per milliliter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40
Efavirenz 600 mg-1.875-2.092-2.344-2.533-2.602-2.666-2.694-2.733-2.714-2.672-2.679-2.679-2.676-2.615-2.738-2.739-2.731

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Change From Baseline in Hemoglobin Level Over Time by Visit

Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionGrams per liter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=57, 57, 59, 57Week 8; n=58, 56, 56, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 55, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=50, 52, 52, 45Week 32; n=51, 53, 55, 45Week 36; n=52, 53, 55, 44Week 40; n=51, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 52, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 51, 42Week 96; n=46, 46, 52, 41Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 46, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=35, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=32, 39, 44, 0Week 228; n=31, 39, 47, 0Week 240; n=32, 39, 47, 0Week 252; n=31, 36, 45, 0Week 264; n=32, 38, 46, 0Week 276; n=31, 38, 46, 0Week 288; n=30, 38, 44, 0Week 300; n=30, 37, 43, 0Week 312; n=31, 33, 42, 0Week 324; n=3, 4, 2, 0
GSK1265744 10 mg0.1-0.22.72.01.12.12.61.81.71.60.30.51.22.61.83.32.74.04.23.54.04.06.35.53.34.54.75.16.26.26.36.67.34.67.04.3
GSK1265744 30 mg0.00.54.83.93.53.84.83.44.03.12.92.22.74.74.54.03.33.44.73.02.65.16.04.03.54.74.14.85.86.46.05.56.85.16.110.0
GSK1265744 60 mg-0.70.62.02.62.33.13.62.51.53.52.72.1-0.52.22.43.03.63.02.12.52.32.74.82.73.03.23.43.12.15.85.55.46.95.58.020.5

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Change From Baseline in Hemoglobin Level Over Time by Visit

Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionGrams per liter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=57, 57, 59, 57Week 8; n=58, 56, 56, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 55, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=50, 52, 52, 45Week 32; n=51, 53, 55, 45Week 36; n=52, 53, 55, 44Week 40; n=51, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 52, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 51, 42Week 96; n=46, 46, 52, 41
Efavirenz 600 mg0.70.72.02.81.10.81.92.20.10.6-0.8-0.20.02.32.41.71.9

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Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2

Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2

InterventionMicrograms per milliliter (Geometric Mean)
GSK1265744 10 mg2.77
GSK1265744 30 mg7.49
GSK1265744 60 mg13.12

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Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 48

(NCT01651403)
Timeframe: Baseline; Week 48

InterventionParticipants (Count of Participants)
TDF (Blinded Randomized Phase)5
Placebo (Blinded Randomized Phase)7

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Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 96

(NCT01651403)
Timeframe: Baseline; Week 96

InterventionParticipants (Count of Participants)
TDF to TDF1
Placebo to TDF2

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Percent Change From Baseline in BMD of Spine at Week 192

(NCT01651403)
Timeframe: Baseline; Week 192

InterventionPercent change in spine BMD (Mean)
TDF to TDF19.168
Placebo to TDF26.085

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Percent Change From Baseline in BMD of Spine at Week 48

(NCT01651403)
Timeframe: Baseline; Week 48

InterventionPercent change in spine BMD (Mean)
TDF (Blinded Randomized Phase)3.798
Placebo (Blinded Randomized Phase)7.557

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Percentage of Participants With ≥ 4% Decrease From Baseline in Spine BMD at Week 192

(NCT01651403)
Timeframe: Baseline; Week 192

Interventionpercentage of participants (Number)
TDF to TDF18.3
Placebo to TDF6.9

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Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density (BMD) at Week 48

(NCT01651403)
Timeframe: Baseline; Week 48

Interventionpercentage of participants (Number)
TDF (Blinded Randomized Phase)18.3
Placebo (Blinded Randomized Phase)6.9

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Percentage of Participants With HBsAg Loss at Week 192

HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative. (NCT01651403)
Timeframe: Week 192

Interventionpercentage of participants (Number)
TDF to TDF10.0
Placebo to TDF0

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Percentage of Participants With HBsAg Loss at Week 48

HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative. (NCT01651403)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TDF (Blinded Randomized Phase)3.3
Placebo (Blinded Randomized Phase)3.4

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Percentage of Participants With HBsAg Seroconversion at Week 192

HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive. (NCT01651403)
Timeframe: Week 192

Interventionpercentage of participants (Number)
TDF to TDF0
Placebo to TDF0

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Percentage of Participants With HBsAg Seroconversion at Week 48

HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive. (NCT01651403)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TDF (Blinded Randomized Phase)0
Placebo (Blinded Randomized Phase)0

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Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48

(NCT01651403)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TDF (Blinded Randomized Phase)71.7
Placebo (Blinded Randomized Phase)6.9

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Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48

HBeAg seroconversion was defined as HBeAg loss and a change from HBeAb negative or missing at baseline to HBeAb positive. (NCT01651403)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TDF (Blinded Randomized Phase)25.0
Placebo (Blinded Randomized Phase)24.1

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Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48, Based on the American Association for the Study of Liver Diseases (AASLD) Normal Range

Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. (NCT01651403)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TDF (Blinded Randomized Phase)51.7
Placebo (Blinded Randomized Phase)17.2

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Percentage of Participants With Normal ALT at Week 192, Based on the AASLD Normal Range

Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. (NCT01651403)
Timeframe: Week 192

Interventionpercentage of participants (Number)
TDF to TDF71.7
Placebo to TDF51.7

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Percentage of Participants With Normal ALT at Week 192, Based on the Central Lab Normal Range

Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. (NCT01651403)
Timeframe: Week 192

Interventionpercentage of participants (Number)
TDF to TDF80.0
Placebo to TDF62.1

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Percentage of Participants With Normal ALT at Week 48, Based on the Central Lab Normal Range

Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. (NCT01651403)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TDF (Blinded Randomized Phase)65.0
Placebo (Blinded Randomized Phase)17.2

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Percentage of Participants With Normalized ALT at Week 192, Based on the AASLD Normal Range

Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. (NCT01651403)
Timeframe: Week 192

Interventionpercentage of participants (Number)
TDF to TDF71.7
Placebo to TDF50.0

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Percentage of Participants With Normalized ALT at Week 192, Based on the Central Lab Normal Range

Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. (NCT01651403)
Timeframe: Week 192

Interventionpercentage of participants (Number)
TDF to TDF79.3
Placebo to TDF59.3

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Percentage of Participants With Normalized ALT at Week 48, Based on the AASLD Normal Range

Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. (NCT01651403)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TDF (Blinded Randomized Phase)51.7
Placebo (Blinded Randomized Phase)17.9

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Percentage of Participants With Normalized ALT at Week 48, Based on the Central Lab Normal Range

Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. (NCT01651403)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TDF (Blinded Randomized Phase)65.5
Placebo (Blinded Randomized Phase)14.8

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Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach)

(NCT01651403)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TDF (Blinded Randomized Phase)83.6
Placebo (Blinded Randomized Phase)7.7

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Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)

(NCT01651403)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TDF (Blinded Randomized Phase)76.7
Placebo (Blinded Randomized Phase)6.9

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Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 192

(NCT01651403)
Timeframe: Week 192

Interventionpercentage of participants (Number)
TDF to TDF81.7
Placebo to TDF62.1

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Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 192

Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. (NCT01651403)
Timeframe: Week 192

Interventionpercentage of participants (Number)
TDF to TDF70.0
Placebo to TDF42.9

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Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 48

Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. (NCT01651403)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TDF (Blinded Randomized Phase)46.7
Placebo (Blinded Randomized Phase)7.1

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Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 192

Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. (NCT01651403)
Timeframe: Week 192

Interventionpercentage of participants (Number)
TDF to TDF75.9
Placebo to TDF55.6

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Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 48

Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. (NCT01651403)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TDF (Blinded Randomized Phase)53.4
Placebo (Blinded Randomized Phase)7.4

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Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 144

(NCT01651403)
Timeframe: Baseline; Week 144

InterventionParticipants (Count of Participants)
TDF to TDF1
Placebo to TDF0

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Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 192

(NCT01651403)
Timeframe: Baseline; Week 192

InterventionParticipants (Count of Participants)
TDF to TDF0
Placebo to TDF0

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Pharmacokinetics: End Period Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Tissue

Compare end period emtricitabine concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)

Interventionlog10 ng/mg (Mean)
Product 1-0.35
Product 2-1.26
Product 3-1.26

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Pharmacokinetics: End Period Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Tissue

Compare end period tenofovir concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)

Interventionlog10 ng/mg (Mean)
Product 10.18
Product 20.84
Product 30.02

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Pharmacokinetics: End Period Tenofovir-Diphosphate (TFV-DP) Concentrations (log10 ng/mg) in Rectal Tissue

Compare end period tenofovir-diphosphate (TFV-DP) concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)

Interventionlog10 ng/mg (Mean)
Product 11.52
Product 22.06
Product 31.54

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Safety: Grade 2 or Higher Adverse Events

Compare the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Analysis of the primary endpoint of grade 2 or higher AEs was performed on only the evaluable participants based on the principle of intent-to-treat (ITT) whereby participants who were randomized were included in the analysis regardless of whether or not they received product in a given period (i.e, were lost to follow-up, or terminated early and/or were on a product hold). (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)

Interventionparticipants (Number)
Product 164
Product 261
Product 356

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Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?

To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of ease of use, a variable was created to compare regimens. This variable combines questions 1A and 1BC from Section I. Ease of Use of the MTN-017 Follow-up Behavioral Questionnaire. Categories 1 and 2 were combined and categories 3 and 4 were combined to create dichotomous variables. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)

,,
Interventionparticipants (Number)
Very Difficult/DifficultVery Easy/Easy
Product 114169
Product 224160
Product 318165

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Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it?

To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of likelihood to use product in the future, a variable was created by combining Section N. Likelihood to Use Product in the Future of the MTN-017 Follow-up Behavioral Questionnaire questions 1A, 1B, and 1C. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)

,,
Interventionparticipants (Number)
Very Unlikely/UnlikelyVery Likely/Likely
Product 124159
Product 252132
Product 331145

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Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently?

To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of liking the product, a variable was created by combining from Section H. Liking the Product of the MTN-017 Follow-up Behavioral Questionnaire question 1A and question 1BC. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)

,,
Interventionparticipants (Number)
Disliked Very Much/A LittleLiked Very Much/A Little
Product 116163
Product 247134
Product 338145

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Adherence: Percentage of Prescribed Doses Taken Orally or Administered Rectally in an 8-week Period

Compare percentage of prescribed doses taken orally or administered rectally in an 8-week period based on the Final Converged Rates. Final Converged Rates were measured first via self-report through Short Message Service (SMS). The clinic staff also reported the most likely number of doses taken. Finally, the MTN Behavioral Research Working Group (BRWG) provided the final estimate of the number of doses taken for each participant for each period based on self-report, staff estimates and PK testing results. Note that these final judgement data are missing if PK results are missing. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)

,,
InterventionParticipants (Count of Participants)
Less Than 80%At or Greater than 80%
Product 112173
Product 231153
Product 313170

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Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge

Compare emtricitabine concentrations in rectal sponge among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)

,,
Interventionlog10 ng/mg (Mean)
Initiate Period FTC ConcentrationMid-Period FTC ConcentrationEnd Period FTC Concentration
Product 1-1.750.310.14
Product 2-1.76-1.76-1.80
Product 3-1.57-1.67-1.69

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Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma

Compare emtricitabine concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)

,,
Interventionlog10 ng/mL (Mean)
Mid-Period FTC ConcentrationEnd Period FTC Concentration
Product 12.342.25
Product 2-0.35-0.37
Product 3-0.37-0.33

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Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge

Compare tenofovir concentrations in rectal sponge specimens among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)

,,
Interventionlog10 ng/mg (Mean)
Initiate Period TFV ConcentrationMid-Period TFV ConcentrationEnd Period TFV Concentration
Product 1-1.530.710.66
Product 2-1.650.971.00
Product 3-1.29-0.030.01

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Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma

Compare tenofovir concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)

,,
Interventionlog10 ng/mL (Mean)
Mid-Period TFV ConcentrationEnd Period TFV Concentration
Product 11.851.77
Product 20.420.37
Product 3-0.01-0.02

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Human Papillomavirus Incidence Rates

For the calculation of the incidence rate, seroconversion was assumed to have occurred at the midpoint between the first positive HPV test and the previous HPV negative test. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months

InterventionIncidence rate/100 women years (Number)
Intervention1.0
Control3.0

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Percentage of Participants With Detectable Tenofovir Levels From Vaginal Samples at 12 Months of Follow-up

Percentage of participants with detectable tenofovir levels from vaginal samples at 12 months of follow-up. All drug levels below limit of quantification were considered to be undetectable. (NCT01691768)
Timeframe: All participants with drug levels at 12 months of follow-up

Interventionpercentage of participants (Number)
Intervention39.5
Control43.6

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Mean Number of Returned Used Applicators Per Month (i.e in 30 Days)

The primary endpoint is the mean number of returned used applicators per month. Since participants in the intervention arm followed two and three monthly schedule (as opposed to monthly in the intervention arm), the number of returned used applicators per month for each participant will be estimated as the total number of returned applicators at that visit divided by the number of days since the previous visit, multiplied by 30. Thus a uniform distribution of gel use will be assumed in participants whom we did not see monthly. Intent to treat and per protocol analyses were carried out of this outcome. Intent to treat population includes all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data. The per protocol population is a subset of the intent to treat population.The per-protocol analysis excluded visits where no gel had been dispensed for >120 days. (NCT01691768)
Timeframe: Between 2012 to 2015, up to 28 months

,
InterventionUsed gel applicators per month (Least Squares Mean)
Intent to treat analysesPer protocol analyses
Control5.75.8
Intervention5.25.5

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Pregnancy Incidence Rates

Time to pregnancy, was as the difference between the estimated date of conception and the enrolment date, plus one. The date of conception was defined as 14 days after the last normal menstrual period or the estimated date of delivery minus 40 weeks if the first date of last normal menstrual period is not available or the midpoint between the date of the first positive pregnancy test and the date of the previous negative pregnancy test. The censoring time for a woman who did not become pregnant during the study equals the difference between the calculated censoring date and the enrolment date, plus one. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months

InterventionIncidence rate/100 women years (Number)
Intervention4.9
Control5.1

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Percentage of Participants Achieving Adherence >80%.

Self-reported adherence to the tenofovir gel dosing strategy.Gel adherence was defined as the estimated proportion of reported sex acts covered by two gel doses and calculated for each woman by dividing half the number of returned used applicators each month by the number of reported sex acts that month.For participants attending 2-3 monthly clinic visits, their number of gels used in the last 30 days will be estimated as the total number of returned used gels, divided by the number of days between the current and the previous visit, times 30. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months

Interventionpercentage of participants (Number)
Intervention70.2
Control65.2

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Product Acceptability

This is the number of participants who reported that they liked the study product. The questionnaire was administered at study exit, therefore participants who were loss to follow-up and those who died could not complete the questionnaire. (NCT01691768)
Timeframe: At study completion, up to 28 months

InterventionParticipants (Count of Participants)
Intervention180
Control170

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HIV Viral Load Among HIV Seroconverters

This is mean log transformed HIV viral load measured at the first visit post HIV infection. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months

Interventionlog10 copies/ml (Mean)
Intervention4.4
Control4.8

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HIV Incidence Rates

Time to HIV infection was calculated as the difference between estimated date of infection (midpoint between the last negative HIV test date and the first confirmed positive HIV test date) and enrolment date, plus one. Where a participant has a positive PCR and a negative rapid test on the same date, the date of infection is calculated as 14 days prior to this date. Women who do not become HIV positive before their last study visit will be censored on the day of their last negative HIV test. Their follow-up time will be calculated as the difference between date of censoring and enrolment date, plus one. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months

InterventionIncidence rate/100 women years (Number)
Intervention3.5
Control3.6

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Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48

Percentage of Participants with plasma HIV-1 RNA <50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method. (NCT01709084)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
TDF/FTC/RPV93.9
TDF/FTC/EFV96.2

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Percentage of Participant With Treatment Adherence Based on Tablet Count

In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of >95% (97% and 98% in RPV and EFV treated treatment groups respectively). (NCT01709084)
Timeframe: Up to 48 Weeks

InterventionPercentage of Participants (Number)
TDF/FTC/RPV97.2
TDF/FTC/EFV97.6

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Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations

To compare the loss of treatment options, the number of participants with treatment-emergent N[t]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups. (NCT01709084)
Timeframe: Up to Week 48

InterventionParticipants (Number)
TDF/FTC/RPV0
TDF/FTC/EFV0

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Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48

Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method. (NCT01709084)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
TDF/FTC/RPV93.9
TDF/FTC/EFV96.2

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Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.

Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA >=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <400 copies/mL. (NCT01709084)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
TDF/FTC/RPV0.5
TDF/FTC/EFV0.5

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Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.

Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA >=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <50 copies/mL. (NCT01709084)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
TDF/FTC/RPV1.5
TDF/FTC/EFV1.0

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Percentage of Infants With Hepatitis B Infection at or After 6 Months Through 12 Months of Age

Infants will be considered HBV infected if at any time point at or after 6 months through 12 months of age, a sample tests positive for HBsAg and HBV DNA (NCT01745822)
Timeframe: at or after 6 months through 12 months of age

InterventionParticipants (Count of Participants)
Tenofovir Disoproxil Fumarate0
Placebo3

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Percentage of Participants With Flares After Study Treatment Interruption

Flare, or acute exacerbation of hepatitis B, after study treatment interruption is defined as an Alanine Aminotransferase plasma level above 300 IU/mL (NCT01745822)
Timeframe: Following planned discontinuation of study treatment up to 12 months postpartum

InterventionParticipants (Count of Participants)
Tenofovir Disoproxil Fumarate9
Placebo5

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Percentage of Participants With Adverse Events

Occurrence of maternal and infant adverse events, including maternal and infants Serious Adverse Events (as defined by the International Conference on Harmonization Good Clinical Practice) and NIH Division of AIDS grade 3/4 signs and symptoms, regardless of their relatedness to the study treatment. (NCT01745822)
Timeframe: from enrollment (28 weeks' gestation) to 12 months postpartum

,
InterventionParticipants (Count of Participants)
MaternalInfant
Placebo4438
Tenofovir Disoproxil Fumarate4143

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Weight, Height and Head Circumference for Age

Weight, length/height and head circumference WHO Z scores are measures of relative weight, height and head circumference adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. (NCT01745822)
Timeframe: assessed at 6 months and 12 months of age, 6 months reported

,
InterventionZ-score (Mean)
Weight for ageLength for ageHead circumference for age
Placebo-0.2-0.2-0.6
Tenofovir Disoproxil Fumarate-0.4-0.2-0.6

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Percentage of Infants With Hepatitis B Infection at 6 Months of Age

Infection is defined as a HBsAg positive test confirmed by detectable HBV DNA (NCT01745822)
Timeframe: 6 months of age

InterventionParticipants (Count of Participants)
Tenofovir Disoproxil Fumarate0
Placebo3

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Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48

"The percent change in total hip BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Baseline, Week 48

Interventionpercent change (Mean)
PCC Behavioral Intervention Group1.27

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Number of Participants Using Text Messaging Reminders

This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders. (NCT01769456)
Timeframe: Baseline through Week 48

InterventionParticipants (Count of Participants)
Signed up for text message remindersDiscontinued reminders while on study agentDiscontinued reminders while still on study
PCC Behavioral Intervention Group2221

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Number of Participants With Decrease in Bone Mineral Density

"The proportion of subjects with DXA data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body).~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Decrease in absolute BMD >=1% baseline to Wk48Decrease in absolute BMD >=5% baseline to Wk48Decrease in absolute BMD >10% baseline to Wk48
PCC Behavioral Intervention Group1620

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Acceptability of PrEP Regimen and Study Visits

"This represents one of the indicators associated with the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions." (NCT01769456)
Timeframe: Week 12

InterventionParticipants (Count of Participants)
Size of the pill71989854Taste of the pill71989854Color of the pill71989854Taking the pill every day71989854Taking part in the study71989854HIV test at every visit71989854Risk Reduction Counseling at every visit71989854Questions about sexual behavior at every visit71989854Physician exam by a doctor71989854Health clinic for study visits71989854
Did not like it at allLikedDid not likeLiked a lot
PCC Behavioral Intervention Group14
PCC Behavioral Intervention Group36
PCC Behavioral Intervention Group6
PCC Behavioral Intervention Group27
PCC Behavioral Intervention Group22
PCC Behavioral Intervention Group3
PCC Behavioral Intervention Group2
PCC Behavioral Intervention Group8
PCC Behavioral Intervention Group42
PCC Behavioral Intervention Group9
PCC Behavioral Intervention Group1
PCC Behavioral Intervention Group17
PCC Behavioral Intervention Group34
PCC Behavioral Intervention Group7
PCC Behavioral Intervention Group0
PCC Behavioral Intervention Group26
PCC Behavioral Intervention Group35
PCC Behavioral Intervention Group4
PCC Behavioral Intervention Group25
PCC Behavioral Intervention Group32
PCC Behavioral Intervention Group30
PCC Behavioral Intervention Group10
PCC Behavioral Intervention Group15
PCC Behavioral Intervention Group41

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Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex

"Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to unprotected sex from the participant ACASI:~Of these males [male partners], how many did you have unprotected oral or anal sex with since the last time you took this survey? An event is defined as an answer of greater than 0.~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Week 48

InterventionParticipants (Count of Participants)
PCC Behavioral Intervention Group25

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Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48

"The percent change in femoral neck BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Baseline, Week 48

Interventionpercent change (Mean)
PCC Behavioral Intervention Group1.16

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Estimation of Medication Adherence by Dried Blood Spot (DBS) Results

"This outcome addresses the objective: Rates of adherence and measured levels of drug exposure when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.~Medication adherence is estimated by factors including levels of drug exposure as measured by DBS red blood cell (RBC) samples.~The TFV dosing level was translated into number of dosing days per week for week 8 onwards using lab estimates as follows: '<2 days' is defined as <350 (fmol/punch), '2 days' as 350 to 700 (fmol/punch), '4 days' as >700 to 1250 (fmol/punch), and 'Daily' as >1250 (fmol/punch).~The TFV dosing level was translated into number of dosing days for week 4 using lab estimates as follows: '<2 days' is defined as <275 (fmol/punch), '2 days' as 275 to 525 (fmol/punch), '4 days' as >525 to 950 (fmol/punch),and 'Daily' as >950 (fmol/punch)" (NCT01769456)
Timeframe: Week 4, Week 12, Week 24, Week 36, Week 48

InterventionParticipants (Count of Participants)
DBS RBC TFV-DP (fmol/punch), Week 471989854DBS RBC TFV-DP (fmol/punch), Week 871989854DBS RBC TFV-DP (fmol/punch), Week 1271989854DBS RBC TFV-DP (fmol/punch), Week 2471989854DBS RBC TFV-DP (fmol/punch), Week 3671989854DBS RBC TFV-DP (fmol/punch), Week 4871989854
2 days4 daysDailyBelow level of quantification<2 days
PCC Behavioral Intervention Group24
PCC Behavioral Intervention Group13
PCC Behavioral Intervention Group14
PCC Behavioral Intervention Group21
PCC Behavioral Intervention Group12
PCC Behavioral Intervention Group3
PCC Behavioral Intervention Group17
PCC Behavioral Intervention Group7
PCC Behavioral Intervention Group22
PCC Behavioral Intervention Group11
PCC Behavioral Intervention Group15
PCC Behavioral Intervention Group18
PCC Behavioral Intervention Group5
PCC Behavioral Intervention Group6
PCC Behavioral Intervention Group19
PCC Behavioral Intervention Group8
PCC Behavioral Intervention Group2
PCC Behavioral Intervention Group4

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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.

"This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders, as measured by subject rating of the reasons for missing medications on a 4-point Likert scale.~Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:" (NCT01769456)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Were away from home71989854Were too busy with other things71989854Simply forgot71989854Had too many study pills to take71989854Wanted to avoid side effects71989854Did not want others to notice you taking meds71989854Had a change in daily routine71989854
RarelySometimesOftenNever
PCC Behavioral Intervention Group12
PCC Behavioral Intervention Group15
PCC Behavioral Intervention Group10
PCC Behavioral Intervention Group7
PCC Behavioral Intervention Group8
PCC Behavioral Intervention Group21
PCC Behavioral Intervention Group37
PCC Behavioral Intervention Group2
PCC Behavioral Intervention Group36
PCC Behavioral Intervention Group3
PCC Behavioral Intervention Group0
PCC Behavioral Intervention Group1
PCC Behavioral Intervention Group27
PCC Behavioral Intervention Group5
PCC Behavioral Intervention Group4

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Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study

"This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.~Participants were assessed for any serum creatinine event of Grade 1 or higher over the course of the study (Week 0 through Week 48)." (NCT01769456)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
PCC Behavioral Intervention Group0

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Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48

"The percent change in lumbar spine BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Baseline, Week 48

Interventionpercent change (Mean)
PCC Behavioral Intervention Group2.59

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Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners

"Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to related to number of male sexual partners from the participant ACASI:~Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Week 48

Interventionmale sexual partners (Mean)
PCC Behavioral Intervention Group1.64

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Total Body Bone Mineral Density: Percent Change From Baseline to Week 48

"The percent change in total body BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Baseline, Week 48

Interventionpercent change (Mean)
PCC Behavioral Intervention Group1.29

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Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age)

"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's age at enrollment." (NCT01772823)
Timeframe: 48 weeks

Interventionyears (Mean)
On Prep20.28
Off Prep19.93

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Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders

Total number of subjects who signed up for text message reminders (NCT01772823)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
All Study Participants76

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Lumbar Spine Bone Mineral Density at Baseline and at Week 48

"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for lumbar spine." (NCT01772823)
Timeframe: Baseline, Week 48

Interventiong/cm2 (Mean)
Lumbar spine BMD at baselineLumbar spine BMD Week 48
All Study Participants1.091.08

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Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)

PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular FTC-triphosphate concentrations. (NCT01772823)
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Interventionpmol/punch (Mean)
DBS RBC FTC-TP at Week 4DBS RBC FTC-TP at Week 8DBS RBC FTC-TP at Week 12DBS RBC FTC-TP at Week 24DBS RBC FTC-TP at Week 36DBS RBC FTC-TP at Week 48
All Study Participants0.200.190.180.160.170.15

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Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders

Number of subjects who discontinued receiving text message reminders while they were still on the study agent (NCT01772823)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
All Study Participants3

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Femoral Neck Bone Mineral Density at Baseline and at Week 48

"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for femoral neck." (NCT01772823)
Timeframe: Baseline, Week 48

Interventiong/cm2 (Mean)
Femoral neck BMD at baselineFemoral neck Week 48
All Study Participants1.041.03

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Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48

"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~The total number of participants with dual-energy radiography absorptiometry scanning (DXA) data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body) between Baseline and Week 48." (NCT01772823)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Decrease in absolute BMD >=1%Decrease in absolute BMD >=5%Decrease in absolute BMD >10%
All Study Participants97161

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Number of Participants With Unprotected Sex Acts

"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM, specifically behavioral disinhibition/risk compensation endpoints.~Responses to the participant ACASI question referring to male partners in the past month/since the last survey:~Of these males (male partners), how many did you have unprotected oral or anal sex with in the last month? (Baseline), or Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey? (Week 48) An event is defined as an answer of greater than 0." (NCT01772823)
Timeframe: Baseline and 48 weeks

InterventionParticipants (Count of Participants)
Had unprotected oral/anal w/male (BL)Had unprotected oral/anal w/ male (Wk48)
All Study Participants143103

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Number of Sex Partners

"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM, specifically behavioral disinhibition/risk compensation endpoints.~Responses to the participant ACASI question referring to number of male partners in the past month/since the last survey:~During the past month, how many male partners have you had sexual contact with (oral or anal)? (Baseline), or Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)? (Week 48)~And responses to the participant ACASI question referring to number of HIV-positive male partners in the past month/since the last survey:~Of those you had unprotected sex with, how many did you know were HIV positive?" (NCT01772823)
Timeframe: Baseline and 48 weeks

Interventionsexual partners (Mean)
Male sexual partners last month (baseline)Male sexual partners since last survey (Wk 48)Number HIV+ male partners last month (baseline)Number HIV+ male partners since last survey(Wk48)
All Study Participants5.412.461.650.15

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Total Body Bone Mineral Density at Baseline and at Week 48

"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for total body." (NCT01772823)
Timeframe: Baseline, Week 48

Interventiong/cm2 (Mean)
Total body BMD at baselineTotal body BMD Week 48
All Study Participants1.201.18

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Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)

"This outcome addresses the objective: Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP concentrations." (NCT01772823)
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Interventionfmol/punch (Mean)
DBS RBC TFV-DP at Week 4DBS RBC TFV-DP at Week 8DBS RBC TFV-DP at Week 12DBS RBC TFV-DP at Week 24DBS RBC TFV-DP at Week 36DBS RBC TFV-DP at Week 48
All Study Participants584.56783.18793.37657.66671.72528.24

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Total Hip Bone Mineral Density at Baseline and at Week 48

"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for total hip." (NCT01772823)
Timeframe: Baseline, Week 48

Interventiong/cm2 (Mean)
Total hip BMD at baselineTotal hip BMD Week 48
All Study Participants1.101.08

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Number of Participants With Serum Creatinine Event of Grade 1 or Higher

"This measure addresses the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM~Serum creatinine was tested at every study visit (Baseline through Week 48). The number of participants with a serum creatinine laboratory toxicity of Grade 1 or higher was assessed. Grade 1 (Mild) toxicity was defined as: 1.1 - 1.3 x ULN, where ULN is the Upper limit of normal." (NCT01772823)
Timeframe: 48 Weeks

InterventionParticipants (Count of Participants)
All Study Participants1

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Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure

"This outcome addresses the objective: Patterns of Use, Rates of Adherence and Measured Levels of Drug Exposure When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP and FTC-triphosphate concentrations. DBS results were translated into dosing categories previously used in PrEP trials with adult MSM. Dosing categories included below lower limit of quantitation (BLQ), lower limit of quantitation to 349 fmol per punch (fewer than 2 tablets per week), 350- 699 fmol per punch (2-3 tablets per week), 700-1250 fmol per punch (4 tablets per week), and >1250 fmol per punch (daily)." (NCT01772823)
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

InterventionParticipants (Count of Participants)
Week 471977136Week 871977136Week 1271977136Week 2471977136Week 3671977136Week 4871977136
Below level of quantification<2 days2 days4 daysDaily
All Study Participants13
All Study Participants35
All Study Participants58
All Study Participants59
All Study Participants8
All Study Participants7
All Study Participants30
All Study Participants69
All Study Participants12
All Study Participants32
All Study Participants26
All Study Participants55
All Study Participants34
All Study Participants36
All Study Participants14
All Study Participants42
All Study Participants27
All Study Participants23
All Study Participants28
All Study Participants37
All Study Participants24
All Study Participants18
All Study Participants15

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Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load)

"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's viral load, assessed here as Log 10 Viral Load (copies/ml)" (NCT01772823)
Timeframe: 48 weeks

Interventioncopies/ml (Mean)
On Prep1.22
Off Prep1.14

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Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay

At a specific week, the proportion of participants with HIV-1 RNA by iSCA less than assay limit of detection (0.6 copies/mL) (NCT01777997)
Timeframe: At pre-ART and weeks 0, 4, 12, 24, 36 and 48 on ART

Interventionproportion of participants (Number)
Pre-ARTWeek 0 on ARTWeek 4 on ARTWeek 12 on ARTWeek 24 on ARTWeek 36 on ARTWeek 48 on ART
FTC/RPV/TDF0.190.190.610.900.930.920.96

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Change in Quality of Life (QoL) Index

"QoL index was obtained by averaging the five responses on the Euro-Quality of Life questionnaire (EQ-5D), where a response of 0 indicates no problems/no discomfort, 1 indicates some problems/moderate discomfort and 2 indicates unable to perform activities/extreme discomfort. Change equals each specific week index, respectively, minus the baseline index (mean of the two averages obtained prior to the start of ART)" (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ART

Interventionunits on a scale (Median)
Week 4 on ARTWeek 24 on ARTWeek 48 on ART
FTC/RPV/TDF0-0.10

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Change in Levels of D-dimer

Change equals each specific week result, respectively, minus the baseline result (mean of the two log10-transformed measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ART

Interventionlog10(ng/mL) (Median)
Week 4 on ARTWeek 24 on ARTWeek 48 on ART
FTC/RPV/TDF0.010.010.02

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Change in Levels of CD8+ T-cell Activation

Change equals each specific week percentage, respectively, minus the baseline percentage (mean of the two measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART

Intervention% of CD8+ T-cells (Median)
Week 4 on ARTWeek 12 on ARTWeek 24 on ARTWeek 48 on ART
FTC/RPV/TDF-0.7-1.6-2.2-4.7

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Change in CD4+ T-cell Count

Change equals each specific week CD4+ T-cell count, respectively, minus the baseline CD4+ T-cell count (mean of the two measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 12, 24, 36 and 48 on ART

Interventioncells/mm^3 (Median)
Week 12 on ARTWeek 24 on ARTWeek 36 on ARTWeek 48 on ART
FTC/RPV/TDF-15-52519

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Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+)

Change equals each specific week percentage, respectively, minus the baseline percentage (mean of the two measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART

Intervention% of CD4+ T-cells (Median)
Week 4 on ARTWeek 12 on ARTWeek 24 on ARTWeek 48 on ART
FTC/RPV/TDF0.1-0.1-0.2-0.2

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Number of Subjects Who Experience Grade 3 or 4 Signs and Symptoms or Laboratory Abnormalities, Diagnoses (Any Grade), or Other Serious Adverse Events (SAEs)

Grading uses the Division of AIDS (DAIDS) 2004 (clarification 2009) Severity of Adverse Events Table, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life-threatening. (NCT01777997)
Timeframe: From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation

Interventionparticipants (Number)
FTC/RPV/TDF18

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Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART

Mean change from baseline (pre-ART [study entry] and week 0 on ART [study week 12]), estimated with a repeated measures analysis (jointly to weeks 24 and 48 on ART) using generalized estimating equations (GEE) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 24 and 48 on ART

Intervention% of CD8+ T-cells (Mean)
FTC/RPV/TDF-4.01

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Change in Levels of Interleukin (IL)-6

Change equals each specific week result, respectively, minus the baseline result (mean of the two log10-transformed measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART

Interventionlog10(pg/mL) (Median)
Week 4 on ARTWeek 12 on ARTWeek 24 on ARTWeek 48 on ART
FTC/RPV/TDF0.050.010.020

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Number of Participants With a Grade 2 or Higher Adverse Event by Cohort

Number and frequency rate of clinical and laboratory AEs (Gr 2 and above), including SAEs by Cohort. (NCT01781806)
Timeframe: Baseline to 48 weeks

InterventionParticipants (Count of Participants)
Cohort H (PrEP)230
Cohort LM (PEP)0

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Number of HIV Seroconversions by Cohort.

(NCT01781806)
Timeframe: Baseline to 48 weeks

InterventionParticipants (Count of Participants)
Cohort H (PrEP)1
Cohort LM (PEP)0

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Cohort H PrEP Engagement by Study Visit

Optimal adherence to daily oral emtricitabine/tenofovir disoproxil fumarate by study visit as measured by tenofovir diphosphate (TFV-DP) in dried blood spots (DBS). Optimal adherence is defined as TFV-DP levels great than or equal to 700 femtomoles per punch in DBS samples (approximately 4 or more doses a week over the past 60 days). (NCT01781806)
Timeframe: Baseline to 48 weeks

InterventionParticipants (Count of Participants)
Week 4Week 12Week 24Week 36Week 48
Cohort H (PrEP)246247224212194

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Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B

Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 42

,,,
InterventionCells/microliter (Mean)
CD4+CD8+
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir-89-147
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir-133.2-442.8
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir-106.4-466.1
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine33-216.3

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Maximum Observed Plasma Concentrations (Cmax) - Part B

Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 28

,,
InterventionNanogram/milliliter (Geometric Mean)
Day 1Day 28
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir1493.3363159.181
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir695.5961667.817
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir770.9751852

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Maximum Observed Plasma Concentrations (Cmax) - Part A and C

Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 10

,,,,,,,
InterventionNanogram/milliliter (Geometric Mean)
Day 1Day 10
Part A-Group 1: BMS-955176 (5 mg)79.376170.778
Part A-Group 10: BMS-955176 (120 mg)1515.3892809.671
Part A-Group 2: BMS-955176 (10 mg)201.498337.379
Part A-Group 3: BMS-955176 (20 mg)349.466705.073
Part A-Group 4: BMS-955176 (40 mg)791.3171476.166
Part A-Group 9: BMS-955176 (80 mg)1155.4482466.447
Part C-Group 13: BMS-955176 (120 mg)1907.7473377.967
Part C-Group 8: BMS-955176 (40 mg)793.5691560.122

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Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C

Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 24

,,,,,,,,,
InterventionCells/microliter (Mean)
CD4+CD8+
Part A-Group 1: BMS-955176 (5 mg)-21.8-95
Part A-Group 10: BMS-955176 (120 mg)-56.7-161.3
Part A-Group 2: BMS-955176 (10 mg)14.6-8.3
Part A-Group 3: BMS-955176 (20 mg)-70.1-107.4
Part A-Group 4: BMS-955176 (40 mg)-23.6-57.3
Part A-Group 9: BMS-955176 (80 mg)-43.8-194.6
Part C-Group 13: BMS-955176 (120 mg)24.5-155.8
Part C-Group 8: BMS-955176 (40 mg)-53.7-214.4
Placebo Clade B-77.3-93.1
Placebo Clade C18-136.3

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Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B

AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 28

,,
InterventionNanogram*hour/milliliter (Geometric Mean)
Day 1Day 28
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir24478.3559915.72
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir12147.2331406.32
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir12954.834225.08

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Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C

AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 10

,,,,,,,
InterventionNanogram*hour/milliliter (Geometric Mean)
Day 1Day 10
Part A-Group 1: BMS-955176 (5 mg)1151.0622720.237
Part A-Group 10: BMS-955176 (120 mg)21872.7244182.4
Part A-Group 2: BMS-955176 (10 mg)2869.6265168.553
Part A-Group 3: BMS-955176 (20 mg)5132.95111751.82
Part A-Group 4: BMS-955176 (40 mg)10088.2322984.83
Part A-Group 9: BMS-955176 (80 mg)17057.2639341.11
Part C-Group 13: BMS-955176 (120 mg)26753.7453972.71
Part C-Group 8: BMS-955176 (40 mg)10936.925556.64

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Accumulation Index (AI): Part A and C

Accumulation index was calculated by dividing the AUC(tau) or Cmax or C24 of BMS-955176 on Day 10 by the AUC(TAU) or Cmax or C24, respectively, of BMS-955176 on Day 1. (NCT01803074)
Timeframe: Baseline and Day 10

,,,,,,,
InterventionRatio (Geometric Mean)
CmaxC24AUC
Part A-Group 1: BMS-955176 (5 mg)2.1522.3362.363
Part A-Group 10: BMS-955176 (120 mg)1.8542.0632.02
Part A-Group 2: BMS-955176 (10 mg)1.6741.7571.801
Part A-Group 3: BMS-955176 (20 mg)2.0182.112.289
Part A-Group 4: BMS-955176 (40 mg)1.8562.4912.278
Part A-Group 9: BMS-955176 (80 mg)2.1352.3852.306
Part C-Group 13: BMS-955176 (120 mg)1.7711.9532.017
Part C-Group 8: BMS-955176 (40 mg)1.9662.2982.337

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Time to Maximum Decline in Log 10 HIV-1 RNA - Part B

Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 42

InterventionHours (Median)
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir624
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir636.05
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine588
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir636.05

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Plasma Half-life: Part A and C

Half-life of the terminal log-linear phase, (T-half), was calculated as natural logarithm of 2 (ln2)/λ, where λ is the absolute value of the slope of the terminal log-linear phase. T-half was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). (NCT01803074)
Timeframe: Baseline (Day 1) to Day 10

InterventionHours (Median)
Part A-Group 1: BMS-955176 (5 mg)32.134
Part A-Group 2: BMS-955176 (10 mg)31.967
Part A-Group 3: BMS-955176 (20 mg)27.382
Part A-Group 4: BMS-955176 (40 mg)33.475
Part A-Group 9: BMS-955176 (80 mg)29.171
Part A-Group 10: BMS-955176 (120 mg)34.574
Part C-Group 8: BMS-955176 (40 mg)31.565
Part C-Group 13: BMS-955176 (120 mg)35.278

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Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11

Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Change in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 monotherapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) and Day 11 after the final dose with BMS-955176

InterventionLog10 copies per milliliter (c/mL) (Mean)
Part A-Group 1: BMS-955176 (5 mg)-0.138
Part A-Group 2: BMS-955176 (10 mg)-0.567
Part A-Group 3: BMS-955176 (20 mg)-0.889
Part A-Group 4: BMS-955176 (40 mg)-1.279
Part A-Group 9: BMS-955176 (80 mg)-1.339
Part A-Group 10: BMS-955176 (120 mg)-1.326
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir-1.216
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir-1.431
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine-1.544
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir-1.521
Part C-Group 8: BMS-955176 (40 mg)-1.29
Part C-Group 13: BMS-955176 (120 mg)-0.938
Placebo Clade B0.118
Placebo Clade C-0.172

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Apparent Total Body Clearance: Part A and C

Apparent total body clearance was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). (NCT01803074)
Timeframe: Baseline (Day 1) to Day 10

InterventionMilliliters/minute (Geometric Mean)
Part A-Group 1: BMS-955176 (5 mg)30.635
Part A-Group 2: BMS-955176 (10 mg)32.246
Part A-Group 3: BMS-955176 (20 mg)28.364
Part A-Group 4: BMS-955176 (40 mg)29.005
Part A-Group 9: BMS-955176 (80 mg)33.892
Part A-Group 10: BMS-955176 (120 mg)45.267
Part C-Group 8: BMS-955176 (40 mg)26.086
Part C-Group 13: BMS-955176 (120 mg)37.056

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Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C

Css-avg was calculated by the quotient of AUC(TAU) and the dosing interval (24 h). Css-avg was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). (NCT01803074)
Timeframe: Baseline (Day 1) to Day 10

InterventionNanogram/milliliter (Geometric Mean)
Part A-Group 1: BMS-955176 (5 mg)113.326
Part A-Group 2: BMS-955176 (10 mg)215.111
Part A-Group 3: BMS-955176 (20 mg)489.507
Part A-Group 4: BMS-955176 (40 mg)956.222
Part A-Group 9: BMS-955176 (80 mg)1639.471
Part A-Group 10: BMS-955176 (120 mg)1841.413
Part C-Group 8: BMS-955176 (40 mg)1065.435
Part C-Group 13: BMS-955176 (120 mg)2256.793

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Degree of Fluctuation (DF): Part A and C

DF was calculated as the difference between Cmax and Cmin divided by Css-avg. DF was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). (NCT01803074)
Timeframe: Baseline (Day 1) to Day 10

InterventionRatio (Geometric Mean)
Part A-Group 1: BMS-955176 (5 mg)0.766
Part A-Group 2: BMS-955176 (10 mg)0.912
Part A-Group 3: BMS-955176 (20 mg)0.758
Part A-Group 4: BMS-955176 (40 mg)0.78
Part A-Group 9: BMS-955176 (80 mg)0.779
Part A-Group 10: BMS-955176 (120 mg)0.818
Part C-Group 8: BMS-955176 (40 mg)0.723
Part C-Group 13: BMS-955176 (120 mg)0.727

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Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C

Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 24

InterventionLog10 copies/mL (Median)
Part A-Group 1: BMS-955176 (5 mg)-0.498
Part A-Group 2: BMS-955176 (10 mg)-0.976
Part A-Group 3: BMS-955176 (20 mg)-1.115
Part A-Group 4: BMS-955176 (40 mg)-1.701
Part A-Group 9: BMS-955176 (80 mg)-1.555
Part A-Group 10: BMS-955176 (120 mg)-1.654
Part C-Group 8: BMS-955176 (40 mg)-1.352
Part C-Group 13: BMS-955176 (120 mg)-1.257
Placebo Clade B-0.381
Placebo Clade C-0.419

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Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B

Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 42

InterventionLog10 copies/mL (Median)
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir-1.858
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir-2.202
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine-2.39
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir-2.228

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Number of Participants With Clinically Significant Changes in Heart Rate

Heart rate was measured after the participants had been seated quietly for at least 5 minutes. Criteria used to determine heart rate that are outside of a pre-specified range, where changes from Baseline are based on matched postural positions and are calculated as parameter value - Baseline parameter value: Value >100 and change from Baseline > 30, or Value < 55 and change from Baseline < -15. (NCT01803074)
Timeframe: Day 1 to end of the study (Day 42)

InterventionParticipants (Count of Participants)
Part A-Group 1: BMS-955176 (5 mg)0
Part A-Group 2: BMS-955176 (10 mg)0
Part A-Group 3: BMS-955176 (20 mg)0
Part A-Group 4: BMS-955176 (40 mg)0
Part A-Group 9: BMS-955176 (80 mg)0
Part A-Group 10: BMS-955176 (120 mg)0
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir0
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir0
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine1
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir0
Part C-Group 8: BMS-955176 (40 mg)0
Part C-Group 13: BMS-955176 (120 mg)2
Placebo Clade B1
Placebo Clade C0

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Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C

Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 24

InterventionHours (Median)
Part A-Group 1: BMS-955176 (5 mg)168
Part A-Group 2: BMS-955176 (10 mg)216
Part A-Group 3: BMS-955176 (20 mg)203.9
Part A-Group 4: BMS-955176 (40 mg)240.15
Part A-Group 9: BMS-955176 (80 mg)204
Part A-Group 10: BMS-955176 (120 mg)240.2
Part C-Group 8: BMS-955176 (40 mg)228.05
Part C-Group 13: BMS-955176 (120 mg)215.8
Placebo Clade B216.2
Placebo Clade C132.05

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Time to Reach Maximum Plasma Concentration (Tmax) - Part B

Tmax was directly determined from concentration time data. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 28

,,
InterventionHours (Median)
Day 1Day 28
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir54.5
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir5.014.5
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir5.055

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Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C

Time to reach the maximum plasma concentration was directly determined from concentration time data. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 10

,,,,,,,
InterventionHours (Median)
Day 1Day 10
Part A-Group 1: BMS-955176 (5 mg)33
Part A-Group 10: BMS-955176 (120 mg)32.5
Part A-Group 2: BMS-955176 (10 mg)2.513
Part A-Group 3: BMS-955176 (20 mg)34
Part A-Group 4: BMS-955176 (40 mg)43
Part A-Group 9: BMS-955176 (80 mg)3.53
Part C-Group 13: BMS-955176 (120 mg)3.533
Part C-Group 8: BMS-955176 (40 mg)3.53

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Plasma Concentration 24 Hours Post-Dose (C24) - Part B

C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose. (NCT01803074)
Timeframe: 24 hours post-dose

,,
InterventionNanogram/milliliter (Geometric Mean)
Day 1Day 28
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir899.3642010.679
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir462.3121099.313
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir520.0481163.177

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Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C

C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose. (NCT01803074)
Timeframe: 24 hours post-dose

,,,,,,,
InterventionNanogram/milliliter (Geometric Mean)
Day 1Day 10
Part A-Group 1: BMS-955176 (5 mg)34.94681.642
Part A-Group 10: BMS-955176 (120 mg)624.7451288.985
Part A-Group 2: BMS-955176 (10 mg)79.002138.775
Part A-Group 3: BMS-955176 (20 mg)154.5325.934
Part A-Group 4: BMS-955176 (40 mg)286.268713.077
Part A-Group 9: BMS-955176 (80 mg)482.3491150.397
Part C-Group 13: BMS-955176 (120 mg)865.8671691.306
Part C-Group 8: BMS-955176 (40 mg)339.173779.438

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Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B

Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 42

,,,
InterventionPercent change (Mean)
CD4+CD8+
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir-0.75-1.25
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir2.4-2.8
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir3.25-6.25
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine4.75-3.75

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Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C

Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 24

,,,,,,,,,
InterventionPercent change (Mean)
CD4+CD8+
Part A-Group 1: BMS-955176 (5 mg)2.331.17
Part A-Group 10: BMS-955176 (120 mg)0.29-2.29
Part A-Group 2: BMS-955176 (10 mg)0.290.43
Part A-Group 3: BMS-955176 (20 mg)-1.290
Part A-Group 4: BMS-955176 (40 mg)0.861
Part A-Group 9: BMS-955176 (80 mg)2.13-0.25
Part C-Group 13: BMS-955176 (120 mg)3.17-4.25
Part C-Group 8: BMS-955176 (40 mg)0.50
Placebo Clade B-0.221.75
Placebo Clade C2.75-1.33

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Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline

Laboratory abnormalities were determined and graded using the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004. (NCT01803074)
Timeframe: Day 1 to up to end of the study (Day 42)

,,,,,,,,,,,,,
InterventionParticipants (Count of Participants)
Neutrophils (Absolute)Bilirubin (Total)
Part A-Group 1: BMS-955176 (5 mg)00
Part A-Group 10: BMS-955176 (120 mg)10
Part A-Group 2: BMS-955176 (10 mg)00
Part A-Group 3: BMS-955176 (20 mg)00
Part A-Group 4: BMS-955176 (40 mg)00
Part A-Group 9: BMS-955176 (80 mg)00
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir10
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir02
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir05
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine03
Part C-Group 13: BMS-955176 (120 mg)00
Part C-Group 8: BMS-955176 (40 mg)00
Placebo Clade B00
Placebo Clade C00

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Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Systolic BP (millimeter of mercury [mmHg]): value >140 and change from Baseline >20, or value <90 and change from Baseline <-20; Diastolic BP (mmHg): value >90 and change from Baseline >10, or value <55 and change from Baseline <-10. (NCT01803074)
Timeframe: Day 1 to end of the study (Day 42)

,,,,,,,,,,,,,
InterventionParticipants (Count of Participants)
SBPDBP
Part A-Group 1: BMS-955176 (5 mg)00
Part A-Group 10: BMS-955176 (120 mg)00
Part A-Group 2: BMS-955176 (10 mg)01
Part A-Group 3: BMS-955176 (20 mg)01
Part A-Group 4: BMS-955176 (40 mg)00
Part A-Group 9: BMS-955176 (80 mg)00
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir01
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir00
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir11
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine00
Part C-Group 13: BMS-955176 (120 mg)00
Part C-Group 8: BMS-955176 (40 mg)01
Placebo Clade B01
Placebo Clade C00

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Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)

Participants with out of range ECG intervals were summarized. Criteria used to determine ECG results that are outside of a pre-specified range: PR (milliseconds [msec]): Value >200; QRS (msec): Value >120; QT (msec): Value >500 or change from Baseline >30; corrected QT interval Fridericia's formula (QTcF) (msec): Value >450 or change from Baseline >30. (NCT01803074)
Timeframe: Day 1 to end of the study (Day 42)

,,,,,,,,,,,,,
InterventionParticipants (Count of Participants)
PR > 200 msecQRS > 120 msecQT > 500 msecQTcB > 450 msecQTcF > 450 msec
Part A-Group 1: BMS-955176 (5 mg)10000
Part A-Group 10: BMS-955176 (120 mg)20000
Part A-Group 2: BMS-955176 (10 mg)10000
Part A-Group 3: BMS-955176 (20 mg)10001
Part A-Group 4: BMS-955176 (40 mg)00000
Part A-Group 9: BMS-955176 (80 mg)00000
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir10000
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir01000
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir10000
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine10000
Part C-Group 13: BMS-955176 (120 mg)00000
Part C-Group 8: BMS-955176 (40 mg)10000
Placebo Clade B00000
Placebo Clade C00010

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Number of Participants With Abnormal Changes in Physical Examination

Participants with abnormal changes in physical examination is presented. (NCT01803074)
Timeframe: Day 1 to end of the study (Day 42)

,,,,,,,,,,,,,
InterventionParticipants (Count of Participants)
HeightWeightBody mass index
Part A-Group 1: BMS-955176 (5 mg)000
Part A-Group 10: BMS-955176 (120 mg)000
Part A-Group 2: BMS-955176 (10 mg)000
Part A-Group 3: BMS-955176 (20 mg)000
Part A-Group 4: BMS-955176 (40 mg)000
Part A-Group 9: BMS-955176 (80 mg)000
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir000
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir000
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir000
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine000
Part C-Group 13: BMS-955176 (120 mg)000
Part C-Group 8: BMS-955176 (40 mg)000
Placebo Clade B000
Placebo Clade C000

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Number of Participants With Self-Reported Missed Doses

self-reported missed doses (NCT01855867)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
Stribild29

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nPEP Failure (HIV Infection During Study Participation)

nPEP failure, meaning HIV infection during study participation, as measured during HIV testing at day 0, day 30 and day 90 (NCT01855867)
Timeframe: 90 days

Interventionreactive test (Number)
Stribild0

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Number of Adverse Event Occurrences

The number of adverse events reported (NCT01855867)
Timeframe: 90 days

Interventionevents (Number)
DiarrheaFatigueNausea/VomitingHeadacheDizziness/LightheadnessBody Aches/Muscle and Joint Pain
Stribild3828281462

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ATV PK Parameter Cmax Determined Based on ATV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the ATV PK parameter Cmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionng/mL (Median)
Cmax day 0Cmax day 21
NuvaRing With ATV/r Plus TDF ≥1 NRTIs4291.03583.0

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Proportion of Participants With Progesterone Levels Greater Than 5 ng/mL.

This evaluates alterations in progesterone levels due to the potential PK interaction between NuvaRing and the ARVs EFV and ATV/r by examining progesterone levels at study days 0 (before vaginal ring placement), 7, 14, and 21 (before vaginal ring removal), and study day 28, without regard to menstrual cycle status at study entry. (NCT01903031)
Timeframe: Study days 0, 7, 14, 21 and 28

,,
Interventionproportion of participants (Number)
Proportion with progesterone >5 at day 0Proportion with progesterone >5 at day 7Proportion with progesterone >5 at day 14Proportion with progesterone >5 at day 21Proportion with progesterone >5 at day 28
NuvaRing and no ART0.080.080.000.000.00
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs0.250.080.000.000.00
NuvaRing With EFV Plus ≥2 NRTIs0.040.240.040.000.00

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Ritonavir (RTV) PK Parameter AUC(0-24h) Calculated Based on Intensive RTV PK Samples Obtained From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionh*ng/mL (Median)
AUC0-24h day 0AUC0-24h day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs10740.07210.7

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RTV PK Parameter CLss/F Determined Based on RTV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter CLss/F of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/F defines apparent oral clearance. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionhour (Median)
CLss/F day 0CLss/F day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs9.313.9

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RTV PK Parameter Cmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter Cmax of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionng/mL (Median)
Cmax day 0Cmax day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs1437.01063.0

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RTV PK Parameter Tmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter Tmax of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Tmax defines time to maximum concentration since dose is initiated. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionhour (Median)
Tmax day 0Tmax day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs3.03.0

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Ethinyl Estradiol Concentrations at Study Day 21

This evaluates the effect of EFV and ATV/r on ethinyl estradiol by measuring ethinyl estradiol concentrations on all three study arms 21 days after NuvaRing administration. The PK blood sample for measurement of ethinyl estradiol on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for ethinyl estradiol was 5 pg/mL ; values < 5 were assigned a value of half the lower limit (ie, 2.5 pg/mL). (NCT01903031)
Timeframe: Day 21

Interventionpg/mL (Median)
NuvaRing and no ART21.30
NuvaRing With EFV Plus ≥2 NRTIs11.40
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs16.05

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Etonogestrel Concentrations at Study Day 21

This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 21 days after NuvaRing administration. The pharmacokinetic (PK) blood sample for measurement of etonogestrel on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values < 250 were assigned a value of half the lower limit (ie, 125 pg/mL). (NCT01903031)
Timeframe: Day 21

Interventionpg/mL (Median)
NuvaRing and no ART1860.00
NuvaRing With EFV Plus ≥2 NRTIs429.00
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs3290.00

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ATV PK Parameter AUC(0-24h) Calculated Based on Intensive Atazanavir (ATV) PK Samples Obtained From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of ATV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionh*ng/mL (Median)
AUC0-24h day 0AUC0-24h day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs44313.736764.7

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ATV PK Parameter CLss/F Determined Based on ATV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the ATV PK parameter CLss/F obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/f defines apparent oral clearance. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

InterventionL/h (Median)
CLss/F day 0CLss/F day 21
NuvaRing With ATV/r Plus TDF ≥1 NRTIs6.88.2

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RTV PK Parameter Cmin Determined Based on RTV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter Cmin of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionng/mL (Median)
Cmin day 0Cmin day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs70.051.9

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ATV PK Parameter Cmin Determined Based on ATV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the ATV PK parameter Cmin obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionng/mL (Median)
Cmin day 0Cmin day 21
NuvaRing With ATV/r Plus TDF ≥1 NRTIs796.7599.4

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ATV PK Parameter Time to Cmax (Tmax) Determined Based on ATV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the ATV PK parameter Tmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Tmax defines time to maximum concentration since dose is initiated. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionhour (Median)
Tmax day 0Tmax day 21
NuvaRing With ATV/r Plus TDF ≥1 NRTIs2.93.0

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EFV PK Parameter Area Under the Concentration-Time Curve (AUC0-24hours) Calculated Based on Intensive EFV PK Samples Obtained From Individual Participants Enrolled in Arm B

This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of EFV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionh*ng/mL (Median)
AUC0-24h day 0AUC0-24h day 21
NuvaRing With EFV Plus ≥2 NRTIs68949.157795.9

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EFV PK Parameter Clearance (CLss/F) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B

This evaluates the effect of NuvaRing on the EFV PK parameter CLss/F obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/F defines apparent oral clearance (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

InterventionL/h (Median)
CLss/F day 0CLss/F day 21
NuvaRing With EFV Plus ≥2 NRTIs8.710.4

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EFV PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B

This evaluates the effect of NuvaRing on the EFV PK parameter Cmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionng/mL (Median)
Cmax day 0Cmax day 21
NuvaRing With EFV Plus ≥2 NRTIs4541.03786.0

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EFV PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B

This evaluates the effect of NuvaRing on the EFV PK parameter Cmin obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionng/mL (Median)
Cmin day 0Cmin day 21
NuvaRing With EFV Plus ≥2 NRTIs2121.51766.0

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Ethinyl Estradiol Concentrations Obtained on Study Days 7 and 14.

