Page last updated: 2024-11-06

emtricitabine

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Description

Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) used in the treatment of HIV infection. It is a synthetic analog of cytidine that inhibits the activity of HIV reverse transcriptase, the enzyme responsible for converting viral RNA into viral DNA. Emtricitabine is typically administered in combination with other antiretroviral drugs. It is important because it has been shown to be effective in suppressing viral replication and reducing the risk of HIV-related complications. Emtricitabine is studied to understand its mechanisms of action, potential side effects, and to develop new and improved antiretroviral therapies.'

Emtricitabine: A deoxycytidine analog and REVERSE TRANSCRIPTASE INHIBITOR with antiviral activity against HIV-1 and HEPATITIS B viruses. It is used to treat HIV INFECTIONS. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

emtricitabine : An organofluorine compound that is 5-fluorocytosine substituted at the 1 position by a 2-(hydroxymethyl)-1,3-oxathiolan-5-yl group (2R,5S configuration). It is used in combination therapy for the treatment of HIV-1 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 CID60877
CHEMBL ID885
CHEBI ID31536
SCHEMBL ID39708
MeSH IDM0337569

Synonyms (137)

Synonym
bw-524w91
coviracil
(2r-cis)-4-amino-5-fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-2(1h)-pyrimidinone
drg-0208
emtriva
hsdb 7337
bw 524w91
5-fluoro-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)cytosine
(-)-2'-deoxy-5-fluoro-3'-thiacytidine
bw 1592
ftc, (-)-
2(1h)-pyrimidinone, 4-amino-5-fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, (2r-cis)-
emtricitabine
143491-57-0
.beta.-l-(-)-(2r,5s)-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
emtriva(tm)
bw524w91
524w91
4-amino-5-fluoro-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2-one
coviracil(tm)
(-)-.beta.-l-ftc
(-)-2',3'-dideoxy-5-fluoro-3'-thiacytidine
FTC ,
143491-54-7
(-)-ftc
4-amino-5-fluoro-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2(1h)-one
(-)-cis-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1h)-pyrimidin-2-one
DB00879
4-amino-5-fluoro-1-((2r,5s)-2-hydroxymethyl-[1,3]oxathiolan-5-yl)-1h-pyrimidin-2-one
(-)-beta-2',3'-dideoxy-5-fluoro-3'-thiacytidine
(-)-(2r,5s)-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
4-amino-5-fluoro-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1h)-one ,
D01199
NCGC00164564-01
2(1h)-pyrimidinone, 4-amino-5-fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, cis-(+-)-
2(1h)-pyrimidinone, 4-amino-5-fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, cis-
2',3',5-ftc
c8h10fn3o3s
2(1h)-pyrimidinone, 4-amino-5-fluoro-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, rel-
HMS2089I05
CHEBI:31536 ,
(-)-emtricitabine
ftc-(-)
emtricitabinum
524-w-91
CHEMBL885
emtricitabine, (-)-
psi-5004
emtritabine
((-))-ftc
emtricitabine [usan:inn]
unii-g70b4etf4s
g70b4etf4s ,
ftc-((-))
tox21_112193
dtxsid0040129 ,
cas-143491-57-0
dtxcid8020129
145213-48-5
uls8902u4o ,
unii-uls8902u4o
HY-17427
CS-1370
MLS003882429
smr002533604
emtricitabine [ema epar]
emtricitabine component of eviplera
emtricitabine component of stribild
emtricitabine [usan]
truvada component emtricitabine
stribild component emtricitabine
odefsey component emtricitabine
emtricitabine [inn]
eviplera component emtricitabine
emtricitabine component of truvada
descovy component emtricitabine
emtricitabine [who-dd]
emtricitabine [mart.]
atripla component emtricitabine
emtricitabine component of atripla
emtricitabine [usp-rs]
5-fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)cytosine (2r,5s)
emtricitabine [vandf]
emtricitabine [mi]
2(1h)-pyrimidinone, 4-amino-5-fluoro-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-
5-fluoro-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
emtricitabine component of descovy
descovy component of emtricitabine
emtricitabinum [who-ip latin]
emtricitabine component of odefsey
emtricitabine [orange book]
emtricitabine [hsdb]
emtricitabine [jan]
emtricitabine [who-ip]
emtricitabine component of genvoya
AM84393
S1704
AKOS015853098
AKOS015894950
2',3'-dideoxy-5-fluoro-3'-thiacytidine, dl-
CCG-220615
XQSPYNMVSIKCOC-NTSWFWBYSA-N
MLS006011987
MLS006011556
SCHEMBL39708
AB01275429-01
W-201248
W-201247
2',3'-dideoxy-3-thia-5-fluorocytidine
E1007
bdbm50107843
EX-A150
bw1592
gtpl11244
HMS3713L12
2(1h)-pyrimidinone, 4-amino-5-fluoro-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-, rel-
rel-4-amino-5-fluoro-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1h)-pyrimidinone
SW220172-1
Q422604
4-amino-5-fluoro-1-[(2s,5r)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1h)-pyrimidinone; (+)-2'-deoxy-3'-thia-5-fluorocytidine; (2s-cis)-4-amino-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1h)-pyrimidinone
ent-emtricitabine; emtricitabine ip impurity d
2(1h)-pyrimidinone,4-amino-5-fluoro-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-
AS-14099
2(1h)-pyrimidinone,4-amino-5-fluoro-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-
NCGC00164564-06
D72669
M06302
NCGC00164564-09
CS1125
emtricitabine 100 microg/ml in acetonitrile
nsc-804863
nsc804863
NCGC00164564-10
BE165946
emtricitabine- bio-x
EN300-119501
Z1521553474