This evaluates the effect of EFV and ATV/r on ethinyl estradiol by measuring ethinyl estradiol concentrations on all three study arms 7 and 14 days after NuvaRing administration. The assay lower limit of quantification for ethinyl estradiol was 5 pg/mL; values < 5 were assigned a value of half the lower limit (ie, 2.5 pg/mL). (NCT01903031)
Timeframe: Study days 7 and 14

,,
Interventionpg/mL (Median)
Concentration at Day 7Concentration at Day 14
NuvaRing and no ART18.0519.70
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs15.7016.55
NuvaRing With EFV Plus ≥2 NRTIs9.9810.50

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Etonogestrel Concentrations Obtained on Study Days 7 and 14

This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 7 and 14 days after NuvaRing administration. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values < 250 were assigned a value of half the lower limit (ie, 125 pg/mL). (NCT01903031)
Timeframe: Study days 7 and 14

,,
Interventionpg/mL (Median)
Concentration at Day 7Concentration at Day 14
NuvaRing and no ART1970.002070.00
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs3250.003530.00
NuvaRing With EFV Plus ≥2 NRTIs427.00437.00

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Proportion of Participants With Plasma HIV-1 RNA Levels <40 Copies/mL

This evaluates the short-term impact of Nuvaring on virologic suppression in participants who have been administered Nuvaring alone or together with EFV or ATV/r by measuring proportion of participants with plasma HIV-1 RNA levels <40 copies/mL at study day 0 (before vaginal ring placement) and study day 21 (three weeks after vaginal ring placement). An FDA-approved HIV-1 RNA assay was required. (NCT01903031)
Timeframe: Study day 0 and study day 21

,,
Interventionproportion of participants (Number)
Proportion with HIV-1 RNA <40 copies/mL at day 0Proportion with HIV-1 RNA <40 copies/mL at day 21
NuvaRing and no ART0.220.17
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs0.890.85
NuvaRing With EFV Plus ≥2 NRTIs0.930.85

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups

Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA [BPHR], Baseline CD4+ cell count [BCCC], Baseline Centers for Disease Control and Prevention [CDC] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Age, <50 Years, n=212, 212Age, >=50 Years, n=36, 35Race, White, n=115, 107Race, Non-White, n=133,140Race, African-American/African Heritage, n=102,108Non-African-American/African Heritage, n=146, 139BPHR, <1000, n=5, 10BPHR, 1000 to <10,000, n=66, 62BPHR, 10,000 to <50,000, n=83, 81BPHR, 50,000 to <=100,000, n=25, 28BPHR, >100,000, n=69, 66BCCC, <200, n=64, 49BCCC, >=200, n=184, 198BCCC, <50, n=9, 15BCCC, 50 to <200, n=55, 34BCCC, 200 to <350, n=66, 74BCCC, 350 to <500, n=56, 65BCCC, >=500, n=62, 59CDC category, A, n=210, 208CDC category, B, n=27, 30CDC category, C, n=11, 9HIV-1 subtype: B vs Non-B, B, n=95, 111HIV-1 subtype: B vs Non-B, non-B, n=140, 131Argentina, n=24, 20Canada, n=11, 9France, n=7, 8Italy, n=17, 11Mexico, n=6, 5Portugal, n=4, 5Russia, n=28, 22South Africa, n=33, 33Spain, n=23, 31Thailand, n=19, 21USA, n=62, 69United Kingdom, n=14, 11
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase809286787488608384808081826784897977818191808492911008810075896770957493

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <50 c/mL were reported. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 96 and Week 432

InterventionPercentage of participants (Number)
Week 96, n=99Week 432, n=3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase100100

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Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase

Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL were assessed at Baseline, Weeks 4, 12, 24 , 36 and 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Percentage values are rounded off. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionPercentage of participants (Number)
HIV-1 RNA <50 c/mL, Baseline (Day 1)HIV-1 RNA <50 c/mL, Week 4HIV-1 RNA <50 c/mL, Week 12HIV-1 RNA <50 c/mL, Week 24HIV-1 RNA <50 c/mL, Week 36HIV-1 RNA <50 c/mL, Week 48HIV-1 RNA <400 c/mL, Baseline (Day 1)HIV-1 RNA <400 c/mL, Week 4HIV-1 RNA <400 c/mL, Week 12HIV-1 RNA <400 c/mL, Week 24HIV-1 RNA <400 c/mL, Week 36HIV-1 RNA <400 c/mL, Week 48
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0134977777115484828176
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0648185858219091888683

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Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)

Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met. (NCT01910402)
Timeframe: Up to week 432

InterventionParticipants (Count of Participants)
INSTI; n= 6NNRTI; n=8NRTI; n=8PI; n=8
DTG 50 mg/ABC 600 mg/3TC 300 mg QD0110

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Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase)

Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met. (NCT01910402)
Timeframe: Up to week 48

InterventionParticipants (Count of Participants)
INSTI; n= 3NNRTI; n=4NRTI; n=4PI; n=4
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD-Randomized Phase1010

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Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase

Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. (NCT01910402)
Timeframe: Up to week 48

,
InterventionParticipants (Count of Participants)
CDC Class A to CDC Class CCDC Class B to CDC Class CCDC Class C to new CDC Class CCDC Class A, B or C to Death
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase4201
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase5101

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Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)

Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. (NCT01910402)
Timeframe: Up to week 432

InterventionParticipants (Count of Participants)
CDC Class A to CDC Class CCDC Class B to CDC Class CCDC Class C to new CDC Class CCDC Class A, B or C to Death
DTG 50 mg/ABC 600 mg/3TC 300 mg QD6102

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Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase

Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and end of Randomized Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets. (NCT01910402)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
Hemoglobin, Grade 1Hemoglobin, Grade 2Hemoglobin, Grade 3Hemoglobin, Grade 4Leukocytes, Grade 1Leukocytes, Grade 2Leukocytes, Grade 3Leukocytes, Grade 4Neutrophils, Grade 1Neutrophils, Grade 2Neutrophils, Grade 3Neutrophils, Grade 4Platelets, Grade 1Platelets, Grade 2Platelets, Grade 3Platelets, Grade 4
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase213106200129211200
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase72105100157016010

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups

Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA [BPHR], Baseline CD4+ cell count [BCCC], Baseline Centers for Disease Control and Prevention [CDC] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Age, <50 Years, n=212, 212Age, >=50 Years, n=36, 35Race, White, n=115, 107Race, Non-White, n=133,140Race, African-American/African Heritage, n=102,108Non-African-American/African Heritage, n=146, 139BPHR, <1000, n=5, 10BPHR, 1000 to <10,000, n=66, 62BPHR, 10,000 to <50,000, n=83, 81BPHR, 50,000 to <=100,000, n=25, 28BPHR, >100,000, n=69, 66BCCC, <200, n=64, 49BCCC, >=200, n=184, 198BCCC, <50, n=9, 15BCCC, 50 to <200, n=55, 34BCCC, 200 to <350, n=66, 74BCCC, 350 to <500, n=56, 65BCCC, >=500, n=62, 59CDC category, A, n=210, 208CDC category, B, n=27, 30CDC category, C, n=11, 9HIV-1 subtype: B vs Non-B, B, n=95, 111HIV-1 subtype: B vs Non-B, non-B, n=140, 131Argentina, n=24, 20Canada, n=11, 9France, n=7, 8Italy, n=17, 11Mexico, n=6, 5Portugal, n=4, 5Puerto Rico, n=0, 2Russia, n=28, 22South Africa, n=33, 33Spain, n=23, 31Thailand, n=19, 21USA, n=62, 69United Kingdom, n=14, 11
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase7174806467758077746464697260747374687177566973808975646060100827677526764

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Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points

Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

InterventionMillimoles per liter (Mean)
Carbon Dioxide, Week 4, n= 244, 237Carbon Dioxide, Week 12, n= 236, 226Carbon Dioxide, Week 24, n= 224, 212Carbon Dioxide, Week 36, n= 219, 204Carbon Dioxide, Week 48, n= 208, 192Chloride, Week 4, n= 245, 237Chloride, Week 12, n= 236, 226Chloride, Week 24, n= 225, 212Chloride, Week 36, n= 219, 204Chloride, Week 48, n= 208, 192CHLS, Week 4, n= 1, 3CHLS, Week 12, n= 224, 221CHLS, Week 24, n= 218, 201CHLS, Week 36, n= 205, 191CHLS, Week 48, n= 195, 175Glucose, Week 12, n= 226, 224Glucose, Week 24, n= 219, 204Glucose, Week 36, n= 211, 196Glucose, Week 48, n= 197, 180HDL CHLS, Direct, Week 4, n= 1, 3HDL CHLS, Direct, Week 12, n= 224, 221HDL CHLS, Direct, Week 24, n= 218, 201HDL CHLS, Direct, Week 36, n= 205, 191HDL CHLS, Direct, Week 48, n= 195, 175Hyperglycaemia, Week 12, n= 226, 224Hyperglycaemia, Week 24, n= 219, 204Hyperglycaemia, Week 36, n= 211, 196Hyperglycaemia, Week 48, n= 197, 180Hyperkalemia, Week 4, n= 244, 237Hyperkalemia, Week 12, n= 236, 226Hyperkalemia, Week 24, n= 224, 212Hyperkalemia, Week 36, n= 219, 204Hyperkalemia, Week 48, n= 208, 192Hypernatremia, Week 4, n= 245, 237Hypernatremia, Week 12, n= 236, 226Hypernatremia, Week 24, n= 225, 212Hypernatremia, Week 36, n= 219, 204Hypernatremia, Week 48, n= 208, 192Hypoglycaemia, Week 12, n= 226, 224Hypoglycaemia, Week 24, n= 219, 204Hypoglycaemia, Week 36, n= 211, 196Hypoglycaemia, Week 48, n= 197, 180Hypokalemia, Week 4, n= 244, 237Hypokalemia, Week 12, n= 236, 226Hypokalemia, Week 24, n= 224, 212Hypokalemia, Week 36, n= 219, 204Hypokalemia, Week 48, n= 208, 192Hyponatremia, Week 4, n= 245, 237Hyponatremia, Week 12, n= 236, 226Hyponatremia, Week 24, n= 225, 212Hyponatremia, Week 36, n= 219, 204Hyponatremia, Week 48, n= 208, 192LDL CHLS Calculation, Week 4, n= 1, 3LDL CHLS Calculation, Week 12, n= 221, 219LDL CHLS Calculation, Week 24, n= 213, 201LDL CHLS Calculation, Week 36, n= 201, 188LDL CHLS Calculation, Week 48, n= 190, 175LDL CHLS, Direct, Week 12, n= 0, 1Phosphate, Week 4, n= 245, 237Phosphate, Week 12, n= 236, 226Phosphate, Week 24, n= 225, 212Phosphate, Week 36, n= 219, 204Phosphate, Week 48, n= 208, 192Potassium, Week 4, n= 244, 237Potassium, Week 12, n= 236, 226Potassium, Week 24, n= 224, 212Potassium, Week 36, n= 219, 204Potassium, Week 48, n= 208, 192Sodium, Week 4, n= 245, 237Sodium, Week 12, n= 236, 226Sodium, Week 24, n= 225, 212Sodium, Week 36, n= 219, 204Sodium, Week 48, n= 208, 192Triglycerides, Week 4, n= 1, 3Triglycerides, Week 12, n= 224, 221Triglycerides, Week 24, n= 218, 201Triglycerides, Week 36, n= 205, 191Triglycerides, Week 48, n= 195, 175Urea, Week 4, n= 245, 237Urea, Week 12, n= 236, 226Urea, Week 24, n= 225, 212Urea, Week 36, n= 219, 204Urea, Week 48, n= 208, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.60.80.30.60.4-0.50.2-0.100-0.017-0.058-0.00100.1090.220.260.340.2400.0050.0530.0360.0810.220.260.340.240.120.10.060.130.04-0.50.10.20.20.50.220.260.340.240.120.10.060.130.04-0.50.10.20.20.5-0.123-0.14-0.111-0.099-0.021-0.44-0.0320.0260.0260.00900.120.10.060.130.04-0.50.10.20.20.50.2370.1670.1250.1570.1070.10.160.12-0.030.02

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Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints

Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Weeks 24 and 48

,
InterventionMicrograms per liter (Mean)
BSAP, Week 24, n=219, 207BSAP, Week 48, n=202, 184Osteocalcin, Week 24, n=209, 197Osteocalcin, Week 48, n=194, 178PTP, Week 24, n=223, 206PTP, Week 48, n=205, 186
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase6.007.6014.3816.3032.034.1
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase1.332.643.735.1510.111.2

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Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints

Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionMicromoles per liter (Mean)
Bilirubin, Week 4, n= 244, 237Bilirubin, Week 12, n= 236, 226Bilirubin, Week 24, n= 225, 212Bilirubin, Week 36, n= 219, 204Bilirubin, Week 48, n= 208, 192Creatinine, Week 4, n= 245, 237Creatinine, Week 12, n= 236, 226Creatinine, Week 24, n= 225, 212Creatinine, Week 36, n= 219, 204Creatinine, Week 48, n= 208, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase27.222.82523.823.74.895.835.85.375.86
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-0.8-0.6-0.2-0.2-0.38.49.29.1610.089.29

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Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points

Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
Intervention10^9 cells per liter (Mean)
Basophils, Week 4, n= 241, 234Basophils, Week 12, n= 228, 216Basophils, Week 24, n= 221, 208Basophils, Week 36, n= 214, 203Basophils, Week 48, n= 206, 189Eosinophils, Week 4, n= 241, 234Eosinophils, Week 12, n= 228, 216Eosinophils, Week 24, n= 221, 208Eosinophils, Week 36, n= 214, 203Eosinophils, Week 48, n= 206, 189Lymphocytes, Week 4, n= 241, 234Lymphocytes, Week 12, n= 228, 216Lymphocytes, Week 24, n= 221, 208Lymphocytes, Week 36, n= 214, 203Lymphocytes, Week 48, n= 206, 189Monocytes, Week 4, n= 241, 234Monocytes, Week 12, n= 228, 216Monocytes, Week 24, n= 221, 208Monocytes, Week 36, n= 214, 203Monocytes, Week 48, n= 206, 189
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.0030.0030.0030.0030.0060.021-0.0010.0050.0140.0070.1190.1560.1920.1780.261-0.015-0.031-0.015-0.028-0.024
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.0030.0020.0040.0040.0050.0400.0370.0280.0480.0300.2080.2570.3170.3620.359-0.001-0.0100.008-0.0060.001

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Change From Baseline in Albumin at Indicated Timepoints

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionGrams per liter (Mean)
Week 4, n= 245, 237Week 12, n= 236, 226Week 24, n= 225, 212Week 36, n= 219, 204Week 48, n= 208, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-0.50.10.80.61.3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.10.51.41.41.7

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Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase

Absolute values in CD4+ cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionCells per cubic millimeter (Mean)
Baseline (Day 1), n=248, 247Week 4, n=245, 237Week 12, n=236, 224Week 24, n=226, 210Week 36, n=219, 204Week 48, n=208, 191
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase380.3455.1506.2542.5569.2608.5
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase369.7465.0509.5563.8592.8608.8

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Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase

Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. (NCT01910402)
Timeframe: Week 96 and Week 432

InterventionLog10 copies/mL (Mean)
Week 96, n=99Week 432, n=3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase1.5911.590

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Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase

Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionLog10 copies/mL (Mean)
Baseline (Day 1), n=248, 247Week 4, n=245, 238Week 12, n=236, 226Week 24, n=225, 212Week 36, n=221, 204Week 48, n=207, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase4.4412.5161.9081.7101.6581.657
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase4.4811.8951.7481.7241.6661.619

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Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionInternational units per liter (Mean)
Alanine aminotransferase, Week 4, n= 245, 237Alanine aminotransferase, Week 12, n= 236, 226Alanine aminotransferase, Week 24, n= 225, 212Alanine aminotransferase, Week 36, n= 219, 204Alanine aminotransferase, Week 48, n= 208, 192Alkaline phosphatase, Week 4, n= 245, 237Alkaline phosphatase, Week 12, n= 236, 226Alkaline phosphatase, Week 24, n= 225, 212Alkaline phosphatase, Week 36, n= 219, 204Alkaline phosphatase, Week 48, n= 208, 192Aspartate aminotransferase, Week 4, n= 244, 237Aspartate aminotransferase, Week 12, n= 236, 226Aspartate aminotransferase, Week 24, n= 224, 212Aspartate aminotransferase, Week 36, n= 219, 204Aspartate aminotransferase, Week 48, n= 208, 192Creatine Kinase, Week 4, n= 245, 237Creatine Kinase, Week 12, n= 236, 226Creatine Kinase, Week 24, n= 225, 212Creatine Kinase, Week 36, n= 219, 204Creatine Kinase, Week 48, n= 208, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-3.4-2.3-3.7-5.3-1.59.415.122.420.421.9-3.6-4-5.1-6.5-3.735.67.35.87.23.8
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-3.3-5.2-5.4-4.9-5.7-1.5-2.10.50.62.9-3.3-6.2-6.3-6.4-7.5-0.36.910.311.923.8

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Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase

Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 96, Week 432

InterventionCells per cubic millimeter (Mean)
Week 96, n=99Week 432, n=3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase286.5254.7

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Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline

Bone markers were assessed at indicated timepoints. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analyzed based on log transformed data. Estimates of adjusted mean and difference were calculated from an Analysis of covariance (ANCOVA) model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48

,
InterventionRatio (Number)
BSAP, n=202, 183PTP, n=202, 184Osteocalcin, n=194, 178Type 1 Collagen C-Telopeptide, n=202, 184Vitamin D, n=206, 186
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase1.6291.7522.0391.9181.158
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase1.1881.2141.2821.2570.987

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Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS

The 12-Item Short Form Health Survey (SF-12) is 12 item abbreviated form of SF-36 survey. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health. SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. SF-12 total score ranges from 20 to 60 and higher score indicate a higher level of functioning. SF-12 total score was calculated by a clinician scoring 12-question survey filled by participants. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48

,
InterventionScore on a scale (Mean)
Total Score, Week 48, n=205, 192MCS, Week 48, n=205, 192PCS, Week 48, n=205, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.12.3291.444
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.02.3971.905

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Change From Baseline in TC/HDL Ratio at Week 48

Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48

InterventionRatio (Least Squares Mean)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-0.264
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-0.158

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Change From Baseline in Triglycerides at Week 48

Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48

InterventionMillimoles per liter (Least Squares Mean)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.045
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.070

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Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase4

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Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. (NCT01910402)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase10
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase17

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48

Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells per millimeter cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48

InterventionPercentage of participants (Number)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase82
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase71

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Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase

Absolute values in CD4+ cell count were assessed at indicated time points. (NCT01910402)
Timeframe: Week 96 and Week 432

InterventionCells per cubic millimeter (Mean)
Week 96, n=99Week 432, n=3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase635.3553.0

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Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase

Change from Baseline in cluster of differentiation 4 (CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionCells per cubic millimeter (Mean)
Week 4, n=245, 237Week 12, n=236, 224Week 24, n=226, 210Week 36, n=219, 204Week 48, n=208, 191
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase73.7124.4163.0191.4230.7
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase94.9143.8200.6230.7248.8

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Number of Participants With AEs by Maximum Toxicity-Continuation Phase

Number of participants with Grade 1-4 AEs were assessed in Continuation Phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
Grade 1Grade 2Grade 3Grade 4
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase324876

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Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points

Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

InterventionMillimoles per liter (Mean)
Carbon Dioxide, Week 4, n= 244, 237Carbon Dioxide, Week 12, n= 236, 226Carbon Dioxide, Week 24, n= 224, 212Carbon Dioxide, Week 36, n= 219, 204Carbon Dioxide, Week 48, n= 208, 192Chloride, Week 4, n= 245, 237Chloride, Week 12, n= 236, 226Chloride, Week 24, n= 225, 212Chloride, Week 36, n= 219, 204Chloride, Week 48, n= 208, 192CHLS, Week 4, n= 1, 3CHLS, Week 12, n= 224, 221CHLS, Week 24, n= 218, 201CHLS, Week 36, n= 205, 191CHLS, Week 48, n= 195, 175Glucose, Week 12, n= 226, 224Glucose, Week 24, n= 219, 204Glucose, Week 36, n= 211, 196Glucose, Week 48, n= 197, 180HDL CHLS, Direct, Week 4, n= 1, 3HDL CHLS, Direct, Week 12, n= 224, 221HDL CHLS, Direct, Week 24, n= 218, 201HDL CHLS, Direct, Week 36, n= 205, 191HDL CHLS, Direct, Week 48, n= 195, 175Hyperglycaemia, Week 12, n= 226, 224Hyperglycaemia, Week 24, n= 219, 204Hyperglycaemia, Week 36, n= 211, 196Hyperglycaemia, Week 48, n= 197, 180Hyperkalemia, Week 4, n= 244, 237Hyperkalemia, Week 12, n= 236, 226Hyperkalemia, Week 24, n= 224, 212Hyperkalemia, Week 36, n= 219, 204Hyperkalemia, Week 48, n= 208, 192Hypernatremia, Week 4, n= 245, 237Hypernatremia, Week 12, n= 236, 226Hypernatremia, Week 24, n= 225, 212Hypernatremia, Week 36, n= 219, 204Hypernatremia, Week 48, n= 208, 192Hypoglycaemia, Week 12, n= 226, 224Hypoglycaemia, Week 24, n= 219, 204Hypoglycaemia, Week 36, n= 211, 196Hypoglycaemia, Week 48, n= 197, 180Hypokalemia, Week 4, n= 244, 237Hypokalemia, Week 12, n= 236, 226Hypokalemia, Week 24, n= 224, 212Hypokalemia, Week 36, n= 219, 204Hypokalemia, Week 48, n= 208, 192Hyponatremia, Week 4, n= 245, 237Hyponatremia, Week 12, n= 236, 226Hyponatremia, Week 24, n= 225, 212Hyponatremia, Week 36, n= 219, 204Hyponatremia, Week 48, n= 208, 192LDL CHLS Calculation, Week 4, n= 1, 3LDL CHLS Calculation, Week 12, n= 221, 219LDL CHLS Calculation, Week 24, n= 213, 201LDL CHLS Calculation, Week 36, n= 201, 188LDL CHLS Calculation, Week 48, n= 190, 175LDL CHLS, Direct, Week 24, n= 1, 0LDL CHLS, Direct, Week 36, n= 1, 0Phosphate, Week 4, n= 245, 237Phosphate, Week 12, n= 236, 226Phosphate, Week 24, n= 225, 212Phosphate, Week 36, n= 219, 204Phosphate, Week 48, n= 208, 192Potassium, Week 4, n= 244, 237Potassium, Week 12, n= 236, 226Potassium, Week 24, n= 224, 212Potassium, Week 36, n= 219, 204Potassium, Week 48, n= 208, 192Sodium, Week 4, n= 245, 237Sodium, Week 12, n= 236, 226Sodium, Week 24, n= 225, 212Sodium, Week 36, n= 219, 204Sodium, Week 48, n= 208, 192Triglycerides, Week 4, n= 1, 3Triglycerides, Week 12, n= 224, 221Triglycerides, Week 24, n= 218, 201Triglycerides, Week 36, n= 205, 191Triglycerides, Week 48, n= 195, 175Urea, Week 4, n= 245, 237Urea, Week 12, n= 236, 226Urea, Week 24, n= 225, 212Urea, Week 36, n= 219, 204Urea, Week 48, n= 208, 192
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-0.4-0.2-0.50-0.60.610.70.90.7-0.10.2980.3170.330.4470.30.170.170.18-0.10.1820.2010.2040.2310.30.170.170.18-0.010.03-0.040.03-0.0400.70.60.90.60.30.170.170.18-0.010.03-0.040.03-0.0400.70.60.90.60.080.1250.1110.1120.213-0.64-0.2300.020.0210.0290.016-0.010.03-0.040.03-0.0400.70.60.90.6-0.18-0.040.0360.0370.018-0.040.080.030.080.1

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Change From Baseline in Creatinine Clearance at Indicated Time Points

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionMilliliter per minute (Mean)
Week 4, n= 245, 237Week 12, n= 236, 226Week 24, n= 225, 212Week 36, n= 219, 204Week 48, n= 208, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-7.5-7-9.1-7.5-7.7
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-16.3-17.3-16.2-16.8-15.9

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Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points

Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionFemtoliter (Mean)
Week 4, n= 243, 234Week 12, n= 233, 220Week 24, n= 225, 211Week 36, n= 218, 203Week 48, n= 207, 190
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.51.93.13.13.7
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.93.45.56.07.1

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Change From Baseline in Erythrocytes at Indicated Time Points

Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
Intervention10^12 cells per liter (Mean)
Week 4, n= 243, 234Week 12, n= 233, 220Week 24, n= 225, 211Week 36, n= 218, 203Week 48, n= 207, 190
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-0.07-0.09-0.09-0.08-0.05
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-0.04-0.07-0.08-0.10-0.10

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Change From Baseline in Hematocrit Count at Indicated Time Points

Hematology parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionProportion of red blood cells in blood (Mean)
Week 4, n= 243, 234Week 12, n= 233, 220Week 24, n= 225, 211Week 36, n= 218, 203Week 48, n= 207, 190
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-0.00420.00000.00510.00620.0107
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.00030.00810.01570.01670.0212

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Change From Baseline in Lipase at Indicated Timepoints

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionUnits per liter (Mean)
Week 4, n= 245, 237Week 12, n= 236, 226Week 24, n= 225, 212Week 36, n= 219, 204Week 48, n= 208, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-1.3-2.1-6-6.3-7.8
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-1.2-2.2-6-6.3-6.5

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Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase

Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 96 and Week 432

InterventionLog10 copies/mL (Mean)
Week 96, n=99Week 432, n=3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase-2.911-3.107

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Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase

Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionLog10 copies/mL (Mean)
Week 4, n=245, 238Week 12, n=236, 226Week 24, n=225, 212Week 36, n=221, 204Week 48, n=207, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-1.923-2.541-2.726-2.772-2.752
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-2.591-2.756-2.789-2.838-2.874

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Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionRatio (Mean)
Week 4, n= 1, 4Week 12, n= 233, 223Week 24, n= 224, 209Week 36, n= 212, 198Week 48, n= 207, 186
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.2159-0.1092-0.1922-0.1433-0.1444
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.1264-0.2736-0.3098-0.3286-0.2886

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Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints

Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Weeks 24 and 48

,
InterventionNanograms per liter (Mean)
Week 24, n=221, 207Week 48, n=202, 185
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase272.4267.9
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase89.875.9

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Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points

Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 24 and Week 48

,
Interventionmilligrams per millimole (Mean)
Week 24, n= 179, 186Week 48, n= 170, 164
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-1.03-0.10
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-1.15-0.68

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Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48

Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D, vitamin D2 and vitamin D3 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Weeks 24 and 48

,
InterventionNanomoles per liter (Mean)
Vitamin D, Week 24, n=223, 208Vitamin D, Week 48, n=206, 186Vitamin D2, Week 24, n=223, 208Vitamin D2, Week 48, n=206, 186Vitamin D3, Week 24, n=223, 208Vitamin D3, Week 48, n=206, 186
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase16.38.91.00.915.27.9
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase1.8-1.90.30.11.5-1.9

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HIVTSQs Total Score at Indicated Timepoints

The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. (NCT01910402)
Timeframe: Weeks 4, 12, 24 and 48

,
InterventionScore on a scale (Mean)
Week 4, n=243, 239Week 12, n=236, 226Week 24, n=225, 211Week 48, n=206, 191
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase51.953.654.355.4
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase54.056.156.857.0

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Number of Participants With AEs by Maximum Toxicity-Randomized Phase

Number of participants with Grade 1-4 AEs by maximum toxicity were assessed from the start of study treatment and until end of the Randomization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. (NCT01910402)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
Grade 1Grade 2Grade 3Grade 4
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase6091379
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase7994183

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Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented. (NCT01910402)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
Any AEsAny SAEs
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase19720
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase19512

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Number of Participants With Any AEs, and SAEs in Continuation Phase

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
Any AEsAny SAEs
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase9313

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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase

Number of participants with grades 1-4 emergent chemistry toxicities were assessed in Continuation Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
Hyperglycaemia, Grade 1, n=143Hyperglycaemia, Grade 2, n=143Hyperglycaemia, Grade 3, n=143Hyperglycaemia, Grade 4, n=143Hypernatremia, Grade 1, n=146Hypernatremia, Grade 2, n=146Hypernatremia, Grade 3, n=146Hypernatremia, Grade 4, n=146Hypoglycaemia, Grade 1, n=143Hypoglycaemia, Grade 2, n=143Hypoglycaemia, Grade 3, n=143Hypoglycaemia, Grade 4, n=143Hypokalemia, Grade 1, n=146Hypokalemia, Grade 2, n=146Hypokalemia, Grade 3, n=146Hypokalemia, Grade 4, n=146Hyponatremia, Grade 1, n=146Hyponatremia, Grade 2, n=146Hyponatremia, Grade 3, n=146Hyponatremia, Grade 4, n=146Alanine aminotransferase, Grade 1, n=146Alanine aminotransferase, Grade 2, n=146Alanine aminotransferase, Grade 3, n=146Alanine aminotransferase, Grade 4, n=146Alkaline phosphatase, Grade 1, n=146Alkaline phosphatase, Grade 2, n=146Alkaline phosphatase, Grade 3, n=146Alkaline phosphatase, Grade 4, n=146Aspartate aminotransferase, Grade 1, n=146Aspartate aminotransferase, Grade 2, n=146Aspartate aminotransferase, Grade 3, n=146Aspartate aminotransferase, Grade 4, n=146Bilirubin, Grade 1, n=146Bilirubin, Grade 2, n=146Bilirubin, Grade 3, n=146Bilirubin, Grade 4, n=146Carbon dioxide, Grade 1, n=146Carbon dioxide, Grade 2, n=146Carbon dioxide, Grade 3, n=146Carbon dioxide, Grade 4, n=146Cholesterol, Grade 1, n=71Cholesterol, Grade 2, n=71Cholesterol, Grade 3, n=71Cholesterol, Grade 4, n=71Creatine kinase, Grade 1, n=146Creatine kinase, Grade 2, n=146Creatine kinase, Grade 3, n=146Creatine kinase, Grade 4, n=146Creatinine, Grade 1, n=146Creatinine, Grade 2, n=146Creatinine, Grade 3, n=146Creatinine, Grade 4, n=146LDL cholesterol calculation, Grade 1, n=70LDL cholesterol calculation, Grade 2, n=70LDL cholesterol calculation, Grade 3, n=70LDL cholesterol calculation, Grade 4, n=70LDL cholesterol direct, Grade 1, n=2LDL cholesterol direct, Grade 2, n=2LDL cholesterol direct, Grade 3, n=2LDL cholesterol direct, Grade 4, n=2Lipase, Grade 1, n=146Lipase, Grade 2, n=146Lipase, Grade 3, n=146Lipase, Grade 4, n=146Phosphate, Grade 1, n=146Phosphate, Grade 2, n=146Phosphate, Grade 3, n=146Phosphate, Grade 4, n=146Potassium, Grade 1, n=146Potassium, Grade 2, n=146Potassium, Grade 3, n=146Potassium, Grade 4, n=146Sodium, Grade 1, n=146Sodium, Grade 2, n=146Sodium, Grade 3, n=146Sodium, Grade 4, n=146Triglycerides, Grade 1, n=71Triglycerides, Grade 2, n=71Triglycerides, Grade 3, n=71Triglycerides, Grade 4, n=71Glucose, Grade 1, n=143Glucose, Grade 2, n=143Glucose, Grade 3, n=143Glucose, Grade 4, n=143
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase249302000100113000360007302500010202413058700993061115001582010009611215201300037000010024931

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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase

Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and end of Randomized Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hyperkalemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose. (NCT01910402)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
Hyperglycaemia, Grade 1Hyperglycaemia, Grade 2Hyperglycaemia, Grade 3Hyperglycaemia, Grade 4Hyperkalemia, Grade 1Hyperkalemia, Grade 2Hyperkalemia, Grade 3Hyperkalemia, Grade 4Hypernatremia, Grade 1Hypernatremia, Grade 2Hypernatremia, Grade 3Hypernatremia, Grade 4Hypoglycaemia, Grade 1Hypoglycaemia, Grade 2Hypoglycaemia, Grade 3Hypoglycaemia, Grade 4Hypokalemia, Grade 1Hypokalemia, Grade 2Hypokalemia, Grade 3Hypokalemia, Grade 4Hyponatremia, Grade 1Hyponatremia, Grade 2Hyponatremia, Grade 3Hyponatremia, Grade 4Alanine aminotransferase, Grade 1Alanine aminotransferase, Grade 2Alanine aminotransferase, Grade 3Alanine aminotransferase, Grade 4Albumin, Grade 1Albumin, Grade 2Albumin, Grade 3Albumin, Grade 4Alkaline phosphatase, Grade 1Alkaline phosphatase, Grade 2Alkaline phosphatase, Grade 3Alkaline phosphatase, Grade 4Aspartate aminotransferase, Grade 1Aspartate aminotransferase, Grade 2Aspartate aminotransferase, Grade 3Aspartate aminotransferase, Grade 4Bilirubin, Grade 1Bilirubin, Grade 2Bilirubin, Grade 3Bilirubin, Grade 4Carbon dioxide, Grade 1Carbon dioxide, Grade 2Carbon dioxide, Grade 3Carbon dioxide, Grade 4Cholesterol, Grade 1Cholesterol, Grade 2Cholesterol, Grade 3Cholesterol, Grade 4Creatine kinase, Grade 1Creatine kinase, Grade 2Creatine kinase, Grade 3Creatine kinase, Grade 4Creatinine, Grade 1Creatinine, Grade 2Creatinine, Grade 3Creatinine, Grade 4LDL cholesterol calculation, Grade 1LDL cholesterol calculation, Grade 2LDL cholesterol calculation, Grade 3LDL cholesterol calculation, Grade 4LDL cholesterol direct, Grade 1LDL cholesterol direct, Grade 2LDL cholesterol direct, Grade 3LDL cholesterol direct, Grade 4Lipase, Grade 1Lipase, Grade 2Lipase, Grade 3Lipase, Grade 4Phosphate, Grade 1Phosphate, Grade 2Phosphate, Grade 3Phosphate, Grade 4Potassium, Grade 1Potassium, Grade 2Potassium, Grade 3Potassium, Grade 4Sodium, Grade 1Sodium, Grade 2Sodium, Grade 3Sodium, Grade 4Triglycerides, Grade 1Triglycerides, Grade 2Triglycerides, Grade 3Triglycerides, Grade 4Glucose, Grade 1Glucose, Grade 2Glucose, Grade 3Glucose, Grade 4
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase11930010000005100190005700074202200141007420528657554300319205101730021920100073211192019100570000200151030
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase17164110001000631017100441005611300032001241120006540052284031303010381370310012530571018100451000520221941

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Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase

Number of participants with Grade 1-4 emergent hematology toxicities were assessed in Continuation Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
Hemoglobin, Grade 1Hemoglobin, Grade 2Hemoglobin, Grade 3Hemoglobin, Grade 4Leukocytes, Grade 1Leukocytes, Grade 2Leukocytes, Grade 3Leukocytes, Grade 4Neutrophils, Grade 1Neutrophils, Grade 2Neutrophils, Grade 3Neutrophils, Grade 4Platelets, Grade 1Platelets, Grade 2Platelets, Grade 3Platelets, Grade 4
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase51002010102113100

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Neurocognitive Changes

"Assess for changes in cognitive and affective function prior to and after switching off EFV-based regimen. Indexes used to access neurocognitive changes included:~Wechsler Adult Intelligence Scale (WAIS-R) Digital Symbol Substitution Test: sensitive to brain damage, dementia, age and depressive changes. Range of 0-100, the higher the score the better the person's performance~Hamilton Rating Scale for Depression (HAMD): Measure of depression. Score of 0-7 is normal, score of >20 is moderate/severe depression~Depression Anxiety Stress Scale (DASS-21) the lower the score, the less severe depression, anxiety and stress. Scale range of 0-63~Frontal Systems Behavior Scale (FRSBE): Increased score indicates greater behavioral impairment associated with frontal systems, range 37.2 to 186~6. Spielberger state trait anxiety inventory (STAI): the higher the score the greater then anxiety level, range of 20 to 80." (NCT01929759)
Timeframe: week 0 and week 8

Interventionunits on a scale (Mean)
pre-switch WAISpost-switch WAISpre-switch FRSBEpost-switch FRSBEpre-switch HAMDpost-switch HAMDpre-switch DASS depressionpost-switch DASS depressionpre-swtich STAIpost-switch STAI
Drug Switching49.353.477.570.45.52.87.63.428.824.2

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Change in Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS)

Assess the change in levels of neuro-metabolites measured by MRS from week 0 (before switching to the efavirenz-based therapy) and then at week 8 (after completing 9 weeks of integrase-inhibitor based regimen with Stribild). Two areas of the brain: 1) posterior cingulate gyrus and 2) anterior cingulate will be assessed for the levels of brain Cr, GABA and GLU. (NCT01929759)
Timeframe: week 0 to week 8

Interventionarbitrary units (Mean)
Posterior Cingulate CreatinePosterior Cingulate GlutamatePosterior Cingulate GABAAnterior Cingulate CreatineAnterior Cingulate GlutamateAnterior Cingulate GABA
Drug Switching19.6124.546.7112.0816.163.67

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Change in Other Neurometabolite Measured by MRS Between Week 0 and Week 8

Use MRS to evaluate a fuller panel of known neurometabolites (in addition to the primary endpoints) between week 0 and week 8 to identify prominent and significant changes associated with EFV use. (NCT01929759)
Timeframe: week 0 to week 8

Interventionarbitrary units (Mean)
Posterior cingulate glutathionePosterior cingulate aspartateAnterior cingulate glutathioneAnterior cingulate aspartate
Drug Switching5.063.693.172.57

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Effect of EFV and Its Metabolites

Level of EFV (efavirenz) in Atripla and its two known metabolites known to cause cerebral side effects, 7-hydroxy (OH) EFV and 8-OH EFV, were measured in the plasma prior to switch off Atripla and after 8 weeks of RAL-based regimen (no EFV). (NCT01929759)
Timeframe: week 0 and week 8

Interventionparticipants (Number)
Number with detectable 7-OH and 8-OH (pre-switch)Number with detectable 7-OH and 8-OH (post-switch)
Drug Switching100

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Fasting Lipid Profile

Measure the change in fasting lipid panel prior to and after switching off EFV-based regimen. (NCT01929759)
Timeframe: 8 weeks

Interventionmg/dl (Mean)
pre-switch Total cholesterolpost-switch Total cholesterolpre-switch HDLpost-switch HDLpre-switch LDLpost-switch LDLpre-switch triglyceridepost-switch triglyceride
Drug Switching178.8168.552.652.3106.197.4101.394.5

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Markers of Immune Activation

Change in markers of immune activation and inflammation associated with change to Stibild: sCD14, IP-10,sCD163, IL-6) (NCT01929759)
Timeframe: week 0 and week 8

Interventionpg/ML (Mean)
pre-switch sCD14post-switch sCD14pre-switch IP-10post-switch IP-10pre-switch sCD163post-switch sCD163pre-switch MCP-1post-switch MCP-1pre-switch IL-6post-switch IL-6pre-switch TNFR1post-switch TNFR1
Drug Switching33290002879000237.3224.2732000599500102.291.391.2551.301833.2878.1

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Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)

Assess changes in neural activation correlated with affective disturbances associated with efavirenz-based therapy using fMRI employing an Emotional Word/Go-NoGo task paradigm that probes affective symptomatologies typical with EFV use, specifically anxiety/dysphoria and affective dysregulation and their association with changes in cognitive function. Four brain regions of interests (ROIs) are specified to show the differential frontal-limbic activation patterns in the task-evoked neural responses to the 3 linear contrasts of Pre-switch / Post-switch / Pre- vs. Post-switch: [Negative Word vs. Neutral Word] x [No-Go Trial Block vs. Go Trial Block]: anterior Frontal Pole (aFP), posterior Cingulate Gyrus (pCG), dorsal anterior Cingulate Gyrus (daCG), Left Hippocampus (LHC). A linear mixed-effects model is utilized to examine the effect sizes of the key Regimen/Condition contrasts, with the Subject factor as the random-effect and Age incorporated as a co-variate of no interest. (NCT01929759)
Timeframe: week 0 and week 8

Interventionz-score (Number)
PreVsPostXNegVsNeuXNoGoVsGo: aFPPreVsPostXNegVsNeuXNoGoVsGo: pCGPreVsPostXNegVsNeuXNoGoVsGo: daCGPreVsPostXNegVsNeuXNoGoVsGo:LHCPre: NegVsNeuXNoGoVsGo: aFPPre: NegVsNeuXNoGoVsGo:pCGPre: NegVsNeuXNoGoVsGo: daCGPre: NegVsNeuXNoGoVsGo: LHCPost: NegVsNeuXNoGoVsGo: aFPPost: NegVsNeuXNoGoVsGo: pCGPost: NegVsNeuXNoGoVsGo: daCGPost: NegVsNeuXNoGoVsGo: LHC
Drug Switching3.423.90-2.76-2.963.393.61-3.15-2.27-3.17-2.663.693.47

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Sleep Quality

Assess for changes in sleep pattern and quality prior to and after switching off EFV-based regimen through a self-administered Pittsburg Sleep Quality Index (PSQI). Measure consists of 19 items with each weighted on 0-3 scale and the sum produces a total score, which ranges from 0-21. The lower the score the healthier the sleep quality; minimum Score = 0 (better); maximum Score = 21 (worse). (NCT01929759)
Timeframe: week 0 and week 8

Interventionunits on a scale (Mean)
pre-switch PSQI indexpost-switch PSQI index
Drug Switching4.83.1

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Steady State Concentrations of TFV-DP for Different Dosing Patterns of Truvada

TFV-DP concentrations in DBS respective to dosing regimens of 33%, 67%, 100% of daily dosing. (NCT02022657)
Timeframe: Assessed every 2 weeks during the dosing periods and at steady-state, week 12 for the first dosing period and week 36 for the second dosing period.

Interventionfmol/punch (Mean)
DOT-DBS Dosing 33%530
DOT-DBS Dosing 67%997
DOT-DBS Dosing 100%1605

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Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

Glomerular Filtration Rate (eGFR) was estimated from the Modification of Diet in Renal Disease (MDRD)-6 equation. The MDRD-6 equation = 198 × [serum creatinine(mg/dL)]^-0.858 × [age]-0.167 × [0.822 if patient is female] × [1.178 if patient is black] × [serum urea nitrogen concentration (mg/dL)]^-0.293 × [urine urea nitrogen excretion (g/d)]^0.249. (NCT02116660)
Timeframe: Baseline and Week 48

InterventionmL/min (Mean)
Raltegravir Plus Nevirapine Plus Lamivudine-1.1
Protease Inhibitor/Ritonavir Plus Tenofovir/Emtricitabine-5.5

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Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 48

HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 48

Interventionpercentage of participants (Number)
TDF 48 Weeks0.0
TDF + GS-4774 2 YU0.0
TDF + GS-4774 10 YU4.3
TDF + GS-4774 40 YU9.5

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Mean Change in Serum HBsAg From Baseline to Week 24

The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% confidence intervals (CIs). (NCT02174276)
Timeframe: Baseline to Week 24

Interventionlog10 IU/mL (Least Squares Mean)
TDF 48 Weeks-0.079
TDF + GS-4774 2 YU-0.096
TDF + GS-4774 10 YU-0.016
TDF + GS-4774 40 YU-0.135

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Number of Participants With Drug-Resistance Mutations at Week 48 or at the Last Visit Available

Resistance surveillance analysis was conducted at Week 48 or Early Discontinuation (with at least 24 weeks of exposure to TDF) for any participants who met inclusion criteria (HBV DNA ≥ 69 IU/mL). Drug-resistant mutation status was assessed using HBV polymerase/ reverse transcriptase (pol/RT) population sequencing. (NCT02174276)
Timeframe: Baseline to Week 48

InterventionParticipants (Count of Participants)
TDF 48 Weeks0
TDF + GS-4774 2 YU0
TDF + GS-4774 10 YU0
TDF + GS-4774 40 YU0

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Percentage of Participants Experiencing Virologic Breakthrough at Week 24

Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or having had ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough. (NCT02174276)
Timeframe: Baseline to Week 24

Interventionpercentage of participants (Number)
TDF 48 Weeks0.0
TDF + GS-4774 2 YU1.8
TDF + GS-4774 10 YU1.8
TDF + GS-4774 40 YU0.0

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Percentage of Participants Experiencing Virologic Breakthrough at Week 48

Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or a ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough. (NCT02174276)
Timeframe: Baseline to Week 48

Interventionpercentage of participants (Number)
TDF 48 Weeks3.7
TDF + GS-4774 2 YU5.3
TDF + GS-4774 10 YU5.4
TDF + GS-4774 40 YU0.0

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Percentage of Participants With HBeAg Loss at Week 24

HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 24

Interventionpercentage of participants (Number)
TDF 48 Weeks0.0
TDF + GS-4774 2 YU0.0
TDF + GS-4774 10 YU4.3
TDF + GS-4774 40 YU0.0

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Percentage of Participants With HBeAg Loss at Week 48

HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 48

Interventionpercentage of participants (Number)
TDF 48 Weeks0.0
TDF + GS-4774 2 YU4.5
TDF + GS-4774 10 YU8.7
TDF + GS-4774 40 YU9.5

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Percentage of Participants With HBsAg Loss at Week 24

HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 24

Interventionpercentage of participants (Number)
TDF 48 Weeks0.0
TDF + GS-4774 2 YU0.0
TDF + GS-4774 10 YU0.0
TDF + GS-4774 40 YU0.0

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Percentage of Participants With HBsAg Loss at Week 48

HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 48

Interventionpercentage of participants (Number)
TDF 48 Weeks0.0
TDF + GS-4774 2 YU0.0
TDF + GS-4774 10 YU0.0
TDF + GS-4774 40 YU0.0

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Percentage of Participants With HBV DNA < LLOQ at Week 48

The LLOQ was defined as 20 IU/mL. (NCT02174276)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TDF 48 Weeks70.4
TDF + GS-4774 2 YU69.6
TDF + GS-4774 10 YU69.2
TDF + GS-4774 40 YU76.4

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Percentage of Participants With HBV DNA < Lower Limit of Quantification (LLOQ) at Week 24

The LLOQ was defined as 20 IU/mL. (NCT02174276)
Timeframe: Week 24

Interventionpercentage of participants (Number)
TDF 48 Weeks50.0
TDF + GS-4774 2 YU58.9
TDF + GS-4774 10 YU58.5
TDF + GS-4774 40 YU63.6

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Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 12

HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 12

,,,
Interventionpercentage of participants (Number)
≥ 0.5 and < 1.0 log10 IU/mL Decline≥ 1.0 and < 2.0 log10 IU/mL Decline≥ 2.0 log10 IU/mL Decline
TDF + GS-4774 10 YU1.80.00.0
TDF + GS-4774 2 YU3.53.50.0
TDF + GS-4774 40 YU5.50.01.8
TDF 48 Weeks3.70.00.0

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Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 48

HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 48

,,,
Interventionpercentage of participants (Number)
≥ 0.5 and < 1.0 log10 IU/mL Decline≥ 1.0 and < 2.0 log10 IU/mL Decline≥ 2.0 log10 IU/mL Decline
TDF + GS-4774 10 YU7.11.80.0
TDF + GS-4774 2 YU1.85.30.0
TDF + GS-4774 40 YU7.31.81.8
TDF 48 Weeks11.10.00.0

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Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 24

HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 24

Interventionpercentage of participants (Number)
TDF 48 Weeks0.0
TDF + GS-4774 2 YU0.0
TDF + GS-4774 10 YU4.3
TDF + GS-4774 40 YU0.0

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Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 24

HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 24

,,,
Interventionpercentage of participants (Number)
≥ 0.5 and < 1.0 log10 IU/mL Decline≥ 1.0 and < 2.0 log10 IU/mL Decline≥ 2.0 log10 IU/mL Decline
TDF + GS-4774 10 YU1.80.00.0
TDF + GS-4774 2 YU1.85.30.0
TDF + GS-4774 40 YU7.31.81.8
TDF 48 Weeks0.00.00.0

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Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24

HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 24

Interventionpercentage of participants (Number)
TDF 48 Weeks0.0
TDF + GS-4774 2 YU0.0
TDF + GS-4774 10 YU0.0
TDF + GS-4774 40 YU0.0

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Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48

HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 48

Interventionpercentage of participants (Number)
TDF 48 Weeks0.0
TDF + GS-4774 2 YU0.0
TDF + GS-4774 10 YU0.0
TDF + GS-4774 40 YU0.0

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Mean Change in HBsAg From Baseline to Week 12

The change from baseline to Week 12 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs. (NCT02174276)
Timeframe: Baseline to Week 12

Interventionlog10 IU/mL (Least Squares Mean)
TDF 48 Weeks-0.060
TDF + GS-4774 2 YU-0.061
TDF + GS-4774 10 YU-0.012
TDF + GS-4774 40 YU-0.095

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Mean Change in HBsAg From Baseline to Week 48

The change from baseline to Week 48 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs. (NCT02174276)
Timeframe: Baseline to Week 48

Interventionlog10 IU/mL (Least Squares Mean)
TDF 48 Weeks-0.145
TDF + GS-4774 2 YU-0.136
TDF + GS-4774 10 YU-0.086
TDF + GS-4774 40 YU-0.165

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Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events

(NCT02180438)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Open Label Prospective Single Arm Study of Stribild0

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Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)

(NCT02180438)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
>50 copies/mL>400 copies/mL
Open Label Prospective Single Arm Study of Stribild10

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Interim 24 Weeks Analysis of Death

(NCT02180438)
Timeframe: 24 weeks

Interventionparticipants (Number)
Open Label Prospective Single Arm Study of Stribild0

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Grade 3 or 4 Adverse Events

Adverse event per NIH/DAIDS criteria (NCT02180438)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Lab: Grade 3 or 4Clinical: Grade 3 or 4
Open Label Prospective Single Arm Study of Stribild71

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Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF

(NCT02180438)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Open Label Prospective Single Arm Study of Stribild1

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< 50 CD4 T-cell Increase at 48 Weeks From Baseline

(NCT02180438)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Open Label Prospective Single Arm Study of Stribild2

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CD4 T-cell Count at 48 Weeks < Baseline

(NCT02180438)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Open Label Prospective Single Arm Study of Stribild0

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Death

Number of Participants Experiencing Death within the study period (NCT02180438)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Open Label Prospective Single Arm Study of Stribild0

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Switching Off Stribild Prior to 48 Weeks

(NCT02180438)
Timeframe: 48 Weeks

InterventionParticipants (Count of Participants)
Open Label Prospective Single Arm Study of Stribild0

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New WHO Stage 3 or 4 Event

New AIDS defining event per WHO criteria (NCT02180438)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Open Label Prospective Single Arm Study of Stribild0

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Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event

(NCT02180438)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Open Label Prospective Single Arm Study of Stribild0

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Interim Analysis at 24 Weeks of HIV-2 Virologic Failure

Virologic failure, FDA Snapshot (HIV-2 plasma viral load >50 and >400 copies/ml) (NCT02180438)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Open Label Prospective Single Arm Study of Stribild0

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Change From Baseline in Hemoglobin (Hb)

Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144

InterventionGrams per liter (Mean)
Week 24, n=208Week 48, n=208Week 72, n=207Week 96, n=207Week 120, n=204Week 144, n=204
Tenofovir Disoproxil Fumerate 300 mg2.4-0.2-0.2-1.0-1.0-0.2

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Percentage of Participants With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48 and 96

HBV DNA level were analyzed using the sensitive HBV test in central laboratory using Roche cobas Taqman HBV test from the blood samples collected at Weeks 48 and 96. Virological response was assessed by proportion of participants with serum serum HBV <20 IU/mL and <69 IU/mL at Weeks 48 and 96. Percentage of participants with serum HBV DNA <20 IU/mL and <69 IU/mL at Weeks 48 and 96 have been presented. (NCT02195518)
Timeframe: At Weeks 48 and 96

InterventionPercentage of Participants (Number)
Week 48, HBV DNA <20 IU/mLWeek 48, HBV DNA <69 IU/mLWeek 96, HBV DNA <20 IU/mLWeek 96, HBV DNA <69 IU/mL
Tenofovir Disoproxil Fumerate 300 mg46.976.561.084.0

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Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, and 144 in Participants Who Had Abnormal ALT at Baseline

Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. Normal range for ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, and 144 in Participants who had abnormal ALT at Baseline (Day 0) have been presented. (NCT02195518)
Timeframe: At Weeks 48, 96, and 144

InterventionPercentage of Participants (Number)
Week 48Week 96Week 144
Tenofovir Disoproxil Fumerate 300 mg52.560.768.3

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Percentage of Participants Who Experienced Viral Breakthrough up to Week 144

Viral breakthrough was defined as 1 log increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of participants who experienced viral breakthrough at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144 have been presented. (NCT02195518)
Timeframe: At Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120,132, and 144

InterventionPercentage of Participants (Number)
Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144
Tenofovir Disoproxil Fumerate 300 mg0.500.500000.5000

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Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144

Serum samples were collected and analyzed for HBV DNA levels at indicated time points. Resistance surveillance of the HBV polymerase gene were performed by direct sequencing for all participants at Baseline. Day 0 was considered as Baseline. Percentage of participants in the subgroup with confirmed multi-drug resistance mutations at Baseline with serum HBV DNA <20 IU/mL and serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 have been presented. (NCT02195518)
Timeframe: At Weeks 48, 96, and 144

InterventionPercentage of Participants (Number)
Week 48, HBV DNA <20 IU/mLWeek 48, HBV DNA <69 IU/mLWeek 96, HBV DNA <20 IU/mLWeek 96, HBV DNA <69 IU/mLWeek 144, HBV DNA <20 IU/mLWeek 144, HBV DNA <69 IU/mL
Tenofovir Disoproxil Fumerate 300 mg34.260.555.376.365.884.2

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Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144

Serological response was assessed at Weeks 48, 96 and 144 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive. (NCT02195518)
Timeframe: At Weeks 48, 96 and 144

InterventionPercentage of Participants (Number)
Week 48, HBeAg lossWeek 48, HBeAg seroconversionWeek 48, HBsAg lossWeek 48, HBsAg seroconversionWeek 96, HBeAg lossWeek 96, HBeAg seroconversionWeek 96, HBsAg lossWeek 96, HBsAg seroconversionWeek 144, HBeAg lossWeek 144, HBeAg seroconversionWeek 144, HBsAg lossWeek 144, HBsAg seroconversion
Tenofovir Disoproxil Fumerate 300 mg5.32.60.5010.02.60.50.515.34.71.10.5

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Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144

Serological response was assessed at Weeks 48, 96 and 144 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive. (NCT02195518)
Timeframe: At Weeks 48,96, and 144

InterventionPercentage of Participants (Number)
Week 48, HBsAg lossWeek 48, HBsAg seroconversionWeek 96, HBsAg lossWeek 96, HBsAg seroconversionWeek 144, HBsAg lossWeek 144, HBsAg seroconversion
Tenofovir Disoproxil Fumerate 300 mg000000

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Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs

An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE occurred on or after the first dose date of study drug, SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. The Safety analysis (SA) Population was defined as all participants who received at least one dose of study medication and have at least one post Baseline safety assessment. (NCT02195518)
Timeframe: Up to Week 144

InterventionParticipants (Number)
Any TEAEsSerious TEAEsNon-serious TEAEs
Tenofovir Disoproxil Fumerate 300 mg12420117

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Change From Baseline in Red Blood Cells (RBC)

Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144

InterventionTrillion cells per liter (Mean)
Week 24, n=208Week 48, n=208Week 72, n=207Week 96, n=207Week 120, n=204Week 144, n=204
Tenofovir Disoproxil Fumerate 300 mg0.130.050.070.020.080.06

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Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144