Research Excerpts

Overview

Emtricitabine (FTC) is a first-line antiviral drug recommended for the treatment of AIDS during pregnancy. TDF/emtricItabine is an effective and safe therapy for preventing HIV transmission. EmtricITabine [Emtriva] is a nucleoside reverse transcriptase inhibitor (NRTI)

ExcerptReferenceRelevance
"Emtricitabine is a drug class known as nucleoside reversing transcriptase inhibitors (NRTIs)."( Emtricitabine.
Abdelhameed, AS; Al-Kahtani, HM; Al-Majed, AA; Al-Qahtani, BM; Bakheit, AHH, 2020
)
2.72
"TDF/emtricitabine is an effective and safe therapy for preventing HIV transmission. "( HIV Preexposure Prophylaxis: A Review.
Amico, KR; Mayer, KH; Riddell, J, 2018
)
1.04
"Emtricitabine (FTC) is a first-line antiviral drug recommended for the treatment of AIDS during pregnancy. "( Multiple Drug Transporters Contribute to the Placental Transfer of Emtricitabine.
Bai, M; Jiang, H; Li, C; Lu, S; Ma, Z; Sun, D; Zeng, Q; Zhao, Y; Zheng, C; Zhou, H, 2019
)
2.19
"1. Emtricitabine is a nucleoside reverse transcriptase inhibitor used in combination antiretroviral therapy of HIV (cART). "( Emtricitabine is a substrate of MATE1 but not of OCT1, OCT2, P-gp, BCRP or MRP2 transporters.
Ceckova, M; Cerveny, L; Müller, F; Reznicek, J; Staud, F, 2017
)
2.52
"Emtricitabine (FTC) is an antiretroviral compound that inhibits the HIV-1 reverse transcriptase. "( Characterization of emtricitabine related substances by liquid chromatography coupled to an ion trap mass spectrometer.
Adams, E; Hoogmartens, J; Mamade, DA; Pendela, M; Van Schepdael, A, 2010
)
2.13
"Emtricitabine is an NRTI used to treat HIV-1 infection. "( Emtricitabine: a once-daily nucleoside reverse transcriptase inhibitor.
Herman, RA; Modrzejewski, KA, 2004
)
3.21
"Emtricitabine is a safe and effective option for HIV-1 infection in adults as part of a multidrug regimen. "( Emtricitabine: a once-daily nucleoside reverse transcriptase inhibitor.
Herman, RA; Modrzejewski, KA, 2004
)
3.21
"Emtricitabine [Emtriva] is a nucleoside reverse transcriptase inhibitor (NRTI) with demonstrated potent activity against HIV and hepatitis B virus (HBV)."( Emtricitabine/tenofovir disoproxil fumarate.
, 2004
)
2.49
"Emtricitabine (FTC) is a synthetic nucleoside analogue of cytosine, which is intracellularly phosforylated to form the active form emtricitabine 5'triphosphate (E5TP). "( Emtricitabine (FTC) for the treatment of HIV infection.
Nelson, M; Schiavone, M, 2004
)
3.21
"Emtricitabine is a new, once-daily nucleoside reverse transcriptase inhibitor (NRTI) with potent activity against human immunodeficiency virus (HIV)."( Efficacy and safety of emtricitabine vs stavudine in combination therapy in antiretroviral-naive patients: a randomized trial.
Barry, DW; Borroto-Esoda, K; Cahn, P; Hinkle, J; Molina, JM; Mondou, E; Pearce, D; Powderly, W; Quinn, JB; Raffi, F; Rousseau, F; Saag, MS; Shaw, AL; Wolff, M, 2004
)
2.08
"Emtricitabine (FTC) QD is a newly approved nucleoside reverse transcriptase inhibitor compared in this study to twice daily lamivudine (3TC BID)."( A randomized study of emtricitabine and lamivudine in stably suppressed patients with HIV.
Benson, CA; Haas, DW; Lamarca, A; McDonald, CK; Mondou, E; Quinn, JB; Rousseau, F; Rublein, J; Steinhart, CR; van der Horst, C, 2004
)
1.36
"Emtricitabine (FTC) is a potent deoxycytidine nucleoside analogue that was recently approved for the treatment of HIV infection. "( Pharmacokinetic and pharmacodynamic characteristics of emtricitabine support its once daily dosing for the treatment of HIV infection.
Begley, J; Harris, J; Rousseau, FS; St Claire, RL; Wakeford, C; Wang, LH, 2004
)
2.01
"Emtricitabine (Emtriva) is an orally administered nucleoside reverse transcriptase inhibitor (NRTI) that is indicated in combination with other antiretroviral agents in the treatment of HIV infection in adults. "( Emtricitabine: a review of its use in the management of HIV infection.
Frampton, JE; Perry, CM, 2005
)
3.21
"Emtricitabine is a once-daily nucleoside reverse transcriptase inhibitor (NRTI) that selectively and potently inhibits human immunodeficiency virus type 1 (HIV-1) replication. "( Emtricitabine: a novel nucleoside reverse transcriptase inhibitor.
Cox, SL; Molina, JM, 2005
)
3.21
"Emtricitabine (FTC) is a new nucleoside agent that has activity against both human immunodeficiency virus (HIV) and hepatitis B virus. "( Emtricitabine, a new antiretroviral agent with activity against HIV and hepatitis B virus.
Saag, MS, 2006
)
3.22
"Emtricitabine is a nucleoside analogue approved for treatment of human immunodeficiency virus 1 with clinical activity against hepatitis B virus (HBV)."( A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B.
Anderson, J; Chan, S; Guan, R; Husa, P; Krastev, Z; Kung, N; Lee, SS; Lim, SG; Mondou, E; Ng, TM; Rigney, A; Rousseau, F; Shiffman, ML; Snow, A; Sorbel, J; Volfova, M; Washington, MK, 2006
)
2.04
"Emtricitabine FTC is a cytosine analogue, recently introduced in clinical practice for the treatment of HIV patients. "( Safety and efficacy of regimens containing emtricitabine in HIV-infected patients taking highly active antiretroviral therapy.
Antinori, A; Borrelli, I; Liuzzi, G; Lorenzini, P; Marconi, P; Sette, P; Zaccarelli, M, 2006
)
2.04
"Emtricitabine is a potent nucleoside reverse transcriptase inhibitor approved as a once-daily drug in combination with other antiretroviral agents for the treatment of HIV infection. "( Pharmacokinetic evaluation of emtricitabine in combination with other nucleoside antivirals in healthy volunteers.
Begley, JA; Blum, MR; Chittick, GE; Hui, J; Wang, LH; Zong, J, 2007
)
2.07