Log10 reduction in serum HBV DNA was analyzed by patterns of mutation. The patterns of mutation were summarized by 2 categories. Category 1 included wild-type, LAM-R (Lamivudine-resistant), ADV-R (Adefovir-resistant) and ETV-R (Entecavir-resistant). Category 2 included Wild type, ADV-R single mutation, ADV-R double mutation and other mutation. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks 48,96, and 144

InterventionLog 10 (IU/mL) (Mean)
Category 1, Week 48, Wild type, n=57Category 1,Week 96, Wild type, n=57Category 1,Week 144, Wild type, n=56Category 1,Week 48, ADV-R, n=38Category 1, Week 96, ADV-R, n=38Category 1, Week 144, ADV-R, n=38Category 1, Week 48, ETV-R, n=32Category 1, Week 96, ETV-R, n=32Category 1, Week 144, ETV-R, n=31Category 1, Week 48, LAM-R, n=93Category 1, Week 96, LAM-R, n=92Category 1, Week 144,LAM-R, n=91Category 2, Week 48, Wild type, n=57Category 2,Week 96, Wild type, n=57Category 2 Week 144, Wild type, n=56Category 2, Week 48, ADV-R single mutation, n=28Category 2, Week 96, ADV-R, single mutation, n=28Category 2, Week 144, ADV-R single mutation, n=28Category 2, Week 48,ADV-R double mutation, n=10Category 2, Week 96, ADV-R double mutation, n=10Category 1, Week 144, ADV-R double mutation, n=10Category 2, Week 48, other mutation, n=113Category 2, Week 96, other mutation, n=112Category 2, Week 144, other mutation, n=110
Tenofovir Disoproxil Fumerate 300 mg-2.2-2.3-2.4-3.0-3.3-3.5-3.2-3.4-3.6-3.1-3.3-3.2-2.2-2.3-2.4-2.9-3.3-3.5-3.2-3.3-3.5-3.1-3.2-3.2

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Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets

Blood samples were collected to analyze the hematology parameters: WBC, basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144

InterventionBillion cells per liter (Mean)
Week 24, WBC, n=208Week 48, WBC, n=208Week 72, WBC, n=207Week 96, WBC, n=207Week 120, WBC, n=204Week 144, WBC, n=204Week 24, Neutrophils, n=208Week 48, Neutrophils, n=208Week 72, Neutrophils, n=207Week 96, Neutrophils, n=207Week 120, Neutrophils, n=204Week 144, Neutrophils, n=204Week 24, Lymphocytes, n=208Week 48, Lymphocytes, n=208Week 72, Lymphocytes, n=207Week 96, Lymphocytes, n=207Week 120, Lymphocytes, n=204Week 144, Lymphocyte, n=204Week 24, Monocytes, n=208Week 48, Monocytes, n=208Week 72, Monocytes, n=207Week 96, Monocytes, n=207Week 120, Monocytes, n=204Week 144, Monocytes, n=204Week 24, Eosinophils, n=208Week 48, Eosinophils, n=208Week 72, Eosinophils, n=207Week 96, Eosinophils, n=207Week 120, Eosinophils, n=204Week 144, Eosinophils, n=204Week 24, Basophils, n=208Week 48, Basophils, n=208Week 72, Basophils, n=207Week 96, Basophils, n=207Week 120, Basophils, n=203Week 144, Basophils, n=203Week 24, Platelets, n=208Week 48, Platelets, n=208Week 72, Platelets, n=207Week 96, Platelets, n=207Week 120, Platelets, n=204Week 144, Platelets, n=204
Tenofovir Disoproxil Fumerate 300 mg0.190.150.130.070.100.120.150.090.100.050.140.120.020.050.020.02-0.050.00-0.0010.004-0.010-0.009-0.006-0.0080.02-0.000.02-0.000.000.000.000.00-0.00-0.000.000.003.52.51.93.97.29.3

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Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine

Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144

InterventionMicromoles per liter (Mean)
Week 12, total bilirubin, n=209Week 24, total bilirubin, n=208Week 36, total bilirubin, n=209Week 48, total bilirubin, n=207Week 60, total bilirubin, n=208Week 72, total bilirubin, n=207Week 84, total bilirubin, n=207Week 96, total bilirubin, n=207Week 108, total bilirubin, n=205Week 120, total bilirubin, n=205Week 132, total bilirubin, n=205Week 144, total bilirubin, n=204Week 12, direct bilirubin, n=209Week 24, direct bilirubin, n=208Week 36, direct bilirubin, n=208Week 48, direct bilirubin, n=207Week 60, direct bilirubin, n=208Week 72, direct bilirubin, n=207Week 84, direct bilirubin, n=207Week 96, direct bilirubin, n=207Week 108, direct bilirubin, n=205Week 120, direct bilirubin, n=205Week 132, direct bilirubin, n=205Week 144, direct bilirubin, n=204Week 12, serum creatinine, n=209Week 24, serum creatinine, n=208Week 36, serum creatinine, n=209Week 48, serum creatinine, n=208Week 60, serum creatinine, n=208Week 72, serum creatinine, n=206Week 84, serum creatinine, n=207Week 96, serum creatinine, n=207Week 108, serum creatinine, n=204Week 120, serum creatinine, n=205Week 132, serum creatinine, n=205Week 144, serum creatinine, n=203
Tenofovir Disoproxil Fumerate 300 mg-0.506-0.755-0.878-0.167-0.334-1.209-1.112-0.780-0.795-1.021-1.471-0.869-0.181-0.360-0.541-0.085-0.111-0.654-0.797-0.711-0.632-0.802-0.805-0.5732.941.160.671.430.25-1.00-0.650.22-0.28-1.22-0.81-1.28

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Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)

Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks 12,24,36,48,60,72,84,96,108,120,132,and 144

InterventionInternational units per liter (Mean)
Week 12, ALT, n=209Week 24, ALT, n=208Week 36, ALT, n=209Week 48, ALT, n=208Week 60, ALT, n=208Week 72, ALT, n=207Week 84, ALT, n=207Week 96, ALT, n=207Week 108, ALT, n=205Week 120, ALT, n=205Week 132, ALT, n=205Week 144, ALT, n=204Week 12, AST, n=209Week 24, AST, n=208Week 36, AST, n=209Week 48, AST, n=205Week 60, AST, n=208Week 72, AST, n=207Week 84, AST, n=207Week 96, AST, n=207Week 108, AST, n=205Week 120, AST, n=205Week 132, AST, n=205Week 144, AST, n=204Week 12, ALP, n=208Week 24, ALP, n=208Week 36, ALP, n=209Week 48, ALP, n=208Week 60, ALP, n=208Week 72, ALP, n=207Week 84, ALP, n=207Week 96, ALP, n=207Week 108, ALP, n=205Week 120, ALP, n=205Week 132, ALP, n=205Week 144, ALP, n=205Week 12, GGT, n=208Week 24, GGT, n=208Week 36, GGT, n=209Week 48, GGT, n=207Week 60, GGT, n=208Week 72, GGT, n=207Week 84, GGT, n=207Week 96, GGT, n=207Week 108, GGT, n=205Week 120, GGT, n=205Week 132, GGT, n=205Week 144, GGT, n=203Week 12, CK, n=206Week 24, CK, n=198Week 36, CK, n=201Week 48 CK, n=206Week 60, CK, n=205Week 72, CK, n=206Week 84, CK, n=207Week 96, CK, n=207Week 108, CK, n=199Week 120, CK, n=203Week 132, CK, n=204Week 144, CK, n=204Week 12, LDH, n=209Week 24, LDH, n=208Week 36, LDH, n=209Week 48, LDH, n=208Week 60, LDH, n=208Week 72, LDH, n=207Week 84, LDH, n=207Week 96, LDH, n=207Week 108, LDH, n=205Week 120, LDH, n=205Week 132, LDH, n=205Week 144, LDH, n=204
Tenofovir Disoproxil Fumerate 300 mg1.66-2.80-4.57-7.07-9.20-8.12-10.53-9.13-11.25-11.95-11.56-10.97-1.68-3.20-2.93-4.23-4.68-4.43-5.56-4.37-5.81-5.67-6.05-5.854.467.226.278.248.7510.067.328.737.627.547.367.14-1.83-1.83-2.25-1.90-1.25-1.45-2.10-2.50-1.62-1.61-1.80-0.7610.84-9.2813.87-21.58-22.26-13.45-17.4026.58-20.580.59-19.34-7.171.66-2.80-4.57-7.07-9.20-8.12-10.53-9.13-11.25-11.95-11.56-10.97

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Change From Baseline in Chemistry Parameters: Albumin, Total Protein

Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144

InterventionGrams per liter (Mean)
Week 12, albumin, n=209Week 24, albumin, n=208Week 36, albumin, n=209Week 48, albumin, n=208Week 60, albumin, n=208Week 72, albumin, n=207Week 84, albumin, n=207Week 96, albumin, n=207Week 108, albumin, n=205Week 120, albumin, n=205Week 132, albumin, n=205Week 144, albumin, n=204Week 12, total protein, n=209Week 24, total protein, n=207Week 36, total protein, n=209Week 48, total protein, n=208Week 60, total protein, n=208Week 72, total protein, n=207Week 84, total protein, n=207Week 96, total protein, n=207Week 108, total protein, n=205Week 120, total protein, n=205Week 132, total protein, n=205Week 144, total protein, n=204
Tenofovir Disoproxil Fumerate 300 mg0.220.540.040.240.380.49-0.030.13-0.560.170.510.480.310.92-0.30-0.53-0.32-0.26-0.57-0.44-0.210.951.000.94

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Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)

Blood samples were collected to analyze the chemistry parameter: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144

InterventionGrams per liter (Mean)
Week 12, n=209Week 24, n=209Week 36, n=209Week 48, n=208Week 60, n=208Week 72, n=208Week 84, n=207Week 96, n=207Week 108, n=205Week 120, n=205Week 132, n=205Week 144, n=204
Tenofovir Disoproxil Fumerate 300 mg-2.93-1.11-0.63-1.31-0.120.840.42-0.170.420.770.600.95

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Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate

Blood samples were collected to analyze the chemistry parameter: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144

InterventionMilliliter per minute (Mean)
Week 12, n=208Week 24, n=208Week 36, n=209Week 48, n=208Week 60, n=208Week 72, n=206Week 84, n=207Week 96, n=207Week 108, n=204Week 120, n=203Week 132, n=205Week 144, n=203
Tenofovir Disoproxil Fumerate 300 mg-4.564-2.213-2.311-3.667-2.053-0.519-1.065-2.378-2.512-0.742-1.499-0.821

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Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose.

Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridian, phosphorus, calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144

InterventionMillimoles per liter (Mean)
Week 12, BUN, n=209Week 24, BUN, n=208Week 36, BUN, n=209Week 48, BUN, n=208Week 60, BUN, n=208Week 72, BUN, n=206Week 84, BUN, n=207Week 96, BUN, n=207Week 108, BUN, n=204Week 120, BUN, n=205Week 132, BUN, n=205Week 144, BUN, n=203Week 12, Potassium, n=209Week 24, Potassium, n=208Week 36, Potassium, n=209Week 48, Potassium, n=208Week 60, Potassium, n=208Week 72, Potassium, n=206Week 84, Potassium, n=206Week 96, Potassium, n=206Week 108, Potassium, n=204Week 120, Potassium, n=204Week 132, Potassium, n=204Week 144, Potassium, n=204Week 12, Sodium, n=209Week 24, Sodium, n=208Week 36, Sodium, n=209Week 48, Sodium, n=208Week 60, Sodium, n=208Week 72, Sodium, n=206Week 84, Sodium, n=207Week 96, Sodium, n=206Week 108, Sodium, n=204Week 120, Sodium, n=204Week 132, Sodium, n=204Week 144, Sodium, n=204Week 12, Chloridion n=209Week 24, Chloridion, n=208Week 36, Chloridion, n=209Week 48, Chloridion, n=208Week 60, Chloridion, n=208Week 72, Chloridion, n=206Week 84, Chloridion, n=207Week 96, Chloridion, n=206Week 108, Chloridion, n=204Week 120, Chloridion, n=204Week 132, Chloridion, n=204Week 144, Chloridion, n=204Week 12, Phosphorus, n=209Week 24, Phosphorus, n=208Week 36, Phosphorus, n=209Week 48, Phosphorus, n=208Week 60, Phosphorus, n=208Week 72, Phosphorus, n=207Week 84, Phosphorus, n=207Week 96, Phosphorus, n=206Week 108, Phosphorus, n=201Week 120, Phosphorus, n=203Week 132, Phosphorus, n=204Week 144, Phosphorus, n=204Week 12, Calcium, n=209Week 24, Calcium, n=208Week 36, Calcium, n=209Week 48, Calcium, n=208Week 60, Calcium, n=208Week 72, Calcium, n=207Week 84, Calcium, n=207Week 96, Calcium, n=206Week 108, Calcium, n=204Week 120, Calcium, n=204Week 132, Calcium, n=204Week 144, Calcium, n=204Week 12, Fasting blood glucose, n=205Week 24, fasting blood glucose, n=208Week 36, fasting blood glucose, n=208Week 48, fasting blood glucose, n=208Week 60, fasting blood glucose, n=208Week 72, fasting blood glucose, n=202Week 84, fasting blood glucose, n=207Week 96, fasting blood glucose, n=206Week 108, fasting blood glucose, n=200Week 120, fasting blood glucose, n=204Week 132, fasting blood glucose, n=204Week 144, fasting blood glucose, n=204
Tenofovir Disoproxil Fumerate 300 mg-0.0200.0690.0810.0750.0780.1190.1640.1000.0510.1100.0900.193-0.0290.0280.0730.0160.014-0.0320.022-0.019-0.023-0.0020.001-0.0000.310.520.230.400.590.470.540.440.050.030.350.13-0.23-0.32-0.50-0.31-0.37-0.30-0.380.04-0.27-0.17-0.14-0.28-0.018-0.001-0.001-0.0080.004-0.011-0.023-0.019-0.008-0.0150.002-0.016-0.005-0.027-0.030-0.041-0.038-0.061-0.060-0.051-0.062-0.051-0.052-0.050-0.088-0.087-0.150-0.234-0.206-0.187-0.143-0.132-0.230-0.180-0.151-0.070

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Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Unit Per Milliliter (IU/mL) at Week 144

HBV DNA level were analyzed using the sensitive HBV test in central laboratory using Roche cobas Taqman HBV test from the blood samples collected at Week 144. A 95 percent confidence interval (CI) was constructed by normal approximation and continuity correction method. Percentage of participants with serum HBV DNA <20 IU/mL at Week 144 have been presented. The Modified Intent-to-treat (mITT) Population was defined as all recruited participants who received at least one dose of study medication. (NCT02195518)
Timeframe: At Week 144

InterventionPercentage of Participants (Number)
Tenofovir Disoproxil Fumerate 300 mg77.0

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Number of Participants With Acceptability as Per Questionnaire Administered at Week 48

Acceptability was assessed by asking partcipants if they liked truvada, at the week 48 visit (NCT02213328)
Timeframe: Measured at Week 48

InterventionParticipants (Count of Participants)
Truvada97

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The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package

The percentage of participants who report willingness to use the study regimen, take up PrEP, and remain on PrEP as part of a comprehensive prevention package measured at different time points in the study (NCT02213328)
Timeframe: Measured through Week 48

InterventionParticipants (Count of Participants)
Percentage of partcipants who reported willingness to use the study regimenPercentage of participants who took up PrEPPercentage of participants who remained on PrEP at 12 weeksPercentage of participants who remained on PrEP at 24 weeksPercentage of participants who remained on PrEP at 36 weeksPercentage of participants who remained on PrEP at week 48
Truvada148148122878585

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Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit

Reported substance use and alcohol use as evidenced by participant responses to interviewer-administered questionnaires (NCT02213328)
Timeframe: Baseline visit

InterventionParticipants (Count of Participants)
No. of participants reporting alcohol useNo. of participants reporting drug use
Truvada8325

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Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP

Proportion of adolescents with detectable drug levels who report using PrEP at weeks 12,24,36,48 (NCT02213328)
Timeframe: Measured though Week 48

InterventionParticipants (Count of Participants)
total enrolled participantsweek 12week 24week 36week 48
Truvada148107743122

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Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events

Assessment of Grades 2, 3, and 4 clinical and laboratory adverse events measured through week 48 using the DAIDS table for grading adult and paediatric adverse events, dated Dec 2004, (clarification Aug 2009). Expedited Adverse Event (EAE) reporting followed standard reporting requirements as defined in the DAIDS Manual for Expedited Reporting of Adverse Events version 2·0, March 2011. (NCT02213328)
Timeframe: Measured through Week 48

InterventionParticipants (Count of Participants)
Grade 2Grade 3Grade 4
Truvada1442

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Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period

Number of adolescents who continued to use PrEP (as indicated by dried blood spot level) after the initial 3-month period as indicated by DBS at week 24/36/48 (NCT02213328)
Timeframe: Measured through Week 48

InterventionParticipants (Count of Participants)
Participants with truvada in DBS at week 24Participants with truvada in DBS at week 36Participants with truvada in DBS at week 48
Truvada743122

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Number of Adolescents Enrolled and Retained in the Study

Count of participants who had been enrolled in the study and successfully completed the study (NCT02213328)
Timeframe: Measured through Week 52

InterventionParticipants (Count of Participants)
Number of participants enrolledNumber of participants completing the study
Truvada148120

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Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit

Reported consistent condom use as evidenced by participant responses to interviewer-administered questionnaires (NCT02213328)
Timeframe: Baseline

InterventionParticipants (Count of Participants)
Truvada100

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Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 52

Frequency of HIV infection as measured by seroconversion of study participants during the approximate 12 months of follow up. HIV rapid testing was done in parallel using Determine™ HIV-1/2 Ag/Ab Combo and Uni-Gold™ Recombigen® HIV-1/2. If the rapid HIV test was reactive, an HIV-1 RNA qualitative assay (Abbot) was performed. A positive test was confirmed with a second blood sample collected a week later. (NCT02213328)
Timeframe: Measured through Week 52

InterventionParticipants (Count of Participants)
Truvada1

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Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment

Participants reporting multiple partners during interviewer administered questionnaires (NCT02213328)
Timeframe: Baseline

InterventionParticipants (Count of Participants)
Truvada49

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Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36

Number of participants who used oral PrEP at any time during the study and had drug levels present at any time point (NCT02213328)
Timeframe: Measured through Week 48

InterventionParticipants (Count of Participants)
Truvada141

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Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240

The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules >2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules >1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI). (NCT02224456)
Timeframe: Week 240

InterventionEvents per person-year (Number)
Tenofovir Disoproxil Fumarate 300 mg6.045

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Change From Baseline in Red Blood Cells (RBC)

Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionTrillion cells per liter (Mean)
Week 48, n=191Week 96, n=188Week 144, n=185Week 192, n=179Week 240, n=160
Tenofovir Disoproxil Fumarate 300 mg0.110.130.150.100.12

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Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA

Serum samples were collected for the analysis of HBV DNA levels. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionLog 10 (IU/mL) (Mean)
Week 48, n=191Week 96, n=188Week 144, n=185Week 192, n=174Week 240, n=160
Tenofovir Disoproxil Fumarate 300 mg-4.2-4.3-4.3-4.2-4.3

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Change From Baseline in Hemoglobin (Hb)

Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionGrams per liter (Mean)
Week 48, n=191Week 96, n=188Week 144, n=185Week 192, n=179Week 240, n=160
Tenofovir Disoproxil Fumarate 300 mg-0.60.20.9-0.31.2

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Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets

Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, WBC, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

Intervention10^9 cells per liter (Mean)
Week 48, WBC, n=191Week 96, WBC, n=188Week 144, WBC, n=185Week 192, WBC, n=179Week 240, WBC, n=160Week 48, Neutrophils, n=191Week 96, Neutrophils, n=188Week 144, Neutrophils, n=185Week 192, Neutrophils, n=179Week 240, Neutrophils, n=160Week 48, Lymphocytes, n=191Week 96, Lymphocytes, n=188Week 144, Lymphocytes, n=185Week 192, Lymphocytes, n=179Week 240, Lymphocytes, n=160Week 48, Monocytes, n=191Week 96, Monocytes, n=188Week 144, Monocytes, n=185Week 192, Monocytes, n=179Week 240, Monocytes, n=160Week 48, Eosinophils, n=191Week 96, Eosinophils, n=188Week 144, Eosinophils, n=185Week 192, Eosinophils, n=179Week 240, Eosinophils, n=160Week 48, Basophils, n=191Week 96, Basophils, n=188Week 144, Basophils, n=184Week 192, Basophils, n=179Week 240, Basophils, n=160Week 48, Platelets, n=191Week 96, Platelets, n=188Week 144, Platelets, n=185Week 192, Platelets, n=179Week 240, Platelets, n=160
Tenofovir Disoproxil Fumarate 300 mg0.020.09-0.120.120.060.080.210.070.260.280.00-0.06-0.13-0.10-0.15-0.032-0.033-0.035-0.025-0.005-0.02-0.02-0.04-0.03-0.030.000.000.010.010.017.814.120.625.726.6

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Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine

Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionMicromoles per liter (Mean)
Week 48, total bilirubin, n=191Week 96, total bilirubin, n=188Week 144, total bilirubin, n=185Week 192, total bilirubin, n=177Week 240, total bilirubin, n=158Week 48, direct bilirubin, n=191Week 96, direct bilirubin, n=188Week 144, direct bilirubin, n=185Week 192, direct bilirubin, n=178Week 240, direct bilirubin, n=157Week 48, serum creatinine, n=191Week 96, serum creatinine, n=188Week 144, serum creatinine, n=184Week 192, serum creatinine, n=178Week 240, serum creatinine, n=159
Tenofovir Disoproxil Fumarate 300 mg-1.485-1.823-2.665-2.791-1.772-0.296-0.462-0.713-0.780-0.5991.031.100.761.371.35

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Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)

Blood samples were collected to analyze the chemistry parameters: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionmL/minute per 1.73 square meter (Mean)
Week 48, n=191Week 96, n=188Week 144, n=185Week 192, n=180Week 240, n=161
Tenofovir Disoproxil Fumarate 300 mg-0.86-0.87-0.68-1.06-1.42

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Change From Baseline in Chemistry Parameters: Albumin and Total Protein

Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionGrams per liter (Mean)
Week 48, albumin, n=191Week 96, albumin, n=188Week 144, albumin, n=185Week 192, albumin, n=175Week 240, albumin, n=158Week 48, total protein, n=191Week 96, total protein, n=188Week 144, total protein, n=185Week 192, total protein, n=175Week 240, total protein, n=158
Tenofovir Disoproxil Fumarate 300 mg1.061.231.861.651.81-1.01-0.210.27-0.94-1.61

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Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)

Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionUnits per liter (Mean)
Week 48, ALT, n=190Week 96, ALT, n=187Week 144, ALT, n=185Week 192, ALT, n=178Week 240, ALT, n=158Week 48, AST, n=191Week 96, AST, n=188Week 144, AST, n=184Week 192, AST, n=178Week 240, AST, n=158Week 48, ALP, n=190Week 96, ALP, n=188Week 144, ALP, n=185Week 192, ALP, n=177Week 240, ALP, n=158Week 48, GGT, n=190Week 96, GGT, n=188Week 144, GGT, n=185Week 192, GGT, n=175Week 240, GGT, n=152Week 48 CK, n=188Week 96, CK, n=185Week 144, CK, n=182Week 192, CK, n=173Week 240, CK, n=156Week 48, LDH, n=187Week 96, LDH, n=185Week 144, LDH, n=180Week 192, LDH, n=172Week 240, LDH, n=155
Tenofovir Disoproxil Fumarate 300 mg-23.98-28.99-28.99-31.79-32.02-14.69-17.97-18.10-19.82-20.2410.182.60-2.20-0.94-4.68-17.88-22.20-24.69-24.07-27.2610.5116.775.9613.722.79-10.62-10.213.34-18.4525.79

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Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose

Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridion, phosphorus,calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionMillimoles per liter (Mean)
Week 48, BUN, n=191Week 96, BUN, n=188Week 144, BUN, n=184Week 192, BUN, n=178Week 240, BUN, n=155Week 48, Potassium, n=191Week 96, Potassium, n=186Week 144, Potassium, n=184Week 192, Potassium, n=178Week 240, Potassium, n=158Week 48, Sodium, n=191Week 96, Sodium, n=186Week 144, Sodium, n=184Week 192, Sodium, n=178Week 240, Sodium, n=158Week 48, Chloridion, n=191Week 96, Chloridion, n=186Week 144, Chloridion, n=183Week 192, Chloridion, n=178Week 240, Chloridion, n=158Week 48, Phosphorus, n=190Week 96, Phosphorus, n=187Week 144, Phosphorus, n=184Week 192, Phosphorus, n=175Week 240, Phosphorus, n=159Week 48, Calcium, n=190Week 96, Calcium, n=187Week 144, Calcium, n=184Week 192, Calcium, n=178Week 240, Calcium, n=158Week 48, Fasting Blood Glucose, n=191Week 96, Fasting Blood Glucose, n=188Week 144, Fasting Blood Glucose, n=185Week 192, Fasting Blood Glucose, n=177Week 240, Fasting Blood Glucose, n=158
Tenofovir Disoproxil Fumarate 300 mg-0.0460.0000.0370.1430.131-0.0010.002-0.0390.015-0.0130.21-0.020.350.38-0.13-0.130.400.350.770.49-0.044-0.038-0.037-0.059-0.042-0.023-0.006-0.022-0.004-0.006-0.162-0.109-0.094-0.0520.052

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Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240

Liver stiffness measure was obtained by a non-invasive transient elastography using FibroScan. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline is defined as post-dose visit value minus Baseline value (NCT02224456)
Timeframe: Baseline (Day 0), Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionKilopascals (Mean)
Week 48, n=182Week 96, n= 176Week 144, n= 175Week 192, n=167Week 240, n= 131
Tenofovir Disoproxil Fumarate 300 mg-3.3-4.7-5.1-5.1-6.2

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Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192

The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules >2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules >1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI). (NCT02224456)
Timeframe: Week 48, Week 96, Week 144 and Week 192

InterventionParticipants (Count of Participants)
Week 48Week 96Week 144Week 192
Tenofovir Disoproxil Fumarate 300 mg0049

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Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs

An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE that occurred on or after the first dose date of study drug. SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events possible drug-induced liver injury with hyperbilirubinemia. (NCT02224456)
Timeframe: Up to Week 240

InterventionParticipants (Count of Participants)
Any TEAEsSerious TEAENon-serious TEAE
Tenofovir Disoproxil Fumarate 300 mg13934129

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Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240

Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive. (NCT02224456)
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionPercentage of Participants (Number)
Week 48, HBsAg Loss, n=97Week 48, HBsAg Seroconversion, n=97Week 96, HBsAg , n=93Week 96, HBsAg Seroconversion, n=93Week 144, HBsAg Loss, n=93Week 144, HBsAg Seroconversion, n=93Week 192, HBsAg Loss, n=89Week 192, HBsAg Seroconversion, n=89Week 240, HBsAg Loss, n=77Week 240, HBsAg Seroconversion, n=77
Tenofovir Disoproxil Fumarate 300 mg1.01.0003.204.52.25.21.3

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Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.

Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss and HBeAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. Confidence interval was calculated using normal approximation and continuity correction method. (NCT02224456)
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionPercentage of participants (Number)
Week 48, HBeAg Loss, n=94Week 48, HBeAg Seroconversion, n=94Week 96, HBeAg , n=94Week 96, HBeAg Seroconversion, n=94Week 144, HBeAg Loss, n=90Week 144, HBeAg Seroconversion, n=90Week 192, HBeAg Loss, n=90Week 192, HBeAg Seroconversion, n=90Week 240, HBeAg Loss, n=82Week 240, HBeAg Seroconversion, n=82
Tenofovir Disoproxil Fumarate 300 mg18.19.633.014.935.614.447.816.751.223.2

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Percentage of Participants Who Experienced Viral Breakthrough

Viral breakthrough was defined as >=1 log10 increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of Participants who experienced viral breakthrough at Week 48, Week 96, Week 144, Week 192 and Week 240 is presented. (NCT02224456)
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionPercentage of Participants (Number)
Week 48, n=195Week 96, n=195Week 144, n=185Week 192, n=180Week 240, n=161
Tenofovir Disoproxil Fumarate 300 mg000.51.10.6

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Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline

Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization is defined as ALT outside the normal range at Baseline and within the normal range at Week 48, Week 96, Week 144, Week 192 and Week 240. Normal range of ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, 144, 192 and 240 in participants who had abnormal ALT at Baseline (Day 0) have been presented. Confidence interval was calculated using normal approximation and continuity correction method. (NCT02224456)
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionPercentage of participants (Number)
Week 48, n=97Week 96, n= 97Week 144, n=96Week 192, n=93Week 240, n=87
Tenofovir Disoproxil Fumarate 300 mg63.966.070.882.882.8

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Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240

The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules >2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules >1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).The cumulative percentage of participants with newly diagnosed Hepatocellular Carcinoma has been presented along with 95% confidence interval (CI) (Wald method). (NCT02224456)
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionPercentage of participants (Number)
Week 48Week 96Week 144Week 192Week 240
Tenofovir Disoproxil Fumarate 300 mg002.14.65.6

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Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240

Serum samples were collected for the analysis of HBV DNA levels using Roche Cobas Taqman HBV test. Confidence interval was calculated by normal approximation and continuity correction method. (NCT02224456)
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionPercentage of participants (Number)
Week 48, n=191Week 96, n=188Week 144, n=185Week 192, n=174Week 240, n=160
Tenofovir Disoproxil Fumarate 300 mg81.288.894.197.799.4

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Percentage of Participants With Histological Improvement at Week 216

The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) Periportal or periseptal interface hepatitis (piecemeal necrosis) (scores from 0, 1, 2, 3, 4 or 10); (II) Confluent necrosis (scores from 0, 1, 3, 4, 5, 6 or 10); (III) Focal (spotty) lytic necrosis, apoptosis and focal inflammation (scores from 0, 1, 2, 3, 4 or 10); (IV) Portal inflammation (scores from 0, 1, 2, 3, 4 or 10). Histological improvement is considered as a reduction of two or more points in the Knodell necroinflammatory score with no increase in fibrosis. (NCT02224456)
Timeframe: Week 216

InterventionPercentage of participants (Number)
Tenofovir Disoproxil Fumarate 300 mg45.2

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Percentage of Participants With Disease Progression at Week 240

Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/esophageal varices; 6) hepatocellular carcinoma; 7)liver-related death. (NCT02224456)
Timeframe: Week 240

InterventionPercentage of participants (Number)
Tenofovir Disoproxil Fumarate 300 mg7.2

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Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240

Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/oesophageal varices; 6) hepatocellular carcinoma; 7) liver-related death. The cumulative percentage of participants with disease progression has been presented along with 95% CI (Wald method). (NCT02224456)
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionPercentage of participants (Number)
Week 48Week 96Week 144Week 192Week 240
Tenofovir Disoproxil Fumarate 300 mg2.12.64.17.27.2

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Percentage of Participants With Cirrhosis Reversal at Week 216

Cirrhosis reversal was defined as a reduction of one or more points in the Ishak score with no evidence of cirrhosis. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis. (NCT02224456)
Timeframe: Week 216

InterventionPercentage of participants (Number)
Tenofovir Disoproxil Fumarate 300 mg41.9

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Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate

Blood samples were collected to analyze the chemistry parameters: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240

InterventionMilliliter per minute (mL/min) (Mean)
Week 48, n=190Week 96, n=188Week 144, n=184Week 192, n=177Week 240, n=155
Tenofovir Disoproxil Fumarate 300 mg-3.064-4.214-4.324-6.599-6.658

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Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline

(NCT02251236)
Timeframe: Baseline

Interventionng/mL (Median)
Stribild Arm4.3
Genvoya Arm2.72

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Concentration of Elvitegravir in Cerebrospinal Fluid at Week 24

(NCT02251236)
Timeframe: Week 24

Interventionng/mL (Median)
Stribild Arm5.90
Genvoya Arm3.09

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Concentration of Tenofovir in Cerebrospinal Fluid at Week 24

(NCT02251236)
Timeframe: Week 24

Interventionng/mL (Median)
Stribild Arm0.507
Genvoya Arm0.481

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Concentration of Tenofovir in Cerebrospinal Fluid at Baseline

(NCT02251236)
Timeframe: Baseline

Interventionng/mL (Median)
Stribild Arm3.03
Genvoya Arm0.49

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Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1

The occurrence of new AIDS defining events that is, Centers for Disease Control (CDC) Class C events in participants is presented. (NCT02386098)
Timeframe: Up to Week 96

InterventionParticipants (Count of Participants)
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD1
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD0

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Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24-Stage 1

Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <40 c/mL at Week 24 was assessed using the Food and Drug Administration (FDA) snapshot algorithm which used the last on-treatment plasma HIV-1 RNA measurement, within an FDA-specified visit window (18 to 30 weeks), to determine response. Analysis was performed on the modified intent to treat (mITT) Population which comprised of all randomized participants who received atleast one dose of BMS-955176 or TDF. (NCT02386098)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD73.7
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD60.0

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Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1

Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Response was assessed using the last plasma HIV-1 RNA value in the predefined visit window to classify a participant's response status. The percentage of responders with HIV-1 RNA <40 c/mL at Weeks 48 and 96 using mITT Population (observed) which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (October 10, 2016) is presented. The study was terminated early during the primary end point analysis of Stage 1; hence, data was not collected for Week 96 analysis. (NCT02386098)
Timeframe: Weeks 48 and 96

,
InterventionPercentage of participants (Number)
Week 48; n=8, 9
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD75.0
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD66.7

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Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1

Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Response was assessed using the last plasma HIV-1 RNA value in the predefined visit window to classify a participant's response status. The percentage of responders with HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96 using mITT Population (observed) which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (October 10, 2016) is presented. The study was terminated early during the primary end point analysis of Stage 1; hence, data was not collected for Week 96 analysis. (NCT02386098)
Timeframe: Weeks 24, 48 and 96

,
InterventionPercentage of participants (Number)
Week 24; n=32, 29Week 48; n=8, 9
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD93.8100
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD89.7100

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Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1

An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or medical events that may jeopardize the participant or require intervention (medical or surgical) to prevent one of the outcomes mentioned before. The number of participants with SAEs and AELDs are presented. (NCT02386098)
Timeframe: Up to Week 96

,
InterventionParticipants (Count of Participants)
SAEsAELD
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD42
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD31

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Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1

The percentage of CD4+ cells was assessed using flow cytometry. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point. (NCT02386098)
Timeframe: Baseline and up to Week 72

,
InterventionPercentage of CD4+ cells (Mean)
Week 4; n=37, 33Week 8; n=36, 30Week 12; n=35, 32Week 16; n=34, 31Week 24; n=31, 28Week 32; n=23, 22Week 40; n=20, 15Week 48; n=7, 9Week 60; n=4, 2Week 72; n=1, 1
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD1.941.803.413.144.714.135.387.097.9512.50
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD1.821.692.883.664.724.815.387.1610.0510.70

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Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1

Blood samples were collected for analysis of HIV-1 RNA. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point. (NCT02386098)
Timeframe: Baseline and up to Week 72

,
Interventionlog10 c/mL (Mean)
Week 2; n=10, 5Week 4; n=37, 33Week 8; n=37, 30Week 12; n=36, 32Week 16; n=34, 32Week 24; n=32, 29Week 32; n=23, 23Week 40; n=21, 15Week 48; n=8, 9Week 60; n=4, 3Week 72; n=1, 1
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD-4.232-4.400-4.103-4.394-4.402-4.220-4.381-4.366-4.508-5.037-3.326
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD-4.050-3.922-4.145-4.113-4.074-4.079-3.364-4.400-4.680-4.977-5.713

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Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1

The CD4+ cell count was assessed using flow cytometry. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point. (NCT02386098)
Timeframe: Baseline and up to Week 72

,
InterventionCells per microliter (Mean)
Week 4; n=37, 33Week 8; n=36, 30Week 12; n=35, 32Week 16; n=34, 31Week 24; n=31, 28Week 32; n=23, 22Week 40; n=20, 15Week 48; n=7, 9Week 60; n=4, 2Week 72; n=1, 1
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD57.677.690.483.2127.290.0139.5125.0127.00.0
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD26.753.7115.193.8109.5122.1137.1175.1158.5171.0

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Percentage of Participants Discontinuing From Study Medication Due to an AE(s)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02397096)
Timeframe: Up to Week 24

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)2.5
Delayed Switch Group (DSG)0.4

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Percentage of Participants Experiencing ≥1 Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02397096)
Timeframe: Up to week 24

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)68.9
Delayed Switch Group (DSG)52.5

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Percentage of Participants Experiencing ≥1 Serious Adverse Event (SAE)

A serious adverse event is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants with any SAE was assessed. (NCT02397096)
Timeframe: Up to 24 weeks

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)2.9
Delayed Switch Group (DSG)3.6

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Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL

"The percentage of participants in each arm achieving HIV-1 RNA levels <40 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach and all missing data were considered treatment failures, regardless of the reason." (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)89.7
Delayed Switch Group (DSG)93.3

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Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL

To evaluate the immunological effect of an immediate switch to MK -1439A on Study Day 1 compared with continuation of a ritonavir boosted, PI-based regimen, as measured by the proportion of subjects maintaining HIV-1 RNA below the limit of quantification (BLoQ) by the Abbott RealTime HIV-1 Assay (<40 copies/mL) in both treatment groups. (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Week 24; Delayed Switch to MK-1439A arm: Week 24

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)92.8
Delayed Switch Group (DSG)93.3

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Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL

"The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach and all missing data were considered treatment failures, regardless of the reason." (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)90.8
Delayed Switch Group (DSG)94.6

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Percentage of Participants With HIV-1 RNA >=50 Copies/mL

"The percentage of participants in each arm achieving HIV-1 RNA levels >=50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach." (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)1.6
Delayed Switch Group (DSG)1.8

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Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts

The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay. (NCT02397096)
Timeframe: Baseline and Week 24

,
Interventioncells/mm^3 (Geometric Mean)
BaselineChange from Baseline
Delayed Switch Group (DSG)655.618.0
Immediate Switch Group (ISG)664.55.1

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Mean Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C)

To evaluate the effect on fasting LDL-C of an immediate switch to DOR/3TC/TDF on Study Day 1 compared with continuation of a ritonavir-boosted, PI-based regimen, as measured by mean change from baseline in each treatment group. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02397096)
Timeframe: Baseline and Week 24

,
Interventionmg/dL (Mean)
BaselineChange from Baseline
Delayed Switch (Ritonavir-boosted, PI-based) Group (DSG)109.00-1.94
Immediate Switch (Ritonavir--boosted, PI-based) Group (ISG)108.82-16.54

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Mean Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

Serum non-HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The Last Observation Carry Forward (LOCF) approach was applied for missing data or data collected after modifying lipid lowering therapy. (NCT02397096)
Timeframe: Baseline and Week 24

,
Interventionmg/dL (Mean)
BaselineChange from Baseline
Delayed Switch (Ritonavir-boosted, PI-based) Group (DSG)137.99-1.31
Immediate Switch (Ritonavir--boosted, PI-based) Group (ISG)139.14-24.74

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Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts

The mean change from baseline in CD4 cell counts was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay. (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Baseline and Week 48; Delayed Switch to MK-1439A arm: Baseline and Week 24

,
Interventioncells/mm^3 (Mean)
BaselineChange from Baseline
Delayed Switch Group (DSG)655.618.0
Immediate Switch Group (ISG)660.513.9

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Percentage of Participants Maintaining HIV-1 RNA <50 Copies/mL

"The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach and all missing data were considered treatment failures, regardless of the reason." (NCT02397096)
Timeframe: Week 24

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)93.7
Delayed Switch Group (DSG)94.6

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Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration

Median blood dATP concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Baseline, Post-Intervention (Day 8)

,
Interventionfmol/million cells (Median)
BaselinePost-Intervention (Day 8)
Rectal Gel Lubricant + Truvada140122
Truvada149204

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Median Cumulative Amount of p24

The median cumulative amount of p24 produced in a rectal explant challenge assay as measured by ELISA from participants prior to product use and on day 8 after product use. (NCT02401230)
Timeframe: Baseline, Post-Intervention (Day 8)

,,
Interventionpg/mL (Median)
BaselineDay 8
Rectal Gel Lubricant250363
Rectal Gel Lubricant + Truvada276284
Truvada287133

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Median Rectal Tissue Tenofovir (TDF) Concentration

Median rectal tissue TDF concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)

Interventionfmol/mg tissue (Median)
Truvada510
Rectal Gel Lubricant + Truvada280

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Median Rectal Tissue Emtricitabine (FTC) Concentration

Median rectal tissue FTC concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)

Interventionfmol/mg tissue (Median)
Truvada104
Rectal Gel Lubricant + Truvada112

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Median Rectal Secretion Tenofovir (TDF) Concentration

Median rectal secretions TDF concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)

Interventionng/swab (Median)
Truvada812
Rectal Gel Lubricant + Truvada780

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Median Rectal Secretion Emtricitabine (FTC) Concentration

Median rectal secretions FTC concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)

Interventionng/swab (Median)
Truvada320
Rectal Gel Lubricant + Truvada382

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Median Plasma Tenofovir (TDF) Concentration

Median plasma TDF concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)

Interventionng/ml (Median)
Truvada52
Rectal Gel Lubricant + Truvada64

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Median Plasma Emtricitabine (FTC) Concentration

Median plasma FTC concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)

Interventionng/ml (Median)
Truvada248
Rectal Gel Lubricant + Truvada340

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Median Peripheral Blood Mononuclear Cell (PBMC) Tenofovir (TDF) Concentration

Median blood PBMC TDF concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)

Interventionfmol/million cells (Median)
Truvada45
Rectal Gel Lubricant + Truvada48

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Median Peripheral Blood Mononuclear Cell (PBMC) Emtricitabine (FTC) Concentration

Median blood PBMC FTC concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)

Interventionfmol/million cells (Median)
Truvada4980
Rectal Gel Lubricant + Truvada4020

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Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration

Median rectal tissue dATP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Baseline, Post-Intervention (Day 8)

,
Interventionfmol/mg tissue (Median)
BaselinePost-Intervention (Day 8)
Rectal Gel Lubricant + Truvada7466
Truvada13160

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Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration

Median rectal tissue dCTP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Baseline, Post-Intervention (Day 8)

,
Interventionfmol/mg tissue (Median)
BaselinePost-Intervention (Day 8)
Rectal Gel Lubricant + Truvada5836
Truvada24643

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Median Percentage of CD4 Positive T-Cells

HIV target cell availability will be assessed by the median percentage of CD4+ T cells that express HIV co-receptor CCR5 as measured prior to product use and on day 8 after product use. (NCT02401230)
Timeframe: Baseline, Post-Intervention (Day 8)

,,
Interventionpercentage positive T-cells (Median)
BaselineDay 8
Rectal Gel Lubricant6266
Rectal Gel Lubricant + Truvada5851
Truvada7058

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Change From Baseline in Fasting Non-HDL-C at Week 48

The mean percent change from baseline in fasting (fast duration of ≥8 hours) non-HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48

InterventionPercent Change from Baseline (Mean)
MK-1439A-3.83
ATRIPLA™13.26

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Change From Baseline in Fasting Triglycerides at Week 48

The mean percent change from baseline in fasting (fast duration of ≥8 hours) triglycerides levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48

InterventionPercent Change from Baseline (Mean)
MK-1439A-12.40
ATRIPLA™22.01

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Percentage of Participants Discontinuing From Study Medication Due to an AE(s)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02403674)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
MK-1439A3.0
ATRIPLA™6.6

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Percentage of Participants Experiencing ≥1 AE

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02403674)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
MK-1439A82.7
ATRIPLA™90.7

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Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48

"The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach in which all missing data are considered treatment failures, regardless of the reason." (NCT02403674)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
MK-1439A84.3
ATRIPLA™80.8

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Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48

"The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach in which all missing data are considered treatment failures, regardless of the reason." (NCT02403674)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
MK-1439A83.8
ATRIPLA™79.7

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Percentage of Participants With HIV-1 RNA Below the Limit of Quantification (BLoQ) at Week 48

The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled as observed. (NCT02403674)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
MK-1439A59.6
ATRIPLA™55.5

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Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)

"The percentage of participants in each arm experiencing ≥1 pre-specified Tier-1 neuropsychiatric AEs was determined. The list of Tier-1 neuropsychiatric AE categories included dizziness, sleep disorders and disturbances, and altered sensorium (including disturbance in attention)." (NCT02403674)
Timeframe: Up to Week 48

,
InterventionPercentage of Participants (Number)
DizzinessSleep disorders and disturbancesAltered sensorium
ATRIPLA™37.125.58.2
MK-1439A8.812.14.4

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Percentage of Participants With Tier-2 Neuropsychiatric AEs

"The percentage of participants in each arm experiencing ≥1 pre-specified Tier-2 neuropsychiatric AEs was determined. The list of Tier-2 neuropsychiatric AE categories included depression and suicide/self-injury and psychosis and psychotic disorders." (NCT02403674)
Timeframe: Up to Week 48

,
InterventionPercentage of Participants (Number)
Depression and suicide/self-injuryPsychosis and psychotic disorders
ATRIPLA™6.61.1
MK-1439A4.10.3

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Plasma Concentration of Doravirine at Week 48

Plasma samples were collected for analysis of doravirine concentration at Week 48. A total of 2 samples were collected: 1 prior to dosing and 1 collected between 0.5 and 2 hours post-dose. (NCT02403674)
Timeframe: 0 hours post-dose and 2 hours post-dose on Week 48

InterventionnM (Mean)
Pre-dose0.5 to 2 hours post-dose
MK-1439A12902330

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Change From Baseline in CD4 Cell Counts at Week 48

The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued prior to Week 48 due to lack of efficacy. Cell counts at Baseline and Week 48 were measured and expressed as cells/mm^3, and percent change was then calculated as [(Baseline counts - Week 48 counts)*100]. CD4 cell counts were quantified by a central laboratory using a commercially available assay. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48

InterventionPercent Change from Baseline (Mean)
MK-1439A198.4
ATRIPLA™188.4

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Change From Baseline in Fasting Cholesterol at Week 48

The mean percent change from baseline in fasting (fast duration of ≥8 hours) cholesterol levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48

InterventionPercent Change from Baseline (Mean)
MK-1439A-1.97
ATRIPLA™21.77

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Change From Baseline in Fasting HDL-C at Week 48

The mean percent change from baseline in fasting (fast duration of ≥8 hours) HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48

InterventionPercent Change from Baseline (Mean)
MK-1439A1.86
ATRIPLA™8.51

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Change From Baseline in Fasting LDL-C at Week 48

The mean percent change from baseline in fasting (fast duration of ≥8 hours) LDL-C levels at Week 48 was determined for each arm. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48

InterventionPercent Change from Baseline (Mean)
MK-1439A-1.58
ATRIPLA™8.74

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Change From Reference in log10 HIV-1 RNA Levels at Week 96

Change from reference in log10 HIV-1 RNA levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for Test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionlog10 HIV-1 RNA copies per mL (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-2.72
Switch to D/C/F/TAF-0.0027

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Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula

Change from reference in eGFRcyst was calculated using the CKD-EPI equation as per Stage 1 (normal or high GFR) to Stage 5 (End Stage of CKD): <15 mL/min indicate very severe or end stage kidney failure. The eGFRcyst was assessed by calculated serum cystatin C (Scyst) using the CKD-EPI equation: eGFRcyst mL/min/1.73m^2 = 133 * (Scyst/0,8)^-0.499 * 0.996^age [x 0.932 if female] (Scyst =<0.8 mg/L) and eGFRcr mL/min/1.73m^2 = 133 * (Scyst/0,8)^-1.328 * 0.996^age [* 0.932 if male] (Scyst >0.8 mg/L). Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

InterventionmL/min/1.73 m^2 (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])4.4
Switch to D/C/F/TAF0

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Change From Reference in Serum Creatinine

Change from reference in serum creatinine was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmg/dL (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])0.045
Switch to D/C/F/TAF-0.034

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Change From Reference in UACR

Change from reference in UACR at Week 96 was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmg/g (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-0.70
Switch to D/C/F/TAF-0.49

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Change From Reference in UB2MGCR

Change from reference in UB2MGCR was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmcg/g (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-27.04
Switch to D/C/F/TAF-40.53

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Change From Reference in UPCR

Change from reference in UPCR was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmg/g (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-15.46
Switch to D/C/F/TAF-1.40

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Change From Reference in URBPCR

Change from reference in URBPCR at Week 96 were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmcg/g (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])13.70
Switch to D/C/F/TAF-35.53

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Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Week 48

Percent change from baseline in FEPO4 at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48

InterventionPercent change (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])16.00
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)22.55

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Percent Change From Reference in Urine FEPO4

Percent change from reference in FEPO4 at Week 96 were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

InterventionPercent change in urine FEPO4 (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])18.52
Switch to D/C/F/TAF-7.51

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Percentage of Participants With HIV-1 RNA <50 Copies Per mL at Week 96 Defined by FDA Snapshot Approach

Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 96), 2) virologic failure (HIV RNA greater than or equal to [>=] 20/50/200 copies per mL at Week 96), 3) no viral load data in the Week 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Week 96

Interventionpercentage of participants (Number)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])85.1
Switch to D/C/F/TAF94.2

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Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies Per mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach

Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48), 2) virologic failure (HIV RNA greater than or equal to [>=] 20/50/200 copies per mL at Week 48), 3) no viral load data in the Week 48 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Week 48

Interventionpercentage of participants (Number)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])91.4
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)88.4

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Plasma Concentrations 2 Hours After Dosing (C0-2h) of Tenofovir Alafenamide

C0-2h is defined as the plasma concentrations 2 hours after dosing. (NCT02431247)
Timeframe: 0 to 2 hours post dose

Interventionng/mL (Mean)
Tenofovir Alafenamide 10 mg [D/C/F/TAF (Test)]11.9785

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Predose (Trough) Plasma Concentration (C0h) of Darunavir

C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration. (NCT02431247)
Timeframe: 30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose)

Interventionnanogram per milliliter (ng/mL) (Mean)
Darunavir 800 mg [D/C/F/TAF (Test)]1898.9100

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CD4+ Cell Count Post-Week From 96 to End of Extension

The immunologic change was determined by Cluster of CD4+ cell count. CD4+ cell count post-Week 96 to end of extension were assessed. (NCT02431247)
Timeframe: Week 96 to end of extension (up to 3 years)

,
Interventioncells/mm^3 (Mean)
Week 96 + 6 monthsWeek 96 + 12 monthsWeek 96 + 18 monthsWeek 96 + 24 monthsWeek 96 + 30 monthsWeek 96 + 36 months
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])790.2779.4789.8781.9741.6784.7
Switch to D/C/F/TAF749.7774.3758.4784.1736.7778.4

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Change From Baseline in Alkaline Phosphatase (ALP) Levels at Weeks 24 and 48

Change from baseline in ALP at Weeks 24 and 48 was reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionUnits per liter (U/L) (Mean)
Week 24Week 48
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-3.2-1.1
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)12.015.1

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Change From Baseline in BMD T-score of Hip and Spine

BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionBMD T-score (Mean)
Hip region BMD T-score (Week 24)Spine region BMD T-score (Week 24)Hip region BMD T-score (Week 48)Spine region BMD T-score (Week 48)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])0.019-0.1210.015-0.061
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)-0.109-0.322-0.177-0.225

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Change From Baseline in Levels of 25-Hydroxyvitamin D (25-OH Vitamin D), at Week 24 and 48

Change from baseline in 25-OH Vitamin D levels at Week 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48

,
Interventionnanomol per liter (nmol/L) (Mean)
Week 24Week 48
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])12.716.9
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)22.128.3

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Change From Baseline in Levels of Parathyroid Hormone (PTH) at Weeks 24 and 48

Change from baseline in PTH at Weeks 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionPicomol per liter (pmol/L) (Mean)
Week 24Week 48
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])0.113-0.004
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)0.7770.633

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Change From Baseline in Levels of Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) at Weeks 24 and 48

Change from baseline in serum CTX at Weeks 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48

,
Interventionmcg/L (Mean)
Week 24Week 48
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])0.0470.046
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)0.2830.226

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Change From Baseline in Levels of Serum Procollagen 1 N-Terminal Propeptide (P1NP) at Weeks 24 and 48

Change from baseline in serum P1NP at Weeks 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48

,
Interventionmicrogram per liter (mcg/L) (Mean)
Week 24Week 48
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])1.8920.065
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)24.67924.251

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Change From Reference in BMD T-score of Hip and Spine at Week 96

BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

,
InterventionBMD T-score (Mean)
Hip region BMD T-scoreSpine region BMD T-score
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-0.016-0.090
Switch to D/C/F/TAF0.0250.034

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Number of Participants With ARV Resistance

Number of participants with DRV, FTC, TDF/TAF resistance were reported. (NCT02431247)
Timeframe: Baseline to end of extension (up to 4 years)

,,
InterventionParticipants (Count of Participants)
DRV resistance-associated mutations (RAMs)TFV RAMsFTC RAMs
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])002
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)001
Switch to D/C/F/TAF002

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Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD)

"The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by dual energy x-ray absorptiometry (DEXA) scan. Positive values are best values and negative values are worst values of change. Percent change from baseline in hip and spine BMD was assessed." (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionPercent change (Least Squares Mean)
Hip region BMD (Week 24)Spine region BMD (Week 24)Hip region BMD (Week 48)Spine region BMD (Week 48)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])0.29-1.340.17-0.68
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)-1.66-3.43-2.69-2.38

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Percent Change From Reference in Hip and Spine BMD

"The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by DEXA scan. Positive values are best values and negative values are worst values of change. Percent change from reference in hip and spine BMD was assessed. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group." (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

,
InterventionPercent change in BMD (Mean)
Hip region BMDSpine region BMD
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-0.2565-0.9349
Switch to D/C/F/TAF0.54670.4829

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Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability

Treatment adherence assessed by drug accountability (based on pill count) from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study. Adherent participants were defined as having an adherence >95% as assessed by drug accountability. (NCT02431247)
Timeframe: Baseline to Switch and switch to EOE to Open-Label D/C/F/TAF (Up to 3 years)

Interventionpercentage of participants (Number)
Baseline to Switch (double-blind treatment)
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)82.6

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Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability

Treatment adherence assessed by drug accountability (based on pill count) from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study. Adherent participants were defined as having an adherence >95% as assessed by drug accountability. (NCT02431247)
Timeframe: Baseline to Switch and switch to EOE to Open-Label D/C/F/TAF (Up to 3 years)

Interventionpercentage of participants (Number)
Switch to End of Extension (open-label D/C/F/TAF)
Switch to D/C/F/TAF88.7

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Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability

Treatment adherence assessed by drug accountability (based on pill count) from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study. Adherent participants were defined as having an adherence >95% as assessed by drug accountability. (NCT02431247)
Timeframe: Baseline to Switch and switch to EOE to Open-Label D/C/F/TAF (Up to 3 years)

Interventionpercentage of participants (Number)
Baseline to Switch (double-blind treatment)Switch to End of Extension (open-label D/C/F/TAF)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])87.292.2

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Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 48

AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT02431247)
Timeframe: Up to Weeks 48

,
Interventionpercentage of participants (Number)
Grade 3 AEsGrade 4 AEsSAEsPremature discontinuations due to AEs
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])4.70.64.71.9
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)4.41.75.84.4

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Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 96

AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT02431247)
Timeframe: Up to Week 96

,
Interventionpercentage of participants (Number)
Grade 3 AEsGrade 4 AEsSAEsPremature discontinuations due to AEs
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])11.60.810.82.8
Switch to D/C/F/TAF3.71.42.70.3

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Percentage of Participants With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations Due to Adverse Events Post-Week 96 to End of Extension

AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 3 years)

,
Interventionpercentage of participants (Number)
Grade 3 AEsGrade 4 AEsSAEsPremature discontinuations due to AEs
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])3.503.21.0
Switch to D/C/F/TAF5.21.34.81.3

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Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension

Percentage of participants with HIV RNA <50, <20, and <200 copies/mL post Week 96 to end of extension were reported. (NCT02431247)
Timeframe: Week 96 to end of extension (up to 3 years)

,
Interventionpercentage of participants (Number)
Week 96 + 6 months (<50 copies/mL)Week 96 + 12 months (<50 copies/mL)Week 96 + 18 months (<50 copies/mL)Week 96 + 24 months (<50 copies/mL)Week 96 + 30 months (<50 copies/mL)Week 96 + 36 months (<50 copies/mL)Week 96 + 6 months (<20 copies/mL)Week 96 + 12 months (<20 copies/mL)Week 96 + 18 months (<20 copies/mL)Week 96 + 24 months (<20 copies/mL)Week 96 + 30 months (<20 copies/mL)Week 96 + 36 months (<20 copies/mL)Week 96 + 6 months (<200 copies/mL)Week 96 + 12 months (<200 copies/mL)Week 96 + 18 months (<200 copies/mL)Week 96 + 24 months (<200 copies/mL)Week 96 + 30 months (<200 copies/mL)Week 96 + 36 months (<200 copies/mL)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])97.799.098.197.594.7100.085.889.792.490.189.594.799.7100.098.797.596.5100.0
Switch to D/C/F/TAF96.396.798.295.791.468.888.291.692.887.084.562.599.399.598.297.898.387.5

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Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm

Percentage of participants with HIV-1 RNA less than (<) 20, 50, and 200 copies per mL at Weeks 48 and 96 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation. (NCT02431247)
Timeframe: At Week 48 and 96

Interventionpercentage of participants (Number)
At Week 48: < 20 Copies per mLAt Week 48: <50 Copies per mLAt Week 48: <200 Copies per mL
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)79.988.791.7

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Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm

Percentage of participants with HIV-1 RNA less than (<) 20, 50, and 200 copies per mL at Weeks 48 and 96 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation. (NCT02431247)
Timeframe: At Week 48 and 96

Interventionpercentage of participants (Number)
At Week 96: <20 Copies per mLAt Week 96: <50 Copies per mLAt Week 96: <200 Copies per mL
Switch to D/C/F/TAF78.493.896.9

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Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm

Percentage of participants with HIV-1 RNA less than (<) 20, 50, and 200 copies per mL at Weeks 48 and 96 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation. (NCT02431247)
Timeframe: At Week 48 and 96

Interventionpercentage of participants (Number)
At Week 48: < 20 Copies per mLAt Week 48: <50 Copies per mLAt Week 48: <200 Copies per mLAt Week 96: <20 Copies per mLAt Week 96: <50 Copies per mLAt Week 96: <200 Copies per mL
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])82.691.293.173.285.186.7

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Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine by Cockcroft-Gault Formula

Change from reference in eGFRcr by cockcroft-gault formula was reported. The eGFRcr was assessed by calculated creatinine clearance (CrCl) using the Cockcroft-Gault formula, and was assessed using CrCl [mL/min] = (140 - A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit (kilogram [kg]), C is the serum concentration of creatinine [mg/dL], R = 1 if the participant is male and = 0.85 if female. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

InterventionmL/min (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-5.2
Switch to D/C/F/TAF4.6

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Change From Reference in eGFRcr by CKD-EPI Formula

Change from reference in eGFRcr was calculated using the CKD-EPI equation as per Stage 1 (normal or high GFR) to Stage 5 (End Stage of CKD). The eGFRcr was assessed by calculating serum creatinine (Scr) using the CKD-EPI equation: eGFRcr milliliter per minute per 1.72 meter square (mL/min/1.73m^2) = 144 * (Scr/0.7)^-0.329 * 0.993^age (Scr =< 0.7 mg/dL) and eGFRcr mL/min/1.73m^2 = 144 * (Scr/0.7)^-1.209 * 0.993^age (Scr >0.7 mg/dL) for female participants and eGFRcr mL/min/1.73m^2 = 141 x (Scr/0.9)^-0.411 x 0.993^age (Scr =<0.9 mg/dL) and eGFRcr mL/min/1.73m^2 = 141 * (Scr/0.9)^-1.209 x 0.993^age (Scr >0.9 mg/dL) for male participants. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

InterventionmL/min/1.73 m^2 (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-5.6
Switch to D/C/F/TAF2.3

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Change From Reference in CD4+ Cell Count at Week 96

The immunologic change was determined by changes in cluster of differentiation (CD4+) cell count. Change from reference in CD4+ cell count at Week 96 was assessed. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventioncells/mm^3 (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])228.85
Switch to D/C/F/TAF27.01

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Change From Reference in ALP Levels

Change from reference in ALP levels at Week 96 was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

InterventionU/L (Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-0.9
Switch to D/C/F/TAF-9.7

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Change From Baseline in Urine Retinol Binding Protein To Creatinine Ratio (URBPCR) at Week 48

Change from baseline in URBPCR at Week 48 were reported. (NCT02431247)
Timeframe: Baseline and Week 48

Interventionmicrogram per gram (mcg/g) (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])7.00
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)35.02

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Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48

Change from baseline in UPCR at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48

Interventionmilligram per gram (mg/g) (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-15.72
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)-10.53

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Change From Baseline in Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Week 48

Change from baseline in UB2MGCR at Week 48 were reported. (NCT02431247)
Timeframe: Baseline and Week 48

Interventionmcg/g (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-30.42
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)18.36

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Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) at Week 48

Change from baseline in UACR at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48

Interventionmg/g (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-0.58
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)-0.15

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Change From Baseline in Serum Creatinine at Week 48

Change from baseline in serum creatinine at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48

Interventionmilligram per deciliter (mg/dL) (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])0.05
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)0.09

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Change From Baseline in log10 HIV-1 RNA Levels at Week 48

Change from baseline in log10 HIV-1 RNA levels were reported. (NCT02431247)
Timeframe: Baseline and Week 48

Interventionlog10 HIV-1 RNA copies per mL (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-2.95
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)-2.91

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Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula at Week 48

Change from baseline in eGFRcyst was calculated using the CKD-EPI equation as per which Stage 1 (normal or high GFR) >= 90 indicates normal kidney function; Stage 2 (Mild CKD): 60 to 89 mL/min indicates mildly reduced kidney function; Stage 3 (Moderate CKD): 30 to 59 mL/min indicates moderately reduced kidney function; Stage 4 (Severe CKD): 15 to 29 mL/min indicates severely reduced kidney function; Stage 5 (End Stage of CKD): <15 mL/min indicate very severe or end stage kidney failure. The eGFRcyst was assessed by calculated serum cystatin C (Scyst) using the equation: eGFRcyst mL/min/1.73m^2 = 133 * (Scyst/0,8)^-0.499 * 0.996^age [* 0.932 if female] (Scyst =<0.8 mg/L) and eGFRcr mL/min/1.73m^2 = 133 * (Scyst/0,8)^-1.328 * 0.996^age [* 0.932 if male] (Scyst >0.8 mg/L). (NCT02431247)
Timeframe: Baseline and Week 48

InterventionmL/min/1.73 m^2 (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])5.32
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)2.92

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Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine by (Cockcroft-Gault Formula) at Week 48

Change from baseline in eGFRcr by cockcroft-gault formula at Week 48. The eGFRcr was assessed by calculated creatinine clearance (CrCl) using the Cockcroft-Gault formula, and was assessed using CrCl [mL/min] = (140 - A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit (kilogram [kg]), C is the serum concentration of creatinine [mg/dL], R = 1 if the participant is male and = 0.85 if female. (NCT02431247)
Timeframe: Baseline and Week 48

Interventionmilliliter per minute (mL/min) (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-5.16
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)-11.20

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Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula at Week 48

Change from baseline in eGFRcr was calculated using the CKD-EPI equation as per which Stage 1 (normal or high GFR [>=90 mL/min]); Stage 2 (Mild CKD [60 to 90 mL/min]); Stage 3 (Moderate CKD [30 to 59mL/min]); Stage 4 (Severe CKD [15 to 29 mL/min]); Stage 5 (End Stage CKD [<15 mL/min]). The eGFRcr was assessed by calculating serum creatinine (Scr) using the equation: eGFRcr milliliter per minute per 1.72 meter square (mL/min/1.73m^2) = 144*(Scr/0.7)^-0.329*0.993^age (Scr =< 0.7 mg/dL) and eGFRcr mL/min/1.73m^2 = 144*(Scr/0.7)^-1.209*0.993^age (Scr >0.7 mg/dL) for female participants and eGFRcr mL/min/1.73m^2 = 141*(Scr/0.9)^-0.411*0.993^age (Scr =<0.9 mg/dL) and eGFRcr mL/min/1.73m^2 = 141*(Scr/0.9)^-1.209*0.993^age (Scr >0.9 mg/dL) for male participants. (NCT02431247)
Timeframe: Baseline and Week 48

InterventionmL/min/1.73 m^2 (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-6.04
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)-9.16

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Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Week 48

The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Week 48 were assessed. (NCT02431247)
Timeframe: Baseline and Week 48

InterventionCells per millimeter cube (cells/mm^3) (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])190.49
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)172.01

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Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) of Darunavir

AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post-dose. (NCT02431247)
Timeframe: 0 to 24 hours post dose

Interventionhours*nanogram per milliliter (h*ng/mL) (Mean)
Darunavir 800 mg [D/C/F/TAF]87909.3282

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Area Under the Plasma Concentration Time Curve Across the Dosing Interval (AUCtau) of Tenofovir Alafenamide

The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption. (NCT02431247)
Timeframe: 30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose)

Interventionh*ng/mL (Mean)
Tenofovir Alafenamide 10 mg [D/C/F/TAF (Test)]132.3117

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Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach

Percentage of participants with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach were reported. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48 and 96), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 and 96), 3) no viral load data in the Week 48 and 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Weeks 48 and 96

Interventionpercentage of participants (Number)
At week 48: <20 Copies per mLAt week 48: <200 Copies per mL
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)79.390.6

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Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach

Percentage of participants with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach were reported. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48 and 96), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 and 96), 3) no viral load data in the Week 48 and 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Weeks 48 and 96

Interventionpercentage of participants (Number)
At week 96: <20 Copies per mLAt week 96: <200 Copies per mL
Switch to D/C/F/TAF83.596.9

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Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach

Percentage of participants with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach were reported. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48 and 96), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 and 96), 3) no viral load data in the Week 48 and 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Weeks 48 and 96

Interventionpercentage of participants (Number)
At week 48: <20 Copies per mLAt week 48: <200 Copies per mLAt week 96: <20 Copies per mLAt week 96: <200 Copies per mL
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])82.692.876.286.2

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Percentage of Participants With Non-PDVF by Kaplan-Meier Estimates

Percentage of participants with non-PDVF by Kaplan-Meier Estimates were reported. PDVF was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 2 years and 6 months)

,
Interventionpercentage of participants (Number)
Week 96Week 96 + 6 monthsWeek 96 + 12 monthsWeek 96 + 18 monthsWeek 96 + 24 monthsWeek 96 + 30 months
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])10099.699.698.697.397.3
Switch to D/C/F/TAF10099.299.297.897.892.5

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Percentage of Participants With PDVF Post-week 96 to End of Extension

Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: Week 96 to end of extension (up to 3 years)

,
Interventionpercentage of participants (Number)
Participants who met PDVFVirologic non-responseVirologic reboundViremic at final time point
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])1.001.00
Switch to D/C/F/TAF2.101.40.7

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Percentage of Participants With Protocol-defined Virologic Failure (PDVF)

Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Baseline up to Week 96

Interventionpercentage of participants (Number)
Participants who met PDVF (Baseline - Switch)Virologic non-response (Baseline - Switch)Virologic rebound (Baseline - Switch)Viremic at final time point (Baseline - Switch)
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)4.403.90.6

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Percentage of Participants With Protocol-defined Virologic Failure (PDVF)

Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Baseline up to Week 96

Interventionpercentage of participants (Number)
Participants who met PDVF (Baseline - Week 96)Virologic non-response (Baseline - Week 96)Virologic rebound (Baseline-Week 96)Viremic at final time point (Baseline-Week 96)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])4.10.60.30.6

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Percentage of Participants With Protocol-defined Virologic Failure (PDVF)

Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Baseline up to Week 96

Interventionpercentage of participants (Number)
Participants who met PDVF (Switch - Week 96)Virologic non-response (Switch - Week 96)Virologic rebound (Switch - Week 96)Viremic at final time point (Switch - Week 96)
Switch to D/C/F/TAF1.101.10

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Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates

Percentage of participants with time to treatment failure by Kaplan-Meier Estimates were reported. Treatment failure was defined as having either protocol-defined virologic failure or having discontinued for reasons other than alternate access to D/C/F/TAF (or other ARVs). (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 3 years)

Interventionpercentage of participants (Number)
Week 96Week 96 + 6 monthsWeek 96 + 12 monthsWeek 96 + 18 monthsWeek 96 + 24 monthsWeek 96 + 30 months
Switch to D/C/F/TAF10097.494.189.586.479.1

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Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates

Percentage of participants with time to treatment failure by Kaplan-Meier Estimates were reported. Treatment failure was defined as having either protocol-defined virologic failure or having discontinued for reasons other than alternate access to D/C/F/TAF (or other ARVs). (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 3 years)

Interventionpercentage of participants (Number)
Week 96Week 96 + 6 monthsWeek 96 + 12 monthsWeek 96 + 18 monthsWeek 96 + 24 monthsWeek 96 + 30 monthsWeek 96 + 36 months
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])10098.995.690.687.184.884.8

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Change From Reference in Levels of Serum CTX

Change from reference in serum CTX levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmcg/L (Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])0.041
Switch to D/C/F/TAF-0.162

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Change From Reference in Levels of PTH

Change from reference in PTH levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionpmol/L (Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-0.290
Switch to D/C/F/TAF-1.283

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Change From Reference in Levels of 25-OH Vitamin D

Change from reference in 25-OH Vitamin D were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionnmol/L (Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])21.3
Switch to D/C/F/TAF-10.3

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Change From Reference in Levels of Serum P1NP

Change from reference in serum P1NP levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmcg/L (Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])2.817
Switch to D/C/F/TAF-11.963

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with treatment. An SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. An AE was classified as a TEAE if the AE was not present prior to the first study medication administration and started at or after the time of initiation of administration of study medication, or if the AE presented prior to initiation of administration of study medication, continued and increased in intensity after administration of study medication. (NCT02452528)
Timeframe: From time of informed consent through Day 147 ± 3 days

,
InterventionParticipants (Count of Participants)
TEAEsSAEsDeathsDiscontinuations due to AEs
ARC-5200000
Placebo1000

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Number of Participants With PrEP Adherence

Biological measure of medication in the blood. Adherence will be measured using plasma analyses. We used the cut off of 4 doses/week to determine protective levels of adherence. The determination of this was drug levels equal to TFV 4.2 ng/mL FTC 4.6 ng/mL. (NCT02495779)
Timeframe: Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)

InterventionParticipants (Count of Participants)
Intervention45

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HIV RNA Change From Baseline to Day 10

An HIV RNA decline of >=0.5 log by day 10 will be considered to be an adequate virologic response, to proceed to the second phase of the study. (NCT02556333)
Timeframe: 10 days

Interventionlog HIV RNA copies/mL (Number)
TAF Treatment0.01

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Spine Bone Mineral Density (BMD) at Baseline

(NCT02603120)
Timeframe: Baseline

Interventiong/cm^2 (Mean)
B/F/TAF1.124
ABC/DTG/3TC1.103

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02603120)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF93.6
ABC/DTG/3TC95.0

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Percentage Change From Baseline in Spine BMD at Week 48

(NCT02603120)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
B/F/TAF0.692
ABC/DTG/3TC0.416

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Percentage Change From Baseline in Hip BMD at Week 48

(NCT02603120)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
B/F/TAF0.156
ABC/DTG/3TC0.299

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Hip Bone Mineral Density at Baseline

(NCT02603120)
Timeframe: Baseline

Interventiong/cm^2 (Mean)
B/F/TAF1.006
ABC/DTG/3TC0.996

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Change From Baseline in CD4+ Cell Count at Week 48

(NCT02603120)
Timeframe: Baseline; Week 48

Interventioncells/µL (Mean)
B/F/TAF-31
ABC/DTG/3TC4

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Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02603120)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF1.1
ABC/DTG/3TC0.4

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Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113

Change From Baseline in log qHBsAg at Day 113 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. (NCT02604199)
Timeframe: Baseline, Day 113

Interventionlog IU/mL (Least Squares Mean)
Placebo-0.070
ARC-520 Injection 1 mg/kg-0.157
ARC-520 Injection 2 mg/kg-0.379

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Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs

An AE is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. An SAE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. A treatment emergent AE (TEAE) was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration. (NCT02604199)
Timeframe: Through Day 169

,,,
InterventionParticipants (Count of Participants)
≥ 1 AE≥ 1 TEAE≥ 1 Serious TEAEDeaths≥ 1 TEAE Leading to Study Discontinuation≥ 1 TEAE Leading to Treatment Discontinuation
ARC-520 Injection 1 mg/kg662000
ARC-520 Injection 2 mg/kg12121000
PBO High Dose540000
PBO Low Dose440000

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Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) Over Time

Change From Baseline in log qHBsAg at Day 113 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. (NCT02604199)
Timeframe: Baseline, Day 15, 29, 43, 57, 71, 85, 99

,,
Interventionlog IU/mL (Least Squares Mean)
Day 15Day 29Day 43Day 57Day 71Day 85Day 99
ARC-520 Injection 1 mg/kg3.0843.0983.0163.0723.0512.9072.938
ARC-520 Injection 2 mg/kg2.5062.5032.5092.3292.3012.3662.360
Placebo3.2973.2913.1883.2913.2063.3093.302

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Change From Baseline at Day 29 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 29

Interventionlog IU/mL (Mean)
Decrease > 0 to < 0.5 log IU/mL
ARC-520 1.0 mg/kg-0.129

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Change From Baseline at Day 15 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 15

Interventionlog IU/mL (Mean)
No DecreaseDecrease > 0 to < 0.5 log IU/mLDecrease 0.5 to 1.0 log IU/mL
ARC-520 2.0 mg/kg0.032-0.266-0.666

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Change From Baseline at Day 15 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 15

Interventionlog IU/mL (Mean)
No DecreaseDecrease > 0 to < 0.5 log IU/mL
Placebo0.026-0.035

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Change From Baseline at Day 15 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 15

Interventionlog IU/mL (Mean)
Decrease > 0 to < 0.5 log IU/mLDecrease 0.5 to 1.0 log IU/mL
ARC-520 1.0 mg/kg-0.153-0.707

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Change From Baseline at Day 113 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 113

Interventionlog IU/mL (Mean)
No Decrease1 participant analyDecrease > 0 to < 0.5 log IU/mL
Placebo0.042-0.115

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Change From Baseline at Day 113 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 113

Interventionlog IU/mL (Mean)
1 participant analyDecrease > 0 to < 0.5 log IU/mLDecrease 0.5 to 1.0 log IU/mL
ARC-520 2.0 mg/kg-0.359-0.726

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Change From Baseline at Day 85 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 85

Interventionlog IU/mL (Mean)
1 participant analyDecrease > 0 to < 0.5 log IU/mL
ARC-520 1.0 mg/kg-0.171

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Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113

Change From Baseline in log qHBsAg at Day 113 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. (NCT02604212)
Timeframe: Baseline, Day 113

Interventionlog IU/mL (Least Squares Mean)
Placebo-0.104
ARC-520 1.0 mg/kg-0.146
ARC-520 2.0 mg/kg-0.542

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Change From Baseline at Day 113 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 113

Interventionlog IU/mL (Mean)
1 participant analyDecrease > 0 to < 0.5 log IU/mL
ARC-520 1.0 mg/kg-0.142

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Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs

An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. A treatment emergent AE (TEAE) was defined as an AE that was not present prior to the first study drug administration and started at/after the time of initiation of administration of study drug, or an AE which was present prior to initiation of study drug administration, which increased in severity after study drug administration. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction. (NCT02604212)
Timeframe: Through Day 169 (± 3 days)

,,,
Interventionparticipants (Number)
≥ 1 AE≥ 1 TEAE≥ 1 Serious TEAEDeaths≥ 1 TEAE Leading to Study Discontinuation≥ 1 TEAE Leading to Treatment Discontinuation
ARC-520 1.0 mg/kg650000
ARC-520 2.0 mg/kg330000
Placebo High Dose Comparator000000
Placebo Low Dose Comparator440000

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Change From Baseline in Log qHBsAg Over Time

Change From Baseline in log qHBsAg up to Day 99 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. (NCT02604212)
Timeframe: Baseline, Days 15, 29, 43, 57, 71, 85, 99

,,
Interventionlog IU/mL (Mean)
Day 15Day 29Day 43Day 57Day 71Day 85Day 99
ARC-520 1.0 mg/kg3.0693.1483.0973.1483.0883.1983.048
ARC-520 2.0 mg/kg3.0003.0272.8932.8822.7142.6982.606
Placebo3.7343.6923.8123.7933.7563.7433.767

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Change From Baseline at Day 99 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 99

Interventionlog IU/mL (Mean)
1 participant analyDecrease > 0 to < 0.5 log IU/mLDecrease 0.5 to 1.0 log IU/mLDecrease > 1.0 log IU/mL
ARC-520 2.0 mg/kg-0.343-0.652-1.011

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Change From Baseline at Day 99 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 99

Interventionlog IU/mL (Mean)
No Decrease1 participant analyDecrease > 0 to < 0.5 log IU/mL
Placebo0.027-0.160

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Change From Baseline at Day 99 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 99

Interventionlog IU/mL (Mean)
1 participant analyDecrease > 0 to < 0.5 log IU/mL
ARC-520 1.0 mg/kg-0.210

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Change From Baseline at Day 85 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 85

Interventionlog IU/mL (Mean)
No Decrease1 participant analyDecrease > 0 to < 0.5 log IU/mL
Placebo0.009-0.112

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Change From Baseline at Day 85 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 85

Interventionlog IU/mL (Mean)
1 participant analyDecrease > 0 to < 0.5 log IU/mLDecrease 0.5 to 1.0 log IU/mL
ARC-520 2.0 mg/kg-0.293-0.684

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Change From Baseline at Day 71 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 71

Interventionlog IU/mL (Mean)
No Decrease1 participant analyDecrease > 0 to < 0.5 log IU/mL
Placebo0.011-0.094

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Change From Baseline at Day 71 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 71

Interventionlog IU/mL (Mean)
1 participant analyDecrease > 0 to < 0.5 log IU/mLDecrease 0.5 to 1.0 log IU/mL
ARC-520 2.0 mg/kg-0.296-0.662

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Change From Baseline at Day 71 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 71

Interventionlog IU/mL (Mean)
1 participant analyDecrease > 0 to < 0.5 log IU/mL
ARC-520 1.0 mg/kg-0.235

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Change From Baseline at Day 57 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 57

Interventionlog IU/mL (Mean)
No Decrease1 participant analyDecrease > 0 to < 0.5 log IU/mL
Placebo0.027-0.067

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Change From Baseline at Day 57 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 57

Interventionlog IU/mL (Mean)
1 participant analyDecrease > 0 to < 0.5 log IU/mLDecrease 0.5 to 1.0 log IU/mL
ARC-520 2.0 mg/kg-0.276-0.571

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Change From Baseline at Day 57 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 57

Interventionlog IU/mL (Mean)
1 participant analyDecrease > 0 to < 0.5 log IU/mL
ARC-520 1.0 mg/kg-0.176

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Change From Baseline at Day 43 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 43

Interventionlog IU/mL (Mean)
No Decrease1 participant analyDecrease > 0 to < 0.5 log IU/mLDecrease 0.5 to 1.0 log IU/mL
ARC-520 2.0 mg/kg0.017-0.275-0.633

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Change From Baseline at Day 43 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 43

Interventionlog IU/mL (Mean)
No Decrease1 participant analyDecrease > 0 to < 0.5 log IU/mL
Placebo0.022-0.050

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Change From Baseline at Day 43 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 43

Interventionlog IU/mL (Mean)
1 participant analyDecrease > 0 to < 0.5 log IU/mL
ARC-520 1.0 mg/kg-0.226

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Change From Baseline at Day 29 in Log qHBsAg, by Category

Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 29

,
Interventionlog IU/mL (Mean)
No DecreaseDecrease > 0 to < 0.5 log IU/mL
ARC-520 2.0 mg/kg0.064-0.251
Placebo0.048-0.084

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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96

The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. (NCT02629822)
Timeframe: Week 96

InterventionPercentage of Participants (Number)
DOR/3TC/TDF100.0

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Change From Baseline in CD4 Cell Count at Week 48

The change from baseline in CD4 cell count at Week 48 was calculated. (NCT02629822)
Timeframe: Baseline (Day 1) and Week 48

InterventionCells/mm^3 (Mean)
Baseline for the Week 48 PopulationChange from Baseline at Week 48
DOR/3TC/TDF409132

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Change From Baseline in CD4 Cell Count at Week 192

The change from baseline in CD4 cell count at Week 192 was calculated. (NCT02629822)
Timeframe: Baseline (Day 1) and Week 192

InterventionCells/mm^3 (Mean)
Baseline for the Week 192 PopulationChange from Baseline at Week 192
DOR/3TC/TDF479196

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Time to Loss of Virologic Response

The time to loss of virologic response (TLOVR) was reported. For participants who achieved HIV-1 RNA <50 copies/mL of plasma and subsequently had two consecutive HIV-1 RNA values of ≥50 copies/mL measured at least 1 week apart, TLOVR was the time between Day 1 and the date of the first of the two consecutive values ≥50 copies/mL. For participants who achieved and sustained HIV-1 RNA <50 copies/mL, time to loss of virologic response was censored at the time of the last available measurement. (NCT02629822)
Timeframe: Up to Week 96

InterventionDays (Mean)
DOR/3TC/TDF166

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Change From Baseline in CD4 Cell Count at Week 96

The change from baseline in CD4 cell count at Week 96 was calculated. (NCT02629822)
Timeframe: Baseline (Day 1) and Week 96

InterventionCells/mm^3 (Mean)
Baseline for the Week 96 PopulationChange from Baseline at Week 96
DOR/3TC/TDF437153

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Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96

The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. (NCT02629822)
Timeframe: Up to Week 96

InterventionPercentage of Participants (Number)
DOR/3TC/TDF0.0

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Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48.

The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. (NCT02629822)
Timeframe: Up to Week 48

InterventionPercentage of Participants (Number)
DOR/3TC/TDF0.0

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Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96

The percentage of participants experiencing ≥1 AE up to Week 96 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. (NCT02629822)
Timeframe: Up to Week 96

InterventionPercentage of Participants (Number)
DOR/3TC/TDF90.0

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Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48

The percentage of participants experiencing ≥1 AE up to Week 48 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. (NCT02629822)
Timeframe: Up to Week 48

InterventionPercentage of Participants (Number)
DOR/3TC/TDF90.0

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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96

The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. (NCT02629822)
Timeframe: Week 96

InterventionPercentage of Participants (Number)
DOR/3TC/TDF100.0

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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48

The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. (NCT02629822)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
DOR/3TC/TDF100.0

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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 192

The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 192 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 192 visit. (NCT02629822)
Timeframe: Week 192

InterventionPercentage of Participants (Number)
DOR/3TC/TDF100.0

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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 192

The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 192 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 192 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. (NCT02629822)
Timeframe: Week 192

InterventionPercentage of Participants (Number)
DOR/3TC/TDF100.0

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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48

The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. (NCT02629822)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
DOR/3TC/TDF100.0

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Percentage of Participants With HIV-1 RNA <50 and <40 Copies/ml at Week 24 Post-switch for the Combined Treatment Groups

Blood was collected under fasting conditions at 24 weeks post-switch in order to determine the HIV-1 RNA. For the ISG week 24 post-switch was week 24. For the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch

InterventionPercentage of participants (Number)
< 50 copies/mL< 40 copies/mL
Combined Treatment Groups95.395.3

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CNS Toxicity Scores at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups

A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A higher CNS score indicates worse symptoms. A positive change in CNS score indicates worsening symptoms. A negative change indicates improvement in symptoms. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch

InterventionPercentage of maximum score (Mean)
Combined Treatment Groups: Time of Switch24.2
Combined Treatment Groups: Week 24 Post-Switch10.7

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Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups

Blood was collected under fasting conditions at time of switch and 24 weeks post-switch in order to determine the change from baseline of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch

Interventionmg/dL (Mean)
LDL CholesterolNon-HDL CholesterolCholesterolHDL CholesterolTriglyceride
Combined Treatment Groups-10.97-13.18-20.91-7.72-12.99

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Change From Baseline in Fasting Lipids at Week 12

Blood was collected under fasting conditions on Day 1 and on week 12 in order to determine the concentration of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride. (NCT02652260)
Timeframe: Baseline (study Day 1) and study week 12

,
Interventionmg/dL (Mean)
LDL CholesterolNon-HDL CholesterolCholesterolHDL CholesterolTriglyceride
Deferred Switch to MK-1439A-1.88-0.370.000.377.10
Immediate Switch to MK-1439A-10.78-14.08-22.14-8.05-21.19

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Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Week 4

A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach. (NCT02652260)
Timeframe: Week 4

InterventionPercentage of participants (Number)
Immediate Switch to MK-1439A46.5
Deferred Switch to MK-1439A65.1

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Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups

A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. For the Immediate Switch Group (ISG) time of switch was study Day 1, and week 24 post-switch was week 24. For the Delayed Switch Group (DSG) time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch

InterventionPercentage of participants (Number)
Combined Treatment Groups: Time of Switch68.6
Combined Treatment Groups: Week 24 Post-Switch30.2

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Percentage of Participants With at Least One Central Nervous System (CNS) Toxicity of at Least Grade 2 Intensity at Week 12

A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach. (NCT02652260)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Immediate Switch to MK-1439A41.9
Deferred Switch to MK-1439A37.2

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Number of Participants With One or More Serious Adverse Events (SAEs) Through Study Week 12

A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. (NCT02652260)
Timeframe: Up to Week 12

InterventionParticipants (Count of Participants)
Immediate Switch to MK-1439A0
Deferred Switch to MK-1439A0

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Number of Participants With One or More SAEs for the Combined Treatment Groups 24 Weeks After the Switch

A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch

InterventionParticipants (Count of Participants)
Combined Treatment Groups1

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Change From Baseline in CNS Toxicity Score at Week 12

A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms. (NCT02652260)
Timeframe: Baseline and Week 12

InterventionPercentage of maximum score (Mean)
Immediate Switch to MK-1439A-18.1
Deferred Switch to MK-1439A-21.7

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Number of Participants With One or More AEs for the Combined Treatment Groups 24 Weeks After the Switch

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch

InterventionParticipants (Count of Participants)
Combined Treatment Groups71

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Number of Participants With One or More Adverse Events (AEs) Through Study Week 12

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02652260)
Timeframe: Up to Week 12

InterventionParticipants (Count of Participants)
Immediate Switch to MK-1439A34
Deferred Switch to MK-1439A34

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Number of Participants Who Discontinued Treatment Due to an AE Through Study Week 12

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02652260)
Timeframe: Up to Week 12

InterventionParticipants (Count of Participants)
Immediate Switch to MK-1439A0
Deferred Switch to MK-1439A0

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Number of Participants Who Discontinued Treatment Due to an AE for the Combined Treatment Groups 24 Weeks After the Switch

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch

InterventionParticipants (Count of Participants)
Combined Treatment Groups0

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Change From Baseline in CNS Toxicity Score at Week 4

A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms. (NCT02652260)
Timeframe: Baseline and Week 4

InterventionPercentage of maximum score (Mean)
Immediate Switch to MK-1439A-17.6
Deferred Switch to MK-1439A-15.6

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Change From Time of Switch to Week 24 Post Switch in CD4 T-cell Count for the Combined Treatment Groups

Blood was collected at time of switch and at 24 weeks post-switch in order to determine the CD4 T-cell count. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch

Interventioncells/mm^3 (Mean)
Combined Treatment Groups70.4

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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An adverse event (AE) is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. An SAE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration. (NCT02738008)
Timeframe: From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up

,,
InterventionParticipants (Count of Participants)
AEsSAEs
Heparc-2002: ARC-520 1.0 mg/kg10
Heparc-2002: ARC-520 2.0 mg/kg40
Heparc-2003: ARC-520 2.0 mg/kg40

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Number of Participants With TEAEs: CHB Participants

An AE is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious AE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related. (NCT02797522)
Timeframe: From first dose of study drug through Day 142 (± 3 days)

,,,
InterventionParticipants (Count of Participants)
>/= 1 TEAE>/= 1 Serious TEAE>/= 1 Related TEAE>/= 1 Related Serious TEAE
CHB Participants: Cohort 3b2000
CHB Participants: Cohort 3c4020
CHB Participants: Cohort 4b1111
CHB Participants: Cohort 4c1000

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy Volunteers

An adverse event (AE) is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious AE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related. (NCT02797522)
Timeframe: From first dose of study drug through Day 29 (± 1 day)

,,,,,,
InterventionParticipants (Count of Participants)
>/= 1 TEAE>/= 1 Serious TEAE>/= 1 Related TEAE>/= 1 Related Serious TEAE
NHV Participants: Cohort 11000
NHV Participants: Cohort 22000
NHV Participants: Cohort 33010
NHV Participants: Cohort 44020
NHV Participants: Cohort 53020
NHV Participants: Cohort 62010
NHV Participants: Placebo10030

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% Change in Bone Mineral Density From Baseline at the Femoral Neck

The outcome measures presented are descriptive as enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There are limited results at the week 48 timepoint due to the COVID pandemic. (NCT02815566)
Timeframe: Baseline, 48 weeks and 96 weeks

,
InterventionPercent Change (Median)
48 weeks96 weeks
Delayed Switch0.220.70
Immediate Switch1.462.33

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Percent Change in Bone Mineral Density From Baseline at the Lumbar Spine

The outcome measures presented are descriptive as enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There are limited results at the week 48 timepoint due to the COVID pandemic. (NCT02815566)
Timeframe: Baseline, 48 weeks and 96 weeks

,
InterventionPercent Change (Median)
48 weeks96 weeks
Delayed Switch-2.320.7
Immediate Switch1.972.33

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Changes From Baseline in CD4+ Cell Counts at Week 96

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96

InterventionCells per cubic millimeter (Mean)
DTG + 3TC - Double-blind Phase264.7
DTG + TDF/FTC-Double Blind Phase253.8

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Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionRatio (Geometric Mean)
Serum B2M, Week 24, n=338, 335Serum B2M, Week 48, n=324, 332Urine B2M, Week 24, n=121, 95Urine B2M, Week 48, n=119, 103Urine Albumin/Creatinine, Week 24, n=254, 252Urine Albumin/Creatinine , Week 48, n=237, 244Urine B2M/Urine Creatinine, Week 24, n=121, 95Urine B2M/Urine Creatinine, Week 48, n=114, 100Urine Phosphate, Week 24, n=330, 332Urine Phosphate, Week 48, n=316, 330Urine Protein/Creatinine, Week 24, n=269, 265Urine Protein/Creatinine, Week 48, n=252, 269Urine RBP 4, Week 24, n=332, 330Urine RBP 4, Week 48, n=318, 328Urine RBP 4/Urine Creatinine, Week 24, n=329, 330Urine RBP 4/Urine Creatinine, Week 48, n=304, 318
DTG + 3TC-Double Blind Phase0.7980.8060.8870.9001.0140.9340.8520.8881.1151.0610.8500.8790.9341.1150.9191.147
DTG + TDF/FTC-Double Blind Phase0.8720.8921.3511.3381.0501.0481.3311.2781.0121.0751.0161.0611.0731.4901.1101.500

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Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96

,
InterventionRatio (Geometric Mean)
Urine Albumin/Creatinine, Week 96, n=222, 243Urine B2M/Urine Creatinine , Week 96, n=107, 104Urine Phosphate, Week 96, n=292, 316Urine Protein/Creatinine, Week 96, n=238, 258Urine RBP 4/Urine Creatinine, Week 96, n=289, 311
DTG + 3TC-Double Blind Phase0.9240.7941.1130.8681.310
DTG + TDF/FTC-Double Blind Phase1.1011.4411.0661.0531.771

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Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144

,
InterventionRatio (Geometric Mean)
Urine Albumin/Creatinine , Week 144, n=207, 212Urine B2M/Urine Creatinine , Week 144, n=100, 102Urine Phosphate, Week 144, n=274, 294Urine Protein/Creatinine , Week 144, n=225,232Urine RBP 4/Urine Creatinine, Week 144, n=276, 292
DTG + 3TC - Double-blind Phase + Open-label Phase1.0500.7511.0400.9881.648
DTG + TDF/FTC - Double-blind Phase + Open-label Phase1.1461.5180.9551.2102.425

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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents are not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Weeks 24 and Week 48

,
InterventionPercentage of participants (Number)
Week 24, n=309, 316Week 48, n=318, 320
DTG + 3TC-Double Blind Phase44
DTG + TDF/FTC-Double Blind Phase23

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200, >200), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian, Other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 24

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count, <=200,n=31,29Baseline CD4+ cell count, >200,n=325,329Female, n=59, 52Male, n=297, 306Age, <35,n= 211, 205Age, 35 to <50,n=116, 107Age, >=50, n=29, 46Baseline plasma HIV-1 RNA, <=100000,n=282,282Baseline plasma HIV-1 RNA, >100000,n=74, 76Race, White, n=244,247Race, African American/African H., n=39, 36Race, Asian, n=37, 42Race, Other, n=36, 33
DTG + 3TC-Double Blind Phase90939392939193939293928994
DTG + TDF/FTC-Double Blind Phase86949692959385958795819394

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 96

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count, <=200,n=31, 29Baseline CD4+ cell count, >200,n=325,329Female, n=59, 52Male, n=297,306,Age, <35,n= 211, 205Age, 35 to <50,n=116, 107Age, >=50, n=29,46Baseline plasma HIV-1 RNA, <=100000,n=282,282Baseline plasma HIV-1 RNA, >100000,n=74, 76Race, White, n=244,247Race, African American/African H., n=39,36Race, Asian, n=37, 42Race, Other, n=36, 33
DTG + 3TC-Double Blind Phase65868385848486858186797886
DTG + TDF/FTC-Double Blind Phase90898890908987908890819091

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200, >200), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian, Other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 48

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count, <=200,n=31,29Baseline CD4+ cell count, >200,n=325,329Female, n=59, 52Male, n=297, 306Age, <35,n= 211, 205Age, 35 to <50,n=116, 107Age, >=50, n=29, 46Baseline plasma HIV-1 RNA, <=100000,n=282,282Baseline plasma HIV-1 RNA, >100000,n=74, 76Race, White, n=244,247Race, African American/African H., n=39, 36Race, Asian, n=37, 42Race, Other, n=36, 33
DTG + 3TC-Double Blind Phase81918890928690908890879289
DTG + TDF/FTC-Double Blind Phase90939492939487939194819894

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 144

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count, <=200,n=31, 29Baseline CD4+ cell count, >200,n=325,329Female, n=59, 52Male, n=297,306,Age, <35,n= 211, 205Age, 35 to <50,n=116, 107Age, >=50, n=29,46Baseline plasma HIV-1 RNA, <=100000,n=282,282Baseline plasma HIV-1 RNA, >100000,n=74, 76Race, White, n=244,247Race, African American/African H., n=39,36Race, Asian, n=37, 42Race, Other, n=36, 33
DTG + 3TC - Double-blind Phase + Open-label Phase58817180778183797882697378
DTG + TDF/FTC - Double-blind Phase + Open-label Phase83838582838378828785728179

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Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionPercentage change (Mean)
Serum or Plasma Cholesterol, Week 24, n=294, 297Serum or Plasma Cholesterol, Week 48, n=280, 289HDL Cholesterol, Direct, Week 24, n=294, 297HDL Cholesterol, Direct, Week 48, n=280, 289LDL Cholesterol, Week 24, n=294, 297LDL Cholesterol, Week 48, n=280, 289Triglycerides ,Week 24, n=294, 297Triglycerides , Week 48, n=280, 289
DTG + 3TC-Double Blind Phase9.410.516.415.012.414.88.512.8
DTG + TDF/FTC-Double Blind Phase-4.7-2.43.45.0-8.1-4.04.34.4

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Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionPercentage change (Mean)
Total/HDL Cholesterol Ratio, Week 24, n=294, 297Total/HDL Cholesterol Ratio, Week 48, n=280, 289
DTG + 3TC-Double Blind Phase-4.0-0.2
DTG + TDF/FTC-Double Blind Phase-4.6-4.4

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Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144

Number of participants, who meet CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data. (NCT02831673)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
INSTI, DTG, Sensitive, n=,5,4INSTI, DTG, Resistant, n=5,4INSTI, EGV, Sensitive, n=5,4INSTI, EGV, Resistant, n=5,4INSTI, RAL, Sensitive, n=5,4INSTI, RAL, Resistant, n=5,4NRTI, 3TC, Sensitive, n=5,5NRTI, 3TC, Resistant, n=5,5NRTI, ABC, Sensitive, n=5,5NRTI, ABC, Resistant, n=5,5NRTI, AZT, Sensitive, n=5,5NRTI, AZT, Resistant, n=5,5NRTI, D4T, Sensitive, n=5,5NRTI, D4T, Resistant, n=5,5NRTI, DDI, Sensitive, n=5,5NRTI, DDI, Resistant, n=5,5NRTI, FTC, Sensitive, n=5,5NRTI, FTC, Resistant, n=5,5NRTI, TDF, Sensitive, n=5,5NRTI, TDF, Resistant, n=5,5
DTG + 3TC - Double-blind Phase + Open-label Phase50505050505050505050
DTG + TDF/FTC - Double-blind Phase + Open-label Phase40404050505050505050

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Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144

Number of participants, who met confirmed virologic withdrawal (CVW) criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data. (NCT02831673)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
INSTI MutationsMajor mutations of NRTI
DTG + 3TC - Double-blind Phase + Open-label Phase00
DTG + TDF/FTC - Double-blind Phase + Open-label Phase00

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Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 48

,
InterventionCells per cubic millimeter (Mean)
Baseline plasma HIV-1 RNA,<=100000, n=257,264Baseline plasma HIV-1 RNA,>100000, n=67,70Baseline CD4+ cell count,<=200, n=26, 27Baseline CD4+ cell count,>200, n=298, 307Age group-1, <35,n= 194, 192Age group-1, 35 to <50, n=104, 101Age group-1, >=50, n=26, 41Female, n=54, 49Male, n=270, 285Race, White, n=224, 231Race, African Am/African H., n=33, 31Race, Asian, n=34, 41Race, Other, n=33, 31
DTG + 3TC-Double Blind Phase220.0238.5200.5225.9233.6208.7212.6237.1221.2226.0209.4246.4200.2
DTG + TDF/FTC-Double Blind Phase212.4235.5177.9220.7225.2211.2194.8226.8215.6219.7239.9197.2202.7

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Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age, Gender, and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 24

,
InterventionCells per cubic millimeter (Mean)
Baseline plasma HIV-1 RNA,<=100000, n=268,268Baseline plasma HIV-1 RNA,>100000, n=72,73Baseline CD4+ cell count,<=200, n=29,27Baseline CD4+ cell count,>200, n=311, 314Age, <35,n= 203,199Age, 35 to <50, n=109, 100Age, >=50, n=28, 42Female, n=57,50Male, n=283,291Race, White, n=236,235Race, African Am/African H., n=36,33Race, Asian, n=34, 41Race, Other, n=34,32
DTG + 3TC-Double Blind Phase187.72206.63157.01195.11202.76172.05188.79199.45190.21204.78143.84169.80174.30
DTG + TDF/FTC-Double Blind Phase167.93205.96120.17180.73177.62179.87159.34181.78175.05182.27170.51165.36149.34

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Changes From Baseline in CD4+ Cell Counts at Week 24 and 48

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and Weeks 24, 48

,
InterventionCells per cubic millimeter (Mean)
Week 24, n=340,341Week 48, n=324,334
DTG + 3TC-Double Blind Phase192.2222.2
DTG + TDF/FTC-Double Blind Phase175.1217.7

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Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144

,
InterventionCells per cubic millimeter (Mean)
Baseline plasma HIV-1 RNA,<=100000, n=214,223Baseline plasma HIV-1 RNA,>100000, n=56, 64Baseline CD4+ cell count,<=200, n=17, 24Baseline CD4+ cell count,>200, n=253, 263Age group, <35,n=155, 167Age group-1, 35 to <50, n=92, 87Age group-1, >=50, n=23,33Female, n=43, 43Male, n=227, 244Race group, White, n=190,201Race group, African Am/African H., n=26, 26Race group, Asian, n=26, 34Race group, Other, n=28,26
DTG + 3TC - Double-blind Phase + Open-label Phase295.7334.3290.2304.7298.0305.6337.4346.6295.9314.2243.8244.0346.2
DTG + TDF/FTC - Double-blind Phase + Open-label Phase296.1329.6272.9306.2316.0302.1242.2321.7300.0314.0295.1264.1279.9

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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96

Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

,
InterventionMilliliter/minute/1.73*meter^2 (Mean)
GFR Cystatin C adjusted, Week 96GFR creatinine adjusted, Week 96
DTG + 3TC-Double Blind Phase11.3-15.3
DTG + TDF/FTC-Double Blind Phase9.3-19.0

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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144

Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

,
InterventionMilliliter/minute/1.73*meter^2 (Mean)
GFR Cystatin C adjusted, Week 144, n=283,298GFR creatinine adjusted, Week 144, n=271, 289
DTG + 3TC - Double-blind Phase + Open-label Phase13.0-16.7
DTG + TDF/FTC - Double-blind Phase + Open-label Phase12.1-19.3

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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted)and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionMilliliter/minute/1.73*meter^2 (Mean)
GFR-cystatin C adjusted, Week 24, n=338, 336GFR-cystatin C adjusted, Week 48, n=324, 332GFR-creatinine adjusted, Week 24, n=340, 341GFR-creatinine adjusted, Week 48, n=326,335
DTG + 3TC-Double Blind Phase4.47.0-13.5-12.1
DTG + TDF/FTC-Double Blind Phase2.24.1-16.7-15.6

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Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Serum Cystatin C and Serum Retinol Binding Protein (RBP). Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionMilligrams per Liter (mg/L) (Mean)
Serum Cystatin C, Week 24, n=338, 336Serum Cystatin C, Week 48, n=324, 332Serum RBP, Week 24, n=332, 334Serum RBP, Week 48, n=322, 332
DTG + 3TC-Double Blind Phase-0.05-0.071.60.5
DTG + TDF/FTC-Double Blind Phase-0.03-0.041.90.6

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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48

Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionMicromoles per Liter (umol/L) (Mean)
Serum or Plasma Creatinine, Week 24, n=340, 343Serum or Plasma Creatinine, Week 48, n=326, 335
DTG + 3TC-Double Blind Phase11.8810.39
DTG + TDF/FTC-Double Blind Phase15.0713.61

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Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

,
InterventionMillimoles per liter (Mean)
Serum or Plasma Cholesterol, Week 96HDL Cholesterol, Direct, Week 96LDL Cholesterol, Week 96,Triglycerides, Week 96,
DTG + 3TC-Double Blind Phase0.3790.1990.1470.129
DTG + TDF/FTC-Double Blind Phase-0.1040.090-0.154-0.112

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Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

,
InterventionMillimoles per liter (Mean)
Serum or Plasma Cholesterol, Week 144,HDL Cholesterol, Direct, Week 144LDL Cholesterol, Week 144,Triglycerides, Week 144
DTG + 3TC - Double-blind Phase + Open-label Phase0.3670.1810.1700.117
DTG + TDF/FTC - Double-blind Phase + Open-label Phase-0.0370.098-0.105-0.104

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Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48

,
InterventionScores on a scale (Mean)
Week 4, n=349, 348Week 24, n=352, 351Week 48, n=352, 351
DTG + 3TC-Double Blind Phase0.01300.01310.0134
DTG + TDF/FTC-Double Blind Phase0.00780.01680.0129

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Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48

,
InterventionScores on a scale (Mean)
Week 4, n=349, 348Week 24, n=352, 350Week 48, n=352, 350
DTG + 3TC-Double Blind Phase2.33.74.3
DTG + TDF/FTC-Double Blind Phase1.23.22.8

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Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96

Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

,
InterventionMicrograms per Liter (ug/L) (Mean)
Bone-ALP, Week 96, n=296, 317Serum Osteocalcin, Week 96, n=297, 320PINP, Week 96, n=297, 319CTX-1, Week 96, n=297, 315
DTG + 3TC-Double Blind Phase0.300.4015.00.1351
DTG + TDF/FTC-Double Blind Phase2.374.5728.30.2943

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Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144

Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

,
InterventionMicrograms per Liter (ug/L) (Mean)
Bone-ALP, Week 144, n=281, 295Serum Osteocalcin, Week 144, n=281, 299PINP, Week 144, n=281,299CTX-1, Week 144, n=281, 296
DTG + 3TC - Double-blind Phase + Open-label Phase-0.250.294.60.0750
DTG + TDF/FTC - Double-blind Phase + Open-label Phase1.433.2113.80.2164

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Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48

Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionMicrograms per Liter (ug/L) (Mean)
Bone-ALP, Week 24, n=334, 332Bone-ALP, Week 48, n=321, 331Serum Osteocalcin, Week 24, n=335, 334Serum Osteocalcin, Week 48, n=322, 330PINP, Week 24, n=337, 336PINP, Week 48, n=321, 334CTX-1, Week 24, n=337, 334CTX-1, Week 48, n=323, 331
DTG + 3TC-Double Blind Phase0.911.212.560.784.50.50.11920.1338
DTG + TDF/FTC-Double Blind Phase3.133.796.746.0118.313.10.28200.3352

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Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48

Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionNanomoles per Liter (nmol/L) (Mean)
Serum Vitamin D, Week 24, n=337, 337Serum Vitamin D, Week 48, n=322, 333
DTG + 3TC-Double Blind Phase5.9-3.1
DTG + TDF/FTC-Double Blind Phase12.43.1

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CD4+ Cell Counts at Weeks 24 and 48

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. (NCT02831673)
Timeframe: Weeks 24 and 48

,
InterventionCells per cubic millimeter (cells/mm^3) (Mean)
Week 24, n=340,341Week 48, n=324,334
DTG + 3TC Double Blind Phase655.3687.7
DTG + TDF/FTC-Double Blind Phase632.8675.3

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Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144

Time of viral suppression is defined as the first viral load value <50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method. (NCT02831673)
Timeframe: Up to Week 144

InterventionDays (Median)
DTG + 3TC - Double-blind Phase + Open-label Phase29.0
DTG + TDF/FTC - Double-blind Phase + Open-label Phase29.0

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Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who received at least one dose of study treatment. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 48

InterventionPercentage of participants (Number)
DTG + 3TC-Double Blind Phase90
DTG + TDF/FTC-Double Blind Phase93

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel weights. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 96

InterventionPercentage of participants (Number)
DTG + 3TC-Double Blind Phase84
DTG + TDF/FTC-Double Blind Phase89

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel weights. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 24

InterventionPercentage of participants (Number)
DTG + 3TC-Double Blind Phase92
DTG + TDF/FTC-Double Blind Phase93

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 144

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase + Open-label Phase79
DTG + TDF/FTC - Double-blind Phase + Open-label Phase83

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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 96 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 96 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 96

InterventionPercentage of participants (Number)
DTG + 3TC-Double Blind Phase5
DTG + TDF/FTC-Double Blind Phase4

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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 144 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 144 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 144

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase + Open-label Phase5
DTG + TDF/FTC - Double-blind Phase + Open-label Phase4

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Number of Participants Who Discontinue Treatment Due to AEs Over Week 144

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. (NCT02831673)
Timeframe: Up to Week 144

InterventionParticipants (Count of Participants)
DTG + 3TC - Double-blind Phase + Open-label Phase18
DTG + TDF/FTC - Double-blind Phase + Open-label Phase17

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Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. . Number of participants who discontinued treatment due to AEs have been reported. (NCT02831673)
Timeframe: Up to Week 24, Week 48 and Week 96

,
InterventionParticipants (Count of Participants)
Up to Week 24Up to Week 48Up to Week 96
DTG + 3TC-Double Blind Phase6714
DTG + TDF/FTC-Double Blind Phase4811

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Changes From Baseline in CD4+ Cell Counts at Week 144

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144

InterventionCells per cubic millimeter (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase301.8
DTG + TDF/FTC - Double-blind Phase + Open-label Phase303.2

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Change From Baseline in Renal Biomarker-Serum RBP at Week 96

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

InterventionMicrogram per millimoles (ug/mmol) (Mean)
DTG + 3TC-Double Blind Phase1.535
DTG + TDF/FTC-Double Blind Phase7.704

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Change From Baseline in Renal Biomarker-Serum RBP at Week 144

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

InterventionMicrogram per millimoles (ug/mmol) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase1.760
DTG + TDF/FTC - Double-blind Phase + Open-label Phase8.855

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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96

Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

InterventionMicromoles per Liter (umol/L) (Mean)
DTG + 3TC-Double Blind Phase12.75
DTG + TDF/FTC-Double Blind Phase16.10

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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144

Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

InterventionMicromoles per Liter (umol/L) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase12.89
DTG + TDF/FTC - Double-blind Phase + Open-label Phase15.87

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Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96

Blood samples were collected to perform evaluation of renal inflammation biomarkers which included Serum Cystatin C . Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

InterventionMilligrams per Liter (mg/L) (Mean)
DTG + 3TC-Double Blind Phase-0.11
DTG + TDF/FTC-Double Blind Phase-0.09

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Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144

Blood samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

InterventionMilligrams per Liter (mg/L) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase-0.12
DTG + TDF/FTC - Double-blind Phase + Open-label Phase-0.11

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Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

InterventionRatio (Mean)
DTG + 3TC-Double Blind Phase-0.213
DTG + TDF/FTC-Double Blind Phase-0.402

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Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

InterventionRatio (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase-0.229
DTG + TDF/FTC - Double-blind Phase + Open-label Phase-0.386

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Change From Baseline in EQ-5D-5L Utility Score at Week 96

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96

InterventionScores on a scale (Mean)
DTG + 3TC-Double Blind Phase0.0079
DTG + TDF/FTC-Double Blind Phase0.0091

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Change From Baseline in EQ-5D-5L Utility Score at Week 144

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144

InterventionScores on a scale (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase0.0143
DTG + TDF/FTC - Double-blind Phase + Open-label Phase0.0135

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Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96

,
InterventionCells per cubic millimeter (Mean)
Baseline plasma HIV-1 RNA,<=100000, n=240,253Baseline plasma HIV-1 RNA,>100000, n=61,67Baseline CD4+ cell count,<=200, n=21,26Baseline CD4+ cell count,>200, n=280,294Age group-1, <35,n= 179,185Age group-1, 35 to <50, n=97,95Age group-1, >=50, n=25, 40Female, n=49,46Male, n=252, 274Race group, White, n=210,223Race group, African Am/African H., n=31,29Race group, Asian, n=29,38Race group, Other, n=31,30
DTG + 3TC-Double Blind Phase254.8300.2240.5265.9270.2259.5237.6277.9261.4275.2228.5212.1273.4
DTG + TDF/FTC-Double Blind Phase252.9260.1244.4255.1263.0262.0195.9259.1253.5260.0230.2244.8247.3

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Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144

EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144

InterventionScores on a scale (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase5.2
DTG + TDF/FTC - Double-blind Phase + Open-label Phase3.0

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Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96

Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

InterventionNanomoles per Liter (nmol/L) (Mean)
DTG + 3TC-Double Blind Phase-2.2
DTG + TDF/FTC-Double Blind Phase0.7

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Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144

Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

InterventionNanomoles per Liter (nmol/L) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase-2.0
DTG + TDF/FTC - Double-blind Phase + Open-label Phase2.9

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CD4+ Cell Counts at Week 96

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831673)
Timeframe: Week 96

InterventionCells per cubic millimeter (cells/mm^3) (Mean)
DTG + 3TC Double Blind Phase732.8
DTG + TDF/FTC-Double Blind Phase711.5

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Number of Participants With AEs by Maximum Severity Grades up to Week 144

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. (NCT02831673)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
Grade 1 AEsGrade 2 AEsGrade 3 AEsGrade 4 AEsGrade 5 AEs
DTG + 3TC - Double-blind Phase + Open-label Phase332293771
DTG + TDF/FTC - Double-blind Phase + Open-label Phase352423450

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Number of Participants With Any AE and SAE up to Week 148

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or protocol defined event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment. (NCT02831673)
Timeframe: Up to Week 148

,
InterventionParticipants (Count of Participants)
Any AEAny SAE
DTG + 3TC - Double-blind Phase + Open-label Phase30737
DTG + TDF/FTC - Double-blind Phase + Open-label Phase31638

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Number of Participants With HIV-1 Disease Progression up to Week 144

HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progressions summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death. (NCT02831673)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
No HIV-1 disease progressionFrom CDC Stage 1 to CDC Stage 3 EventFrom CDC Stage 2 to CDC Stage 3 EventFrom CDC Stage 3 to New CDC Stage 3 EventFrom CDC Stage 1, 2 or 3 to Death
DTG + 3TC - Double-blind Phase + Open-label Phase3520211
DTG + TDF/FTC - Double-blind Phase + Open-label Phase3560200

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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144