Effects

Emtricitabine (FTC) has been reported to cause skin pigmentation (SP) The incidence of SP associated with FTC varied with ethnicity, with a higher rate in African-American patients (8%)

ExcerptReferenceRelevance
"Emtricitabine has both inhibitor and substrate characteristics with MRP1 in PBMCs in vitro, and does not interact with PI accumulation."( Emtricitabine: Inhibitor and substrate of multidrug resistance associated protein.
Bousquet, L; Didier, N; Farinotti, R; Mabondzo, A; Pruvost, A, 2008
)
2.51
"Emtricitabine (FTC) has been reported to cause skin pigmentation (SP), and the incidence of SP associated with FTC varied with ethnicity, with a higher rate in African-American patients (8%). "( Investigation of emtricitabine-associated skin pigmentation and safety in HIV-1-infected Japanese patients.
Ajisawa, A; Fukutake, K; Kato, Y; Nakamura, T; Negishi, M; Odawara, T; Shirasaka, T; Tadokoro, T; Yamamoto, Y, 2011
)
2.15

Treatment

ExcerptReferenceRelevance
"Emtricitabine use also for treatment of hepatitis B virus."( Emtricitabine.
Abdelhameed, AS; Al-Kahtani, HM; Al-Majed, AA; Al-Qahtani, BM; Bakheit, AHH, 2020
)
2.72

Toxicity

Emmetricitabine and tenofovir alafenamide is safe and effective for longer-term pre-exposure prophylaxis in cisgender men and transgender women who have sex with men. Significantly fewer participants in the dolutegravir, emtric itabine, and ten ofovir disoproxil fumarate group had a composite adverse pregnancy outcome than those in the other groups.