Blood samples were collected up to Week 144 for assessment of Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate aminotransferase (AST), Bilirubin, Carbon dioxide (CO2), Cholesterol, Creatine kinase (CK), Creatinine, Direct Bilirubin, Glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hyponatremia, Low density lipid (LDL) Cholesterol, Lactate Dehydrogenase, Lipase, Phosphate, and Triglycerides. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented (NCT02831673)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
ALT, Grades 1 to 4ALT, Grades 2 to 4ALT, Grades 3 to 4ALT, Grade 1ALT, Grade 2ALT, Grade 3ALT, Grade 4Albumin, Grades 1 to 4Albumin, Grades 2 to 4Albumin, Grades 3 to 4Albumin, Grade 1Albumin, Grade 2Albumin, Grade 3Albumin, Grade 4ALP, Grades 1 to 4ALP, Grades 2 to 4ALP, Grades 3 to 4ALP, Grade 1ALP, Grade 2ALP, Grade 3ALP, Grade 4AST, Grades 1 to 4AST, Grades 2 to 4AST, Grades 3 to 4AST, Grade 1AST, Grade 2AST, Grade 3AST, Grade 4Bilirubin, Grades 1 to 4Bilirubin, Grades 2 to 4Bilirubin, Grades 3 to 4Bilirubin, Grade 1Bilirubin, Grade 2Bilirubin, Grade 3Bilirubin, Grade 4CO2, Grades 1 to 4CO2, Grades 2 to 4CO2, Grades 3 to 4CO2, Grade 1CO2, Grade 2CO2, Grade 3CO2, Grade 4Cholesterol, Grades 1 to 4Cholesterol, Grades 2 to 4Cholesterol, Grades 3 to 4Cholesterol, Grade 1Cholesterol, Grade 2Cholesterol, Grade 3Cholesterol, Grade 4CK, Grades 1 to 4CK, Grades 2 to 4CK, Grades 3 to 4CK, Grade 1CK, Grade 2CK, Grade 3CK, Grade 4Creatinine, Grades 1 to 4Creatinine, Grades 2 to 4Creatinine, Grades 3 to 4Creatinine, Grade 1Creatinine, Grade 2Creatinine, Grade 3Creatinine, Grade 4Direct Bilirubin, Grades 1 to 4Direct Bilirubin, Grades 2 to 4Direct Bilirubin, Grades 3 to 4Direct Bilirubin, Grade 1Direct Bilirubin, Grade 2Direct Bilirubin, Grade 3Direct Bilirubin, Grade 4GFR from creatinine adjusted for BSA Grades 1 to 4GFR from creatinine adjusted for BSA Grades 2 to 4GFR from creatinine adjusted for BSA Grades 3 to 4GFR from creatinine adjusted for BSA, Grade 1GFR from creatinine adjusted for BSA, Grade 2GFR from creatinine adjusted for BSA Grades 3GFR from creatinine adjusted for BSA, Grade 4Hypercalcaemia, Grades 1 to 4Hypercalcaemia, Grades 2 to 4Hypercalcaemia, Grades 3 to 4Hypercalcaemia, Grade 1Hypercalcaemia, Grade 2Hypercalcaemia, Grade 3Hypercalcaemia, Grade 4Hyperglycemia, Grades 1 to 4Hyperglycemia, Grades 2 to 4Hyperglycemia, Grades 3 to 4Hyperglycemia, Grade 1Hyperglycemia, Grade 2Hyperglycemia, Grade 3Hyperglycemia, Grade 4Hyperkalemia, Grades 1 to 4Hyperkalemia, Grades 2 to 4Hyperkalemia, Grades 3 to 4Hyperkalemia, Grade 1Hyperkalemia, Grade 2Hyperkalemia, Grade 3Hyperkalemia, Grade 4Hypernatremia, Grades 1 to 4Hypernatremia, Grades 2 to 4Hypernatremia, Grades 3 to 4Hypernatremia, Grade 1Hypernatremia, Grade 2Hypernatremia, Grade 3Hypernatremia, Grade 4Hypocalcaemia, Grades 1 to 4Hypocalcaemia, Grades 2 to 4Hypocalcaemia, Grades 3 to 4Hypocalcaemia, Grade 1Hypocalcaemia, Grade 2Hypocalcaemia, Grade 3Hypocalcaemia, Grade 4Hypoglycemia, Grades 1 to 4Hypoglycemia, Grades 2 to 4Hypoglycemia, Grades 3 to 4Hypoglycemia, Grade 1Hypoglycemia, Grade 2Hypoglycemia, Grade 3Hypoglycemia, Grade 4Hypokalemia, Grades 1 to 4Hypokalemia, Grades 2 to 4Hypokalemia, Grades 3 to 4Hypokalemia, Grade 1Hypokalemia, Grade 2Hypokalemia, Grade 3Hypokalemia, Grade 4Hyponatremia, Grades 1 to 4Hyponatremia, Grades 2 to 4Hyponatremia, Grades 3 to 4Hyponatremia, Grade 1Hyponatremia, Grade 2Hyponatremia, Grade 3Hyponatremia, Grade 4LDL Cholesterol, Grades 1 to 4LDL Cholesterol, Grades 2 to 4LDL Cholesterol, Grades 3 to 4LDL Cholesterol, Grade 1LDL Cholesterol, Grade 2LDL Cholesterol, Grade 3LDL Cholesterol, Grade 4Lactate Dehydrogenase, Grades 1 to 4Lactate Dehydrogenase, Grades 2 to 4Lactate Dehydrogenase, Grades 3 to 4Lactate Dehydrogenase, Grade 1Lactate Dehydrogenase, Grade 2Lactate Dehydrogenase, Grade 3Lactate Dehydrogenase, Grade 4Lipase, Grades 1 to 4Lipase, Grades 2 to 4Lipase, Grades 3 to 4Lipase, Grade 1Lipase, Grade 2Lipase, Grade 3Lipase, Grade 4Phosphate, Grades 1 to 4Phosphate, Grades 2 to 4Phosphate, Grades 3 to 4Phosphate, Grade 1Phosphate, Grade 2Phosphate, Grade 3Phosphate, Grade 4Triglycerides, Grades 1 to 4Triglycerides, Grades 2 to 4Triglycerides, Grades 3 to 4Triglycerides, Grade 1Triglycerides, Grade 2Triglycerides, Grade 3Triglycerides, Grade 4
DTG + 3TC - Double-blind Phase + Open-label Phase5523143297711001008305300522782519624214428102212680118800772405324007643263317151121102010014141400140185185130172130700700091383533530100100060060001440104002282146116006000252023200571754012503003000653510302582703523533208012768561
DTG + TDF/FTC - Double-blind Phase + Open-label Phase81259561645100100010109100793113481894511743413401169010790040131271210755236231621153132281201313130013022622627019925240040008125256232041130013003000133110210173114201710610028002800035144211040510410080491831311086847621416062143481121

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Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144

Blood samples were collected up to Week 144 for assessment of hemoglobin, leukocytes, neutrophils and platelets. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the listed hematology parameters have been presented. (NCT02831673)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
Hemoglobin, Grades 1 to 4Hemoglobin, Grades 2 to 4Hemoglobin, Grades 3 to 4Hemoglobin, Grade 1Hemoglobin, Grade 2Hemoglobin, Grade 3Hemoglobin, Grade 4Leukocytes, Grades 1 to 4Leukocytes, Grades 2 to 4Leukocytes, Grades 3 to 4Leukocytes, Grade 1Leukocytes, Grade 2Leukocytes, Grade 3Leukocytes, Grade 4Neutrophils, Grades 1 to 4Neutrophils, Grades 2 to 4Neutrophils, Grades 3 to 4Neutrophils, Grade 1Neutrophils, Grade 2Neutrophils, Grade 3Neutrophils, Grade 4Platelets, Grades 1 to 4Platelets, Grades 2 to 4Platelets, Grades 3 to 4Platelets, Grade 1Platelets, Grade 2Platelets, Grade 3Platelets, Grade 4
DTG + 3TC - Double-blind Phase + Open-label Phase9108100164012400251976125214816701
DTG + TDF/FTC - Double-blind Phase + Open-label Phase7106100320120018116755111417310

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CD4+ Cell Counts at Week 144

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831673)
Timeframe: Week 144

InterventionCells per cubic millimeter (cells/mm^3) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase767.8
DTG + TDF/FTC - Double-blind Phase + Open-label Phase758.2

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Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96

EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96

InterventionScores on a scale (Mean)
DTG + 3TC-Double Blind Phase4.1
DTG + TDF/FTC-Double Blind Phase2.4

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Change From Baseline in Renal Biomarker-Serum RBP at Week 144

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 144

InterventionMicrogram per millimoles (ug/mmol) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase0.560
DTG + TDF/FTC - Double-blind Phase + Open-label Phase3.813

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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96

Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error has been presented. (NCT02831764)
Timeframe: Baseline and at Week 96

InterventionMicromoles per Liter (umol/L) (Mean)
DTG + 3TC - Double-blind Phase11.71
DTG + TDF/FTC - Double-blind Phase14.75

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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144

Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error has been presented. (NCT02831764)
Timeframe: Baseline and at Week 144

InterventionMicromoles per Liter (umol/L) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase12.28
DTG + TDF/FTC - Double-blind Phase + Open-label Phase15.14

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Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline and at Week 96

Interventionmg/L (Mean)
DTG + 3TC - Double-blind Phase-0.09
DTG + TDF/FTC - Double-blind Phase-0.08

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Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline and at Week 144

Interventionmg/L (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase-0.11
DTG + TDF/FTC - Double-blind Phase + Open-label Phase-0.08

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Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 96

InterventionRatio (Mean)
DTG + 3TC - Double-blind Phase-0.113
DTG + TDF/FTC - Double-blind Phase-0.395

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Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 144

InterventionRatio (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase-0.245
DTG + TDF/FTC - Double-blind Phase + Open-label Phase-0.359

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Change From Baseline in EQ-5D-5L Utility Score at Week 144

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 144

InterventionScores on a scale (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase0.0210
DTG + TDF/FTC - Double-blind Phase + Open-label Phase0.0131

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Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96

EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 96

InterventionScores on a scale (Mean)
DTG + 3TC - Double-blind Phase4.4
DTG + TDF/FTC - Double-blind Phase5.1

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Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144

EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 144

InterventionScores on a scale (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase4.8
DTG + TDF/FTC - Double-blind Phase + Open-label Phase4.5

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Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96

Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline and at Week 96

InterventionNanomoles per Liter (nmol/L) (Mean)
DTG + 3TC - Double-blind Phase-1.7
DTG + TDF/FTC - Double-blind Phase1.3

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Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144

Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline and at Week 144

InterventionNanomoles per Liter (nmol/L) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase1.1
DTG + TDF/FTC - Double-blind Phase + Open-label Phase1.4

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CD4+ Cell Counts at Week 96

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831764)
Timeframe: Week 96

InterventionCells/mm^3 (Mean)
DTG + 3TC - Double-blind Phase734.9
DTG + TDF/FTC - Double-blind Phase739.9

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CD4+ Cell Counts at Week 144

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831764)
Timeframe: Week 144

InterventionCells/mm^3 (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase763.8
DTG + TDF/FTC - Double-blind Phase + Open-label Phase770.4

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Change From Baseline in EQ-5D-5L Utility Score at Week 96

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 96

InterventionScores on a scale (Mean)
DTG + 3TC - Double-blind Phase0.0168
DTG + TDF/FTC - Double-blind Phase0.0171

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Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144

Time of viral suppression is defined as the first viral load value <50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method. (NCT02831764)
Timeframe: Up to Week 144

InterventionDays (Median)
DTG + 3TC - Double-blind Phase + Open-label Phase29.0
DTG + TDF/FTC - Double-blind Phase + Open-label Phase29.0

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Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Geometric mean ratio and 95% CI of geometric mean ratio have been presented. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Weeks 24, 48

,
InterventionRatio (Geometric Mean)
Serum B2M, Week 24, n=344,346Serum B2M, Week 48, n=335,336Urine B2M, Week 24, n=124,106Urine B2M, Week 48, n=109, 103Urine Albumin/Creatinine, Week 24, n=259, 251Urine Albumin/Creatinine , Week 48, n=249, 240Urine B2M/Urine Creatinine , Week 24, n=122, 104Urine B2M/Urine Creatinine , Week 48, n=108, 103Urine Phosphate, Week 24, n=343, 340Urine Phosphate, Week 48, n=335, 332Urine Protein/Creatinine, Week 24, n=263,279Urine Protein/Creatinine , Week 48, n=259, 261Urine RBP 4, Week 24, n=340, 338Urine RBP 4, Week 48, n=333, 331Urine RBP 4/Urine Creatinine, Week 24, n=338, 335Urine RBP 4/Urine Creatinine, Week 48, n=331, 328
DTG + 3TC - Double-blind Phase0.8090.8110.8440.9170.9070.9110.8800.9691.0411.1210.8180.8660.6560.7400.6700.749
DTG + TDF/FTC - Double-blind Phase0.8820.8871.1291.3231.0210.9711.1261.3071.0631.0560.9911.0070.8240.8190.8110.844

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Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Week 96

,
InterventionRatio (Geometric Mean)
Urine Albumin/Creatinine, Week 96, n=239, 243Urine B2M/Urine Creatinine, Week 96, n=101, 96Urine Phosphate, Week 96, n=316, 322Urine Protein/Creatinine, Week 96, n=251, 261Urine RBP 4/Urine Creatinine, Week 96, n=314, 318
DTG + 3TC - Double-blind Phase0.9390.8441.1560.8871.030
DTG + TDF/FTC - Double-blind Phase0.9971.2591.0691.0161.287

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Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 144

,
InterventionRatio (Geometric Mean)
Urine Albumin/Creatinine, Week 144, n=230, 221Urine B2M/Urine Creatinine, Week 144, n=108, 93Urine Phosphate, Week 144, n=301, 301Urine Protein/Creatinine, Week 144, n=236, 246Urine RBP 4/Urine Creatinine, Week 144, n=294, 289
DTG + 3TC - Double-blind Phase + Open-label Phase1.0360.8721.0830.9991.159
DTG + TDF/FTC - Double-blind Phase + Open-label Phase1.0671.4941.0841.1801.567

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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off. (NCT02831764)
Timeframe: Weeks 24 and 48

,
InterventionPercentage of participants (Number)
Week 24, n=313, 320Week 48, n=324, 332
DTG + 3TC - Double-blind Phase44
DTG + TDF/FTC - Double-blind Phase02

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3 for group-1), Baseline HIV-1 RNA (<=100000, >100000 c/mL) and Race (White, African American/African heritage (H.), Asian other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 24

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count Group-1, <=200,n=32,26Baseline CD4+ cell count Group-1, >200,n=328,333Female, n=54, 46Male, n=306, 313Age, <35,n= 209, 203Age, 35 to <50,n=115, 122Age, >=50, n=36, 34Baseline plasma HIV-1 RNA, <=100000,n=294,282Baseline plasma HIV-1 RNA, >100000,n=66, 77Race, White, n=240, 252Race, African American/African H., n=51, 35Race, Asian, n=34, 30Race, Other, n=35, 42
DTG + 3TC - Double-blind Phase78959394939694949295909789
DTG + TDF/FTC - Double-blind Phase92948995949491959095899093

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 96

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count, <=200,n=32, 26Baseline CD4+ cell count, >200,n=328,333Female, n=54, 46Male, n=306, 313Age, <35,n= 209, 203Age, 35 to <50,n=115, 122Age, >=50, n=36, 34Baseline plasma HIV-1 RNA, <=100000,n=294, 282Baseline plasma HIV-1 RNA, >100000,n=66, 77Race, White, n=240,252Race, African American/African H., n=51, 35Race, Asian, n=34, 30Race, Other, n=35, 42
DTG + 3TC - Double-blind Phase72898189889083888692698889
DTG + TDF/FTC - Double-blind Phase85908590918988918491869083

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3 for group-1), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 48

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count Group-1, <=200,n=32, 26Baseline CD4+ cell count Group-1, >200,n=328,333Female, n=54, 46Male, n=306, 313Age, <35,n= 209,203Age, 35 to <50,n=115, 122Age, >=50, n=36, 34Baseline plasma HIV-1 RNA, <=100000,n=294,282Baseline plasma HIV-1 RNA, >100000,n=66, 77Race, White, n=240, 252Race, African American/African H., n=51, 35Race, Asian, n=34, 30Race, Other, n=35, 42
DTG + 3TC - Double-blind Phase78958994929789929796809786
DTG + TDF/FTC - Double-blind Phase96948795949494959096869090

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 144

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count, <=200,n=32, 26Baseline CD4+ cell count, >200,n=328,333Female, n=54, 46Male, n=306, 313Age, <35,n= 209, 203Age, 35 to <50,n=115, 122Age, >=50, n=36, 34Baseline plasma HIV-1 RNA, <=100000,n=294, 282Baseline plasma HIV-1 RNA, >100000,n=66, 77Race, White, n=240,252Race, African American/African H., n=51, 35Race, Asian, n=34, 30Race, Other, n=35, 42
DTG + 3TC - Double-blind Phase + Open-label Phase75857885838683848688658589
DTG + TDF/FTC - Double-blind Phase + Open-label Phase69868385838588858187748379

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Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48

,
InterventionPercentage change (Mean)
Serum or Plasma Cholesterol, Week 24, n=298, 310Serum or Plasma Cholesterol, Week 48, n=298, 307HDL Cholesterol, Direct, Week 24, n=299, 310HDL Cholesterol, Direct, Week 48, n=299, 307LDL Cholesterol, Week 24, n=298, 309LDL Cholesterol, Week 48, n=297, 307Triglycerides,Week 24, n=299, 310Triglycerides, Week 48, n=299, 307
DTG + 3TC - Double-blind Phase5.09.313.915.33.810.77.07.3
DTG + TDF/FTC - Double-blind Phase-4.5-3.37.24.0-7.8-4.10.5-0.3

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Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). Lipid last observation carried forwarded (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Participants on lipid-lowering agents at Baseline were excluded. (NCT02831764)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionPercentage change (Mean)
Total/HDL Cholesterol Ratio, Week 24, n=298, 310Total/HDL Cholesterol Ratio, Week 48, n=298, 307
DTG + 3TC - Double-blind Phase-4.4-2.8
DTG + TDF/FTC - Double-blind Phase-7.5-4.5

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Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144

Number of participants, who met CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results were interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drugs (DTG, 3TC, Abacavir [ABC], elvitegravir [EGV], raltegravir [RAL], zidovudine [AZT], stavudine [D4T], didanosine [DDI]), emtricitabine [FTC], tenofovir disiproxil fumarate [TDF]). Partially sensitive and resistant cells were considered resistant in this analysis. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data. (NCT02831764)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
INSTI, DTG, Sensitive, n=7,2INSTI, DTG, Resistant, n=7,2INSTI, EGV, Sensitive, n=7,2INSTI, EGV, Resistant, n=7,2INSTI, RAL, Sensitive, n=7,2INSTI, RAL, Resistant, n=7,2NRTI, 3TC, Sensitive, n=7,3NRTI, 3TC, Resistant, n=7,3NRTI, ABC, Sensitive, n=7,3NRTI, ABC, Resistant, n=7,3NRTI, AZT, Sensitive, n=7,3NRTI, AZT, Resistant, n=7,3NRTI, D4T, Sensitive, n=7,3NRTI, D4T, Resistant, n=7,3NRTI, DDI, Sensitive, n=7,3NRTI, DDI, Resistant, n=7,3NRTI, FTC, Sensitive, n=7,3NRTI, FTC, Resistant, n=7,3NRTI, TDF, Sensitive, n=7,3NRTI, TDF, Resistant, n=7,3
DTG + 3TC - Double-blind Phase + Open-label Phase70707070707070707070
DTG + TDF/FTC - Double-blind Phase + Open-label Phase20202030303030303030

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Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144

Number of participants, who met confirmed virologic withdrawal (CVW) criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data. (NCT02831764)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
INSTI MutationsMajor mutations of the NRTI
DTG + 3TC - Double-blind Phase + Open-label Phase00
DTG + TDF/FTC - Double-blind Phase + Open-label Phase00

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Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144

Blood samples were collected up to Week 144 for assessment of hemoglobin, leukocytes, neutrophils and platelet count. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the listed hematology parameters have been presented. (NCT02831764)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
Hemoglobin, Grades 1 to 4Hemoglobin, Grades 2 to 4Hemoglobin, Grades 3 to 4Hemoglobin, Grade 1Hemoglobin, Grade 2Hemoglobin, Grade 3Hemoglobin, Grade 4Leukocytes, Grades 1 to 4Leukocytes, Grades 2 to 4Leukocytes, Grades 3 to 4Leukocytes, Grade 1Leukocytes, Grade 2Leukocytes, Grade 3Leukocytes, Grade 4Neutrophils, Grades 1 to 4Neutrophils, Grades 2 to 4Neutrophils, Grades 3 to 4Neutrophils, Grade 1Neutrophils, Grade 2Neutrophils, Grade 3Neutrophils, Grade 4Platelets, Grades 1 to 4Platelets, Grades 2 to 4Platelets, Grades 3 to 4Platelets, Grade 1Platelets, Grade 2Platelets, Grade 3Platelets, Grade 4
DTG + 3TC - Double-blind Phase + Open-label Phase8622411510410023841542213508500
DTG + TDF/FTC - Double-blind Phase + Open-label Phase10614510500500073142109504500

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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144

Blood samples were collected up to Week 144 for assessment of Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate aminotransferase (AST), Bilirubin, Carbon dioxide (CO2), Cholesterol, Creatine kinase (CK), Creatinine, Direct Bilirubin, Glomerular filtration rate (GFR), Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hyponatremia, Low density lipid (LDL) Cholesterol, Lactate Dehydrogenase, Lipase, Phosphate, and Triglycerides. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented. (NCT02831764)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
ALT, Grades 1 to 4ALT, Grades 2 to 4ALT, Grades 3 to 4ALT, Grade 1ALT, Grade 2ALT, Grade 3ALT, Grade 4Albumin, Grades 1 to 4Albumin, Grades 2 to 4Albumin, Grades 3 to 4Albumin, Grade 1Albumin, Grade 2Albumin, Grade 3Albumin, Grade 4ALP, Grades 1 to 4ALP, Grades 2 to 4ALP, Grades 3 to 4ALP, Grade 1ALP, Grade 2ALP, Grade 3ALP, Grade 4AST, Grades 1 to 4AST, Grades 2 to 4AST, Grades 3 to 4AST, Grade 1AST, Grade 2AST, Grade 3AST, Grade 4Bilirubin, Grades 1 to 4Bilirubin, Grades 2 to 4Bilirubin, Grades 3 to 4Bilirubin, Grade 1Bilirubin, Grade 2Bilirubin, Grade 3Bilirubin, Grade 4CO2, Grades 1 to 4CO2, Grades 2 to 4CO2, Grades 3 to 4CO2, Grade 1CO2, Grade 2CO2, Grade 3CO2, Grade 4Cholesterol, Grades 1 to 4Cholesterol, Grades 2 to 4Cholesterol, Grades 3 to 4Cholesterol, Grade 1Cholesterol, Grade 2Cholesterol, Grade 3Cholesterol, Grade 4CK, Grades 1 to 4CK, Grades 2 to 4CK, Grades 3 to 4CK, Grade 1CK, Grade 2CK, Grade 3CK, Grade 4Creatinine, Grades 1 to 4Creatinine, Grades 2 to 4Creatinine, Grades 3 to 4Creatinine, Grade 1Creatinine, Grade 2Creatinine, Grade 3Creatinine, Grade 4Direct Bilirubin, Grades 1 to 4Direct Bilirubin, Grades 2 to 4Direct Bilirubin, Grades 3 to 4Direct Bilirubin, Grade 1Direct Bilirubin, Grade 2Direct Bilirubin, Grade 3Direct Bilirubin, Grade 4GFR, Grades 1 to 4GFR, Grades 2 to 4GFR, Grades 3 to 4GFR, Grade 1GFR, Grade 2GFR, Grade 3GFR, Grade 4Hypercalcaemia, Grades 1 to 4Hypercalcaemia, Grades 2 to 4Hypercalcaemia, Grades 3 to 4Hypercalcemia, Grade 1Hypercalcaemia, Grade 2Hypercalcaemia, Grade 3Hypercalcaemia, Grade 4Hyperglycaemia, Grades 1 to 4Hyperglycaemia, Grades 2 to 4Hyperglycaemia, Grades 3 to 4Hyperglycaemia, Grade 1Hyperglycaemia, Grade 2Hyperglycaemia, Grade 3Hyperglycaemia, Grade 4Hyperkalemia, Grades 1 to 4Hyperkalemia, Grades 2 to 4Hyperkalemia, Grades 3 to 4Hyperkalemia, Grade 1Hyperkalemia, Grade 2Hyperkalemia, Grade 3Hyperkalemia, Grade 4Hypernatremia, Grades 1 to 4Hypernatremia, Grades 2 to 4Hypernatremia, Grades 3 to 4Hypernatremia, Grade 1Hypernatremia, Grade 2Hypernatremia, Grade 3Hypernatremia, Grade 4Hypocalcaemia, Grades 1 to 4Hypocalcaemia, Grades 2 to 4Hypocalcaemia, Grades 3 to 4Hypocalcaemia, Grade 1Hypocalcaemia, Grade 2Hypocalcaemia, Grade 3Hypocalcaemia, Grade 4Hypoglycaemia, Grades 1 to 4Hypoglycaemia, Grades 2 to 4Hypoglycaemia, Grades 3 to 4Hypoglycaemia, Grade 1Hypoglycaemia, Grade 2Hypoglycaemia, Grade 3Hypoglycaemia, Grade 4Hypokalemia, Grades 1 to 4Hypokalemia, Grades 2 to 4Hypokalemia, Grades 3 to 4Hypokalemia, Grade 1Hypokalemia, Grade 2Hypokalemia, Grade 3Hypokalemia, Grade 4Hyponatremia, Grades 1 to 4Hyponatremia, Grades 2 to 4Hyponatremia, Grades 3 to 4Hyponatremia, Grade 1Hyponatremia, Grade 2Hyponatremia, Grade 3Hyponatremia, Grade 4LDL Cholesterol, Grades 1 to 4LDL Cholesterol, Grades 2 to 4LDL Cholesterol, Grades 3 to 4LDL Cholesterol, Grade 1LDL Cholesterol, Grade 2LDL Cholesterol, Grade 3LDL Cholesterol, Grade 4Lactate Dehydrogenase, Grades 1 to 4Lactate Dehydrogenase, Grades 2 to 4Lactate Dehydrogenase, Grades 3 to 4Lactate Dehydrogenase, Grade 1Lactate Dehydrogenase, Grade 2Lactate Dehydrogenase, Grade 3Lactate Dehydrogenase, Grade 4Lipase, Grades 1 to 4Lipase, Grades 2 to 4Lipase, Grades 3 to 4Lipase, Grade 1Lipase, Grade 2Lipase, Grade 3Lipase, Grade 4Phosphate, Grades 1 to 4Phosphate, Grades 2 to 4Phosphate, Grades 3 to 4Phosphate, Grade 1Phosphate, Grade 2Phosphate, Grade 3Phosphate, Grade 4Triglycerides, Grades 1 to 4Triglycerides, Grades 2 to 4Triglycerides, Grades 3 to 4Triglycerides, Grade 1Triglycerides, Grade 2Triglycerides, Grade 3Triglycerides, Grade 4
DTG + 3TC - Double-blind Phase + Open-label Phase773013471767220020010208200713015411587461343390411110010110009823175221091492942201118185013500111111001101981982001782004004000106493574621721510141031001761115102264162319009000230023000662164515604301300723793528637550725437089224671840
DTG + TDF/FTC - Double-blind Phase + Open-label Phase712915421487111001017311421083321451181135616340132111140107400501203812008347283619111728212611010101000100219219290190281511400186383483521711601070070002111310821215116401510410022311920140132271120200200081431738261347851727447075151601410

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Number of Participants With HIV-1 Disease Progression up to Week 144

HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progressions summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death. Participants may have more than one indicators of clinical disease progression including death, hence they may contribute to data in more than one categories. (NCT02831764)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
No disease progressionFrom CDC Stage 1 to CDC Stage 3 EventFrom CDC Stage 2 to CDC Stage 3 EventFrom CDC Stage 3 to New CDC Stage 3 EventFrom CDC Stage 1, 2 or 3 to Death
DTG + 3TC - Double-blind Phase + Open-label Phase3560212
DTG + TDF/FTC - Double-blind Phase + Open-label Phase3570101

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Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) up to Week 148

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or protocol-defined event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment. (NCT02831764)
Timeframe: Up to Week 148

,
InterventionParticipants (Count of Participants)
Any AEAny SAE
DTG + 3TC - Double-blind Phase + Open-label Phase30639
DTG + TDF/FTC - Double-blind Phase + Open-label Phase30947

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Number of Participants With AEs by Maximum Severity Grades up to Week 148

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. (NCT02831764)
Timeframe: Up to Week 148

,
InterventionParticipants (Count of Participants)
Grade 1 AEsGrade 2 AEsGrade 3 AEsGrade 4 AEsGrade 5 AEs
DTG + 3TC - Double-blind Phase + Open-label Phase542113272
DTG + TDF/FTC - Double-blind Phase + Open-label Phase542054361

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Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. (NCT02831764)
Timeframe: Up to Weeks 24, 48 and 96

,
InterventionParticipants (Count of Participants)
Week 24Week 48Week 96
DTG + 3TC - Double-blind Phase6810
DTG + TDF/FTC - Double-blind Phase4812

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Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 96

,
InterventionCells/mm^3 (Mean)
Baseline plasma HIV-1 RNA,<=100000, n=259,260Baseline plasma HIV-1 RNA,>100000, n=59,67Baseline CD4+ cell count,<=200, n=25, 23Baseline CD4+ cell count,>200, n=293, 304Age group-1, <35,n= 186, 187Age group-1, 35 to <50, n=101, 110Age group-1, >=50, n=31, 30Female, n=44, 40Male, n=274, 287Race group, White, n=221, 234Race group, African Am/African H., n=35, 30Race group, Asian, n=31, 27Race group, Other, n=31, 36
DTG + 3TC - Double-blind Phase257.9312.1229.4272.3266.0273.6265.8312.7261.4272.1246.3224.0312.0
DTG + TDF/FTC - Double-blind Phase257.5297.4202.9269.4257.7286.8233.1307.6259.3258.3303.7264.0278.9

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Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 48

,
InterventionCells/mm^3 (Least Squares Mean)
Baseline plasma HIV-1 RNA,<=100000, n=273,271Baseline plasma HIV-1 RNA,>100000, n=64,69Baseline CD4+ cell count,<=200, n=28, 25Baseline CD4+ cell count,>200, n=309, 315Age group-1, <35,n= 193, 191Age group-1, 35 to <50, n=112, 117Age group-1, >=50, n=32, 32Age group-2, <50,n= 305, 308Age group-2, >=50, n= 32, 32Female, n=48, 41Male, n=289, 299Race group, White, n=230, 244Race group, African Am/African H., n=42, 31Race group, Asian, n=33, 27Race group, Other, n=32, 38
DTG + 3TC - Double-blind Phase215.6261.8210.9225.8234.2212.7209.1226.4208.5236.2222.8225.5201.2204.9270.2
DTG + TDF/FTC - Double-blind Phase208.7248.7153.2221.7201.7244.2203.9217.8204.1263.6210.0214.2239.0189.3232.6

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Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 24

,
InterventionCells/mm^3 (Mean)
Baseline plasma HIV-1 RNA,<=100000, n=283,273Baseline plasma HIV-1 RNA,>100000, n=66,72Baseline CD4+ cell count,<=200, n=29, 26Baseline CD4+ cell count,>200, n=320, 319Age group, <35,n= 201, 193Age group-1, 35 to <50, n=113, 119Age group-1, >=50, n=35, 33Female, n=52, 42Male, n=297, 303Race group, White, n=236, 243Race group, African Am/African H., n=48, 34Race group, Asian, n=33, 28Race group, Other, n=32, 40
DTG + 3TC - Double-blind Phase186.01193.90167.95189.91190.12180.50198.74213.58183.41186.48195.18154.03222.21
DTG + TDF/FTC - Double-blind Phase148.21220.71106.23167.35151.13190.40133.21153.92164.18167.44151.93141.24160.20

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Changes From Baseline in CD4+ Cell Counts at Week 24 and 48

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted least mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Weeks 24, 48

,
InterventionCells/mm^3 (Least Squares Mean)
Week 24, n=349, 345Week 48, n=337, 340
DTG + 3TC - Double-blind Phase188.8225.7
DTG + TDF/FTC - Double-blind Phase163.2217.2

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Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 144

,
InterventionCells/mm^3 (Mean)
Baseline plasma HIV-1 RNA,<=100000, n=241,234Baseline plasma HIV-1 RNA,>100000, n=55,58Baseline CD4+ cell count,<=200, n=25, 19Baseline CD4+ cell count,>200, n=271, 273Age group, <35,n=171, 159Age group-1, 35 to <50, n=95, 103Age group-1, >=50, n=30, 30Female, n=40, 37Male, n=256, 255Race group, White, n=202, 211Race group, African Am/African H., n=34, 24Race group, Asian, n=29, 25Race group, Other, n=31, 32
DTG + 3TC - Double-blind Phase + Open-label Phase286.8338.2264.8300.3302.9292.8274.1355.0287.7300.0256.4258.5355.0
DTG + TDF/FTC - Double-blind Phase + Open-label Phase277.8354.7208.9297.9277.1329.2250.0381.8279.6296.5377.6245.4240.7

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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96

Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 96

,
InterventionMilliliter/minute/1.73 meter^2 (Mean)
GFR Cystatin C adjusted, Week 96, n=316,326GFR creatinine adjusted, Week 96, n=315,325
DTG + 3TC - Double-blind Phase9.1-14.2
DTG + TDF/FTC - Double-blind Phase9.5-17.5

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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144

Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 144

,
InterventionMilliliter/minute/1.73 meter^2 (Mean)
GFR Cystatin C adjusted, Week 144, n=301,304GFR creatinine adjusted, Week 144, n=292,292
DTG + 3TC - Double-blind Phase + Open-label Phase10.3-15.5
DTG + TDF/FTC - Double-blind Phase + Open-label Phase10.1-18.2

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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48

Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted) and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48

,
InterventionMilliliter/minute/1.73 meter^2 (Mean)
GFR Cystatin C adjusted, Week 24, n=345,345GFR Cystatin C adjusted, Week 48, n=335,336GFR creatinine adjusted, Week 24, n=346,344GFR creatinine adjusted, Week 48, n=335, 337
DTG + 3TC - Double-blind Phase3.85.4-12.0-12.1
DTG + TDF/FTC - Double-blind Phase0.23.6-15.4-15.4

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Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C and Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48

,
InterventionMilligrams per Liter (mg/L) (Least Squares Mean)
Serum Cystatin C, Week 24, n=345,345Serum Cystatin C, Week 48, n=335,336Serum RBP, Week 24, n=345,343Serum RBP, Week 48, n=334, 334
DTG + 3TC - Double-blind Phase-0.04-0.051.20.6
DTG + TDF/FTC - Double-blind Phase0.00-0.041.4-0.1

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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48

Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48

,
InterventionMicromoles per Liter (umol/L) (Mean)
Serum or Plasma Creatinine, Week 24, n=346, 344Serum or Plasma Creatinine, Week 48, n=335, 337
DTG + 3TC - Double-blind Phase10.5110.32
DTG + TDF/FTC - Double-blind Phase13.5313.44

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Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 96

,
InterventionMillimoles per liter (Mean)
Serum or Plasma Cholesterol, Week 96, n=270, 289HDL Cholesterol, Direct, Week 96, n=271, 289LDL Cholesterol, Week 96, n=270, 289Triglycerides, Week 96, n=271, 289
DTG + 3TC - Double-blind Phase0.3450.1850.1390.105
DTG + TDF/FTC - Double-blind Phase-0.1320.071-0.160-0.102

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Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 144

,
InterventionMillimoles per liter (Mean)
Serum or Plasma Cholesterol, Week 144, n=263, 278HDL Cholesterol, Direct, Week 144, n=264, 278LDL Cholesterol, Week 144, n=263, 278Triglycerides, Week 144, n=264, 278
DTG + 3TC - Double-blind Phase + Open-label Phase0.3600.1800.1430.078
DTG + TDF/FTC - Double-blind Phase + Open-label Phase-0.0150.093-0.085-0.057

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Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24, 48

EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value. (NCT02831764)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48

,
InterventionScores on a scale (Least Squares Mean)
Week 4, n=358, 355Week 24, n=359, 358Week 48, n=359, 358
DTG + 3TC - Double-blind Phase1.83.94.0
DTG + TDF/FTC - Double-blind Phase3.14.54.6

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Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. (NCT02831764)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48

,
InterventionScores on a scale (Least Squares Mean)
Week 4, n=359, 355Week 24, n=360, 358Week 48, n=360, 358
DTG + 3TC - Double-blind Phase0.01110.02070.0189
DTG + TDF/FTC - Double-blind Phase0.01300.02030.0208

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Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96

Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type CTX-1. Adjusted mean is the estimated mean change from Baseline in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 96

,
InterventionMicrograms per Liter (ug/L) (Mean)
Bone-ALP, Week 96, n=315, 326Serum Osteocalcin, Week 96, n=315, 326PINP, Week 96, n=315, 325CTX-1, Week 96, n=311, 318
DTG + 3TC - Double-blind Phase0.260.137.00.0604
DTG + TDF/FTC - Double-blind Phase2.393.9019.50.1787

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Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144

Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type CTX-1. Adjusted mean is the estimated mean change from Baseline in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 144

,
InterventionMicrograms per Liter (ug/L) (Mean)
Bone-ALP, Week 144, n=302, 305Serum Osteocalcin, Week 144, n=300, 304PINP, Week 144, n=299, 300CTX-1, Week 144, n=291, 298
DTG + 3TC - Double-blind Phase + Open-label Phase-0.25-1.02-0.10.0505
DTG + TDF/FTC - Double-blind Phase + Open-label Phase1.882.879.40.1868

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Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48

Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionMicrograms per Liter (ug/L) (Mean)
Bone-ALP, Week 24, n=345, 346Bone-ALP, Week 48, n=334, 337Serum Osteocalcin, Week 24, n=345, 346Serum Osteocalcin, Week 48, n=335, 336PINP, Week 24, n=344, 346PINP, Week 48, n=335, 337CTX-1, Week 24, n=342, 342CTX-1, Week 48, n=332, 333
DTG + 3TC - Double-blind Phase0.721.242.130.401.70.40.15410.1345
DTG + TDF/FTC - Double-blind Phase3.384.336.806.3015.213.30.28120.3388

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Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48

Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48

,
InterventionNanomoles per Liter (nmol/L) (Least Squares Mean)
Serum Vitamin D, Week 24, n=346, 344Serum Vitamin D, Week 48, n=336, 335
DTG + 3TC - Double-blind Phase11.20.3
DTG + TDF/FTC - Double-blind Phase15.40.4

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CD4+ Cell Counts at Weeks 24 and 48

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831764)
Timeframe: Weeks 24 and 48

,
InterventionCells/mm^3 (Mean)
Week 24, n=349,345Week 48, n=337,340
DTG + 3TC - Double-blind Phase650.4688.1
DTG + TDF/FTC - Double-blind Phase633.0689.8

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Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who received at least one dose of study treatment. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 48

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase93
DTG + TDF/FTC - Double-blind Phase94

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 96

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase88
DTG + TDF/FTC - Double-blind Phase90

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 24

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase94
DTG + TDF/FTC - Double-blind Phase94

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 144

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase + Open-label Phase84
DTG + TDF/FTC - Double-blind Phase + Open-label Phase84

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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 96 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 96 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 96

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase6
DTG + TDF/FTC - Double-blind Phase2

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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 144 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 144 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 144

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase + Open-label Phase6
DTG + TDF/FTC - Double-blind Phase + Open-label Phase4

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Number of Participants Who Discontinue Treatment Due to AEs Over Week 144

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. (NCT02831764)
Timeframe: Up to Week 144

InterventionParticipants (Count of Participants)
DTG + 3TC - Double-blind Phase + Open-label Phase13
DTG + TDF/FTC - Double-blind Phase + Open-label Phase16

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Changes From Baseline in CD4+ Cell Counts at Week 96

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Week 96

InterventionCells/mm^3 (Mean)
DTG + 3TC - Double-blind Phase272.0
DTG + TDF/FTC - Double-blind Phase264.6

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Changes From Baseline in CD4+ Cell Counts at Week 144

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Week 144

InterventionCells/mm^3 (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase301.7
DTG + TDF/FTC - Double-blind Phase + Open-label Phase296.6

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Change From Baseline in Renal Biomarker-Serum RBP at Week 96

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 96

InterventionMicrogram per millimoles (ug/mmol) (Mean)
DTG + 3TC - Double-blind Phase0.557
DTG + TDF/FTC - Double-blind Phase2.483

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Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation

Proportion of participants with 0 copies of CAHD per million CD4+ blood-derived CD4+ T-cells (assayed by quantitative PCR [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed. (NCT02859558)
Timeframe: At week 0

,,
InterventionProportion of participants (Number)
Joint Assay (Integrase + Gag)Integrase AssayGag Assay
Arm 1: Fiebig I/II0.000.040.00
Arm 2: Fiebig III/IV0.010.030.01
Arm 3: Fiebig V0.000.070.00

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Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)

Proportion of participants with 0 copies of CAHD per 5 million CD4+ blood-derived CD4+ T-cells (assayed by quantitative polymerase chain reaction [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed. (NCT02859558)
Timeframe: At week 48

,,
InterventionProportion of participants (Number)
Joint Assay (Integrase + Gag)Integrase AssayGag Assay
Arm 1: Fiebig I/II0.000.100.03
Arm 2: Fiebig III/IV0.000.060.02
Arm 3: Fiebig V0.000.100.00

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HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry

"Percent of HIV-1-specific CD8+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero.~Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)" (NCT02859558)
Timeframe: At 48 weeks

,,
InterventionPercentage of CD8+ T-cells (Median)
CD8+ T-cell Response to EnvCD8+ T-cell Response to GagCD8+ T-cell Response to NefCD8+ T-cell Response to Pol
Arm 1: Fiebig I/II0.000.150.030.00
Arm 2: Fiebig III/IV0.000.330.150.05
Arm 3: Fiebig V0.000.280.330.08

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HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry

"Percent of HIV-1-specific CD4+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero.~Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)" (NCT02859558)
Timeframe: At week 48

,,
InterventionPercentage of CD4+ T-cells (Median)
CD4+ T-cell Response to EnvCD4+ T-cell Response to GagCD4+ T-cell Response to NefCD4+ T-cell Response to Pol
Arm 1: Fiebig I/II0.000.060.040.00
Arm 2: Fiebig III/IV0.000.190.100.04
Arm 3: Fiebig V0.080.140.100.04

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Percentage of Patients With HBsAg Negativation

Undetectable HВsAg with appearance of HbsAg antibodies or without it. (NCT02888106)
Timeframe: 48 and 72 weeks

,,,,,
InterventionPercentage of participants (Number)
Week 48 HBsAg negativation with appearance of HbsAg antibodiesWeek 72 HBsAg negativation with appearance of HbsAg antibodiesWeek 48 HBsAg negativation without appearance of HbsAg antibodiesWeek 72 HBsAg negativation without appearance of HbsAg antibodies
Arm A0000
Arm B13.323.16.77.7
Arm C0000
Arm D0000
Arm E6.77.100
Arm F0000

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Percentage of Patients With HВsAg Response

HВsAg response was defined as HBsAg negativation or > 1 log10 IU/mL decline from baseline. (NCT02888106)
Timeframe: 24, 48 and 72 weeks

,,,,,
InterventionPercentage of participants (Number)
Week 24Week 48Week 72
Arm A6.700
Arm B40.046.740.0
Arm C13.320.013.3
Arm D000
Arm E6.76.713.3
Arm F6.700

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Percentage of Patients With Negative HBV DNA by PCR

Percentage of patients with undetectable HBV DNA by PCR at Weeks 24, 48 and 72 (NCT02888106)
Timeframe: 24, 48 and 72 weeks

,,,,,
InterventionPercentage of participants (Number)
Week 24Week 48Week 72
Arm A33.326.733.3
Arm B53.373.366.7
Arm C40.040.040.0
Arm D33.333.340.0
Arm E53.366.726.7
Arm F80.093.346.7

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Percentage of Patients With Normalized ALT

Percentage of patients with normalized ALT at Weeks 24, 48 and 72. ALT normalisation was defined as having an ALT value within the normal range (≤31 U/L for females and ≤41 U/L for males) (NCT02888106)
Timeframe: 24, 48 and 72 weeks

,,,,,
InterventionPercentage of participants (Number)
Week 24Week 48Week 72
Arm A026.710.0
Arm B6.726.753.8
Arm C20.046.733.3
Arm D64.373.323.1
Arm E20.026.735.7
Arm F60.040.035.7

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The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.

Change in liver stiffness and intensity of liver fibrosis based on results of transient elastometry of liver at weeks 48 and 72. (NCT02888106)
Timeframe: 48 and 72 weeks

,,,,,
InterventionkPa (Mean)
Change from baseline to Week 48Change from baseline to Week 72
Arm A-0.67-0.67
Arm B1.970.65
Arm C-0.27-2.06
Arm D-0.660.00
Arm E-2.350.21
Arm F-1.12-1.20

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Percentage of Patients With Negative HDV RNA by PCR

Negativation of HDV RNA by PCR (undetectable HDV RNA) at Week 72 (end of follow-up period) (NCT02888106)
Timeframe: 72 weeks

InterventionPercentage of participants (Number)
Arm A0
Arm B53.3
Arm C26.7
Arm D6.7
Arm E6.7
Arm F33.3

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Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment

"Change (improvement/ worsening) in fibrosis and histological activity stage according to the liver biopsy study results from baseline to post-treatment Liver fibrosis was evaluated by histological staging systems with stage 0 corresponding to absence of fibrosis and with the highest score (the last stage in all systems) corresponding to cirrhosis.~Improvement is defined as a decrease of at least 1 point in histological staging systems; worsening is defined as an increase of at least 1 point.~Data should be interpreted with caution due to low number of paired biopsies available." (NCT02888106)
Timeframe: 72 weeks

InterventionParticipants (Count of Participants)
Ishak fibrosis score72521881Ishak fibrosis score72521882Ishak fibrosis score72521883Ishak fibrosis score72521884Ishak fibrosis score72521885Ishak fibrosis score72521886Knodell fibrosis score72521881Knodell fibrosis score72521883Knodell fibrosis score72521884Knodell fibrosis score72521885Knodell fibrosis score72521882Knodell fibrosis score72521886Metavir fibrosis stage72521883Metavir fibrosis stage72521884Metavir fibrosis stage72521881Metavir fibrosis stage72521882Metavir fibrosis stage72521885Metavir fibrosis stage72521886Metavir activity grade72521884Metavir activity grade72521885Metavir activity grade72521881Metavir activity grade72521882Metavir activity grade72521883Metavir activity grade72521886Histological activity index72521884Histological activity index72521885Histological activity index72521881Histological activity index72521882Histological activity index72521883Histological activity index72521886
ImprovementNo changeWorsening
Arm D4
Arm D2
Arm F2
Arm D1
Arm D3
Arm B4
Arm A0
Arm B0
Arm C1
Arm F7
Arm B1
Arm C3
Arm E3
Arm F3
Arm A2
Arm E1
Arm F4
Arm F8
Arm C2
Arm F5
Arm A1
Arm B2
Arm F1
Arm D6
Arm E2
Arm F9
Arm B3
Arm C0
Arm D0

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Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).

"Molecular analyses of relative HDV RNA expression, relative HBV pregenomic expression, relative total HBV RNA expression (X region), relative HBV RNA expression (S region) from baseline to post-treatment.~*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN." (NCT02888106)
Timeframe: 48 and 72 weeks

,,,,,
InterventionRelative value (Mean)
Relative HDV RNA expressionRelative HBV pregenomic expressionRelative total HBV RNA expression (X region)Relative HBV RNA expression (S region)
Arm A-0.062-0.0280.080-0.688
Arm B-0.068-0.004-1.088-2.295
Arm C0.2960.003-1.295-1.696
Arm D-1.220-0.001-0.282-0.451
Arm E-1.676-0.0410.1600.223
Arm F-0.9750.0490.4030.733

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Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.

"Molecular analyses of total HBV DNA (X region) copies/cell, HBV DNA (S region) copies/cell, cccDNA copies/cell from baseline to post-treatment.~*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN." (NCT02888106)
Timeframe: 48 and 72 weeks

,,,,,
InterventionCopies/cell (Mean)
Total HBV DNA (X region) copies/cellHBV DNA (S region) copies/cellcccDNA copies/cell
Arm A-0.041-0.413-0.045
Arm B-0.027-0.9440.030
Arm C-0.132-0.7470.004
Arm D0.0360.124-0.003
Arm E-0.297-1.545-0.117
Arm F0.0870.1960.058

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Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment

"Molecular analysis of HDAg positive Hepatocytes (percentage of HDAg positive Hepatocytes) from baseline to post-treatment.~*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN." (NCT02888106)
Timeframe: 48 and 72 weeks

,,,,,
InterventionPercentage (Mean)
BaselineChange from baseline to post-treatment
Arm A0.7570.099
Arm B2.178-1.961
Arm C1.209-1.134
Arm D7.550-10.334
Arm E12.521-9.028
Arm F3.641-3.616

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Change in the Gene Expression Analyses From Baseline to Post-treatment

"Change in the gene expression analyses of CXCL10, NTCP, CYP7A1, ISG15, MX1, OAS, HLA-E, TAP1 and USP18 from baseline to post-treatment.~Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN." (NCT02888106)
Timeframe: Weeks 48 - 72

,,,,,
InterventionRelative value (Mean)
CXCL10 relative expressionNTCP relative expressionCYP7A1 relative expressionISG15 relative expressionMX1 relative expressionOAS relative expressionHLA-E relative expressionTAP1 relative expressionUSP18 relative expression
Arm A-0.0170.0010.0020.2070.1750.0670.0380.0000.021
Arm B-0.012-0.0160.002-0.092-0.020-0.019-0.322-0.012-0.003
Arm C0.0100.0010.000-0.003-0.0130.0050.015-0.001-0.003
Arm D-0.0340.0020.001-0.037-0.034-0.015-0.386-0.017-0.005
Arm E0.0030.011-0.001-0.163-0.056-0.0250.1490.007-0.002
Arm F-0.0150.0040.001-0.005-0.0000.003-0.061-0.0040.001

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Percentage of Patients With Combined Response

Combined response is defined as negative HDV RNA and ALT normalization at Weeks 24, 48, and 72. The criteria for combined response were HDV RNA value below LLoD (where LLoD=10 IU/ml) and ALT within normal range (≤31 U/L for females and ≤41 U/L for males) (NCT02888106)
Timeframe: 24, 48 and 72 weeks

,,,,,
InterventionPercentage of participants (Number)
Week 24Week 48Week 72
Arm A06.70
Arm B6.720.046.7
Arm C20.033.313.3
Arm D13.313.36.7
Arm E13.320.06.7
Arm F13.313.313.3

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Percentage of Patients With Negative HDV RNA by PCR

Percentage of patients with negative HDV RNA by PCR (undetectable HDV RNA) at Weeks 24 and 48 (NCT02888106)
Timeframe: 24 and 48 weeks

,,,,,
InterventionPercentage of participants (Number)
Week 24Week 48
Arm A6.713.3
Arm B60.080.0
Arm C60.086.7
Arm D13.313.3
Arm E66.780
Arm F26.746.7

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Steady State Concentrations of TFV-DP for Different Dosing Patterns of Descovy

Tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS) respective to dosing regimens of 33%, 67%, 100% of daily dosing. (NCT02962739)
Timeframe: Assessed weekly for 9 months

Interventionfmol/punch (Mean)
DOT 33%657
DOT 67%1451
DOT 100%2381

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Area Under the Concentration-time Curve (AUC)

Tenofovir and emtricitabine area under the concentration-time curve (AUC) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology. (NCT02968576)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

Interventionng*h/mL (Geometric Mean)
TFV AUC-unencapsulatedTFV AUC-coencapsulatedFTC AUC-unencapsulatedFTC AUC-coencapsulated
All Participants1978204293429512

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Peak Plasma Concentration (Cmax)

Tenofovir and emtricitabine concentration max (Cmax) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology. (NCT02968576)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

Interventionng/mL (Geometric Mean)
TFV Cmax-unencapsulatedTFV Cmax-coencapsulatedFTC Cmax-unencapsulatedFTC Cmax-coencapsulated
All Participants22222915671684

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Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event

"The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.~Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks." (NCT03048422)
Timeframe: From randomization up to 74 weeks

,
InterventionCumulative probability per 100 persons (Number)
Arm 1: Maternal DTG+FTC/TAF25.1
Arm 2: Maternal DTG+FTC/TDF30.8
Arm 3: Maternal EFV/FTC/TDF27.9
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF27.9
Arm 3: Maternal EFV/FTC/TDF27.9

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Maternal Change in Creatinine Clearance

Maternal change in creatinine clearance per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline to 50 weeks postpartum

InterventionmL/min (Mean)
Arm 1: Maternal DTG+FTC/TAF-0.980
Arm 2: Maternal DTG+FTC/TDF-0.887
Arm 3: Maternal EFV/FTC/TDF-0.935

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Percentage of Infants Born Small for Gestational Age

Percentage of infants born small for gestational age (<10th percentile adjusted for sex assigned at birth) based on Intergrowth 21st Standards (NCT03048422)
Timeframe: Birth

Interventionpercentage of participants (Number)
Arm 1 Infants16.3
Arm 2 Infants22.5
Arm 3 Infants20.5

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Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome

Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile by INTERGROWTH 21st Standards) (NCT03048422)
Timeframe: Delivery

Interventionpercentage of mother-infant pairs (Number)
Arm 1: Maternal DTG+FTC/TAF24.1
Arm 2: Maternal DTG+FTC/TDF32.9
Arm 3: Maternal EFV/FTC/TDF32.7

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Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome

Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile per INTERGROWTH 21st Standards) (NCT03048422)
Timeframe: Delivery

Interventionpercentage of mother-infant pairs (Number)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF28.4
Arm 3: Maternal EFV/FTC/TDF32.7

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Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly

Percentage of mother-infant pairs with an adverse pregnancy outcome or major congenital anomaly. Adverse pregnancy outcomes include spontaneous abortions (<20 weeks gestation), stillbirths (≥20 weeks gestation), preterm deliveries (<37 weeks gestation), and infants small for gestational age (<10th percentile per INTERGROWTH 21st Standards). Major congenital anomaly was defined consistent with the definition of malformation provided by Holmes and Westgate (i.e., a structural abnormality with surgical, medical, or cosmetic importance) and evaluated by an internal study team blinded to treatment arm. (NCT03048422)
Timeframe: Delivery through 50 weeks postpartum

Interventionpercentage of mother-infant pairs (Number)
Arm 1: Maternal DTG+FTC/TAF24.1
Arm 2: Maternal DTG+FTC/TDF32.9
Arm 3: Maternal EFV/FTC/TDF33.2

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Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure

Percentage of mothers with HIV-1 antiretroviral (ARV) drug resistance mutations at the time of maternal virologic failure. Virologic failure was defined as two consecutive plasma HIV-1 RNA viral loads <200 copies/mL on or after 24 weeks on study. Drug resistance mutations were assessed using the Stanford algorithm, and all ARV regimens were assessed for mutations. (NCT03048422)
Timeframe: From 24 weeks after randomization through Week 50 postpartum

Interventionpercentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF0.92
Arm 2: Maternal DTG+FTC/TDF1.86
Arm 3: Maternal EFV/FTC/TDF6.16

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Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum

Percentage of mothers with HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: 50 weeks postpartum

Interventionpercentage of participants (Number)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF96.3
Arm 3: Maternal EFV/FTC/TDF96.4

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Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory

Percentage of mothers with HIV-1 RNA less than 50 copies/mL at delivery using batched test results obtained from central laboratory (NCT03048422)
Timeframe: Delivery

Interventionpercentage of participants (Number)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF94.4
Arm 3: Maternal EFV/FTC/TDF78.8

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Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm

Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum based on FDA snapshot algorithm using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: 50 weeks postpartum

Interventionpercentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF75.6
Arm 2: Maternal DTG+FTC/TDF77.7
Arm 3: Maternal EFV/FTC/TDF76.3

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Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm

Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at delivery based on FDA snapshot algorithm using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: Delivery

Interventionpercentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF88.9
Arm 2: Maternal DTG+FTC/TDF92.6
Arm 3: Maternal EFV/FTC/TDF81.0

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Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery

Time to first viral HIV-1 RNA less than 200 copies/mL through delivery, determined using real-time results obtained from site laboratories (NCT03048422)
Timeframe: Randomization to delivery

Interventionweeks (Mean)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF4.26
Arm 3: Maternal EFV/FTC/TDF6.49

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Change in Maternal Weight Antepartum

Change in maternal antepartum weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline through before delivery (up to one day prior)

Interventionkg/week (Mean)
Arm 1: Maternal DTG+FTC/TAF0.378
Arm 2: Maternal DTG+FTC/TDF0.319
Arm 3: Maternal EFV/FTC/TDF0.291

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Change in Maternal Weight Overall

Change in maternal weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline to 50 weeks postpartum

Interventionkg/week (Mean)
Arm 1: Maternal DTG+FTC/TAF-0.027
Arm 2: Maternal DTG+FTC/TDF-0.050
Arm 3: Maternal EFV/FTC/TDF-0.084

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Change in Maternal Weight Postpartum

Change in maternal postpartum weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Delivery to 50 weeks postpartum

Interventionkg/week (Mean)
Arm 1: Maternal DTG+FTC/TAF0.014
Arm 2: Maternal DTG+FTC/TDF-0.008
Arm 3: Maternal EFV/FTC/TDF-0.032

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Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis

Count of infants with HIV-1 antiretroviral drug resistance mutations (to any antiretroviral drug) at the time of infant HIV diagnosis, based on laboratory blood test results. (NCT03048422)
Timeframe: From birth through 50 weeks postpartum

InterventionParticipants (Count of Participants)
Arm 1 Infants1
Arm 2 Infants0
Arm 3 Infants1

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Infant Creatinine Clearance

Infant creatinine clearance based on Schwartz formula (NCT03048422)
Timeframe: Delivery and 26 weeks postpartum

,,
InterventionmL/min (Mean)
Delivery26 Weeks Postpartum
Arm 1 Infants52.7134.8
Arm 2 Infants53.1123.6
Arm 3 Infants49.0135.0

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Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery

Percentage of mothers with plasma HIV-1 RNA viral load less than 200 copies/mL at delivery determined using real-time test results obtained at site laboratories. This outcome was evaluated in the non-inferiority (primary outcome) and superiority (secondary outcome) analyses. The intention-to-treat analysis included all randomized women who had viral load data available. The per-protocol analysis excluded women who modified randomized treatment (stopped, paused, switched, added any treatment) before viral load evaluation at delivery, with the exception of women who modified randomized treatment for use of a concomitant medication. (NCT03048422)
Timeframe: Delivery

,
InterventionPercentage of participants (Number)
Intention-to-Treat AnalysisPer-Protocol Analysis
Arm 3: Maternal EFV/FTC/TDF91.091.4
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF97.597.5

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Percentage of Mother-Infant Pairs With Preterm Deliveries

Percentage of mother-infant pairs with preterm deliveries (<37 weeks gestation) resulting in live born infant (NCT03048422)
Timeframe: Delivery

Interventionpercentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF5.8
Arm 2: Maternal DTG+FTC/TDF9.4
Arm 3: Maternal EFV/FTC/TDF12.1

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Cumulative Probability of Infant Deaths

The Kaplan-Meier estimate of the cumulative probability of infant deaths from birth through 50 weeks after birth. (NCT03048422)
Timeframe: Birth through 50 weeks after birth

InterventionCumulative probability per 100 persons (Number)
Arm 1 Infants1.0
Arm 2 Infants2.0
Arm 3 Infants6.9

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Cumulative Probability of Infant HIV-infection

The Kaplan-Meier estimate of the cumulative probability of infants acquiring HIV-1 infection from birth through 50 weeks after birth based on nucleic acid test results. (NCT03048422)
Timeframe: Birth through 50 weeks after birth

InterventionCumulative probability per 100 persons (Number)
Arm 1 Infants0.98
Arm 2 Infants0.50
Arm 3 Infants0.55

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Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event

The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. (NCT03048422)
Timeframe: Birth through Week 50 postpartum

InterventionCumulative probability per 100 persons (Number)
Arms 1 and 2 Infants26.8
Arm 3 Infants30.9

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Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event

The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. (NCT03048422)
Timeframe: From birth through Week 50 postpartum

InterventionCumulative probability per 100 persons (Number)
Arm 1 Infants25.3
Arm 2 Infants28.6
Arm 3 Infants30.9

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Change From Week 12 Plasma Tenofovir Area Under the Plasma Concentration vs. Time Curve From Time 0 to 24 Hours (AUC0-24) at 24 and 28 Weeks

Compare plasma tenofovir AUC0-24 between TAF with boosted PI vs. TDF with boosted PI (Phase 2 vs. 1), and between TAF with boosted PI and LDV/SOF vs. TDF with boosted PI (Phase 3 vs. 1) (NCT03126370)
Timeframe: 12 weeks and 24 weeks and 28 weeks

Interventionng*h/mL (Geometric Mean)
TDF With a Boosted PI3466
TAF With a Boosted PI743
TAF With a Boosted PI and LDV/SOF868

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Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS)

Compare tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) between TAF with a boosted PI vs. TDF with a boosted PI (Phase 2 vs. 1), and TAF with a boosted PI and LDV/SOF vs. TDF with a boosted PI (Phase 3 vs. 1) (NCT03126370)
Timeframe: 12 weeks and 24 and 28 weeks

Interventionfmol/2x7mm punches (Geometric Mean)
TDF With a Boosted PI36014
TAF With a Boosted PI6735
TAF With a Boosted PI and LDV/SOF6100

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Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs) at 24 and 28 Weeks

Compare tenofovir-diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs) between TAF with a boosted PI vs. TDF with a boosted PI (Phase 2 vs. 1), and TAF with a boosted PI and LDV/SOF vs. TDF with a boosted PI (Phase 3 vs. 1). (NCT03126370)
Timeframe: 12 weeks, and 24 weeks and 28 weeks

Interventionfmol/10^6 cells (Geometric Mean)
TDF With a Boosted PI83.0
TAF With a Boosted PI926
TAF With a Boosted PI and LDV/SOF1129

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Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: eGFR

Change in estimated glomerular filtration rate (eGFR) (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks

InterventionmL/min/1.73 m^2 (Geometric Mean)
TDF With a Boosted PI86.7
TAF With a Boosted PI91.0
TAF With a Boosted PI and LDV/SOF88.1

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Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: UPCR

Change in estimated glomerular filtration rate (eGFR) and renal biomarkers: Urine protein to creatinine ratio (UPCR) (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks

Interventionmg/g (Geometric Mean)
TDF With a Boosted PI134
TAF With a Boosted PI118
TAF With a Boosted PI and LDV/SOF97.3

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Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: B2M/Cr Ratio, and RBP/Cr Ratio

Change in renal biomarkers: urinary beta-2 microglobulin (B2M)/creatinine (Cr) ratio, and urinary retinol binding protein (RBP)/Cr ratio (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks

,,
Interventionug/g (Geometric Mean)
β2M:Cr ratioRBP:Cr ratio
TAF With a Boosted PI224242
TAF With a Boosted PI and LDV/SOF178146
TDF With a Boosted PI419436

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Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2

AEs will be summarized using MedDRA System Organ Class and preferred terms. (NCT03164564)
Timeframe: Treatment emergent AE measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks)

InterventionParticipants (Count of Participants)
Arm A: CAB + Placebo TDF/FTC + CAB LA1487
Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA1486

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Number of Pariicipants With Documented Incident HIV Infections

The number of participants with an incident HIV infection that is confirmed by the HPTN Laboratory Center and Endpoint Adjudication Committee. (NCT03164564)
Timeframe: HIV tests at enrollment, weeks 2, 4, and 5, then every 4 weeks through week 25, then every 8 weeks. Analyzed through week 185 or the date of DSMB decision to unblind all participants, whichever is earliest.

InterventionParticipants (Count of Participants)
Arm A: CAB + Placebo TDF/FTC + CAB LA4
Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA36

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PBMC TFV-DP AUC GMR

The geometric mean ratio (GMR) of the PBMC TFV-DP area under the curve (AUC) comparing the test phase (T) to control phase (C) was assessed. PK samples were collected from 0 to 72 hours post-dose. (NCT03202511)
Timeframe: The first 72 hours of each phase.

Interventionfmol*h/10^6cells (Least Squares Mean)
Treatment Phase7.12
Control Phase7.38

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Plasma TFV AUC0-INF GMR

The geometric mean ratio (GMR) of the plasma TFV area under the curve (AUC) comparing the test phase (T) to control phase (C) was assessed. PK samples were collected from 0 to 72 hours post-dose. (NCT03202511)
Timeframe: The first 72 hours of each phase.

Interventionng*h/mL (Least Squares Mean)
Treatment Phase8.75
Control Phase8.27

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Whole Blood Antiretroviral Concentrations

Concentrations will be measured in dried blood spots of all study drugs, inclusive of FTC (emtricitabine), TFV (tenofovir), MRV (Maraviroc), and DTG (dolutegravir). Truvada is a combination pill, so results for both FTC and TFV are reported in separate columns. (NCT03218592)
Timeframe: Up to 28 days post-dose

,,,
Interventionfmol / 3mm punch (Median)
Phase 1: Single DosePhase 2: 7 Doses per WeekPhase 3: 3 Doses Per WeekPhase 3: 1 Dose Per WeekPhase 3: 0 Doses per week
Dolutegravir10718.560.951010
Emtricitabine50280150.55050
Maraviroc39.185333
Tenofovir50809.5811644.5621

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Plasma Antiretroviral Concentrations

Concentrations will be measured in hair of all study drugs, inclusive of FTC (emtricitabine), TFV (tenofovir), MRV (Maraviroc), and DTG (dolutegravir) (NCT03218592)
Timeframe: Up to 28 days post-dose

,,,
Interventionng/mL (Median)
Phase 1: Single dosePhase2: 7 Doses per WeekPhase 3: 3 Doses Per WeekPhase 3: 1 Dose Per WeekPhase 3: 0 Doses per week
Dolutegravir1124069.33.0951
Emtricitabine0.572.317.21.20.5
Maraviroc19.7151.7111
Tenofovir0.561.99.40.50.5

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Peripheral Blood Mononuclear Cells (PBMC) Antiretroviral Concentrations

Concentrations of emtricitabine-triphosphate, tenofovir-diphosphate will be measured in peripheral blood mononuclear cells in the Truvada arm only. Truvada is a combination pill, so results for both FTC and TFV are reported in separate columns. (NCT03218592)
Timeframe: Up to 28 days post-dose

,
Interventionfmol/10^6 cells (Median)
Phase 1 Single DosePhase 2: 7 Doses per WeekPhase 3: 3 Doses Per WeekPhase 3: 1 Dose Per WeekPhase 3: Zero Doses per week
Emtricitabine (Truvada)27.0944602388.69267.8227.48
Tenfovir (Truvada)2.1127.16015.710.4

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Hair Antiretroviral Imaging

Signal Strength concentrations will be measured in hair for all study drugs, inclusive of FTC (emtricitabine), tenofovir (TFV), maraviroc (MRV), and dolutegravir (DTG) using Matrix-assisted Laser Desorption Electrospray Ionization (IR-MALDESI) to be reported by signal abundance (au). Signal abundance is the industry standard unit, and higher values represent greater signal with capability to relate to comparative concentrations. (NCT03218592)
Timeframe: Up to 28 days post dose

,,
InterventionSignal Abundance (au) (Median)
Phase 3: Zero Doses Per WeekPhase 3: 1 Dose Per weekPhase 3: 3 Doses Per WeekPhase 2: Daily DosingPhase 1: Single Dose
Dolutegravir1092.1308682377.8682265504.88316914251.46653NA
Maraviroc156.48266563942.69239627814.9882346013.29104NA
Truvada0.501209156.1127125466.7986895824.721385NA

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Percentage of Eosinophils at Indicated Time Points

Blood samples were collected for the analysis of hematology parameter: eosinophils. Mean and standard deviation values for percentage of eosinophils reported was presented. (NCT03258710)
Timeframe: At Weeks 36 , 48, 60, 72, 84 and 96

InterventionPercentage of eosinophils (Mean)
Week 36, n=32Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate2.442.942.853.092.842.57

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Percentage of Basophils at Indicated Time Points

Blood samples were collected for the analysis of hematology parameter: basophils. Mean and standard deviation values for percentage of basophils reported was presented. (NCT03258710)
Timeframe: At Weeks 36, 48, 60, 72, 84 and 96

InterventionPercentage of basophils (Mean)
Week 36, n=32Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate0.460.490.570.500.540.57

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Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Values

Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Abnormal values with clinically significant and not clinically significant values has been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. (NCT03258710)
Timeframe: Up to Week 96

InterventionParticipants (Count of Participants)
Abnormal-not clinically significantAbnormal-clinically significant
Tenofovir Disoproxil Fumarate201

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Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96

Urine samples were collected for analysis of urinalysis data for glucose, protein and urinary sediment by dipstick method. The urine sediments analyzed were amorphous phosphate crystals, amorphous urate crystals, bacteria, calcium oxalate crystals, ammonium magnesium phosphate, renal tubular epithelial cells (RTEC), fungi, hyaline casts, mucous threads, RBCs, spermatozoa, squamous epithelial cells (SEC), transitional epithelial cells (TEC), uric acid crystals (UAC) and WBCs. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample. Results for RTEC, hyaline casts, RBC, SEC, TEC and WBC can be read as counts per field (some/ every/ whole field). Only abnormal parameters and participants with abnormal data has been reported. (NCT03258710)
Timeframe: Weeks 60, 72, 84 and 96

InterventionParticipants (Count of Participants)
Amorphous phosphate crystals, Week 60, 1+Amorphous phosphate crystals, Week 72, 1+Amorphous phosphate crystals, Week 84, 1+Amorphous urate crystals, Week 60, 1+Amorphous urate crystals, Week 72, 1+Amorphous urate crystals, Week 84, 1+Amorphous urate crystals, Week 96, 1+Bacteria, Week 60, 1+Bacteria, Week 72, 1+Bacteria, Week 72, 2+Bacteria, Week 84, 1+Bacteria, Week 84, 2+Bacteria, Week 96, 1+Bacteria, Week 96, 2+Calcium oxalate crystals, Week 60, 1+Calcium oxalate crystals, Week 72, 1+Calcium oxalate crystals, Week 84, 1+Calcium oxalate crystals, Week 96, 1+RTEC, Week 60, 0-0.1/Some FieldRTEC, Week 60, 0.2-0.4/Some FieldRTEC, Week 60, 1-2/Every FieldRTEC, Week 72, 0-0.1/Some FieldRTEC, Week 72, 0.2-0.4/Some FieldRTEC, Week 84, 0-0.1/Some FieldRTEC, Week 84, 0.2-0.4/Some FieldRTEC, Week 84, 1-2/Every FieldRTEC, Week 84, 3-5/Every FieldRTEC, Week 96, 0-0.1/Some FieldRTEC, Week 96, 0.2-0.4/Some FieldRTEC, Week 96, 1-2/Every FieldUrine glucose, Week 60, 3+Urine glucose, Week 72, 1+Urine glucose, Week 72, 2+Hyaline casts, Week 60, 0-0.1/Some FieldHyaline casts, Week 72, 0-0.1/Some FieldHyaline casts, Week 72, 0.2-0.4/Some FieldHyaline casts, Week 84, 0-0.1/Some FieldHyaline casts, Week 84, 1-2/Whole FieldHyaline casts, Week 84, 3-5/Whole FieldHyaline casts, Week 96, 0-0.1/Some FieldHyaline casts, Week 96, 0.2-0.4/Some FieldHyaline casts, Week 96, 3-5/Whole FieldMucus threads, Week 60, 1+Mucus threads, Week 72, 1+Mucus threads, Week 84, 1+Mucus threads, Week 96, 1+Urine protein, Week 60, 1+Urine protein, Week 60, TraceUrine protein, Week 72, 1+Urine protein, Week 72, TraceUrine protein, Week 84, 1+Urine protein, Week 84, TraceUrine protein, Week 96, 1+Urine protein, Week 96, TraceRBC, Week 60, 0-0.1/Some FieldRBC, Week 60, 0.2-0.4/Some FieldRBC, Week 60, 1-2/Every FieldRBC, Week 60, 3-5/Every FieldRBC, Week 60, 6-10/Every FieldRBC, Week 60, 10-20/Every FieldRBC, Week 60, 30-50/Every FieldRBC, Week 72, 0-0.1/Some FieldRBC, Week 72, 0.2-0.4/Some FieldRBC, Week 72, 1-2/Every FieldRBC, Week 72, 3-5/Every FieldRBC, Week 72, 30-50/Every FieldRBC, Week 84, many/Every FieldRBC, Week 84, 0-0.1/Some FieldRBC, Week 84, 0.2-0.4/Some FieldRBC, Week 84, 1-2/Every FieldRBC, Week 84, 3-5/Every FieldRBC, Week 84, 6-10/Every FieldRBC, Week 84, 20-30/Every FieldRBC, Week 84, 30-50/Every FieldRBC, Week 96, many/Every FieldRBC, Week 96, 0-0.1/Some FieldRBC, Week 96, 0.2-0.4/Some FieldRBC, Week 96, 1-2/Every FieldRBC, Week 96, 3-5/Every FieldRBC, Week 96, 10-20/Every FieldSpermatozoa, Week 84, 1+SEC, Week 60, 0-0.1/Some FieldSEC, Week 60, 0.2-0.4/Some FieldSEC, Week 60, 1-2/Every FieldSEC, Week 60, 3-5/Every FieldSEC, Week 60, 10-20/Every FieldSEC, Week 60, 20-30/Every FieldSEC, Week 72, 0-0.1/Some FieldSEC, Week 72, 0.2-0.4/Some FieldSEC, Week 72, 1-2/Every FieldSEC, Week 72, 3-5/Every FieldSEC, Week 72, 6-10/Every FieldSEC, Week 72, 10-20/Every FieldSEC, Week 72, 20-30/Every FieldSEC, Week 84, many/Every FieldSEC, Week 84, 0-0.1/Some FieldSEC, Week 84, 0.2-0.4/Some FieldSEC, Week 84, 1-2/Every FieldSEC, Week 84, 3-5/Every FieldSEC, Week 84, 6-10/Every FieldSEC, Week 96, 0-0.1/Some FieldSEC, Week 96, 0.2-0.4/Some FieldSEC, Week 96, 1-2/Every FieldSEC, Week 96, 3-5/Every FieldSEC, Week 96, 6-10/Every FieldSEC, Week 96, 10-20/Every FieldTEC, Week 60, 0-0.1/Some FieldTEC, Week 60, 0.2-0.4/Some FieldTEC, Week 72, 0-0.1/Some FieldTEC, Week 84, 0-0.1/Some FieldTEC, Week 96, 0-0.1/Some FieldUAC, Week 60, 1+UAC, Week 72, 1+UAC, Week 96, 1+WBC, Week 60, 0-0.1/Some FieldWBC, Week 60, 0.2-0.4/Some FieldWBC, Week 60, 1-2/Every FieldWBC, Week 60, 3-5/Every FieldWBC, Week 60, 6-10/Every FieldWBC, Week 60, 10-20/Every FieldWBC, Week 72, 0-0.1/Some FieldWBC, Week 72, 0.2-0.4/Some FieldWBC, Week 72, 1-2/Every FieldWBC, Week 72, 3-5/Every FieldWBC, Week 72, 6-10/Every FieldWBC, Week 72, 30-50/Every FieldWBC, Week 84, many/Every FieldWBC, Week 84, 0-0.1/Some FieldWBC, Week 84, 0.2-0.4/Some FieldWBC, Week 84, 1-2/Every FieldWBC, Week 84, 10-20/Every FieldWBC, Week 84, 20-30/Every FieldWBC, Week 84, 30-50/Every FieldWBC, Week 96, 0-0.1/Some FieldWBC, Week 96, 0.2-0.4/Some FieldWBC, Week 96, 1-2/Every FieldWBC, Week 96, 6-10/Every FieldWBC, Week 96, 20-30/Every Field
Tenofovir Disoproxil Fumarate222328315739291141216419711459421152111144121121327151819111214217311351712512145111232140915321114411114115279221556512131528542564812131735112381912211391972512471263114118841

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Absolute Values for Hematology Parameter: Hemoglobin

Blood samples were collected for the analysis of hematology parameter, hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionGrams per liter (Mean)
Baseline (Day 1), n=75Week 4, n=75Week 12, n=74Week 24, n=74Week 36, n=73Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate148.2148.9148.4146.3144.1146.5147.1146.4144.6146.4

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Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Blood pressure of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionMillimeters of mercury (Mean)
SBP, Baseline (Day 1), n=75SBP, Week 4, n=75SBP, Week 12, n=74SBP, Week 24, n=74SBP, Week 36, n=73SBP, Week 48, n=73SBP, Week 60, n=73SBP, Week 72, n=73SBP, Week 84, n=72SBP, Week 96, n=72DBP, Baseline (Day 1), n=75DBP, Week 4, n=75DBP, Week 12, n=74DBP, Week 24, n=74DBP, Week 36, n=73DBP, Week 48, n=73DBP, Week 60, n=73DBP, Week 72, n=73DBP, Week 84, n=72DBP, Week 96, n=72
Tenofovir Disoproxil Fumarate122.5122.9124.9121.9121.5122.5124.7124.2122.1120.876.075.278.175.675.377.878.077.576.376.1

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Absolute Values for Hematology Parameter: Prothrombin Time

Blood samples were collected for the analysis of hematology parameter, prothrombin time. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionSeconds (Mean)
Baseline (Day 1), n=75Week 4, n=75Week 12, n=74Week 24, n=74Week 36, n=73Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate11.8211.9111.9511.7611.9412.7112.3212.4012.5812.78

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Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count

Blood samples were collected for the analysis of hematology parameter, RBC count. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionTrillion cells per liter (Mean)
Baseline (Day 1), n=75Week 4, n=75Week 12, n=74Week 24, n=74Week 36, n=73Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate4.7854.8414.8654.8204.7044.7804.8194.7934.7574.777

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Absolute Values for Hematology Parameter: Hematocrit

Blood samples were collected for the analysis of hematology parameter, hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionProportion of red blood cells in blood (Mean)
Baseline (Day 1), n=75Week 4, n=75Week 12, n=74Week 24, n=74Week 36, n=73Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate0.43930.44410.44520.43670.42830.43500.43980.43910.43390.4355

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Absolute Values for Heart Rate

Heart rate of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionBeats per minute (Mean)
Baseline (Day 1), n=75Week 4, n=75Week 12, n=74Week 24, n=74Week 36, n=73Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate74.775.876.074.874.375.375.874.975.573.1

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Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid

Blood samples were collected for the analysis of clinical chemistry parameters: direct bilirubin, total bilirubin, creatinine and uric acid. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionMicromoles per liter (Mean)
Direct bilirubin, Baseline (Day 1), n=75Direct bilirubin, Week 4, n=75Direct bilirubin, Week 12, n=74Direct bilirubin, Week 24, n=74Direct bilirubin, Week 36, n=73Direct bilirubin, Week 48, n=73Direct bilirubin, Week 60, n=73Direct bilirubin, Week 72, n=73Direct bilirubin, Week 84, n=72Direct bilirubin, Week 96, n=72Total bilirubin, Baseline (Day 1), n=75Total bilirubin, Week 4, n=75Total bilirubin, Week 12, n=74Total bilirubin, Week 24, n=74Total bilirubin, Week 36, n=73Total bilirubin, Week 48, n=73Total bilirubin, Week 60, n=73Total bilirubin, Week 72, n=73Total bilirubin, Week 84, n=72Total bilirubin, Week 96, n=72Creatinine, Baseline (Day 1), n=75Creatinine, Week 4, n=75Creatinine, Week 12, n=74Creatinine, Week 24, n=74Creatinine, Week 36, n=73Creatinine, Week 48, n=73Creatinine, Week 60, n=73Creatinine, Week 72, n=73Creatinine, Week 84, n=72Creatinine, Week 96, n=72Uric acid, Baseline (Day 1), n=75Uric acid, Week 4, n=75Uric acid, Week 12, n=74Uric acid, Week 24, n=74Uric acid, Week 36, n=73Uric acid, Week 48, n=73Uric acid, Week 60, n=73Uric acid, Week 72, n=73Uric acid, Week 84, n=72Uric acid, Week 96, n=72
Tenofovir Disoproxil Fumarate3.8993.9443.9284.0213.9594.0293.6073.9593.9194.41810.69310.0099.89010.58410.51810.6359.55710.23710.28411.32962.999764.166665.810265.296565.985265.912565.319165.488766.557867.3436333.0880322.9367323.3622321.3528320.9476320.8661309.3775318.0958318.0528328.0487

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Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN)

Blood samples were collected for the analysis of clinical chemistry parameters: calcium, chloride, glucose, potassium, lactic acid, sodium, phosphorus inorganic and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionMillimoles per liter (Mean)
Calcium, Baseline (Day 1), n=75Calcium, Week 4, n=75Calcium, Week 12, n=74Calcium, Week 24, n=74Calcium, Week 36, n=73Calcium, Week 48, n=73Calcium, Week 60, n=73Calcium, Week 72, n=73Calcium, Week 84, n=72Calcium, Week 96, n=72Chloride, Baseline (Day 1), n=75Chloride, Week 4, n=75Chloride, Week 12, n=74Chloride, Week 24, n=74Chloride, Week 36, n=73Chloride, Week 48, n=73Chloride, Week 60, n=73Chloride, Week 72, n=73Chloride, Week 84, n=72Chloride, Week 96, n=72Glucose, Baseline (Day 1), n=75Glucose, Week 4, n=75Glucose, Week 12, n=74Glucose, Week 24, n=74Glucose, Week 36, n=73Glucose, Week 48, n=73Glucose, Week 60, n=73Glucose, Week 72, n=73Glucose, Week 84, n=72Glucose, Week 96, n=72Potassium, Baseline (Day 1), n=75Potassium, Week 4, n=75Potassium, Week 12, n=74Potassium, Week 24, n=74Potassium, Week 36, n=73Potassium, Week 48, n=73Potassium, Week 60, n=73Potassium, Week 72, n=73Potassium, Week 84, n=72Potassium, Week 96, n=72Lactic acid, Baseline (Day 1), n=75Lactic acid, Week 4, n=75Lactic acid, Week 12, n=74Lactic acid, Week 24, n=74Lactic acid, Week 36, n=73Lactic acid, Week 48, n=73Lactic acid, Week 60, n=73Lactic acid, Week 72, n=73Lactic acid, Week 84, n=72Lactic acid, Week 96, n=72Sodium, Baseline (Day 1), n=75Sodium, Week 4, n=75Sodium, Week 12, n=74Sodium, Week 24, n=74Sodium, Week 36, n=73Sodium, Week 48, n=73Sodium, Week 60, n=73Sodium, Week 72, n=73Sodium, Week 84, n=72Sodium, Week 96, n=72Phosphorus inorganic, Baseline (Day 1), n=75Phosphorus inorganic, Week 4, n=75Phosphorus inorganic, Week 12, n=74Phosphorus inorganic, Week 24, n=74Phosphorus inorganic, Week 36, n=73Phosphorus inorganic, Week 48, n=73Phosphorus inorganic, Week 60, n=73Phosphorus inorganic, Week 72, n=73Phosphorus inorganic, Week 84, n=72Phosphorus inorganic, Week 96, n=72BUN, Baseline (Day 1), n=75BUN, Week 4, n=75BUN, Week 12, n=74BUN, Week 24, n=74BUN, Week 36, n=73BUN, Week 48, n=73BUN, Week 60, n=73BUN, Week 72, n=73BUN, Week 84, n=72BUN, Week 96, n=72
Tenofovir Disoproxil Fumarate2.2907432.2724462.2653932.2512322.2571212.2977922.3169322.2974512.2898562.306489103.5103.3103.5103.9104.0103.6103.6104.1104.9104.35.8322515.7042085.5907575.6522685.5829375.7091655.8878625.8011755.9387995.5440614.074.074.044.034.024.054.094.104.034.051.104671.023421.075351.049701.060891.028651.151821.063321.125260.93703141.6141.9142.3142.2142.0142.0142.2142.0142.0141.31.0720281.0315581.0612061.0524791.0615891.0730901.0713201.0823781.0709521.0951694.895184.807124.865814.965194.864494.712894.848844.868894.700004.65389

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Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase

Blood samples were collected for the analysis of clinical chemistry parameters: amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionUnits per liter (Mean)
Amylase, Baseline (Day 1), n=75Amylase, Week 4, n=75Amylase, Week 12, n=74Amylase, Week 24, n=74Amylase, Week 36, n=73Amylase, Week 48, n=73Amylase, Week 60, n=73Amylase, Week 72, n=73Amylase, Week 84, n=72Amylase, Week 96, n=72Lipase, Baseline (Day 1), n=75Lipase, Week 4, n=75Lipase, Week 12, n=74Lipase, Week 24, n=74Lipase, Week 36, n=73Lipase, Week 48, n=73Lipase, Week 60, n=73Lipase, Week 72, n=73Lipase, Week 84, n=72Lipase, Week 96, n=72
Tenofovir Disoproxil Fumarate87.389.588.283.782.384.992.288.884.486.740.041.939.136.036.936.239.137.133.534.2

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Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24, 48 and 96

Blood samples were collected to evaluate the percentage of participants who achieved HBeAg/Ab seroconversion at Weeks 24, 48 and 96. Seroconversion of HBeAg means antigen is negative and antibody is positive. HBeAg Seroconversion percentage is defined as number of participants with HBeAg/Ab Seroconversion divided by number of participants with positive HBeAg and Negative HBeAb at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: At Weeks 24, 48 and 96

InterventionPercentage of Participants (Number)
Week 24Week 48Week 96
Tenofovir Disoproxil Fumarate81325

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Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH)

Blood samples were collected for the analysis of clinical chemistry parameters: ALP, ALT, AST, CPK, GGT and LDH. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionInternational units per liter (Mean)
ALP, Baseline (Day 1), n=75ALP, Week 4, n=75ALP, Week 12, n=74ALP, Week 24, n=74ALP, Week 36, n=73ALP, Week 48, n=73ALP, Week 60, n=73ALP, Week 72, n=73ALP, Week 84, n=72ALP, Week 96, n=72ALT, Baseline (Day 1), n=75ALT, Week 4, n=75ALT, Week 12, n=74ALT, Week 24, n=74ALT, Week 36, n=73ALT, Week 48, n=73ALT, Week 60, n=73ALT, Week 72, n=73ALT, Week 84, n=72ALT, Week 96, n=72AST, Baseline (Day 1), n=75AST, Week 4, n=75AST, Week 12, n=74AST, Week 24, n=74AST, Week 36, n=73AST, Week 48, n=73AST, Week 60, n=73AST, Week 72, n=73AST, Week 84, n=72AST, Week 96, n=72CPK, Baseline (Day 1), n=75CPK, Week 4, n=75CPK, Week 12, n=74CPK, Week 24, n=74CPK, Week 36, n=73CPK, Week 48, n=73CKP, Week 60, n=73CKP, Week 72, n=73CKP, Week 84, n=72CKP, Week 96, n=72GGT, Baseline (Day 1), n=75GGT, Week 4, n=75GGT, Week 12, n=74GGT, Week 24, n=74GGT, Week 36, n=73GGT, Week 48, n=73GGT, Week 60, n=73GGT, Week 72, n=73GGT, Week 84, n=72GGT, Week 96, n=72LDH, Baseline (Day 1), n=75LDH, Week 4, n=75LDH, Week 12, n=74LDH, Week 24, n=74LDH, Week 36, n=73LDH, Week 48, n=73LDH, Week 60, n=73LDH, Week 72, n=73LDH, Week 84, n=72LDH, Week 96, n=72
Tenofovir Disoproxil Fumarate210.4227.6243.1242.1245.3249.4253.1249.2237.6237.723.528.327.927.525.927.026.624.226.326.422.726.125.825.524.625.725.124.125.024.9138.9151.0144.5127.9131.9148.7134.1143.3127.4132.330.931.631.530.427.627.828.225.627.427.8165.2173.9171.0169.4170.3175.3174.4174.6172.7173.2

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Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein

Blood samples were collected for the analysis of clinical chemistry parameters: albumin and total protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionGrams per liter (Mean)
Albumin, Baseline (Day 1), n=75Albumin, Week 4, n=75Albumin, Week 12, n=74Albumin, Week 24, n=74Albumin, Week 36, n=73Albumin, Week 48, n=73Albumin, Week 60, n=73Albumin, Week 72, n=73Albumin, Week 84, n=72Albumin, Week 96, n=72Total protein, Baseline (Day 1) n=75Total protein, Week 4, n=75Total protein, Week 12, n=74Total protein, Week 24, n=74Total protein, Week 36, n=73Total protein, Week 48, n=73Total protein, Week 60, n=73Total protein, Week 72, n=73Total protein, Week 84, n=72Total protein, Week 96, n=72
Tenofovir Disoproxil Fumarate44.744.945.244.544.244.845.144.944.645.472.472.673.172.071.772.672.872.472.473.0

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Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR)

Blood samples were collected for the analysis of clinical chemistry parameter, GFR. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionMilliliters per second per 1.73*meter^2 (Mean)
Baseline (Day 1), n=75Week 4, n=75Week 12, n=74Week 24, n=74Week 36, n=73Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate1.469811.438251.392821.402281.379711.385641.395011.389981.362991.34355

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Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance

Blood samples were collected for the analysis of clinical chemistry parameter, creatinine clearance. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionMilliliters per minute (Mean)
Baseline (Day 1), n=75Week 4, n=75Week 12, n=74Week 24, n=74Week 36, n=73Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate114.06112.50108.76108.86105.23105.50107.51106.73104.00101.47

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Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)

Blood samples were collected for the analysis of clinical chemistry parameter, AFP. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionMicrograms per liter (Mean)
Baseline (Day 1), n=75Week 4, n=75Week 12, n=74Week 24, n=74Week 36, n=73Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate3.133.393.463.503.483.553.503.273.103.18

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Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count

Blood samples were collected for the analysis of hematology parameters: platelet count and WBC count. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionGiga cells per liter (Mean)
Platelet count, Baseline (Day 1), n=75Platelet count, Week 4, n=75Platelet count, Week 12, n=74Platelet count, Week 24, n=74Platelet count, Week 36, n=73Platelet count, Week 48, n=73Platelet count, Week 60, n=73Platelet count, Week 72, n=73Platelet count, Week 84, n=72Platelet count, Week 96, n=72WBC count, Baseline (Day 1), n=75WBC count, Week 4, n=75WBC count, Week 12, n=74WBC count, Week 24, n=74WBC count, Week 36, n=73WBC count, Week 48, n=73WBC count, Week 60, n=73WBC count, Week 72, n=73WBC count, Week 84, n=72WBC count, Week 96, n=72
Tenofovir Disoproxil Fumarate226.7227.1228.9226.1231.4229.9231.8224.9224.8226.65.185.215.305.064.995.164.845.005.005.08

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Percentage of Participants Who Achieved 0.25 Log10 HBsAg Reduction From the Baseline at Weeks 24 and 96

Blood samples were collected to evaluate the HBsAg reduction potential from Baseline at Weeks 24 and 96. HBsAg reduction potential was obtained by evaluating log10 observation values minus log10 Baseline values. Data for HBsAg responders have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 24 and 96

InterventionPercentage of Participants (Number)
Week 24Week 96
Tenofovir Disoproxil Fumarate112

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Absolute Values for Temperature

Temperature of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

Interventiondegrees Celsius (Mean)
Baseline (Day 1), n=75Week 4, n=75Week 12, n=74Week 24, n=74Week 36, n=73Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate36.4136.4336.4036.4336.4536.4136.4336.4236.4636.40

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Change From Baseline Log Values for HBcrAg Titer at Weeks 24, 48 and 96

Blood samples were collected to evaluate the HBcrAg titer at Weeks 24, 48 and 96. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 24, 48 and 96

InterventionLog Kilounits per Liter (Mean)
Week 24, n=74Week 48, n=73Week 96, n=72
Tenofovir Disoproxil Fumarate-0.12-0.17-0.30

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Change From Baseline Log Values for HBsAg Titer at Weeks 24, 48 and 96

Blood samples were collected to evaluate the HBsAg titer at Weeks 24, 48 and 96. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 24, 48 and 96

InterventionLog Kilo International Units per Liter (Mean)
Week 24, n=74Week 48, n=73Week 96, n=72
Tenofovir Disoproxil Fumarate-0.049-0.114-0.139

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Change From Baseline Values for Beta-2-microglobulin

Urine samples were collected for analysis of urinalysis data for beta-2-microglobulin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionMicrograms per liter (Mean)
Week 4, n=75Week 12, n=74Week 24, n=74Week 36, n=73Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate206.9254.6392.7261.1206.8309.4235.7271.3196.1

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Change From Baseline Values for Bone Density

Bone densitometry was performed on lumbar spine and femur using dual-energy X-ray absorptiometry (DEXA). Bone density percentage was calculated as bone density observation minus bone density Baseline divided by bone density Baseline. Baseline was considered as Day -1. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value. (NCT03258710)
Timeframe: Baseline (Day -1) and at Weeks 24, 48, 72 and 96

InterventionGrams per centimeter^2 (Mean)
Femur, Week 48, n=4Femur, Week 96, n=22Lumbar vertebra, Week 24, n=1Lumbar vertebra, Week 48, n=6Lumbar vertebra, Week 72, n=1Lumbar vertebra, Week 96, n=72
Tenofovir Disoproxil Fumarate-0.0125-0.02050.0100-0.0100-0.0620-0.0193

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Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate

Urine samples were collected for analysis of urinalysis data for urine creatinine concentration and urine phosphate. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96

InterventionMilligrams per deciliter (Mean)
Urine Creatinine, Week 4, n=75Urine Creatinine, Week 12, n=74Urine Creatinine, Week 24, n=74Urine Creatinine, Week 36, n=73Urine Creatinine, Week 48, n=73Urine Creatinine, Week 60, n=73Urine Creatinine, Week 72, n=73Urine Creatinine, Week 84, n=72Urine Creatinine, Week 96, n=72Urine phosphate, Week 4, n=75Urine phosphate, Week 12, n=74Urine phosphate, Week 24, n=74Urine phosphate, Week 36, n=73Urine phosphate, Week 48, n=73Urine phosphate, Week 60, n=73Urine phosphate, Week 72, n=73Urine phosphate, Week 84, n=72Urine phosphate, Week 96, n=72
Tenofovir Disoproxil Fumarate-5.3532.04711.71515.8494.6745.567-1.37819.33710.346-3.87-2.082.460.850.68-0.090.855.21-0.72

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Number of Participants Who Reported Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population consists of participants who have received at least one dose of study treatment after enrolment. (NCT03258710)
Timeframe: Up to Week 96

InterventionParticipants (Count of Participants)
Any SAEAny non-SAE
Tenofovir Disoproxil Fumarate236

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Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48

Urine samples were collected for analysis of urinalysis data for glucose, protein and urinary sediment by dipstick method. The urine sediments analyzed were amorphous phosphate crystals, amorphous urate crystals, bacteria, calcium oxalate crystals, ammonium magnesium phosphate, renal tubular epithelial cells (RTEC), fungi, hyaline casts, mucous threads, RBCs, spermatozoa, squamous epithelial cells (SEC), transitional epithelial cells (TEC), uric acid crystals (UAC) and WBCs. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample. Results for RTEC, hyaline casts, RBC, SEC, TEC and WBC can be read as counts per field (some/ every/ whole field). Only abnormal parameters and participants with abnormal data has been reported. (NCT03258710)
Timeframe: Weeks 4, 12, 24, 36 and 48

InterventionParticipants (Count of Participants)
Amorphous phosphate crystals, Week 4, 1+Amorphous phosphate crystals, Week 12, 1+Amorphous phosphate crystals, Week 24, 1+Amorphous phosphate crystals, Week 36, 1+Amorphous phosphate crystals, Week 48, 1+Amorphous urate crystals, Week 4, 1+Amorphous urate crystals, Week 12, 1+Amorphous urate crystals, Week 24, 1+Amorphous urate crystals, Week 36, 1+Amorphous urate crystals, Week 48, 1+Bacteria, Week 4, 1+Bacteria, Week 12, 1+Bacteria, Week 24, 1+Bacteria, Week 24, 2+Bacteria, Week 36, 1+Bacteria, Week 48, 1+Bacteria, Week 48, 2+Calcium oxalate crystals, Week 4, 1+Calcium oxalate crystals, Week 12, 1+Calcium oxalate crystals, Week 24, 1+Calcium oxalate crystals, Week 36, 1+Calcium oxalate crystals, Week 48, 1+RTEC, Week 4, 0-0.1/Some FieldRTEC, Week 4, 0.2-0.4/Some FieldRTEC, Week 4, 1-2/Every FieldRTEC, Week 12, 0-0.1/Some FieldRTEC, Week 12, 0.2-0.4/Some FieldRTEC, Week 24, 0-0.1/Some FieldRTEC, Week 24, 0.2-0.4/Some FieldRTEC, Week 24, 1-2/Every FieldRTEC, Week 36, 0-0.1/Some FieldRTEC, Week 36, 0.2-0.4/Some FieldRTEC, Week 36, 1-2/Every FieldRTEC, Week 48, 0-0.1/Some FieldRTEC, Week 48, 0.2-0.4/Some FieldRTEC, Week 48, 1-2/Every FieldFungi, Week 4, 1+Fungi, Week 12, 1+Fungi, Week 24, 1+Fungi, Week 36, 1+Fungi, Week 48, 1+Urine glucose, Week 4, 1+Urine glucose, Week 4, TraceUrine glucose, Week 12, 2+Urine glucose, Week 12, TraceUrine glucose, Week 24, 3+Urine glucose, Week 36, TraceUrine glucose, Week 48, 1+Urine glucose, Week 48, 3+Urine glucose, Week 48, TraceHyaline casts, Week 4, 0-0.1/Some FieldHyaline casts, Week 12, 0-0.1/Some FieldHyaline casts, Week 12, 3-5/Whole FieldHyaline casts, Week 24, 0-0.1/Some FieldHyaline casts, Week 24, 1-2/Whole FieldHyaline casts, Week 24, 3-5/Whole FieldHyaline casts, Week 36, 0-0.1/Some FieldHyaline casts, Week 36, 0.2-0.4/Some FieldHyaline casts, Week 36, 1-2/Every FieldHyaline casts, Week 36, 1-2/Whole FieldHyaline casts, Week 48, 0-0.1/Some FieldHyaline casts, Week 48, 0.2-0.4/Some FieldMucus threads, Week 4, 1+Mucus threads, Week 12, 1+Mucus threads, Week 24, 1+Mucus threads, Week 36, 1+Mucus threads, Week 48, 1+Urine protein, Week 4, 1+Urine protein, Week 4, 2+Urine protein, Week 4, TraceUrine protein, Week 12, 1+Urine protein, Week 12, TraceUrine protein, Week 24, 1+Urine protein, Week 24, 2+Urine protein, Week 24, TraceUrine protein, Week 36, 1+Urine protein, Week 36, 2+Urine protein, Week 36, TraceUrine protein, Week 48, TraceRBC, Week 4, 0-0.1/Some FieldRBC, Week 4, 0.2-0.4/Some FieldRBC, Week 4, 1-2/Every FieldRBC, Week 4, 3-5/Every FieldRBC, Week 4, 6-10/Every FieldRBC, Week 12, numerous/Every FieldRBC, Week 12, 0-0.1/Some FieldRBC, Week 12, 0.2-0.4/Some FieldRBC, Week 12, 1-2/Every FieldRBC, Week 12, 3-5/Every FieldRBC, Week 12, 6-10/Every FieldRBC, Week 12, 10-20/Every FieldRBC, Week 24, 0-0.1/Some FieldRBC, Week 24, 0.2-0.4/Some FieldRBC, Week 24, 1-2/Every FieldRBC, Week 24, 3-5/Every FieldRBC, Week 24, 6-10/Every FieldRBC, Week 24, 10-20/Every FieldRBC, Week 24, 20-30/Every FieldRBC, Week 36, 0-0.1/Some FieldRBC, Week 36, 0.2-0.4/Some FieldRBC, Week 36, 1-2/Every FieldRBC, Week 36, 3-5/Every FieldRBC, Week 36, 6-10/Every FieldRBC, Week 36, 10-20/Every FieldRBC, Week 48, 0-0.1/Some FieldRBC, Week 48, 0.2-0.4/Some FieldRBC, Week 48, 1-2/Every FieldRBC, Week 48, 3-5/Every FieldRBC, Week 48, 6-10/Every FieldRBC, Week 48, 10-20/Every FieldSpermatozoa, Week 4, 1+Spermatozoa, Week 12, 1+Spermatozoa, Week 24, 1+Spermatozoa, Week 36, 1+Spermatozoa, Week 48, 1+SEC, Week 4, 0-0.1/Some FieldSEC, Week 4, 0.2-0.4/Some FieldSEC, Week 4, 1-2/Every FieldSEC, Week 4, 3-5/Every FieldSEC, Week 4, 10-20/Every FieldSEC, Week 12, 0-0.1/Some FieldSEC, Week 12, 0.2-0.4/Some FieldSEC, Week 12, 1-2/Every FieldSEC, Week 12, 3-5/Every FieldSEC, Week 12, 6-10/Every FieldSEC, Week 12, 10-20/Every FieldSEC, Week 12, 30-50/Every FieldSEC, Week 24, 0-0.1/Some FieldSEC, Week 24, 0.2-0.4/Some FieldSEC, Week 24, 1-2/Every FieldSEC, Week 24, 3-5/Every FieldSEC, Week 24, 6-10/Every FieldSEC, Week 24, 10-20/Every FieldSEC, Week 24, 20-30/Every FieldSEC, Week 36, 0-0.1/Some FieldSEC, Week 36, 0.2-0.4/Some FieldSEC, Week 36, 1-2/Every FieldSEC, Week 36, 3-5/Every FieldSEC, Week 48, 0-0.1/Some FieldSEC, Week 48, 0.2-0.4/Some FieldSEC, Week 48, 1-2/Every FieldSEC, Week 48, 3-5/Every FieldSEC, Week 48, 6-10/Every FieldTEC, Week 4, 0-0.1/Some FieldTEC, Week 12, 0-0.1/Some FieldTEC, Week 24, 0-0.1/Some FieldTEC, Week 24, 0.2-0.4/Some FieldTEC, Week 36, 0-0.1/Some FieldTEC, Week 36, 0.2-0.4/Some FieldTEC, Week 36, 1-2/Every FieldTEC, Week 48, 0-0.1/Some FieldUAC, Week 4, 1+UAC, Week 12, 1+UAC, Week 24, 1+UAC, Week 36, 1+UAC, Week 48, 1+WBC, Week 4, 0-0.1/Some FieldWBC, Week 4, 0.2-0.4/Some FieldWBC, Week 4, 1-2/Every FieldWBC, Week 4, 3-5/Every FieldWBC, Week 4, 10-20/Every FieldWBC, Week 12, 0-0.1/Some FieldWBC, Week 12, 0.2-0.4/Some FieldWBC, Week 12, 1-2/Every FieldWBC, Week 12, 3-5/Every FieldWBC, Week 12, 6-10/Every FieldWBC, Week 24, 0-0.1/Some FieldWBC, Week 24, 0.2-0.4/Some FieldWBC, Week 24, 1-2/Every FieldWBC, Week 24, 3-5/Every FieldWBC, Week 24, 6-10/Every FieldWBC, Week 24, 10-20/Every FieldWBC, Week 24, 30-50/Every FieldWBC, Week 36, 0-0.1/Some FieldWBC, Week 36, 0.2-0.4/Some FieldWBC, Week 36, 1-2/Every FieldWBC, Week 36, 3-5/Every FieldWBC, Week 36, 6-10/Every FieldWBC, Week 36, 30-50/Every FieldWBC, Week 48, 0-0.1/Some FieldWBC, Week 48, 0.2-0.4/Some FieldWBC, Week 48, 1-2/Every FieldWBC, Week 48, 3-5/Every FieldWBC, Week 48, 6-10/Every Field
Tenofovir Disoproxil Fumarate22322368555116281111191415102351254192119212153001001111121116321311111311721232522111522441283127153520134313323114114014141212422071213914143211023058772154962111556811215949158455144523115000213527101237228614220531214520142143141122

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Percentage of Total Neutrophils at Indicated Time Points

Blood samples were collected for the analysis of hematology parameter: total neutrophils. Mean and standard deviation values for percentage of neutrophils reported was presented. (NCT03258710)
Timeframe: At Weeks 36, 48, 60, 72, 84 and 96

InterventionPercentage of neutrophils (Mean)
Week 36, n=32Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate58.4658.7258.2058.4558.9758.43

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Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24, 48 and 96

Blood samples were collected to evaluate the percentage of participants who achieved HBsAg/Ab seroconversion at Weeks 24, 48 and 96. Seroconversion of HBsAg means antigen is negative and antibody is positive. HBsAg Seroconversion percentage is defined as number of participants with HBsAg/Ab Seroconversion divided by number of participants with positive HBsAg and Negative HBsAb at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: At Weeks 24, 48 and 96

InterventionPercentage of Participants (Number)
Week 24Week 48Week 96
Tenofovir Disoproxil Fumarate000

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Percentage of Participants Who Achieved HBsAg Loss at Weeks 24, 48 and 96

Blood samples were collected to evaluate the percentage of participants with HBsAg loss at Weeks 24, 48 and 96. A 'Loss' of HBsAg means antigen is negative. HBsAg loss percentage is defined as number of participants with HBsAg loss divided by number of participants with positive HBsAg at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: At Weeks 24, 48 and 96

InterventionPercentage of Participants (Number)
Week 24Week 48Week 96
Tenofovir Disoproxil Fumarate000

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Percentage of Participants Who Achieved HBeAg Loss at Weeks 24, 48 and 96

Blood samples were collected to evaluate the percentage of participants with HBeAg loss at Weeks 24, 48 and 96. A 'Loss' of HBeAg means antigen is negative. HBeAg Loss percentage is defined as number of participants with HBeAg loss divided by number of participants with positive HBeAg at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: At Weeks 24, 48 and 96

InterventionPercentage of Participants (Number)
Week 24Week 48Week 96
Tenofovir Disoproxil Fumarate121225

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Percentage of Participants Who Achieved 0.25 Logarithm to the Base 10 (Log10) Hepatitis B Surface Antigen (HBsAg) Reduction From the Baseline at Week 48

Blood samples were collected to evaluate the HBsAg reduction from Baseline at Week 48. HBsAg reduction potential was obtained by evaluating log10 observation values minus log10 Baseline values. The HBsAg responder values were<=-0.25 log10 and non-responder values were >-0.25 log10 . Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Full analysis set (FAS) Population is defined as population of all participants enrolled in the study, excluding those who meet either of the following criteria: who have not received any dose of study treatment and who have no efficacy data (HBsAg, HBV-DNA, hepatitis B core-related antigen [HBcrAg], HBeAg, hepatitis B surface antibody [HBsAb],Hepatitis B envelope antibody [HBeAb], alanine aminotransferase [ALT]) from at least 15 days after the start of study treatment. Data for HBsAg responders have been presented. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Week 48

InterventionPercentage of Participants (Number)
<= -0.25 log10> -0.25 log10
Tenofovir Disoproxil Fumarate496

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Percentage of Monocytes at Indicated Time Points

Blood samples were collected for the analysis of hematology parameter: monocytes. Mean and standard deviation values for percentage of monocytes reported was presented. (NCT03258710)
Timeframe: At Weeks 36, 48, 60, 72, 84 and 96

InterventionPercentage of monocytes (Mean)
Week 36, n=32Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate5.305.465.655.675.715.45

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Percentage of Lymphocytes at Indicated Time Points

Blood samples were collected for the analysis of hematology parameter: lymphocytes. Mean and standard deviation values for percentage of lymphocytes reported was presented. (NCT03258710)
Timeframe: At Weeks 36, 48, 60, 72, 84 and 96

InterventionPercentage of lymphocytes (Mean)
Week 36, n=32Week 48, n=73Week 60, n=73Week 72, n=73Week 84, n=72Week 96, n=72
Tenofovir Disoproxil Fumarate33.3432.3932.7332.2931.9432.98

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48

Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. (NCT03272347)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Islatravir 0.25 mg89.7
Islatravir 0.75 mg90.0
Islatravir 2.25 mg77.4
DOR/3TC/TDF83.9

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Change From Baseline in Mature T-helper (CD4+ T)-Cell Count at Week 24

Blood samples were collected and cluster of differentiation (CD4)+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication. (NCT03272347)
Timeframe: Baseline and Week 24

Interventioncells/mm^3 (Mean)
Islatravir 0.25 mg220.5
Islatravir 0.75 mg192.8
Islatravir 2.25 mg142.9
DOR/3TC/TDF142.1

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Change From Baseline in CD4+ T-cell Count at Week 96

Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication. (NCT03272347)
Timeframe: Baseline and Week 96

Interventioncells/mm^3 (Mean)
Islatravir 0.25 mg243.4
Islatravir 0.75 mg161.3
Islatravir 2.25 mg136.5
DOR/3TC/TDF268.9

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Change From Baseline in CD4+ T-cell Count at Week 192 (Part 4)

Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Week 144 value. The change from baseline in CD4+ T-cell count at Week 192 (Part 4) are reported. (NCT03272347)
Timeframe: Baseline and Week 192

Interventioncells/mm^3 (Mean)
DOR/ISL Continued (Part 4)3.8
DOR/ISL Switch (Part 4)-3.4

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Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After Starting Open-label Doravirine/Islatravir Regimen (Part 4)

Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. The percentage of participants with HIV-1 RNA <50 copies in Part 4 are reported. (NCT03272347)
Timeframe: Up to Week 192

InterventionPercentage of participants (Number)
DOR/ISL Continued (Part 4)85.1
DOR/ISL Switch (Part 4)95.5

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Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After 3TC and Placebo Are Discontinued From the Regimen

Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52. (NCT03272347)
Timeframe: Up to 48 weeks

InterventionPercentage of participants (Number)
Islatravir 0.25 mg62.1
Islatravir 0.75 mg56.7
Islatravir 2.25 mg59.3
DOR/3TC/TDF60.7

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Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen

Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52. (NCT03272347)
Timeframe: Up to 24 weeks after 3TC and Placebo are discontinued from the regimen (up to approximately 60 weeks after initiating treatment)

InterventionPercentage of participants (Number)
Islatravir 0.25 mg86.2
Islatravir 0.75 mg90.0
Islatravir 2.25 mg88.9
DOR/3TC/TDF96.4

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Number of Participants Discontinuing Study Drug Due to AEs up to Week 144

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. (NCT03272347)
Timeframe: Up to 144 weeks

InterventionParticipants (Count of Participants)
Islatravir 0.25 mg1
Islatravir 0.75 mg0
Islatravir 2.25 mg2
DOR/3TC/TDF1

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 24

Blood samples were collected and plasma human immunodeficiency virus 1 (HIV-1) ribonucleic acid (RNA) were quantified using a real time polymerase chain reaction (PCR) assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. (NCT03272347)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Islatravir 0.25 mg93.1
Islatravir 0.75 mg100.0
Islatravir 2.25 mg90.3
DOR/3TC/TDF90.3

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Number of Participants Experiencing AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52. (NCT03272347)
Timeframe: Up to 24 weeks

InterventionParticipants (Count of Participants)
Islatravir 0.25 mg18
Islatravir 0.75 mg20
Islatravir 2.25 mg14
DOR/3TC/TDF16

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Number of Participants Experiencing AEs From Week 96 Through Study Duration

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. (NCT03272347)
Timeframe: Week 96 up to Week 192

InterventionParticipants (Count of Participants)
Islatravir 0.25 mg12
Islatravir 0.75 mg19
Islatravir 2.25 mg11
DOR/3TC/TDF12
DOR/ISL Continued36
DOR/ISL Switch14

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Number of Participants Experiencing AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced AEs during Part 4 are reported. (NCT03272347)
Timeframe: Week 144 up to Week 192

InterventionParticipants (Count of Participants)
DOR/ISL Continued (Part 4)36
DOR/ISL Switch (Part 4)14

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Change From Baseline in CD4+ T-cell Count at Week 144

Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication. (NCT03272347)
Timeframe: Baseline and Week 144

Interventioncells/mm^3 (Mean)
Islatravir 0.25 mg204.4
Islatravir 0.75 mg209.0
Islatravir 2.25 mg162.9
DOR/3TC/TDF270.0

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Number of Participants Discontinuing Study Drug Due to AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued the study drug due to AEs in Part 4 are reported. (NCT03272347)
Timeframe: Week 144 up to Week 192

InterventionParticipants (Count of Participants)
DOR/ISL Continued (Part 4)0
DOR/ISL Switch (Part 4)0

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Number of Participants Discontinuing Study Drug Due to AEs From Week 96 Through Study Duration

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. (NCT03272347)
Timeframe: Week 96 up to Week 192

InterventionParticipants (Count of Participants)
Islatravir 0.25 mg1
Islatravir 0.75 mg0
Islatravir 2.25 mg0
DOR/3TC/TDF0
DOR/ISL Continued0
DOR/ISL Switch0

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Number of Participants Discontinuing Study Drug Due to AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52. (NCT03272347)
Timeframe: Up to 24 weeks

InterventionParticipants (Count of Participants)
Islatravir 0.25 mg0
Islatravir 0.75 mg0
Islatravir 2.25 mg2
DOR/3TC/TDF1

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Number of Participants Experiencing Adverse Events (AEs) up to Week 144

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. (NCT03272347)
Timeframe: Up to 144 weeks

InterventionParticipants (Count of Participants)
Islatravir 0.25 mg26
Islatravir 0.75 mg27
Islatravir 2.25 mg24
DOR/3TC/TDF27

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Change From Baseline in CD4+ T-cell Count at Week 48

Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication. (NCT03272347)
Timeframe: Baseline and Week 48

Interventioncells/mm^3 (Mean)
Islatravir 0.25 mg182.0
Islatravir 0.75 mg183.0
Islatravir 2.25 mg100.7
DOR/3TC/TDF181.4

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Summary of Changes in CD4 Count From Baseline to Week 96 (Cohort 2)

The mean difference is calculated as CD4 count at Week 96 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 96.

Interventioncells/mm^3 (Mean)
Cohort 2: DOR/3TC/TDF42.5

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Summary of Changes in CD4 Count From Baseline to Week 48 (Cohort 2)

The mean differences is calculated as CD4 count at Week 48 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 48.

Interventioncells/mm^3 (Mean)
Cohort 2: DOR/3TC/TDF80.1

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Summary of Changes in CD4 Count From Baseline to Week 24 (Cohort 2)

The mean difference is calculated as CD4 count at Week 24 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 24.

Interventioncells/mm^3 (Mean)
Cohort 2: DOR/3TC/TDF84.8

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PK Parameter: Single-dose Maximum Concentration (Cmax) of DOR (Cohort 1)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). (NCT03332095)
Timeframe: Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.

InterventionµM (Geometric Mean)
Cohort 1: DOR2.14

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PK Parameter: Single-dose 24 Hour-concentration (C24hr) of DOR (Cohort 1)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). (NCT03332095)
Timeframe: Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.

InterventionnM (Geometric Mean)
Cohort 1: DOR514

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PK Parameter: Cmax of Tenofovir (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

Interventionng/mL (Geometric Mean)
Cohort 2: DOR/3TC/TDF293

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PK Parameter: Cmax of DOR (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.

InterventionµM (Geometric Mean)
Cohort 2: DOR/3TC/TDF2.13

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PK Parameter: Cmax of 3TC (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

Interventionng/mL (Geometric Mean)
Cohort 2: DOR/3TC/TDF2100

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PK Parameter: C24hr of DOR (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.

InterventionnM (Geometric Mean)
Cohort 2: DOR/3TC/TDF282

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PK Parameter: C24hr of 3TC (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

Interventionng/mL (Geometric Mean)
Cohort 2: DOR/3TC/TDF66.3

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Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug (Cohort 2) Through End of Study

Percentage and Clopper-Pearson 95% CI of participants with Grade 5 adverse events (death). (NCT03332095)
Timeframe: Measured from Day 0 through Week 96.

Interventionpercentage of participants (Number)
Cohort 2: DOR/3TC/TDF0

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Summary of log10 Drop From Baseline to Week 48 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)

The differences between log10 HIV RNA at Week 48 minus at Day 0 are summarized. (NCT03332095)
Timeframe: Measured at Day 0 and week 48.

InterventionLog10 plasma HIV-1 RNA (Mean)
Cohort 2: DOR/3TC/TDF-2.1

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Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 24 (Cohort 2)

Virologic responses were assessed at week 24 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >50 copies/mL. Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 24.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF97.7

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Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 48 (Cohort 2)

Virologic responses were assessed at week 48 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >50 copies/mL. Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 48.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF97.6

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Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 96 (Cohort 2)

Virologic responses were assessed at week 96 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >50 copies/mL. Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 96.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF92.5

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Pharmacokinetic (PK) Parameter: Single-dose Area-under-the-curve (AUC0-∞) of Doravirine (DOR) (Cohort 1)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to infinity. Steady state AUC0-24 is equivalent to single dose AUC0-∞. (NCT03332095)
Timeframe: Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.

InterventionµM*hr (Geometric Mean)
Cohort 1: DOR34.8

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PK Parameter: AUC0-24hr of 3TC (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to 24 hours. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

Interventionh.ng/mL (Geometric Mean)
Cohort 2: DOR/3TC/TDF11300

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PK Parameter: AUC0-24hr of DOR (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to 24 hours. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.

InterventionµM*hr (Geometric Mean)
Cohort 2: DOR/3TC/TDF22.9

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PK Parameter: AUC0-24hr of Tenofovir (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to 24 hours. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

Interventionh.ng/mL (Geometric Mean)
Cohort 2: DOR/3TC/TDF2550

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Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug

Percentage and Clopper-Pearson 95% CI of participants with Grade 5 AEs (death) regardless of relationship to study drug. (NCT03332095)
Timeframe: Cohort 1: Measured from Day 0 through Week 2; Cohort 2: Measured from Day 0 through Week 24.

Interventionpercentage of participants (Number)
Cohort 1: DOR0
Cohort 2: DOR/3TC/TDF0

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Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 48 (Cohort 2)

Virologic responses were assessed at week 48 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >40 copies/mL; Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 48.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF97.6

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PK Parameter: C24hr of Tenofovir (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

Interventionng/mL (Geometric Mean)
Cohort 2: DOR/3TC/TDF50.2

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Summary of log10 Drop From Baseline to Week 96 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)

The differences between log10 HIV RNA at Week 96 minus at Day 0 are summarized. (NCT03332095)
Timeframe: Measured at Day 0 and week 96.

InterventionLog10 plasma HIV-1 RNA (Mean)
Cohort 2: DOR/3TC/TDF-4.3

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Summary of log10 Drop From Baseline to Week 24 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)

The differences between log10 HIV RNA at Week 24 minus at Day 0 are summarized. (NCT03332095)
Timeframe: Measured at Day 0 and week 24.

InterventionLog10 plasma HIV-1 RNA (Mean)
Cohort 2: DOR/3TC/TDF-2.6

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Summary of Changes in CD4% From Baseline to Week 96 (Cohort 2)

The mean difference is calculated as CD4% at Week 96 minus CD4% at the Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 96.

InterventionPercent of total lymphocytes (Mean)
Cohort 2: DOR/3TC/TDF-0.5

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Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 96 (Cohort 2)

Virologic responses were assessed at week 96 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >40 copies/mL; Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 96.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF92.5

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Summary of Changes in CD4% From Baseline to Week 48 (Cohort 2)

The mean difference is calculated as CD4% at Week 48 minus CD4% at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 48.

InterventionPercent of total lymphocytes (Mean)
Cohort 2: DOR/3TC/TDF-0.4

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Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 24 (Cohort 2)

Virologic responses were assessed at week 24 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >40 copies/mL; Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 24.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF97.7

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Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 96 (Cohort 2)

Virologic responses were assessed at week 96 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >200 copies/mL; otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 96.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF92.9

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Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 48 (Cohort 2)

Virologic responses were assessed at week 48 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >200 copies/mL; otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 48.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF97.7

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Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 24 (Cohort 2)

Virologic responses were assessed at week 24 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >200 copies/mL; otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 24.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF97.7

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Summary of Changes in CD4% From Baseline to Week 24 (Cohort 2)

The mean difference is calculated as CD4% at Week 24 minus CD4% at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 24.

InterventionPercent of total lymphocytes (Mean)
Cohort 2: DOR/3TC/TDF-1.5

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DOT Diary Mobile App Ease of Use

5-point Likert scale (1=strongly disagree that app is easy to use; 5=strongly agree that app is easy to use) on a single question of the key attribute of ease of use of DOT Diary over 8 weeks by MSM on PrEP. (NCT03387462)
Timeframe: 8 weeks

InterventionScore on a scale (Likert) (Median)
DOT Diary Optimization Intervention4

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Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP

Adherence and Persistence of use of the DOT and sexual diary components of DOT Diary by young MSM on PrEP is measured by the percentage of doses taken with visual confirmation of pill ingestion (NCT03387462)
Timeframe: 8 weeks

InterventionPercentage of doses taken (Number)
DOT Diary Optimization Intervention93

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Assessment of Situations and Reasons for Sub-optimal Use of the App

Combined analysis of situations and reasons for sub-optimal use of the app, for the purpose of app optimization (NCT03387462)
Timeframe: 8 weeks

InterventionCount of participants for each reason (Number)
Technical problemsAway from home
DOT Diary Optimization Intervention86

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DOT Diary Mobile App Acceptability

System Usability Scale (SUS) is a 10 item questionnaire with 5 response options: strongly disagree to strongly agree. These are scored 0-4. The scores are then summed up (making sure all positive responses -- increased usability -- are given the higher scores). The final score is multiplied by 2.5 Possible scores are from 0-100, with maximal usability achieving the higher score. Although the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. (NCT03387462)
Timeframe: 8 weeks

InterventionScore on scale (Mean)
DOT Diary Optimization Intervention79.8

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The Mean Bone Mass Density (T-score) Change

To describe trends in bone mass density from baseline to end of study. Bone Mass Density(BMD) was evaluated using T-score of Lumber-spine. The T-score is a comparison of the results to a average peak bone mass of healthy young adult. 0 indicates healthy young adult's mean with a SD of 1. Normal BMD was defined with T-score of -1.0 or above; osteopenia with T-score between -1.1 and -2.4, and osteoporosis with T-score of -2.5 or below (ref). Worsened BMD was defined by upstaging of BMD class from normal to osteopenia or worse or from osteopenia to osteoporosis. Improved BMD was defined by downstaging of BMD class from osteopenia to normal or osteoporosis to osteopenia or normal. (NCT03471624)
Timeframe: Baseline, month 24

InterventionT-score (Mean)
Baseline24 month
Tenofovir Alafenamide for 24 Months-1.43-1.17

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Number of Participants With Normal Alanine Aminotransferase (ALT).

Alanine aminotransferase (ALT) normalization is defined if ALT was less than 35 U/L for men or 25 U/L for women (NCT03471624)
Timeframe: Baseline, 6, 12, 18, 24 months

InterventionParticipants (Count of Participants)
Baselinemonth 6month 12month 18month 24
Tenofovir Alafenamide for 24 Months203212197203203

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Calculated eGFR

To describe trends in calculated eGFR as available by local labs. Estimated glomerular filtration rates (eGFR) were calculated using the Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI) equation (eGFR [mL∕min∕1.73m2] =141 × [minimum Scr∕K, 1]α × [maximum Scr/K, 1]1.209 × 0.993age × 1.018 [if female] × 1.159 [if black]) where Scr is serum creatinine in µmol/L, K is 61.9 for females and 79.6 for males, α is -0.329 for females and -0.411 for males (NCT03471624)
Timeframe: Baseline, 6, 12, 18, 24 months

InterventionmL/min/1.73m^2 (Median)
Baselinemonth 6month 12month 18month 24
Tenofovir Alafenamide for 24 Months90.290.891.291.892.1

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Number of Participants With HBV DNA <20 IU Per mL

To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV treatment. (NCT03471624)
Timeframe: Baseline, 6, 12, 18, 24 months

InterventionParticipants (Count of Participants)
Baselinemonth 6month 12month 18month 24
Tenofovir Alafenamide for 24 Months257261257256255

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Plasma Area Under the Curve (AUC) for Tenofovir (TFV) During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)

Plasma area under the curve (AUC) during the dosing interval of 0 to 24 hours (AUC0-24hr) on day 14, 22, and 31 of TFV was calculated using the linear-up/log-down trapezoidal rule using noncompartmental methods on Phoenix WinNonlin ® (NCT03510468)
Timeframe: 0-24 hours post dosing on days 14, 22, and 31

Interventionhr*ng/ml (Geometric Mean)
Day 14Day 22Day 31
Pharmacokinetic Study in Healthy Volunteers262.2265.3230.8

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Number of Patients Who Accepted Rapid HIV Treatment Initiation

(NCT03512964)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Rapid HIV Treatment Initiation32

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Rapid HIV Treatment Initiation Acceptability as Assessed by the Number of Patients Who Respond Yes to Starting ART Same Day

Number of patients who respond yes to starting ART same day versus those who respond no in the survey. (NCT03512964)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Rapid HIV Treatment Initiation32

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Number of Patients Who Receive Rapid HIV Treatment Initiation

Number of patients who do start Anti-retroviral Therapy (ART) the same day it is offered. (NCT03512964)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Rapid HIV Treatment Initiation32

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Number of Patients Offered Rapid HIV Treatment Initiation

(NCT03512964)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Rapid HIV Treatment Initiation32

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AUCtau of Raltegravir

Area Under the Concentration-time curve during a dosing interval τ at steady state of Tenofovir at Day 5 of treatment B and C of Part 2 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose of Day 5 of treatment B and C (Part 2)

Interventionng*h/ml (Geometric Mean)
Treatment B (Part 2)2912.45
Treatment C (Part 2)2653.65

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AUCtau of Narlaprevir

Area Under the Concentration-time curve during a dosing interval τ at steady state of Narlaprevir at Day 5 of treatment A and C of Part 1/ Part 2 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 5 of treatment A and C (Part 1/ Part 2)

Interventionng*h/ml (Geometric Mean)
Treatment A (Part 1)20504.31
Treatment C (Part 1)21366.2
Treatment A (Part 2)26199.19
Treatment C (Part 2)24458.48

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AUCtau of Tenofovir

Area Under the Concentration-time curve during a dosing interval τ at steady state of Tenofovir at Day 5 of treatment B and C of Part 1 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 18 and 24 hrs post-dose on Day 5 of treatment B and C (Part 1)

Interventionng*h/ml (Geometric Mean)
Treatment B (Part 1)2599.95
Treatment C (Part 1)2799.72

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Number of Patients With Abnormal ECG Changes

There were no subjects with abnormal ECG changes during the study (NCT03537404)
Timeframe: Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study

,,
InterventionParticipants (Count of Participants)
Part 1Part 2
Treatment A (Part 1/Part 2)00
Treatment B (Part 1/Part 2)00
Treatment C (Part 1/Part 2)00

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Number of Patients With Changes in Vital Signs

There were no subjects with abnormal changes in vital signs (NCT03537404)
Timeframe: Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study

InterventionParticipants (Count of Participants)
Treatment A (Part 1)0
Treatment B (Part 1)0
Treatment C (Part 1)0
Treatment A (Part 2)0
Treatment B (Part 2)0
Treatment C (Part 2)0

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Number of Patients With Adverse Events

(NCT03537404)
Timeframe: Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study

InterventionParticipants (Count of Participants)
Treatment A (Part 1)1
Treatment B (Part 1)0
Treatment C (Part 1)4
Treatment A (Part 2)0
Treatment B (Part 2)0
Treatment C (Part 2)1

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Cmax of Tenofovir

Maximum observed Concentration of Tenofovir at Day 5 of treatment B and C of Part 1 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 18 and 24 hrs post-dose on Day 5 of treatment B and C (Part 1)

Interventionng/ml (Geometric Mean)
Treatment B (Part 1)263.037
Treatment C (Part 1)344.796

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Cmax of Raltegravir

Maximum observed Concentration of Raltegravir at Day 5 of treatment B and C of Part 2 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose of Day 5 of treatment B and C (Part 2)

Interventionng/ml (Geometric Mean)
Treatment B (Part 2)830.204
Treatment C (Part 2)715.726

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Cmax of Narlaprevir

Maximum observed Concentration of Narlaprevir at Day 5 of treatment A and C of Part 1 or 2 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 5 of treatment A and C (Part 1/ Part 2)

Interventionng/ml (Geometric Mean)
Treatment A (Part 1)2130.2742
Treatment C (Part 1)2172.233
Treatment A (Part 2)2946.131
Treatment C (Part 2)2880.612

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Number of Patients With Abnormal Laboratory Values

(NCT03537404)
Timeframe: Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study

,,
InterventionParticipants (Count of Participants)
Part 1Part 2
Treatment A (Part 1)00
Treatment B (Part 1)00
Treatment C (Part 1)21

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Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results

"Change (improvement/ worsening) in fibrosis and histological activity stage according to the liver biopsy study results at week 24 compared to baseline.~Liver fibrosis was evaluated by histological staging systems with stage 0 corresponding to absence of fibrosis and with the highest score (the last stage in all systems) corresponding to cirrhosis.~Improvement is defined as a decrease of at least 1 point in histological staging systems; worsening is defined as an increase of at least 1 point.~Data should be interpreted with caution due to low number of paired biopsies available." (NCT03546621)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Ishak fibrosis score72506758Ishak fibrosis score72506760Ishak fibrosis score72506761Ishak fibrosis score72506759Knodell fibrosis score72506759Knodell fibrosis score72506760Knodell fibrosis score72506761Knodell fibrosis score72506758Metavir fibrosis stage72506760Metavir fibrosis stage72506761Metavir fibrosis stage72506758Metavir fibrosis stage72506759Metavir activity grade72506758Metavir activity grade72506759Metavir activity grade72506760Metavir activity grade72506761Histological activity index72506758Histological activity index72506760Histological activity index72506761Histological activity index72506759
No changeWorseningImprovement
Arm B1
Arm C2
Arm B3
Arm D2
Arm A2
Arm B2
Arm A4
Arm A1
Arm C4
Arm C0
Arm C3
Arm D3
Arm A0
Arm C1
Arm D0
Arm A3
Arm D1

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Combined Response: HDV RNA Response and Normal ALT at Treatment Week 24

Combined response: HDV RNA negativation or ≥2 log decline and normal ALT at treatment week 24 (NCT03546621)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Week 2472506758Week 2472506759Week 2472506760Week 2472506761Week 4872506758Week 4872506759Week 4872506760Week 4872506761
ResponderNon-Responder
Arm A6
Arm B9
Arm C11
Arm A22
Arm B23
Arm C19
Arm A2
Arm B1
Arm C1
Arm D0
Arm A26
Arm B31
Arm C29
Arm D28

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Durability of HDV RNA Response

Durability of HDV RNA response to 24 weeks post treatment (NCT03546621)
Timeframe: 48 weeks

,,,
InterventionParticipants (Count of Participants)
Response at Week 24 onlyResponse at Week 24 and 48
Arm A152
Arm B161
Arm C233
Arm D10

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Changes in ALT Values

Changes in ALT values at Week 24 and Week 48 compared to baseline. (NCT03546621)
Timeframe: 24 and 48 weeks

,,,
InterventionU/L (Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Arm A-49.6-1.6
Arm B-79.4-18.2
Arm C-78.91.4
Arm D-29.2-26.3

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Change in Hepatitis B Surface Antigen

Changes in hepatitis B surface antigen (HBsAg) (defined as decline in HBsAg levels, disappearance of HBsAg and HBsAg seroconversion to anti-HBsAg) at week 24 and week 48 compared to baseline (NCT03546621)
Timeframe: 24 and 48 weeks

,,,
InterventionIU/mL (Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Arm A-0.048-0.138
Arm B0.003-0.162
Arm C0.034-0.134
Arm D0.025-0.070

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Change (Absence of Increase) in Fibrosis Marker

Change (absence of increase) in fibrosis marker: serum alpha-2-macroglobulin at Week 24 and Week 48 compared to baseline (NCT03546621)
Timeframe: 24 and 48 weeks

,,,
Interventiong/L (Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Arm A-0.076-0.056
Arm B0.0200.075
Arm C0.024-0.008
Arm D-0.141-0.031

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Absence of a Fibrosis Progression According to the Findings of Transient Elastometry

Decrease in liver stiffness and absence of a fibrosis progression according to the findings of transient elastometry (fibroscan) at week 24 compared to baseline (NCT03546621)
Timeframe: 24 weeks

,,,
InterventionkPa (Mean)
BaselineChange from Baseline to Week 24
Arm A14.45-2.85
Arm B17.18-2.52
Arm C16.00-3.38
Arm D16.20-0.78

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Change in HBV DNA Levels at Week 24 and Week 48 Compared to Baseline

Change in hepatitis B virus (HBV) DNA levels at Week 24 and Week 48 compared to baseline. (NCT03546621)
Timeframe: 24 and 48 weeks

,,,
InterventionIU/mL (Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Arm A-0.314-0.244
Arm B-0.484-0.194
Arm C-0.173-0.267
Arm D-0.343-0.257

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Number of Infants Receiving Timely Birth Dose Vaccination

Timeliness of infant HBV vaccination is defined as >90% of infants receiving birth dose vaccine within 24 hours of life (NCT03567382)
Timeframe: Within 24 hours after birth

InterventionParticipants (Count of Participants)
Infants Born to High-risk Mothers8
Infants Born to Low-risk Mothers38

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Number of Participants With Lab Testing Acceptability Survey Scores >80%

"The acceptability of laboratory testing approach to participants will be defined as >80% acceptability on a two questions each measured using a 5-point Likert scale (range 1-5, highest score of 5 representing the highest acceptability). For example, the options for participant responses will include: Very unacceptable (1), Somewhat unacceptable (2), No opinion (3), Somewhat acceptable (4), Very acceptable (5) and Did not allow study personnel to take my blood. Scores equal to or greater than 4 considered 80%." (NCT03567382)
Timeframe: Upon completion of the exit survey, or up to 12 months

,
InterventionParticipants (Count of Participants)
Testing for MothersTesting for Infants
High-risk Mothers77
Low-risk Mothers4140

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Number of Mothers With Infant Vaccination Acceptability Survey Scores >80%

"The acceptability of the intervention approach to participants will be defined as >80% acceptability on a single question measured using a 5-point Likert scale (range 1-5, highest score of 5 representing the highest acceptability). For example, the options for responses will include: Very unacceptable (1), Somewhat unacceptable (2), No opinion (3), Somewhat acceptable (4), Very acceptable (5) and Did not allow study personnel to vaccinate my infant. Scores equal to or greater than 4 considered 80%." (NCT03567382)
Timeframe: Upon completion of the exit survey, or up to 12 months

InterventionParticipants (Count of Participants)
High-risk Mothers7
Low-risk Mothers42

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Number of Mothers With High-risk HBV Demonstrating Adherence to Tenofovir Therapy

Adherence to tenofovir therapy is defined as <20% of pills remaining on monthly pill counts for high-risk mothers with HBV receiving tenofovir (NCT03567382)
Timeframe: Pill counts to be measured monthly. Total adherence averaged over 6-month treatment period.

InterventionParticipants (Count of Participants)
High-risk Mothers9

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Number of Infants With HBV Positivity at 6 Months of Life to Indicate Mother-to-Child Transmission of HBV

Mother-to-child transmission of HBV is defined as HBsAg positivity in the infant at 6 months of life. (NCT03567382)
Timeframe: Measured at 6 months after birth

InterventionParticipants (Count of Participants)
Infants Born to High-risk Mothers0
Infants Born to Low-risk Mothers0

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Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy

(NCT03576066)
Timeframe: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24

,
Interventionng/mL (Mean)
Baseline (Day 1)Week 2Week 4Week 12Week 24
ABI-H0731 + SOC NUC77.585.586.879.379.3
Placebo + SOC NUC89.176.284.186.778.3

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Number of Participants With a Clinically-significant Change in Vital Signs

Vital signs assessed were body temperature, respiratory rate, and pulse rate (NCT03576066)
Timeframe: Baseline and up to Week 24

InterventionParticipants (Count of Participants)
ABI-H0731 + SOC NUC0
Placebo + SOC NUC0

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Number of Participants With a Clinically-significant Electrocardiogram Abnormality

(NCT03576066)
Timeframe: Up to Week 24

InterventionParticipants (Count of Participants)
ABI-H0731 + SOC NUC0
Placebo + SOC NUC0

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Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy

Abnormal ALT was defined as ≥1.25 x upper limit of normal (34 Units/L for female and 43 Units/L for male participants). (NCT03576066)
Timeframe: Baseline to Week 24

InterventionParticipants (Count of Participants)
ABI-H0731 + SOC NUC1
Placebo + SOC NUC0

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Number of Participants With One or More Abnormal Safety Laboratory Result

(NCT03576066)
Timeframe: Up to Week 36

InterventionParticipants (Count of Participants)
ABI-H0731 + SOC NUC27
Placebo + SOC NUC20

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Number of Participants With One or More Adverse Events

(NCT03576066)
Timeframe: Up to Follow-up (maximum up to Week 36)

InterventionParticipants (Count of Participants)
ABI-H0731 + SOC NUC24
Placebo + SOC NUC8

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Number of Participants With Premature Study Discontinuation

(NCT03576066)
Timeframe: Up to Follow-up (maximum up to Week 36)

InterventionParticipants (Count of Participants)
ABI-H0731 + SOC NUC0
Placebo + SOC NUC1

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Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC

(NCT03576066)
Timeframe: Baseline to Week 24

,
InterventionLog10 International Units (IU)/mL (Mean)
BaselineChange from baseline
HBeAg-positive Participants: ABI-H0731 + SOC NUC0.55-0.05
HBeAg-positive Participants: Placebo + SOC NUC0.43-0.10

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Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC

(NCT03576066)
Timeframe: Baseline to Week 24

,,,
InterventionLog10 International Units (IU)/mL (Mean)
BaselineChange from baseline
HBeAg-negative Participants: ABI-H0731 + SOC NUC2.990.09
HBeAg-negative Participants: Placebo + SOC NUC3.35-0.00
HBeAg-positive Participants: ABI-H0731 + SOC NUC3.480.03
HBeAg-positive Participants: Placebo + SOC NUC3.570.03

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Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy

(NCT03576066)
Timeframe: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24

Interventionng/mL (Mean)
Baseline (Day 1)Week 2Week 4Week 12Week 24
ABI-H0731 + SOC NUC0.4361390139013301330

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Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy

(NCT03576066)
Timeframe: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24

,
Interventionng/mL (Mean)
Baseline (Day 1)Week 2Week 4Week 12Week 24
ABI-H0731 + SOC NUC1.100.5540.8720.5831.04
Placebo + SOC NUC1.780.3460.6210.7040.739

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Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy

(NCT03576066)
Timeframe: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24

,
Interventionng/mL (Mean)
Baseline (Day 1)Week 2Week 4Week 12Week 24
ABI-H0731 + SOC NUC9.6713.121.318.418.9
Placebo + SOC NUC12.214.111.811.713.3

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Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets

"Participants were asked would you prefer to use the ring or the tablets for HIV prevention? at their enrollment, Month 12, and product use end visit (Month 18) visits." (NCT03593655)
Timeframe: All three study periods (enrollment, month 12, and month 18 study visits)

InterventionParticipants (Count of Participants)
Enrollment71925906Enrollment71925905Month 1271925905Month 1271925906Month 1871925905Month 1871925906
Neither productSkipped questionPreferred ringPreferred tabletsEither product equally
Sequence A: Dapivirine Vaginal Ring + FTC/TDF51
Sequence B: FTC/TDF + Dapivirine Vaginal Ring43
Sequence A: Dapivirine Vaginal Ring + FTC/TDF43
Sequence B: FTC/TDF + Dapivirine Vaginal Ring57
Sequence A: Dapivirine Vaginal Ring + FTC/TDF29
Sequence B: FTC/TDF + Dapivirine Vaginal Ring18
Sequence A: Dapivirine Vaginal Ring + FTC/TDF0
Sequence A: Dapivirine Vaginal Ring + FTC/TDF1
Sequence A: Dapivirine Vaginal Ring + FTC/TDF74
Sequence B: FTC/TDF + Dapivirine Vaginal Ring76
Sequence A: Dapivirine Vaginal Ring + FTC/TDF37
Sequence B: FTC/TDF + Dapivirine Vaginal Ring30
Sequence A: Dapivirine Vaginal Ring + FTC/TDF5
Sequence B: FTC/TDF + Dapivirine Vaginal Ring2
Sequence B: FTC/TDF + Dapivirine Vaginal Ring1
Sequence A: Dapivirine Vaginal Ring + FTC/TDF67
Sequence B: FTC/TDF + Dapivirine Vaginal Ring66
Sequence A: Dapivirine Vaginal Ring + FTC/TDF35
Sequence B: FTC/TDF + Dapivirine Vaginal Ring33
Sequence A: Dapivirine Vaginal Ring + FTC/TDF13
Sequence B: FTC/TDF + Dapivirine Vaginal Ring5
Sequence B: FTC/TDF + Dapivirine Vaginal Ring4
Sequence B: FTC/TDF + Dapivirine Vaginal Ring0

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Number of Participant-Visits Reporting Acceptability of Study Product

"During the study period where participants were randomized to use FTC/TDF they were asked to rate how much they liked using the tablets for HIV prevention (3 and 6 months after initiating the product).~During the study period where participants were randomized to use the dapivirine vaginal ring they were asked to rate how much they liked using the ring for HIV prevention (3 and 6 months after initiating the product)." (NCT03593655)
Timeframe: Study periods 1 and 2

InterventionVisits (Count of Units)
Week 1271925903Week 1271925904Week 2471925903Week 2471925904Week 3671925903Week 3671925904Week 4871925904Week 4871925903
Neither like nor dislike, dislike, or dislike veryLike, or like very much
FTC/TDF72
Dapivirine Vaginal Ring5
FTC/TDF35
Dapivirine Vaginal Ring105
FTC/TDF73
Dapivirine Vaginal Ring6
FTC/TDF32
Dapivirine Vaginal Ring91
FTC/TDF93
Dapivirine Vaginal Ring14
FTC/TDF18
Dapivirine Vaginal Ring90
FTC/TDF68
Dapivirine Vaginal Ring21
FTC/TDF47

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Number of Participants With Grade 2 or Higher Adverse Events (AEs)

"During participants' first year on study (i.e., during first and second product use periods) participants were randomized to use either the dapivirine vaginal ring for 6 months followed by FTC/TDF for 6 months or vice versa. All AEs were reported as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. AEs that were graded as at least Grade 2 (i.e., moderate or higher) were classified into the two periods based on reported date of AE onset, with AEs occurring between the participant's randomization date and the date 30 days after their Week 24 visit classified into Period 1, and AEs occurring between their Week 24 visit and the date 30 days after their Week 48 visit classified into Period 2. AEs occurring within 30 days of the Week 24 visit were counted in both periods.~This is the number of participant-periods with at least one grade 2 or higher AE by product (combining the two product use periods)." (NCT03593655)
Timeframe: Study periods 1 and 2

InterventionParticipants (Count of Participants)
Study Period 1 (Weeks 1-24)71925903Study Period 1 (Weeks 1-24)71925904Study Period 2 (Weeks 25-48)71925903Study Period 2 (Weeks 25-48)71925904
No grade 2+ AEAt least one grade 2+ AE
Dapivirine Vaginal Ring36
FTC/TDF36
Dapivirine Vaginal Ring88
FTC/TDF87
Dapivirine Vaginal Ring22
FTC/TDF28
Dapivirine Vaginal Ring95
FTC/TDF94

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Number of Participant-Visits With No Product Use

"During the study period where participants were randomized to use FTC/TDF they were assessed for FTC/TDF adherence by dried blood spot (DBS) at monthly visits. Results that were below the lower limit of detection (< 16.6 fmol/punch) were classified as no use of FTC/TDF during the preceding month, and detectable results (>= 16.6 fmol/punch) classified as at least some FTC/TDF use.~During the study period where participants were randomized to use the dapivirine vaginal ring (VR) they were assessed for ring adherence by residual drug levels in returned VRs. Results that were less than or equal to a rate of 0.9mg dapivirine released per month were classified as no use of the VR during that month, and results greater than 0.9mg dapivirine release per month classified as at least some VR use." (NCT03593655)
Timeframe: Study periods 1 and 2

InterventionVisits (Count of Units)
Study Period 171925903Study Period 171925904Study Period 271925904Study Period 271925903
No useAt least some use
Dapivirine Vaginal Ring19
FTC/TDF11
Dapivirine Vaginal Ring705
FTC/TDF660
Dapivirine Vaginal Ring41
FTC/TDF10
Dapivirine Vaginal Ring642
FTC/TDF635

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Change in Serum Biomarkers of Inflammation (Hs-CRP (in mg/L))

"Change in serum biomarkers of inflammation (hs-CRP (in mg/L)) at 24 weeks after initiation of B/F/TAF.~Serum biomarkers of inflammation (high sensitivity C-reactive protein) were measured. hs-CRP > 1 mg/L are considered abnormal and associated with increased cardiovascular risk." (NCT03656783)
Timeframe: Baseline and 24 weeks

Interventionmg/L (Mean)
HIV Patients on Stable Therapy-0.40

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Change in Myocyte Injury and Strain (hs Troponin (in ng/L))

"Change in Myocyte Injury and Strain (hs Troponin (in ng/L)) at 24 weeks after initiation of B/F/TAF.~Serum biomarkers of myocardial injury/strain (high sensitivity troponin) were measured. hs-troponin >14 ng/L are considered abnormal and associated with increased cardiovascular risk." (NCT03656783)
Timeframe: Baseline and 24 weeks

Interventionng/L (Mean)
HIV Patients on Stable Therapy-0.04

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Change in Myocyte Injury and Strain (NT-proBNP (in pg/mL))

"Change in Myocyte Injury and Strain (NT-proBNP (in pg/mL)) at 24 weeks after initiation of B/F/TAF.~Serum biomarkers of myocardial injury/strain (NT-pro-BNP) were measured. NT-proBNP > 100 pg/mL are considered abnormal and associated with increased cardiovascular risk." (NCT03656783)
Timeframe: Baseline and 24 weeks

Interventionpg/mL (Mean)
HIV Patients on Stable Therapy-14.2

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Change in Peak Stress Global MBF

"Change (from baseline) in peak-stress global myocardial blood flow (in mL/min/g) at 24 weeks after initiation of B/F/TAF.~Absolute MBF was computed from the rest and stress myocardial perfusion PET images using commercially available software (Corridor4DM; Ann Arbor, Michigan) and a two-compartment tracer kinetic model. Impaired stress MBF is defined as <1.8 mL/min/g and is associated with increased cardiovascular risk." (NCT03656783)
Timeframe: baseline and 24 weeks

InterventionmL/min/g (Mean)
HIV Patients on Stable Therapy0.09

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Change in Global CFR

"Change in global coronary flow reserve, as measured by PET imaging at baseline and 24 weeks after initiation of B/F/TAF therapy.~Coronary flow reserve (CFR), the ratio of peak vasodilator stress to rest myocardial blood flow (MBF), represents the maximal ability to augment coronary flow and myocardial perfusion. Absolute MBF was computed from the rest and stress myocardial perfusion PET images using commercially available software (Corridor4DM; Ann Arbor, Michigan) and a two-compartment tracer kinetic model. Impaired MBFR is defined as a ratio of <2.0, which is associated with increased cardiovascular risk." (NCT03656783)
Timeframe: baseline and week 24

Interventionratio (Mean)
HIV Patients on Stable Therapy-.05

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EVG Cmax

Maximum Plasma Concentration (Cmax) for Elvitegravir (ng/mL) (NCT03717129)
Timeframe: 72 Hr

Interventionng/mL (Mean)
Genvoya Oral Dose1650
Genvoya Crushed Dose1946

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AUC0-∞ for FTC

AUC 0 to Infinity for Emtricitabine (ng*h/mL) (NCT03717129)
Timeframe: 72 hours

Interventionng*h/mL (Mean)
Genvoya Oral Dose11603
Genvoya Crushed Dose10969

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Area Under the Curve From 0 to Infinity (AUC0-∞) for EVG

AUC 0 to Infinity for Elvitegravir (ng*h/mL) (NCT03717129)
Timeframe: 72 hours

Interventionng*h/mL (Mean)
Genvoya Oral Dose24219
Genvoya Crushed Dose26948

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TFV Half-life

Terminal elimination half-life for TFV (hours). (NCT03717129)
Timeframe: 72 hours

Interventionhours (Mean)
Genvoya Oral Dose42.5
Genvoya Crushed Dose40.7

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TFV Cmax

Maximum Plasma Concentration (Cmax) for Tenofovir (ng/mL) (NCT03717129)
Timeframe: 72 hr

Interventionng/mL (Mean)
Genvoya Oral Dose11
Genvoya Crushed Dose9.5

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FTC Half-life

Terminal elimination half-life for FTC (hours). (NCT03717129)
Timeframe: 72 hours

Interventionhours (Mean)
Genvoya Oral Dose15.2
Genvoya Crushed Dose16.1

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EVG Half-life

Terminal elimination half-life for EVG (hours). (NCT03717129)
Timeframe: 72 hours

Interventionhours (Mean)
Genvoya Oral Dose5
Genvoya Crushed Dose5.1

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FTC Cmax

Maximum Plasma Concentration (Cmax) for Emtricitabine (ng/mL) (NCT03717129)
Timeframe: 72 hr

Interventionng/mL (Mean)
Genvoya Oral Dose2095
Genvoya Crushed Dose1968

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AUC0-∞ for Tenofovir (TFV)

AUC 0 to Infinity for TFV (ng*h/mL) (NCT03717129)
Timeframe: 72 hours

Interventionng*h/mL (Mean)
Genvoya Oral Dose253
Genvoya Crushed Dose241

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Number of Subjects With Suppression/Loss of Viral HBeAg Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy

"Incidence of subjects with suppression/loss of viral Hepatitis B e antigen (HBeAg) antigen/DNA on combination treatment whose viral antigens rebound off therapy" (NCT03780543)
Timeframe: upto Week 148

InterventionParticipants (Count of Participants)
Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-2014
Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-2014

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Sustained Viral Response (SVR) at 24 Weeks Off Treatment

"To evaluate the potential for combination therapy with ABI-H0731+ NrtI to increase SVR rates in subjects who have chronic hepatitis B (CHB). To evaluate the proportion of subjects who meet the definition of SVR at 24 weeks off treatment, the SVR rate and corresponding 95% confidence interval will be presented for the overall population while on combination therapy.~SVR is defined as sustained viral response with HBV DNA , LOQ (20 IU/mL) through off-treatment Week 24." (NCT03780543)
Timeframe: Completing from week 52 until week 76

InterventionParticipants (Count of Participants)
Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-2010
Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-2010
Treatment-naïve Subjects With HBeAg Positive cHBV0

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Number of Subjects With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at End of Treatment (EOT) and End of Study (EOS)

"To measure the number and proportion of subjects with abnormal ALT at baseline who have normal ALT at end of treatment (EOT) and end of study (EOS)~To measure the number and proportion of subjects regardless of levels of ALT at baseline at EOT and EOS" (NCT03780543)
Timeframe: EOT: up to Week 52 or 148; EOS: up to 3 years off treatment

,,
InterventionParticipants (Count of Participants)
Numbers with normal ALT levels at EOTNumber with normal ALT levels at EOS
Treatment-naïve Subjects With HBeAg Positive cHBV55
Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-20121
Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-20100

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Number of Subjects With Adverse Events

Incidence of treatment emergent adverse events (AEs) (NCT03780543)
Timeframe: Up to Week 148

,,
InterventionParticipants (Count of Participants)
Number of subjects with AEsNumber of subjects with discontinuation due to an AENumber of subjects with significant abnormal ECGs
Treatment-naïve Subjects With HBeAg Positive cHBV1220
Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-2011610
Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-2012601

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ALT Normalization at Week 24

Proportion of participants with normal ALT at Week 24 (NCT03797014)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
B/F/TAF4

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HBeAg Loss at Week 48

Proportion of participants with hepatitis B envelop antigen (HBeAg) loss at Week 48 visit. (NCT03797014)
Timeframe: Week 48

InterventionParticipants (Count of Participants)
B/F/TAF0

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CD4 Cell Count Change at Week 24

Change from baseline in CD4 cell count at Week 24 (NCT03797014)
Timeframe: Baseline; Week 24

Interventioncells/microliter (Mean)
B/F/TAF32.8

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CD4 Cell Count Change at Week 48

Change from baseline in CD4 cell count at Week 48 (NCT03797014)
Timeframe: Baseline; Week 48

Interventioncells/microliter (Mean)
B/F/TAF76.6

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HBsAg Loss at Week 48

Proportion of participants with hepatitis B surface antigen (HBsAg) loss at Week 48 visit. (NCT03797014)
Timeframe: Week 48

InterventionParticipants (Count of Participants)
B/F/TAF0

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HBV DNA at Week 24

Proportion of participants with plasma HBV DNA <29 IU/mL at Week 24 as defined by Missing=Failure Approach (NCT03797014)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
B/F/TAF24

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HBV DNA at Week 48

Proportion of participants with plasma HBV DNA <29 IU/mL at Week 48 as defined by Missing=Failure Approach (NCT03797014)
Timeframe: Week 48

InterventionParticipants (Count of Participants)
B/F/TAF22

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HIV-1 RNA at Week 24

Proportion of participants with HIV-1 RNA <50 copies/mL at Week 24 by US FDA Snapshot Algorithm (NCT03797014)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
B/F/TAF25

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HIV-1 RNA at Week 48

Proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 by US FDA Snapshot Algorithm (NCT03797014)
Timeframe: Week 48

InterventionParticipants (Count of Participants)
B/F/TAF22

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ALT Normalization at Week 48

Proportion of participants with normal ALT at Week 48 (NCT03797014)
Timeframe: Week 48

InterventionParticipants (Count of Participants)
B/F/TAF4

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Period 2: Change From Baseline in Hematology Parameter of MCV

Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionFemtoliters (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK3640254-1.02-0.17-0.82

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Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours (Median)
TAF/FTC+GSK36402545.000

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Period 2: Tmax of FTC

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours (Median)
TAF/FTC+GSK36402541.500

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Period 2: Tmax of TAF

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours (Median)
TAF/FTC+GSK36402541.000

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Period 2: Tmax of TFV

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours (Median)
TAF/FTC+GSK36402543.000

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Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE)

An adverse events (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before (NCT03836729)
Timeframe: Up to Day 24

,
InterventionParticipants (Number)
Non-SAEsSAEs
TAF/FTC90
TAF/FTC+GSK364025430

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Period 1: Absolute Values of Blood Pressure

SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionMillimeters of mercury (Mean)
SBP, BaselineSBP, Day 2SBP, Day 3SBP, Day 4SBP, Day 5SBP, Day 7DBP, BaselineDBP, Day 2DBP, Day 3DBP, Day 4DBP, Day 5DBP, Day 7
TAF/FTC123.3124.7121.5120.6121.0124.175.375.473.875.473.978.2

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Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionUnits per Liter (Mean)
Amylase, BaselineAmylase, Day 7Amylase, Day 14Lipase, BaselineLipase, Day 7Lipase, Day 14
TAF/FTC56.454.153.622.218.216.9

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Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionInternational units per Liter (Mean)
Alkaline phosphatase, BaselineAlkaline phosphatase, Day 7Alkaline phosphatase, Day 14AST, BaselineAST, Day 7AST, Day 14ALT, BaselineALT, Day 7ALT, Day 14GGT BaselineGGT Day 7GGT Day 14LDH, BaselineLDH, Day 7LDH, Day 9CK, BaselineCK, Day 7CK, Day 14
TAF/FTC60.958.363.424.618.417.626.624.420.41.761.912.40138.0123.4126.0219.6116.6120.4

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Period 1: Absolute Values of Specific Gravity of Urine

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionRatio (Mean)
BaselineDay 7Day 14
TAF/FTC1.01361.01431.0147

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Period 1: Absolute Values of Respiratory Rate

Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionBreaths per minute (Mean)
BaselineDay 2Day 3Day 4Day 5Day 7
TAF/FTC14.012.513.513.515.314.6

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Period 1: Absolute Values of Pulse Rate

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionBeats per minute (Mean)
BaselineDay 2Day 3Day 4Day 5Day 7
TAF/FTC73.972.870.169.972.366.3

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Period 1: Absolute Values of pH of Urine

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionpH (Mean)
BaselineDay 7Day 14
TAF/FTC6.225.886.03

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Period 2: Absolute Values of Pulse Rate

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionBeats per minute (Mean)
Baseline, n= 16Day 4, n=15Day 7, n=15Day 9, n=15Day 10, n=15
TAF/FTC+GSK364025470.571.971.469.279.0

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Period 1: Absolute Values of Heart Rate

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose

InterventionBeats per minute (Mean)
BaselineDay 1, 2 hours post-doseDay 1, 4 hours post-dose
TAF/FTC67.669.164.4

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Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose

InterventionMilliseconds (Mean)
PR Interval, BaselinePR Interval, Day 1, 2 hours post-dosePR Interval, Day 1, 4 hours post-doseQRS Duration, BaselineQRS Duration, Day 1, 2 hours post-doseQRS Duration, Day 1, 4 hours post-doseQT Interval, BaselineQT Interval, Day 1, 2 hours post-doseQT Interval, Day 1, 4 hours post-doseQTcF Interval, BaselineQTcF Interval, Day 1, 2 hours post-doseQTcF Interval, Day 1, 4 hours post-doseQTcB Interval, BaselineQTcB Interval, Day 1, 2 hours post-doseQTcB Interval, Day 1, 4 hours post-dose
TAF/FTC161.3162.8159.491.089.991.3377.8370.3383.6391.6386.7390.3398.8394.6393.3

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Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionGrams per Liter (Mean)
Total Protein, BaselineTotal Protein, Day 7Total Protein, Day 14Globulin, BaselineGlobulin, Day 7Globulin, Day 14Albumin, BaselineAlbumin, Day 7Albumin, Day 14
TAF/FTC69.872.472.625.928.428.743.944.043.9

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Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionHours*nanogram per milliliter (Geometric Mean)
TAF/FTC250.4

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Period 1: AUC (0-tau) of FTC

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionHours*nanogram per milliliter (Geometric Mean)
TAF/FTC9787.5

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Period 1: AUC (0-tau) of Tenofovir (TFV)

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionHours*nanogram per milliliter (Geometric Mean)
TAF/FTC221.9

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Period 1: Cmax of TFV

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC13.14

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Period 1: Ctau of TFV

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC7.688

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Period 1: Maximum Observed Concentration (Cmax) of TAF

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC203.4

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Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC71.81

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Period 1: Tmax of FTC

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionHours (Median)
TAF/FTC1.500

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Period 1: Tmax of TAF

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionHours (Median)
TAF/FTC1.00

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Period 1: Tmax of TFV

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionHours (Median)
TAF/FTC3.000

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Period 1:Cmax of FTC

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC1811

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Period 2: AUC (0-tau) of FTC

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours*nanogram per milliliter (Geometric Mean)
TAF/FTC+GSK36402549421.0

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Period 2: AUC (0-tau) of GSK3640254

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours*nanogram per milliliter (Geometric Mean)
TAF/FTC+GSK364025424.53

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Period 2: AUC (0-tau) of TAF

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours*nanogram per milliliter (Geometric Mean)
TAF/FTC+GSK3640254215.4

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Period 2: AUC (0-tau) of TFV

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours*nanogram per milliliter (Geometric Mean)
TAF/FTC+GSK3640254229.1

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Period 2: Cmax of GSK3640254

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC+GSK36402541.411

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Period 2: Cmax of TAF

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC+GSK3640254175.1

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Period 2: Cmax of TFV

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC+GSK364025413.30

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Period 2: Ctau of FTC

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC+GSK364025482.92

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Period 1: Change From Baseline in Blood Pressure

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionMillimeters of mercury (Mean)
SBP, Day 2SBP, Day 3SBP, Day 4SBP, Day 5SBP, Day 7DBP, Day 2DBP, Day 3DBP, Day 4DBP, Day 5DBP, Day 7
TAF/FTC1.4-1.8-2.7-2.30.80.1-1.60.1-1.42.9

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Period 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK)

Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter like alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionInternational units per Liter (Mean)
Alkaline phosphatase, Day 7Alkaline phosphatase, Day 14AST, Day 7AST, Day 14ALT, Day 7ALT, Day 14GGT Day 7GGT Day 14LDH, Day 7LDH, Day 14CK, Day 7CK, Day 14
TAF/FTC-2.62.4-6.2-6.9-2.1-6.20.2-1.7-14.6-12.0-103.0-99.2

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Period 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionMillimoles per Liter (Mean)
Glucose, Day 7Glucose, Day 14Cholesterol, Day 7Cholesterol, Day 14Anion gap, Day 7Anion gap, Day 14Calcium, Day 7Calcium, Day 14CO2, Day 7CO2, Day 14Chloride, Day 7Chloride, Day 14Phosphate, Day 7Phosphate, Day 14Potassium, Day 7Potassium, Day 14Sodium, Day 7Sodium, Day 14Triglycerides, Day 7Triglycerides, Day 14BUN, Day 7BUN, Day 14
TAF/FTC-0.160-0.320-0.004-0.3891.92.20.0280.028-1.6-0.9-1.1-2.00.0170.0260.03-0.03-0.6-0.60.092-0.044-0.018-0.195

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Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionUnits per Liter (Mean)
Amylase, Day 7Amylase, Day 14Lipase, Day 7Lipase, Day 14
TAF/FTC-2.3-2.8-4.0-5.3

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Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionMicromoles per liter (Mean)
Creatinine, Day 7Creatinine, Day 14Total bilirubin, Day 7Total bilirubin, Day 14Direct bilirubin, Day 7Direct bilirubin, Day 14
TAF/FTC5.697.362.252.100.150.64

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Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionGrams per Liter (Mean)
Total Protein, Day 7Total Protein, Day 14Globulin, Day 7Globulin, Day 14Albumin, Day 7Albumin, Day 14
TAF/FTC2.62.92.52.80.10.1

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Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose

InterventionMilliseconds (Mean)
PR Interval, Day 1, 2 hours post-dosePR Interval, Day 1, 4 hours post-doseQRS Duration, Day 1, 2 hours post-doseQRS Duration, Day 1, 4 hours post-doseQT Interval, Day 1, 2 hours post-doseQT Interval, Day 1, 4 hours post-doseQTcF Interval, Day 1, 2 hours post-doseQTcF Interval, Day 1, 4 hours post-doseQTcB Interval, Day 1, 2 hours post-doseQTcB Interval, Day 1, 4 hours post-dose
TAF/FTC1.5-1.9-1.10.3-7.55.8-4.9-1.3-4.1-5.4

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Period 1: Change From Baseline in Heart Rate

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose

InterventionBeats per minute (Mean)
Day 1, 2 hours post-doseDay 1, 4 hours post-dose
TAF/FTC1.5-3.3

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Period 1: Change From Baseline in Hematology Parameter of Erythrocytes

Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionTrillion cells per liter (Mean)
Day 7Day 14
TAF/FTC0.1890.226

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Period 1: Change From Baseline in Hematology Parameter of Hematocrit

Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionProportion of red blood cells in blood (Mean)
Day 7Day 14
TAF/FTC0.01210.0189

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Period 1: Change From Baseline in Hematology Parameter of Hemoglobin

Blood samples were collected at indicated timepoints for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionGrams per liter (Mean)
Day 7Day 14
TAF/FTC6.18.4

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Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH)

Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionPicograms (Mean)
Day 7Day 14
TAF/FTC0.130.36

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Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, and 14

InterventionGiga cells per liter (Mean)
Basophils, Period 1 Day 7Basophils, Period 1 Day 14Eosinophils, Period 1 Day 7Eosinophils, Period 1 Day 14Monocytes, Period 1 Day 7Monocytes, Period 1 Day 14Leukocytes, Period 1 Day 7Leukocytes, Period 1 Day 14Lymphocytes, Period 1 Day 7Lymphocytes, Period 1 Day 14Neutrophils, Period 1 Day 7Neutrophils, Period 1 Day 14Platelets, Period 1 Day 7Platelets, Period 1 Day 14
TAF/FTC-0.005-0.006-0.021-0.0200.0140.049-0.080.27-0.246-0.2620.1880.5133.321.8

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Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionpH (Mean)
Day 7Day 14
TAF/FTC-0.34-0.19

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Period 1: Change From Baseline in Pulse Rate

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionBeats per minute (Mean)
Day 2Day 3Day 4Day 5Day 7
TAF/FTC-1.2-3.8-4.0-1.6-7.6

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Period 1: Change From Baseline in Respiratory Rate

Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionBreaths per minute (Mean)
Day 2Day 3Day 4Day 5Day 7
TAF/FTC-1.5-0.5-0.51.30.6

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Period 1: Change From Baseline in Specific Gravity of Urine

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionRatio (Mean)
Day 7Day 14
TAF/FTC0.00070.0011

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Period 1: Change From Baseline in Temperature

Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionDegree Celsius (Mean)
Day 2Day 3Day 4Day 5Day 7
TAF/FTC-0.16-0.15-0.09-0.15-0.24

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Period 1: Change From Baseline in Urine Urobilinogen

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionMicromoles per liter (Mean)
Day 7Day 14
TAF/FTC-2.5395-2.5395

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Period 2: Absolute Values of Blood Pressure

SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionMillimeters of mercury (Mean)
SBP, Baseline, n= 16SBP, Day 4, n=15SBP, Day 7, n=15SBP, Day 9, n=15SBP, Day 10, n=15DBP, Baseline, n= 16DBP, Day 4, n= 15DBP, Day 7, n= 15DBP, Day 9, n= 15DBP, Day 10, n= 15
TAF/FTC+GSK3640254120.4119.3120.8117.9123.774.474.377.970.372.1

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Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionUnits per Liter (Mean)
Amylase, Baseline, n= 16Amylase, Day 3, n= 16Amylase, Day 7, n= 15Amylase, Day 9, n= 15Lipase, Baseline, n= 16Lipase, Day 3, n= 16Lipase, Day 7, n= 15Lipase, Day 9, n= 15
TAF/FTC+GSK364025453.656.852.755.716.924.617.521.0

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Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionInternational units per Liter (Mean)
Alkaline phosphatase, Baseline Day 3, n= 16Alkaline phosphatase, Day 3, n= 16Alkaline phosphatase, Day 7, n= 15Alkaline phosphatase, Day 9, n= 15AST, Baseline, n= 16AST, Day 3, n= 16AST, Day 7, n= 15AST, Day 9, n= 15ALT, Baseline, n= 16ALT, Day 3, n= 16ALT, Day 7, n= 15ALT, Day 9, n= 15GGT, Baseline, n= 16GGT, Day 3, n= 16GGT, Day 7, n= 15GGT, Day 9, n= 15LDH, Baseline, n= 16LDH, Day 3, n= 16LDH, Day 7, n= 15LDH, Day 9, n= 15CK, Baseline, n= 16CK, Day 3, n= 16CK, Day 7, n= 15CK, Day 9, n= 15
TAF/FTC+GSK364025463.467.165.461.817.616.217.217.620.418.418.519.72.402.142.411.95126.0119.0118.0119.2120.4123.8135.8122.2

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Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionMillimoles per Liter (Mean)
Glucose, Baseline, n= 16Glucose, Day 3, n= 15Glucose, Day 7, n= 15Glucose, Day 9, n= 15Cholesterol, Baseline, n= 16Cholesterol, Day 3, n=15Cholesterol, Day 7, n= 15Cholesterol, Day 9, n= 16Anion gap, Baseline, n= 16Anion gap, Day 3, n= 16Anion gap, Day 7, n= 15Anion gap, Day 9, n= 15Calcium, Baseline, n= 16Calcium, Day 3, n= 16Calcium, Day 7, n= 15Calcium, Day 9, n= 15CO2, Baseline, n= 16CO2, Day 3, n= 16CO2, Day 7, n= 15CO2, Day 9, n= 15Chloride, Baseline, n= 16Chloride, Day 3, n= 16Chloride, Day 7, n= 15Chloride, Day 9, n= 15Phosphate, Baseline, n= 16Phosphate, Day 3, n= 16Phosphate, Day 7, n= 15Phosphate, Day 9, n= 15Potassium, Baseline, n= 16Potassium, Day 3, n= 16Potassium, Day 7, n= 15Potassium, Day 9, n= 15Sodium, Baseline, n= 16Sodium, Day 3, n= 16Sodium, Day 7, n= 15Sodium, Day 9, n=15Triglycerides, Baseline, n= 16Triglycerides, Day 3, n= 16Triglycerides, Day 7, n= 15Triglycerides, Day 9, n= 15BUN, Baseline, n= 16BUN, Day 3, n= 16BUN, Day 7, n= 15BUN Day 9, n= 15
TAF/FTC+GSK36402544.7915.0275.1294.9503.8643.8753.8943.82210.910.510.310.52.3872.3992.4242.42130.830.330.730.5101.3103.6101.9102.71.1031.1651.1121.1174.224.234.214.35138.8140.2138.8139.31.0331.0291.1200.9614.2464.5584.2604.263

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Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionMicromoles per liter (Mean)
Creatinine, Baseline, n= 16Creatinine, Day 3, n= 16Creatinine, Day 7, n= 15Creatinine, Day 9, n= 15Total bilirubin, Baseline, n= 16Total bilirubin, Day 3, n= 16Total bilirubin, Day 7, n= 15Total bilirubin, Day 9, n= 15Direct bilirubin, Baseline, n= 16Direct bilirubin, Day 3, n= 16Direct bilirubin, Day 7, n= 15Direct bilirubin, Day 9, n= 15
TAF/FTC+GSK364025487.5285.1891.5388.2711.4410.6211.339.682.402.142.411.95

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Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionGrams per Liter (Mean)
Total Protein, Baseline, n= 16Total Protein, Day 3, n= 16Total Protein, Day 7, n= 15Total Protein, Day 9, n= 15Globulin, Baseline, n= 16Globulin, Day 3, n= 16Globulin, Day 7, n= 15Globulin, Day 9, n= 15Albumin, Baseline, n= 16Albumin, Day 3, n= 16Albumin, Day 7, n= 15Albumin, Day 9, n= 15
TAF/FTC+GSK364025472.672.875.773.328.728.930.928.843.943.944.844.5

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Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

InterventionMilliseconds (Mean)
PR Interval, Baseline, n= 16PR Interval, Day 1, 2 hours post-dose, n= 16PR Interval, Day 1, 4 hours post-dose, n= 16PR Interval, Day 4, Pre-dose, n= 15PR Interval, Day 4, 2 hours post-dose, n= 15PR Interval, Day 4, 4 hours post-dose, n= 15PR Interval, Day 7, Pre-dose, n= 15PR Interval, Day 7, 2 hours post-dose, n= 15PR Interval, Day 7, 4 hours post-dose, n= 15PR Interval, Day 9 post-dose, n= 15QRS Duration, Baseline, n= 16QRS Duration, Day 1, 2 hours post-dose, n= 16QRS Duration, Day 1, 4 hours post-dose, n= 16QRS Duration, Day 4, Pre-dose, n= 15QRS Duration, Day 4, 2 hours post-dose, n= 15QRS Duration, Day 4, 4 hours post-dose, n= 15QRS Duration, Day 7, Pre-dose, n= 15QRS Duration, Day 7, 2 hours post-dose, n= 15QRS Duration, Day 7, 4 hours post-dose, n= 15QRS Duration, Day 9 post-dose, n= 15QT Interval, Baseline, n= 16QT Interval, Day 1, 2 hours post-dose, n= 16QT Interval, Day 1, 4 hours post-dose, n= 16QT Interval, Day 4, Pre-dose, n= 15QT Interval, Day 4, 2 hours post-dose, n= 15QT Interval, Day 4, 4 hours post-dose, n= 15QT Interval, Day 7, Pre-dose, n= 15QT Interval, Day 7, 2 hours post-dose, n= 15QT Interval, Day 7, 4 hours post-dose, n= 15QT Interval, Day 9 post-dose, n= 15QTcF Interval, Baseline, n= 16QTcF Interval, Day 1, 2 hours, n= 16QTcF Interval, Day 1, 4 hours post-dose, n= 16QTcF Interval, Day 4, Pre-dose, n= 15QTcF Interval, Day 4, 2 hours post-dose, n= 15QTcF Interval, Day 4, 4 hours post-dose, n= 15QTcF Interval, Day 7, Pre-dose, n= 15QTcF Interval, Day 7, 2 hours post-dose, n= 15QTcF Interval, Day 7, 4 hours post-dose, n= 15QTcF Interval, Day 9 post-dose, n= 15QTcB Interval, Baseline, n= 16QTcB Interval, Day 1, 2 hours post-dose, n= 16QTcB Interval, Day 1, 4 hours post-dose, n= 16QTcB Interval, Day 4, Pre-dose, n= 15QTcB Interval, Day 4, 2 hours post-dose, n= 15QTcB Interval, Day 4, 4 hours post-dose, n= 15QTcB Interval, Day 7, Pre-dose, n= 15QTcB Interval, Day 7, 2 hours post-dose, n= 15QTcB Interval, Day 7, 4 hours post-dose, n= 15QTcB Interval, Day 9 post-dose, n= 15
TAF/FTC+GSK3640254167.3160.4163.6167.1160.7163.7164.9164.3163.9168.891.488.990.191.891.891.194.592.791.694.3377.7365.1375.9385.6371.5383.9381.7369.9384.1382.4390.0385.6392.4395.0388.3393.4393.0383.8389.5396.8395.7396.4400.4399.2396.2398.0398.3390.5391.9404.0

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Period 2: Absolute Values of Heart Rate

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

InterventionBeats per minute (Mean)
Baseline, n= 16Day 1, 2 hours post-dose, n= 16Day 1, 4 hours post-dose, n= 16Day 4, Pre-dose, n= 15Day 4, 2 hours post-dose, n= 15Day 4, 4 hours post-dose, n= 15Day 7, Pre-dose, n= 15Day 7, 2 hours post-dose, n= 15Day 7, 4 hours post-dose, n= 15Day 9 post-dose, n= 15
TAF/FTC+GSK364025466.571.569.365.168.965.365.967.463.367.7

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Period 2: Absolute Values of pH of Urine

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionpH (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402546.036.226.076.07

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Period 2: Absolute Values of Respiratory Rate

Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionBreaths per minute (Mean)
Baseline, n= 16Day 4, n=15Day 7, n=15Day 9, n=15Day 10, n=15
TAF/FTC+GSK364025415.612.513.314.914.3

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Period 2: Absolute Values of Specific Gravity of Urine

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionRatio (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402541.01471.01781.01701.0151

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Period 2: Absolute Values of Temperature

Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionDegree Celsius (Mean)
Baseline, n= 16Day 4, n=15Day 7, n=15Day 9, n=15Day 10, n=15
TAF/FTC+GSK364025436.4936.3736.4036.4636.53

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Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionGiga cells per liter (Mean)
Basophils, Period 2 Baseline, n= 16Basophils, Period 2 Day 3, n= 15Basophils, Period 2 Day 7, n= 15Basophils, Period 2 Day 9, n= 15Eosinophils, Period 2 Baseline, n= 16Eosinophils, Period 2 Day 3, n= 15Eosinophils, Period 2 Day 7, n= 15Eosinophils, Period 2 Day 9, n= 16Monocytes, Period 2 Baseline, n= 16Monocytes, Period 2 Day 3, n= 16Monocytes, Period 2 Day 7, n= 15Monocytes, Period 2 Day 9, n= 15Leukocytes, Period 2 Baseline, n= 16Leukocytes, Period 2 Day 3, n= 16Leukocytes, Period 2 Day 7, n= 15Leukocytes, Period 2 Day 9, n= 15Lymphocytes, Period 2 Baseline, n= 16Lymphocytes, Period 2 Day 3, n= 16Lymphocytes, Period 2 Day 7, n= 15Lymphocytes, Period 2 Day 9, n= 15Neutrophils, Period 2 Baseline, n= 16Neutrophils, Period 2 Day 3, n= 16Neutrophils, Period 2 Day 7, n= 15Neutrophils, Period 2 Day 9, n= 15Platelets, Period 2 Baseline, n= 16Platelets, Period 2 Day 3, n= 16Platelets, Period 2 Day 7, n= 15Platelets, Period 2 Day 9, n= 15
TAF/FTC+GSK36402540.0400.0360.0380.0430.2080.1850.1570.1530.5450.4920.4480.4216.205.145.395.511.7181.5601.5701.5633.7242.8573.1893.324274.3283.4294.0290.4

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Period 2: Absolute Values of the Hematology Parameter: Erythrocytes

Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionTrillion cells per liter (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402545.2035.0905.1905.001

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Period 2: Absolute Values of the Hematology Parameter: Hematocrit

Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionProportion of red blood cells in blood (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402540.44530.43060.44440.4247

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Period 2: Absolute Values of the Hematology Parameter: Hemoglobin

Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionGrams per liter (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK3640254150.4146.4149.1143.9

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Period 2: Absolute Values of the Hematology Parameter: MCH

Blood samples were collected at indicated time-points for analysis of hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionPicograms (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK364025428.9828.8828.8328.87

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Period 2: Absolute Values of the Hematology Parameter: MCV

Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionFemtoliters (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK364025485.8584.8385.8585.20

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Period 2: Absolute Values of Urine Urobilinogen

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionMicromoles per liter (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402543.38603.38603.38603.3860

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Period 2: Change From Baseline in Blood Pressure

SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionMillimeters of mercury (Mean)
SBP, Day 4SBP, Day 7SBP, Day 9SBP, Day 10DBP, Day 4DBP, Day 7DBP, Day 9DBP, Day 10
TAF/FTC+GSK3640254-0.31.1-1.74.10.13.7-4.0-2.1

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Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionInternational units per Liter (Mean)
Alkaline phosphatase, Day 3, n= 16Alkaline phosphatase, Day 7, n= 15Alkaline phosphatase, Day 9, n= 15AST, Day 3, n= 16AST, Day 7, n= 15AST, Day 9, n= 15ALT, Day 3, n= 16ALT, Day 7, n= 15ALT, Day 9, n= 15GGT, Day 3, n= 16GGT, Day 7, n= 15GGT, Day 9, n= 15LDH, Day 3, n= 16LDH, Day 7, n= 15LDH, Day 9, n= 15CK, Day 3, n= 16CK, Day 7, n= 15CK, Day 9, n= 15
TAF/FTC+GSK36402543.72.6-1.0-1.4-0.5-0.1-2.0-1.9-0.7-0.9-1.4-1.9-7.0-8.2-7.03.411.3-2.3

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Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionMillimoles per Liter (Mean)
Glucose, Day 3, n= 15Glucose, Day 7, n= 15Glucose, Day 9, n= 15Cholesterol, Day 3, n=15Cholesterol, Day 7, n= 15Cholesterol, Day 9, n= 16Anion gap, Day 3, n= 16Anion gap, Day 7, n= 15Anion gap, Day 9, n= 15Calcium, Day 3, n= 16Calcium, Day 7, n= 15Calcium, Day 9, n= 15CO2, Day 3, n= 16CO2, Day 7, n= 15CO2, Day 9, n= 15Chloride, Day 3, n= 16Chloride, Day 7, n= 15Chloride, Day 9, n= 15Phosphate, Day 3, n= 16Phosphate, Day 7, n= 15Phosphate, Day 9, n= 15Potassium, Day 3, n= 16Potassium, Day 7, n= 15Potassium, Day 9, n= 15Sodium, Day 3, n= 16Sodium, Day 7, n= 15Sodium, Day 9, n= 15Triglycerides, Day 3, n= 16Triglycerides, Day 7, n= 15Triglycerides, Day 9, n= 15BUN, Day 3, n= 16BUN, Day 7, n= 15BUN, Day 9, n= 15
TAF/FTC+GSK36402540.2360.3150.1360.0110.1020.030-0.4-0.5-0.30.0130.0370.033-0.5-0.1-0.42.30.61.30.0620.0020.0070.01-0.030.101.40.10.6-0.0030.111-0.0490.312-0.031-0.028

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Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionUnits per Liter (Mean)
Amylase, Day 3, n= 16Amylase, Day 7, n= 15Amylase, Day 9, n= 15Lipase, Day 3, n= 16Lipase, Day 7, n= 15Lipase, Day 9, n= 15
TAF/FTC+GSK36402543.3-1.91.17.70.03.5

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Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionMicromoles per liter (Mean)
Creatinine, Day 3, n= 16Creatinine, Day 7, n= 15Creatinine, Day 9, n= 15Total bilirubin, Day 3, n= 16Total bilirubin, Day 7, n= 15Total bilirubin, Day 9, n= 15Direct bilirubin, Day 3, n= 16Direct bilirubin, Day 7, n= 15Direct bilirubin, Day 9, n= 15
TAF/FTC+GSK3640254-2.343.530.28-0.82-0.26-1.91-0.26-0.03-0.49

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Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionGrams per Liter (Mean)
Total Protein, Day 3, n= 16Total Protein, Day 7, n= 15Total Protein, Day 9, n= 15Globulin, Day 3, n= 16Globulin, Day 7, n= 15Globulin, Day 9, n= 15Albumin, Day 3, n= 16Albumin, Day 7, n= 15Albumin, Day 9, n= 15
TAF/FTC+GSK36402540.13.10.80.22.30.2-0.10.90.6

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Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

InterventionMilliseconds (Mean)
PR Interval, Day 1, 2 hours post-dose, n= 16PR Interval, Day 1, 4 hours post-dose, n= 16PR Interval, Day 4, Pre-dose, n= 15PR Interval, Day 4, 2 hours post-dose, n= 15PR Interval, Day 4, 4 hours post-dose, n= 15PR Interval, Day 7, Pre-dose, n= 15PR Interval, Day 7, 2 hours post-dose, n= 15PR Interval, Day 7, 4 hours post-dose, n= 15PR Interval, Day 9 post-dose, n= 15QRS Duration, Day 1, 2 hours post-dose, n= 16QRS Duration, Day 1, 4 hours post-dose, n= 16QRS Duration, Day 4, Pre-dose, n= 15QRS Duration, Day 4, 2 hours post-dose, n= 15QRS Duration, Day 4, 4 hours post-dose, n= 15QRS Duration, Day 7, Pre-dose, n= 15QRS Duration, Day 7, 2 hours post-dose, n= 15QRS Duration, Day 7, 4 hours post-dose, n= 15QRS Duration, Day 9 post-dose, n= 15QT Interval, Day 1, 2 hours post-dose, n= 16QT Interval, Day 1, 4 hours post-dose, n= 16QT Interval, Day 4, Pre-dose, n= 15QT Interval, Day 4, 2 hours post-dose, n= 15QT Interval, Day 4, 4 hours post-dose, n= 15QT Interval, Day 7, Pre-dose, n= 15QT Interval, Day 7, 2 hours post-dose, n= 15QT Interval, Day 7, 4 hours post-dose, n= 15QT Interval, Day 9 post-dose, n= 15QTcF Interval, Day 1, 2 hours post-dose, n= 16QTcF Interval, Day 1, 4 hours post-dose, n= 16QTcF Interval, Day 4, Pre-dose, n= 15QTcF Interval, Day 4, 2 hours post-dose, n= 15QTcF Interval, Day 4, 4 hours post-dose, n= 15QTcF Interval, Day 7, Pre-dose, n= 15QTcF Interval, Day 7, 2 hours post-dose, n= 15QTcF Interval, Day 7, 4 hours post-dose, n= 15QTcF Interval, Day 9 post-dose, n= 15QTcB Interval, Day 1, 2 hours post-dose, n= 16QTcB Interval, Day 1, 4 hours post-dose, n= 16QTcB Interval, Day 4, Pre-dose, n= 15QTcB Interval, Day 4, 2 hours post-dose, n= 15QTcB Interval, Day 4, 4 hours post-dose, n= 15QTcB Interval, Day 7, Pre-dose, n= 15QTcB Interval, Day 7, 2 hours post-dose, n= 15QTcB Interval, Day 7, 4 hours post-dose, n= 15QTcB Interval, Day 9 post-dose, n= 15
TAF/FTC+GSK3640254-6.8-3.7-0.5-6.9-3.9-2.7-3.3-3.71.2-2.5-1.40.50.5-0.23.31.50.33.0-12.6-1.87.3-6.85.63.5-8.45.84.1-4.42.46.1-0.64.54.1-5.10.67.90.74.75.52.54.34.6-3.2-1.710.3

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Period 2: Change From Baseline in Heart Rate

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

InterventionBeats per minute (Mean)
Day 1, 2 hours post-dose, n= 16Day 1, 4 hours post-dose, n= 16Day 4, Pre-dose, n= 15Day 4, 2 hours post-dose, n= 15Day 4, 4 hours post-dose, n= 15Day 7, Pre-dose, n= 15Day 7, 2 hours post-dose, n= 15Day 7, 4 hours post-dose, n= 15Day 9 post-dose, n= 15
TAF/FTC+GSK36402545.02.8-0.53.3-0.30.31.8-2.32.1

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Period 2: Change From Baseline in Hematology Parameter of Erythrocytes

Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionTrillion cells per liter (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK3640254-0.1130.000-0.189

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Period 2: Change From Baseline in Hematology Parameter of Hematocrit

Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionProportion of red blood cells in blood (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK3640254-0.0147-0.0007-0.0204

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Period 2: Change From Baseline in Hematology Parameter of Hemoglobin

Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionGrams per liter (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK3640254-3.9-1.1-6.4

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Period 2: Change From Baseline in Hematology Parameter of MCH

Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionPicograms (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK3640254-0.11-0.21-0.17

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Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Blood samples were collected at indicated timepoints for analysis for hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionGiga cells per liter (Mean)
Basophils, Period 2 Day 3, n= 15Basophils, Period 2 Day 7, n= 15Basophils, Period 2 Day 9, n= 15Eosinophils, Period 2 Day 3, n=15Eosinophils, Period 2 Day 7, n=15Eosinophils, Period 2 Day 9, n=16Monocytes, Period 2 Day 3, n= 16Monocytes, Period 2 Day 7, n= 15Monocytes, Period 2 Day 9, n= 15Leukocytes, Period 2 Day 3, n= 16Leukocytes, Period 2 Day 7, n= 15Leukocytes, Period 2 Day 9, n= 15Lymphocytes, Period 2 Day 3, n= 16Lymphocytes, Period 2 Day 7, n= 15Lymphocytes, Period 2 Day 9, n= 15Neutrophils, Period 2 Day 3, n= 16Neutrophils, Period 2 Day 7, n= 15Neutrophils, Period 2 Day 9, n= 15Platelets, Period 2 Day 3, n= 16Platelets, Period 2 Day 7, n= 15Platelets, Period 2 Day 9, n= 15
TAF/FTC+GSK3640254-0.004-0.0020.003-0.023-0.039-0.043-0.053-0.077-0.104-1.06-0.61-0.49-0.158-0.105-0.111-0.868-0.417-0.2829.219.816.2

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Period 2: Change From Baseline in pH of Urine

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionpH (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402540.190.100.10

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Period 2: Change From Baseline in Pulse Rate

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionBeats per minute (Mean)
Day 4Day 7Day 9Day 10
TAF/FTC+GSK36402542.41.9-0.39.5

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Period 2: Change From Baseline in Respiratory Rate

Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionBreaths per minute (Mean)
Day 4Day 7Day 9Day 10
TAF/FTC+GSK3640254-3.2-2.4-0.8-1.5

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Period 2: Change From Baseline in Specific Gravity of Urine

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionRatio (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402540.00310.00240.0005

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Period 2: Change From Baseline in Temperature

Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionDegree Celsius (Mean)
Day 4Day 7Day 9Day 10
TAF/FTC+GSK3640254-0.10-0.07-0.010.07

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Period 2: Change From Baseline in Urine Urobilinogen

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionMicromoles per liter (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402540.00000.00000.0000

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Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus

Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionMillimoles per Liter (Mean)
Glucose, BaselineGlucose, Day 7Glucose, Day 14Cholesterol, BaselineCholesterol, Day 7Cholesterol, Day 14Anion gap, BaselineAnion gap, Day 7Anion gap, Day 14Calcium, BaselineCalcium, Day 7Calcium, Day 14CO2, BaselineCO2, Day 7CO2, Day 14Chloride, BaselineChloride, Day 7Chloride, Day 14Phosphate, BaselinePhosphate, Day 7Phosphate, Day 14Potassium, BaselinePotassium, Day 7Potassium, Day 14Sodium, BaselineSodium, Day 7Sodium, Day 14Triglycerides, BaselineTriglycerides, Day 7Triglycerides, Day 14BUN, BaselineBUN, Day 7BUN, Day 14
TAF/FTC5.1114.9514.7914.2534.2493.8648.710.610.92.3592.3872.38731.730.130.8103.3102.2101.31.0781.0941.1034.254.284.22139.4138.8138.81.0761.1681.0334.4414.4234.246

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Period 1: Absolute Values of Urine Urobilinogen

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionMicromoles per liter (Mean)
BaselineDay 7Day 14
TAF/FTC5.92553.38603.3860

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Period 1: Absolute Values of the Hematology Parameter: MCV

Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionFemtoliters (Mean)
BaselineDay 7Day 14
TAF/FTC85.9285.0985.85

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Period 1: Absolute Values of the Hematology Parameter: MCH

Blood samples were collected at indicated time-points for analysis for hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionPicograms (Mean)
BaselineDay 7Day 14
TAF/FTC28.6328.7528.98

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Period 1: Absolute Values of the Hematology Parameter: Hemoglobin

Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionGrams per liter (Mean)
BaselineDay 7Day 14
TAF/FTC142.0148.1150.4

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Period 1: Absolute Values of the Hematology Parameter: Hematocrit

Blood samples were collected at indicated time points for analysis for hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionProportion of red blood cells in blood (Mean)
BaselineDay 7Day 14
TAF/FTC0.42640.43840.4453

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Period 1: Absolute Values of the Hematology Parameter: Erythrocytes

Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionTrillion cells per liter (Mean)
BaselineDay 7Day 14
TAF/FTC4.9775.1665.203

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Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, and 14

InterventionGiga cells per liter (Mean)
Basophils, Period 1 BaselineBasophils, Period 1 Day 7Basophils, Period 1 Day 14Eosinophils, Period 1 BaselineEosinophils, Period 1 Day 7Eosinophils, Period 1 Day 14Monocytes, Period 1 BaselineMonocytes, Period 1 Day 7Monocytes, Period 1 Day 14Leukocytes, Period 1 BaselineLeukocytes, Period 1 Day 7Leukocytes, Period 1 Day 14Lymphocytes, Period 1 BaselineLymphocytes, Period 1 Day 7Lymphocytes, Period 1 Day 14Neutrophils, Period 1 BaselineNeutrophils, Period 1 Day 7Neutrophils, Period 1 Day 14Platelets, Period 1 BaselinePlatelets, Period 1 Day 7Platelets, Period 1 Day 14
TAF/FTC0.0460.0410.0400.2250.2040.2050.5220.5360.5716.186.106.451.9451.6991.6833.4413.6283.954253.3256.6275.1

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Period 1: Absolute Values of Temperature

Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionDegree Celsius (Mean)
BaselineDay 2Day 3Day 4Day 5Day 7
TAF/FTC36.4936.3336.3436.4136.3436.25

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Period 2: Ctau of GSK3640254

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2 hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC+GSK36402540.7883

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Period 2: Ctau of TFV

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC+GSK36402548.244

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Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionMicromoles per liter (Mean)
Creatinine, BaselineCreatinine, Day 7Creatinine, Day 14Total bilirubin, BaselineTotal bilirubin, Day 7Total bilirubin, Day 14Direct bilirubin, BaselineDirect bilirubin, Day 7Direct bilirubin, Day 14
TAF/FTC80.1685.8587.529.6411.8911.741.761.912.40

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Period 2:Cmax of FTC

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC+GSK36402541701

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Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV)

Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionFemtoliters (Mean)
Day 7Day 14
TAF/FTC-0.83-0.07

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Average Tenofovir Concentrations in Plasma.

Average tenofovir concentrations in plasma reported in ng/mL. (NCT03917420)
Timeframe: Day 5

Interventionng/ml (Mean)
Tenofovir/Emtricitabine61.02

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Average Tenofovir Diphosphate Concentrations Measured in Mixed Rectal Cells During the Late (High Estradiol) Follicular Phases of the Menstrual Cycle.

Average tenofovir diphosphate concentrations measured in mixed rectal cells collected via cytobrush during the late (high estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells (NCT03917420)
Timeframe: Days 12-15

Interventionfmol/million cells (Mean)
Tenofovir/Emtricitabine480.4

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Average Emtricitabine Concentrations in Peripheral Blood Mononuclear Cells.

Average emtricitabine concentrations in peripheral blood mononuclear cells reported in Fmol/million cells. (NCT03917420)
Timeframe: Day 5

InterventionFmol/million cells (Mean)
Tenofovir/Emtricitabine5601.95

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Average Emtricitabine Concentrations in Plasma.

Average emtricitabine concentrations in plasma reported in ng/mL. (NCT03917420)
Timeframe: Day 5

Interventionng/ml (Mean)
Tenofovir/Emtricitabine78.07

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Average Emtricitabine Triphosphate Concentrations Measured in Mixed Rectal Cells During the Early (Low Estradiol) Follicular Phases of the Menstrual Cycle.

Average emtricitabine triphosphate concentrations measured in mixed rectal cells collected via cytobrush during the early (low estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells. (NCT03917420)
Timeframe: Days 2-5

Interventionfmol/million cells (Mean)
Tenofovir/Emtricitabine13.005

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Average Emtricitabine Triphosphate Concentrations Measured in Mixed Rectal Cells During the Late (High Estradiol) Follicular Phases of the Menstrual Cycle.

Average emtricitabine triphosphate concentrations measured in mixed rectal cells collected via cytobrush during the late (high estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells. (NCT03917420)
Timeframe: Days 12-15

Interventionfmol/million cells (Mean)
Tenofovir/Emtricitabine74.822

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Average Tenofovir Diphosphate Concentrations in Peripheral Blood Mononuclear Cells.

Average tenofovir diphosphate concentrations in peripheral blood mononuclear cells reported in Fmol/million cells. (NCT03917420)
Timeframe: Day 5

InterventionFmol/million cells (Mean)
Tenofovir/Emtricitabine96.40

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Average Tenofovir Diphosphate Concentrations in Mixed Rectal Cells During the Early (Low Estradiol) Follicular Phases of the Menstrual Cycle.

Average tenofovir diphosphate concentrations measured in mixed rectal cells collected via cytobrush during the early (low estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells. (NCT03917420)
Timeframe: Days 2-5

Interventionfmol/million cells (Mean)
Tenofovir/Emtricitabine406.14

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Average Progesterone Concentrations in Serum.

Average progesterone concentrations in serum measured in ng/mL. (NCT03917420)
Timeframe: Day 5

Interventionng/ml (Mean)
Tenofovir/Emtricitabine2.46

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Average Estradiol Concentrations in Serum.

Average estradiol concentrations in serum reported in pg/mL (NCT03917420)
Timeframe: Day 5

Interventionpg/ml (Mean)
Tenofovir/Emtricitabine101.06

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Average Testosterone Concentrations in Serum.

Average testosterone concentrations in serum measured in ng/mL (NCT03917420)
Timeframe: Day 5

Interventionng/ml (Mean)
Tenofovir/Emtricitabine55.45

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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)

A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/10^6 cells (Median)
Baseline2 hours48 hours
Genvoya - 2 and 48 Hours Specimen Collection077052120

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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)

A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/10^6 cells (Median)
Baseline8 hours
Genvoya - Single Time Point Specimen Collection06855

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Rectal Tissue Concentration of Elvitegravir (EVG)

Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medication

Interventionng/mg (Median)
Baseline2 hours48 hours
Genvoya - 2 and 48 Hours Specimen Collection051.231.03

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Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)

Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/mg (Median)
Baseline4 hours72 hours
Genvoya - 4 and 72 Hours Specimen Collection045.911.9

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Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)

Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/mg (Median)
Baseline24 hours96 hours
Genvoya - 24 and 96 Hours Specimen Collection020.214.7

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Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)

Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/mg (Median)
Baseline2 hours48 hours
Genvoya - 2 and 48 Hours Specimen Collection039.118.2

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Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)

Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/mg (Median)
Baseline8 hours
Genvoya - Single Time Point Specimen Collection023.7

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Rectal Tissue Concentration of Tenofovir (TFN)

Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mg (Median)
Baseline4 hours72 hours
Genvoya - 4 and 72 Hours Specimen Collection00.300

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Rectal Tissue Concentration of Tenofovir (TFN)

Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mg (Median)
Baseline24 hours96 hours
Genvoya - 24 and 96 Hours Specimen Collection00.030

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Rectal Tissue Concentration of Tenofovir (TFN)

Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mg (Median)
Baseline2 hours48 hours
Genvoya - 2 and 48 Hours Specimen Collection000

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Rectal Tissue Concentration of Tenofovir (TFN)

Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mg (Median)
Baseline8 hours
Genvoya - Single Time Point Specimen Collection00.01

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Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)

Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/mg (Median)
Baseline4 hours72 hours
Genvoya - 4 and 72 Hours Specimen Collection0198.215.1

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Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)

Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/mg (Median)
Baseline24 hours96 hours
Genvoya - 24 and 96 Hours Specimen Collection0104.312.5

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Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)

Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/mg (Median)
Baseline2 hours48 hours
Genvoya - 2 and 48 Hours Specimen Collection0187.556.3

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Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)

Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/mg (Median)
Baseline8 hours
Genvoya - Single Time Point Specimen Collection0116.5

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Rectal Tissue Concentration of Emtricitabine (FTC)

Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mg (Median)
Baseline4 hours72 hours
Genvoya - 4 and 72 Hours Specimen Collection09.250

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Rectal Tissue Concentration of Emtricitabine (FTC)

Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mg (Median)
Baseline24 hours96 hours
Genvoya - 24 and 96 Hours Specimen Collection01.230.02

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Rectal Tissue Concentration of Emtricitabine (FTC)

Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mg (Median)
Baseline2 hours48 hours
Genvoya - 2 and 48 Hours Specimen Collection09.540.02

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Rectal Tissue Concentration of Emtricitabine (FTC)

Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mg (Median)
Baseline8 hours
Genvoya - Single Time Point Specimen Collection00.17

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Rectal Tissue Concentration of Elvitegravir (EVG)

Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medication

Interventionng/mg (Median)
Baseline4 hours72 hours
Genvoya - 4 and 72 Hours Specimen Collection041.470

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Rectal Tissue Concentration of Elvitegravir (EVG)

Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medication

Interventionng/mg (Median)
Baseline24 hours96 hours
Genvoya - 24 and 96 Hours Specimen Collection00.600.02

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Rectal Tissue Concentration of Elvitegravir (EVG)

Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medication

Interventionng/mg (Median)
Baseline8 hours
Genvoya - Single Time Point Specimen Collection00.31

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Plasma Concentration of Tenofovir (TFV)

Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mL (Median)
Baseline4 hours72 hours
Genvoya - 4 and 72 Hours Specimen Collection000

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Plasma Concentration of Tenofovir (TFV)

Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mL (Median)
Baseline24 hours96 hours
Genvoya - 24 and 96 Hours Specimen Collection000

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Plasma Concentration of Tenofovir (TFV)

Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mL (Median)
Baseline2 hours48 hours
Genvoya - 2 and 48 Hours Specimen Collection000

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Plasma Concentration of Tenofovir (TFV)

Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mL (Median)
Baseline8 hours
Genvoya - Single Time Point Specimen Collection00

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Plasma Concentration of Emtricitabine (FTC)

Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mL (Median)
Baseline4 hours72 hours
Genvoya - 4 and 72 Hours Specimen Collection017250

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Plasma Concentration of Emtricitabine (FTC)

Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mL (Median)
Baseline24 hours96 hours
Genvoya - 24 and 96 Hours Specimen Collection01130

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Plasma Concentration of Emtricitabine (FTC)

Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mL (Median)
Baseline2 hours48 hours
Genvoya - 2 and 48 Hours Specimen Collection027100

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Plasma Concentration of Emtricitabine (FTC)

Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mL (Median)
Baseline8 hours
Genvoya - Single Time Point Specimen Collection0300

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Plasma Concentration of Elvitegravir (EVG)

Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mL (Median)
Baseline4 hours72 hours
Genvoya - 4 and 72 Hours Specimen Collection018180

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Plasma Concentration of Elvitegravir (EVG)

Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mL (Median)
Baseline24 hours96 hours
Genvoya - 24 and 96 Hours Specimen Collection02320

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Plasma Concentration of Elvitegravir (EVG)

Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mL (Median)
Baseline2 hours48 hours
Genvoya - 2 and 48 Hours Specimen Collection022430

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Plasma Concentration of Elvitegravir (EVG)

Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionng/mL (Median)
Baseline8 hours
Genvoya - Single Time Point Specimen Collection0283

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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)

A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/10^6 cells (Median)
Baseline4 hours72 hours
Genvoya - 4 and 72 Hours Specimen Collection0621158

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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)

A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/10^6 cells (Median)
Baseline24 hours96 hours
Genvoya - 24 and 96 Hours Specimen Collection0429117

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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)

A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/10^6 cells (Median)
Baseline2 hours48 hours
Genvoya - 2 and 48 Hours Specimen Collection0569291

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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)

A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/10^6 cells (Median)
Baseline8 hours
Genvoya - Single Time Point Specimen Collection0375

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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)

A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/10^6 cells (Median)
Baseline4 hour72 hours
Genvoya - 4 and 72 Hours Specimen Collection07800955

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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)

A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication

Interventionfmol/10^6 cells (Median)
Baseline24 hours96 hours
Genvoya - 24 and 96 Hours Specimen Collection05140714

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Percentage of Participants With Grade 3 or Greater Adverse Events

The percentage of participants experiencing grade 3 or greater adverse events at Week 24 (NCT03998176)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
B/F/TAF12

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 analyzed by the snapshot algorithm, which defines a participants virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT03998176)
Timeframe: Week 48

InterventionParticipants (Count of Participants)
B/F/TAF21

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 analyzed by the snapshot algorithm, which defines a participants virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT03998176)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
B/F/TAF32

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Percentage of Participants With Grade 3 or Greater Adverse Events

The percentage of participants experiencing grade 3 or greater adverse events at Week 48 (NCT03998176)
Timeframe: Week 48

InterventionParticipants (Count of Participants)
B/F/TAF15

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Tenofovir Diphosphate Concentration in Dried Blood Spots (DBS)

Tenofovir diphosphate concentration in dried blood spots at week 4 (NCT04050371)
Timeframe: After 4 weeks of daily observed dosing of FTC/TDF

Interventionfmol/punch (Median)
Transgender Women973.5
Transgender Men1078

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Estradiol Concentration

Estradiol concentrations in blood plasma by LC-MS/MS (NCT04050371)
Timeframe: Baseline and after 4 weeks of daily FTC/TDF

,
Interventionpg/mL (Median)
Week 0Week 4
Transgender Men24.223.1
Transgender Women141.5116

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Total Testosterone

Total testosterone concentrations in blood plasma by LC-MS/MS (NCT04050371)
Timeframe: Baseline and after 4 weeks of daily FTC/TDF

,
Interventionng/dL (Median)
Week 0Week 4
Transgender Men559595
Transgender Women56.556.7

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Number of Infant Participants With Grade 3 or Higher AEs in Both Study Arms

As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Infants - Group A: DPV VR10
Infants - Group B: Truvada Tablet1

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Participant Willingness to Use Their Assigned Study Products During Breastfeeding in the Future (Y/N)

"Based on participant report to the question Would you be willing to use the study product for HIV prevention while breastfeeding in the future?" (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004142
Mothers - Group B: Truvada Tablet48

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Proportion of Participants Who Find Their Study Product to be at Least as Acceptable as Other HIV Prevention Methods

"Based on participant report on the question Overall, how much did you like using the study product? on the Product End Use Visit Behavioral Assessment." (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004141
Mothers - Group B: Truvada Tablet46

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Geometric Mean of Infant DPV Concentrations From Plasma by Visit

This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The mother endpoints for geometric mean concentrations are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5

Interventionpg/mL (Geometric Mean)
Week 2Month 1Month 2Product Use End VisitStudy End Visit
Infants - Group A: DPV VR11.711.511.010.510

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Geometric Mean of Infant FTC-TP Concentration by Visit

This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5

Interventionpmol/punch (Geometric Mean)
Week 2Month 1Month 2Product Use End VisitStudy End Visit
Infants - Group B: Truvada Tablet0.10.10.10.10.1

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Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit

This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (10pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5

Interventionpg/mL (Geometric Mean)
Week 1Week 2Month 1Month 2Product Use End VisitStudy End Visit
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004529.4492.0457.0418.9402.820.0

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Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations

This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. TFV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV concentrations in breastmilk, the LLOQ is 1 ng/ml. (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Week 1Week 2Month 1Month 2Product Use End VisitStudy End Visit
Mothers - Group B: Truvada Tablet47444238383

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Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations

This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. FTC concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC concentrations in breastmilk, the LLOQ is 5 mg/ml. (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Week 1Week 2Month 1Month 2Product Use End VisitStudy End Visit
Mothers - Group B: Truvada Tablet47454439401

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Geometric Mean of Maternal TFV-DP Concentrations by Visit

This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5

Interventionfmol/punch (Geometric Mean)
Week 1Week 2Month 1Month 2Product Use End VisitStudy End Visit
Mothers - Group B: Truvada Tablet254.6424.2524.7551.9591.5330.8

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Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit

This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (1 ng/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5

Interventionng/mL (Geometric Mean)
Week 1Week 2Month 1Month 2Product Use End VisitStudy End Visit
Mothers - Group B: Truvada Tablet5.64.33.33.22.70.6

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Geometric Mean of Maternal FTC-TP Concentrations by Visit

This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5

Interventionpmol/punch (Geometric Mean)
Week 1Week 2Month 1Month 2Product Use End VisitStudy End Visit
Mothers - Group B: Truvada Tablet0.30.30.30.20.20.1

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Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit

This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (5 mg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5

Interventionmg/mL (Geometric Mean)
Week 1Week 2Month 1Month 2Product Use End VisitStudy End Visit
Mothers - Group B: Truvada Tablet552.6447.6319.9313.0296.62.8

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Geometric Mean of Maternal DPV Concentrations From Plasma by Visit

This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5

Interventionpg/mL (Geometric Mean)
Week 1Week 2Month 1Month 2Product Use End VisitStudy End Visit
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004327.9314.9275.4263.8260.416.7

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Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations

This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentration in DBS specimens, the LLOQ is 0.125 pmol/punch. The infant endpoint is included as a separate section below. (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Week 1Week 2Month 1Month 2Product Use End VisitStudy End Visit
Mothers - Group B: Truvada Tablet45463834381

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Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations

This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in breastmilk, the LLOQ is 10 pg/ml. (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Week 1Week 2Month 1Month 2Product Use End VisitStudy End Visit
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-00413713713813813594

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Geometric Mean of Infant TFV-DP Concentrations by Visit

This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5

Interventionfmol/punch (Geometric Mean)
Week 2Month 1Month 2Product Use End VisitStudy End Visit
Infants - Group B: Truvada Tablet15.615.615.615.615.6

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Number of Mother Participants With Serious Adverse Events (SAEs) Including Maternal Deaths in Both Study Arms

As defined by the Manual for Expedited Reporting of Adverse Events to the Division of AIDS (DAIDS) (Version 2.0, January 2010) (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-0042
Mothers - Group B: Truvada Tablet0

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Number and Proportion of Infants With Detectable TFV-DP Concentrations

This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations from DBS specimens, the LLOQ is 31.3 fmol/punch. The mother endpoints are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Week 2Month 1Month 2Product Use End VisitStudy Exit Visit
Infants - Group B: Truvada Tablet00000

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Number and Proportion of Infants With Detectable Plasma DPV Concentrations

This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The mother endpoints are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Week 2Month 1Month 2Product Use End VisitStudy Exit Visit
Infants - Group A: DPV VR21201470

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Number and Proportion of Infants With Detectable FTC-TP Concentrations

This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentrations from DBS specimens, the LLOQ is 0.125 pmol/punch. The mother endpoints are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Week 2Month 1Month 2Product Use End VisitStudy Exit Visit
Infants - Group B: Truvada Tablet42210

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Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations

This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The infant endpoint is included as a separate section below. (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Week 1Week 2Month 1Month 2Product Use End VisitStudy End Visit
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-00413913613913813648

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The Number of Mothers Non-adherent to Study Product for Each Month of Product Use by Study Product

The number and proportion of mother's visits with drug concentration indicative of non-adherence (no use) are reported by study month. Non-adherence is measured by residual drug in returned VRs for mothers assigned the DPV VR arm and by TFV-DP concentrations in dried blood spot specimens for mothers assigned the Truvada tablet arm. For mothers on the DPV VR arm, no use is defined as residual DPV concentration in the returned VRs <= 0.9mg/month. For mothers on the Truvada arm, no use is defined as TFV-DP concentrations < 16.6 fmol/punch. Only mother participants are included in this endpoint since infants did not directly use study product in this study. (NCT04140266)
Timeframe: Measured through Month 3

,
InterventionParticipants (Count of Participants)
Month 1Month 2Month 3
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004142829
Mothers - Group B: Truvada Tablet200

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Residual Drug Levels in Returned VRs

The residual DPV concentrations from the returned VRs are summarized. (NCT04140266)
Timeframe: Measured through Month 3.5

Interventionmg (Median)
Month 1Month 2Month 3
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-00422.122.422.1

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Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations

This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations, the LLOQ is 31.3 fmol/punch. The infant endpoint is included as a separate section below. (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Week 1Week 2Month 1Month 2Product Use End VisitStudy End Visit
Mothers - Group B: Truvada Tablet474845444745

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Number of Mother Participants With Grade 3 or Higher Adverse Events (AEs) in Both Study Arms

As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies [Dated November 2007]) (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Group A: Dapivirine (DPV) Vaginal Ring (VR)-0043
Group B: Truvada Tablet2

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Number of Infant Participants With SAEs Including Infant Deaths in Both Study Arms

As defined by the Manual for Expedited Reporting of Adverse Events to DAIDS (Version 2.0, January 2010) (NCT04140266)
Timeframe: Measured through Month 3.5

InterventionParticipants (Count of Participants)
Infants - Group A: DPV VR4
Infants - Group B: Truvada Tablet0

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Change From Baseline in Body Weight at Week 48

Body weight was measured at baseline and at Week 48. Baseline measurements were defined as the Day 1 value of each participant. The change from baseline in body weight at Week 48 was presented. (NCT04233879)
Timeframe: Baseline (Day 1) and Week 48

Interventionkilogram (Mean)
Group 1: DOR/ISL3.45
Group 2: BIC/FTC/TAF3.32

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Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 48

Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and 48 weeks by a central laboratory. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in CD4+ T-cell count at Week 48 was presented. (NCT04233879)
Timeframe: Baseline (Day 1) and Week 48

Interventioncells/mm^3 (Mean)
Group 1: DOR/ISL182.4
Group 2: BIC/FTC/TAF233.5

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Incidence of Viral Resistance-Associated Substitutions (RASs) at Week 48

RASs was defined as participants with confirmed HIV-1 RNA ≥200 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated RASs at Week 48 was presented. (NCT04233879)
Timeframe: Week 48

InterventionParticipants (Count of Participants)
Group 1: DOR/ISL1
Group 2: BIC/FTC/TAF0

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Percentage of Participants Who Discontinued Study Treatment Due to an AE up to Week 48

An AE is any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who discontinued study treatment due to an AE were reported. (NCT04233879)
Timeframe: Up to approximately 48 weeks

InterventionPercentage of participants (Number)
Group 1: DOR/ISL7.4
Group 2: BIC/FTC/TAF3.3

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Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48

The percentage of participants with HIV-1 RNA <40 copies/mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The percentage of participants with HIV-1 RNA <40 copies/mL at Week 48 will be presented using the FDA Snapshot missing data approach. (NCT04233879)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Group 1: DOR/ISL88.6
Group 2: BIC/FTC/TAF86.3

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Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48

HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott Real Time polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was presented using the FDA Snapshot missing data approach. (NCT04233879)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Group 1: DOR/ISL88.9
Group 2: BIC/FTC/TAF88.3

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Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48

The percentage of participants with HIV-1 RNA <200 copies/mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The percentage of participants with HIV-1 RNA <200 copies/mL at Week 48 will be presented using the FDA Snapshot missing data approach. (NCT04233879)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Group 1: DOR/ISL89.6
Group 2: BIC/FTC/TAF88.6

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Percentage of Participants Who Experienced an Adverse Event (AE) up to Week 48

An AE is any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who experience an AE was reported. (NCT04233879)
Timeframe: Up to approximately 48 weeks

InterventionPercentage of participants (Number)
Group 1: DOR/ISL90.6
Group 2: BIC/FTC/TAF86.3

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Number of Sex Acts by Condom Usage

"Number of sex acts by condom usage was assessed at baseline and each scheduled monthly visit, for up to 12 months.~Responses to the following question refers to the number of sex acts with up to 3 partners.~In the past 30 days, how many times did you have sex with ['this partner']? When I ask about the number of times you had sex, please count each sexual act. For example, if you had 2 rounds of sexual intercourse with your partner on a single evening, count that as two times you had sex. Please remember that this only refers to vaginal and anal sex. It does not refer to oral sex.~To assess condom use by sex act, the following question was asked to assess the number of sex acts with condoms and without condoms with up to 3 partners:~Of the ___ sex acts, how many times did you not use condoms the entire time?" (NCT04318210)
Timeframe: Up to 12 months

Interventionsex acts (Mean)
Number of sex acts among womenNumber of sex acts among menNumber of condomless sex acts among womenNumber of condomless sex acts among menNumber of sex acts involving a condom among womenNumber of sex acts involving a condom among men
TDF-FTC as PrEP4.015.951.281.702.724.24

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Self-reported Drug Adherence Over the Past 3 Days

"A 30-day supply of TDF/FTC was dispensed at each monthly visit, for up to 12 months.~Participants were asked monthly about their drug adherence and were asked to recall their time of dosing over the past 3 days.~Question: Please think back to [yesterday, 2 days ago, 3 days ago]. What time did you take Truvada? Was it in the morning, afternoon, evening, or you weren't able to take the pill that day?" (NCT04318210)
Timeframe: Up to 12 Months

InterventionParticipants (Count of Participants)
Took daily dosage in past 3 daysTook 2 doses in past 3 daysTook 1 doses in past 3 daysNo doses taken in past 3 days
TDF-FTC as PrEP1999219

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Serious Adverse Events

Study visits were scheduled every month until study completion. Participants were instructed to return to the clinic for evaluation in event of illness. Participants reported any adverse effects (AEs) at monthly or interim visits and were determined as serious adverse events (SAE) when at least possibly related to study drug. DAIDS Table for Grading Severity of Adult Adverse Experiences for Vaccine & Prevention Research Programs was used for grading. Definitions: Grade 3-'probably related'-strong temporal relationship to study product that cannot be explained by participant's clinical state or other factors and a causal relationship is biologically plausible. Grade 4-'definitely related'-distinct temporal relationship to administration of the study product that cannot be explained by the participant's clinical state or other factors or AE occurs on re-challenge or the AE is a known reaction to the product or chemical group or can be predicted by the product's pharmacology. (NCT04318210)
Timeframe: Up to 12 Months

Interventionparticipants (Number)
Hyperamylasemia, Grade 3Hypophosphatemia, Grade 3Hypercreatininemia, Grade 1
TDF-FTC as PrEP251

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Number of Sex Partners

"Number of sex partners was assessed at baseline and each scheduled monthly visit, for up to 12 months.~Responses to the following question refers to the number of partners reported in the past 30 days:~In the past 30 days, with how many partners have you had sexual intercourse?" (NCT04318210)
Timeframe: Up to 12 months

Interventionsexual partners (Mean)
Number of sex partners among women, overallNumber of sex partners among men, overall
TDF-FTC as PrEP0.871.03

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HIV Seroconversion

Study visits were scheduled every month until completion of the study and during monthly study visits, HIV testing was performed, for up to 12 months. During monthly visits, routine HIV testing was performed with two HIV rapid tests. If HIV-infection was suspected, HIV antigen-antibody (Ag/Ab) combination enzyme immunoassay (EIA) (Bio-Rad, GS HIV Combo Ag/Ab EIA) testing was performed, and RNA viral load was measured. (NCT04318210)
Timeframe: Up to 12 Months

InterventionParticipants (Count of Participants)
TDF-FTC as PrEP0

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Extracellular Tenofovir (TFV) for Recent Drug Exposure

"Dried blood spots were collected at each monthly study visit to characterize drug adherence by measuring extracellular tenofovir (TFV) for recent drug exposure (~24 hours). Of 229 participants, 196 participants had monthly DBSs available for analysis. A sampling algorithm was designed to make inference to TFV and TFV-DP levels at all 12 months. For the TFV extracellular analysis, participants were randomly assigned to one of three sampling schedules, with equal probability: (a) months 1, 2, 5, 8, and 11; (b) months 1, 3, 6, 9, and 12; and (c) months 1, 4, 7, 10, and 12. These 196 participants contributed a total of 777 monthly DBSs for the TFV extracellular analysis.~Extracellular TFV detectability was defined as having a mean TFV level (of up to four measurements) equal to or greater than 5 ng/mL." (NCT04318210)
Timeframe: Up to 12 months

Interventionnumber of DBS samples (Number)
Detectable TFVNo detectable TFV
TDF-FTC as PrEP71364

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Intracellular Tenofovir-diphosphate (TFV-DP)

Dried blood spots were collected at each monthly study visit to characterize drug adherence by measuring intracellular tenofovir-diphosphate (TFV-DP) for long-term drug exposure (~7 days). The 196 participants who had monthly DBSs available were stratified by site, gender, and the 3 patterns previously assigned for the TFV extracellular analysis (2×2×3 = 12 strata). Then 60 participants were selected, 5 from each of the 12 strata, to balance by site, gender, and the above 3 patterns were maintained. In turn, the monthly DBSs indicated by the assigned pattern were analyzed. These 60 participants contributed a total of 237 monthly DBSs for the TFV-DP intracellular analysis. The observed TFV-DP levels in our study population were categorized as follows (units of drug in fmol/mL): 0 doses per week (<912); 1 dose taken per week (≥912 and <1824); 2 doses taken per week (≥1824 and <2688); 3 doses taken per week (≥2688 and <3600); 4 doses taken per week (≥3600 and <4464); 5 to 7 doses taken (NCT04318210)
Timeframe: Up to 12 months

Interventionnumber of DBS samples (Number)
7 doses per week6 doses per week5 doses per week4 doses per week3 doses per week2 doses per week1 dose per week0 doses per week
TDF-FTC as PrEP14129206124519

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HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment

Efficacy of Vonafexor on top of NA assessed as HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment (NCT04465916)
Timeframe: LS mean at week 16 (Day 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, and Week 16)

Interventionlog10 IU/mL (Least Squares Mean)
Experimental Arm-0.029
Control Arm-0.066

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Virologic Failure Rate

Virologic failure rate (breakthrough)2 of HBV-DNA (% patients with a confirmed quantifiable HBV DNA increase of ≥ 1log10 HBV DNA copies/mL above LLOQ3) assessed at Week 16 of treatment period and Weeks 20, 28 and 40 during follow-up period (NCT04465916)
Timeframe: 40 weeks

,
Interventionparticipants (Number)
Week 16Week 20Week 28Week 40
Control Arm0000
Experimental Arm0000

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Acceptability of TFV Douche as Assessed by Product Acceptability Questionnaire

"Using a 4-point scale (1=Completely Unacceptable; 2=Somewhat Unacceptable; 3=Somewhat Acceptable; 4=Highly Acceptable), participants were asked to answer the following question about their experience with the product: If a rectal douche like the one you were administered today at the clinic could protect you against HIV, would you consider using this douche?. The endpoint was operationalized as binary, with scores 1 to 2 grouped as low acceptability and scores 3 to 4 as high acceptability." (NCT04686279)
Timeframe: Following administration of study product, up to 1 hour

InterventionParticipants (Count of Participants)
Low AcceptabilityHigh Acceptability
TFV Medicated Douche08

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Safety of TFV Douche as Assessed by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events

The safety of a single dose of a TFV douche when applied rectally is measured by the number of ≥Grade 2 adverse events (AEs) as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, and whether AEs are attributed to the study product. (NCT04686279)
Timeframe: Following administration of study product, up to 7 days

Interventionevents (Number)
Number of Grade 2 Adverse EventsNumber of Grade 2 AEs attributed to study product
TFV Medicated Douche30

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Tenofovir Diphosphate (TFV-DP) Concentration

Colonic tissue cell TFV-DP concentrations (femtomoles/million cells) will be measured the study douche administration, based on the individual participant's sampling schedule, on Day 1 (at 1 hour post dose), Day 2 (24 hours post dose), or Day 4 (72 hours post dose). (NCT04686279)
Timeframe: At 1 hour, 24 hours, or 72 hours after the TFV douche administration

Interventionfemtomole/million cells (Median)
1 hour post-dose24 hours post-dose72 Hours post-dose
TFV Medicated Douche24413472406

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Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment

(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.

Interventionlog10 IU/mL (Mean)
Off-Treatment Week 4Off-Treatment Week 8Off-Treatment Week 12Off-Treatment Week 16Off-Treatment Week 20Off-Treatment Week 24Off-Treatment Week 28Off-Treatment Week 32Off-Treatment Week 36Off-Treatment Week 40Off-Treatment Week 44Off-Treatment Week 48
VBR + AB-720 + SOC NrtI (Continued NrtI Only)-1.6-1.4-1.4-1.5-1.7-2.0-2.0-1.9-1.8-1.7-1.6-2.2

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Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment

(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.

,
Interventionlog10 IU/mL (Mean)
Off-Treatment Week 4Off-Treatment Week 8Off-Treatment Week 12Off-Treatment Week 16Off-Treatment Week 20Off-Treatment Week 24Off-Treatment Week 28Off-Treatment Week 32Off-Treatment Week 36
VBR + AB-729 + SOC NrtI (Discontinued All)-1.9-1.9-1.8-1.7-1.8-1.7-1.8-1.7-1.6
VBR + SOC Nrtl (Continued NrtI Only)00-0.1-0.10000.00

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Change From Baseline in Mean log10 HBV RNA Off-Treatment

(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.

Interventionlog10 U/mL (Mean)
Off-Treatment Week 4Off-Treatment Week 8Off-Treatment Week 12Off-Treatment Week 16Off-Treatment Week 20Off-Treatment Week 24Off-Treatment Week 28Off-Treatment Week 32Off-Treatment Week 36Off-Treatment Week 40
AB-729 + SOC NrtI (Discontinued All)-1.1-0.8-0.8-0.8-0.6-0.5-0.6-0.1.5-0.4

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Number of Participants With One or More Adverse Events (AEs)

(NCT04820686)
Timeframe: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.

InterventionParticipants (Count of Participants)
VBR + AB-729 + SOC NrtI26
VBR + SOC NrtI12
AB-729 + SOC NrtI12

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Number of Participants With One or More Abnormal Laboratory Result

(NCT04820686)
Timeframe: Laboratory results were collected from the time of signing the informed consent until the study was early terminated, up to 96 weeks.

InterventionParticipants (Count of Participants)
VBR + AB-729 + SOC NrtI30
VBR + SOC NrtI16
AB-729 + SOC NrtI16

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Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment

Subjects remained on their assigned oral agents (ie, VBR+NrtI for Groups 1 and 2; NrtI for Group 3) until Week 48 laboratory results required for Treatment Stopping Criteria assessment were available so there are some results past Week 48. (NCT04820686)
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.

Interventionlog10 IU/mL (Mean)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48
AB-729 + SOC NrtI-0.2-0.3-0.6-1.1-1.3-1.6-1.6-1.7-1.7-1.9-1.8-1.9-1.9

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Change From Baseline in Mean log10 HBV RNA On-Treatment

Subjects remained on their assigned oral agents (ie, VBR+NrtI for Groups 1 and 2; NrtI for Group 3) until Week 48 laboratory results required for Treatment Stopping Criteria assessment were available so there are some results past Week 48. (NCT04820686)
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56.

,
Interventionlog10 U/mL (Mean)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52Week 56
VBR + AB-729 + SOC NrtI-.6-.7-.7-.6-0.6-0.7-0.5-0.9-0.7-0.7-0.6-0.6-0.7-0.7-1.0
VBR + SOC NrtI-.20.2000.1.2.2.1.1.10-0.1-0.1.2

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Number of Participants With Premature Treatment Discontinuation Due to AEs

(NCT04820686)
Timeframe: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.

InterventionParticipants (Count of Participants)
AB-729 discontinuation due to AE
AB-729 + SOC NrtI0

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Number of Participants With Premature Treatment Discontinuation Due to AEs

(NCT04820686)
Timeframe: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.

InterventionParticipants (Count of Participants)
VBR discontinuation due to AE
VBR + SOC NrtI1

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Change From Baseline in Mean log10 HBV RNA On-Treatment

Subjects remained on their assigned oral agents (ie, VBR+NrtI for Groups 1 and 2; NrtI for Group 3) until Week 48 laboratory results required for Treatment Stopping Criteria assessment were available so there are some results past Week 48. (NCT04820686)
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56.

Interventionlog10 U/mL (Mean)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48
AB-729 + SOC NrtI-.4-.6-0.5-0.7-0.8-0.8-0.7-0.8-0.7-0.7-0.6-0.8-0.7

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Change From Baseline in Mean log10 HBV RNA Off-Treatment

(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.

,
Interventionlog10 U/mL (Mean)
Off-Treatment Week 4Off-Treatment Week 8Off-Treatment Week 12Off-Treatment Week 16Off-Treatment Week 20Off-Treatment Week 24Off-Treatment Week 28Off-Treatment Week 32Off-Treatment Week 36
VBR + AB-729 + SOC NrtI (Discontinued All)-0.6-0.5-0.70.7.50.20
VBR + SOC Nrtl (Continued NrtI Only)-0.10-0.20.3-0.2-0.4-0.7-0.20

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Change From Baseline in Mean log10 HBV RNA Off-Treatment

(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.

Interventionlog10 U/mL (Mean)
Off-Treatment Week 4Off-Treatment Week 8Off-Treatment Week 12Off-Treatment Week 16Off-Treatment Week 20Off-Treatment Week 24Off-Treatment Week 28Off-Treatment Week 32Off-Treatment Week 36Off-Treatment Week 40Off-Treatment Week 44Off-Treatment Week 48
VBR + AB-720 + SOC NrtI (Continued NrtI Only)-0.8-0.5-0.6-0.5-0.3-0.4-0.8-1.0-1.0-0.9-1.0-1.2

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Number of Participants With Premature Treatment Discontinuation Due to AEs

(NCT04820686)
Timeframe: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.

InterventionParticipants (Count of Participants)
VBR discontinuation due to AEAB-729 discontinuation due to AE
VBR + AB-729 + SOC NrtI31

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Change From Baseline in Mean log10 HBV RNA Off-Treatment

(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.

Interventionlog10 U/mL (Mean)
Off-Treatment Week 4Off-Treatment Week 8Off-Treatment Week 12Off-Treatment Week 16Off-Treatment Week 20Off-Treatment Week 24Off-Treatment Week 28Off-Treatment Week 32Off-Treatment Week 36Off-Treatment Week 40Off-Treatment Week 44
AB-729 + SOC NrtI (Continued NrtI Only)-0.9-0.9-1.0-0.9-0.70.7-0.6-0.3-0.1-0.6.1

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Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment

(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.

Interventionlog10 IU/mL (Mean)
Off-Treatment Week 4Off-Treatment Week 8Off-Treatment Week 12Off-Treatment Week 16Off-Treatment Week 20Off-Treatment Week 24Off-Treatment Week 28Off-Treatment Week 32Off-Treatment Week 36Off-Treatment Week 40
AB-729 + SOC NrtI (Discontinued All)-1.8-1.8-1.7-1.4-1.2-1.3-1.6-1.5-1.2-1.2

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Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment

(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.

Interventionlog10 IU/mL (Mean)
Off-Treatment Week 4Off-Treatment Week 8Off-Treatment Week 12Off-Treatment Week 16Off-Treatment Week 20Off-Treatment Week 24Off-Treatment Week 28Off-Treatment Week 32Off-Treatment Week 36Off-Treatment Week 40Off-Treatment Week 44
AB-729 + SOC NrtI (Continued NrtI Only)-1.8-1.8-2.0-1.6-2.1-2.9-3.0-3.2-3.0-2.9-2.8

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Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment

Subjects remained on their assigned oral agents (ie, VBR+NrtI for Groups 1 and 2; NrtI for Group 3) until Week 48 laboratory results required for Treatment Stopping Criteria assessment were available so there are some results past Week 48. (NCT04820686)
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.

,
Interventionlog10 IU/mL (Mean)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52Week 56
VBR + AB-729 + SOC NrtI-0.3-.3-0.7-1.2-1.5-1.7-1.7-1.7-1.8-1.9-1.8-1.9-1.9-1.8-1.5
VBR + SOC Nrtl00000000000000-0.1

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Participant Partners Who Tested for HIV

The secondary outcome was number of partners who tested for HIV (as reported by the female partner and confirmed with photo or used HIVST in intervention arm) by study arm. (NCT04897737)
Timeframe: 1 month after intervention

Interventionmale partners (Number)
Intervention35
Control9

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Recent PrEP Adherence

The primary study outcome is recent PrEP adherence according to urine tenofovir test by study arm. (NCT04897737)
Timeframe: 1 month after intervention

InterventionParticipants (Count of Participants)
Intervention33
Control18

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