ExcerptReferenceRelevance
" Two subjects with rashes during the first 2 weeks of therapy were the only adverse events leading to study-drug discontinuation."( Long-term safety and efficacy of a once-daily regimen of emtricitabine, didanosine, and efavirenz in HIV-infected, therapy-naive children and adolescents: Pediatric AIDS Clinical Trials Group Protocol P1021.
Abrams, E; Blum, MR; Britto, P; Chittick, GE; Cunningham, C; Dickover, R; Draper, L; Flynn, P; Hu, C; Hughes, M; Kraimer, J; McKinney, RE; Ortiz, AA; Rathore, M; Reynolds, L; Rodman, J; Scites, M; Serchuck, LK; Smith, ME; Spector, S; Tran, P; Weinberg, A; Yogev, R, 2007
)
0.58
"A once-daily regimen of emtricitabine, didanosine, and efavirenz proved to be safe and tolerable and demonstrated good immunologic and virologic efficacy in this 2-year study."( Long-term safety and efficacy of a once-daily regimen of emtricitabine, didanosine, and efavirenz in HIV-infected, therapy-naive children and adolescents: Pediatric AIDS Clinical Trials Group Protocol P1021.
Abrams, E; Blum, MR; Britto, P; Chittick, GE; Cunningham, C; Dickover, R; Draper, L; Flynn, P; Hu, C; Hughes, M; Kraimer, J; McKinney, RE; Ortiz, AA; Rathore, M; Reynolds, L; Rodman, J; Scites, M; Serchuck, LK; Smith, ME; Spector, S; Tran, P; Weinberg, A; Yogev, R, 2007
)
0.89
" 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
)
0.61
" Three subjects (3%) discontinued the study for adverse events, 8 (7%) for virologic failure, and 1 died through a median follow-up of 164 weeks."( Long-term safety and efficacy results of once-daily emtricitabine-based highly active antiretroviral therapy regimens in human immunodeficiency virus-infected pediatric subjects.
Adda, N; Blum, MR; Cashat, M; Chittick, G; Harris, J; Hinkle, J; Ndiweni, D; Rousseau, F; Saez-Llorens, X; Violari, A; Wiznia, A; Yogev, R, 2008
)
0.6
" 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,
)
0.32
" 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
)
0.58
" 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
" 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
)
0.57
" 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
)
0.57
" 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
)
0.57
" 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
)
0.57
" 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
)
0.6
" 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
)
0.6
" 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,
)
0.33
" 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
"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
)
0.61
" 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
)
0.61
" 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
)
0.62
" 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
)
0.62
"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
)
0.78
"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,
)
0.4
"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,
)
0.4
"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,
)
0.36
" 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,
)
0.36
" 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
" 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
)
0.6
" 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
" 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
" Viral load, CD4 count, and adverse events were assessed at baseline, 24, and 48 weeks."( Removing inactive NRTIs in a salvage regimen is safe, maintains virological suppression and reduces treatment costs: results from the VERITAS study (TMC114HIV4054).
Boissonnault, M; Costiniuk, C; Dion, H; Galanakis, C; Jenabian, MA; Lavoie, S; Longpré, D; Machouf, N; Thomas, R; Trottier, B; Vézina, S,
)
0.13
" No serious adverse events were observed."( Removing inactive NRTIs in a salvage regimen is safe, maintains virological suppression and reduces treatment costs: results from the VERITAS study (TMC114HIV4054).
Boissonnault, M; Costiniuk, C; Dion, H; Galanakis, C; Jenabian, MA; Lavoie, S; Longpré, D; Machouf, N; Thomas, R; Trottier, B; Vézina, S,
)
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
)
0.65
" 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
" 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
)
0.64
" 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
)
0.64
" 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
)
0.67
" 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
)
0.65
" 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
)
0.66
" 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
)
0.71
" 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
)
0.71
" 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
)
0.71
"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
)
0.71
" 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
)
0.75
" 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
)
0.75
" 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
)
0.71
" 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 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
)
0.72
"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
)
1.03
" 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
)
0.69
" 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
)
0.76
" 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
" 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
)
0.72
" Adverse events were monitored to assess safety."( Efficacy and safety of dolutegravir plus emtricitabine versus standard ART for the maintenance of HIV-1 suppression: 48-week results of the factorial, randomized, non-inferiority SIMPL'HIV trial.
Bernasconi, E; Braun, DL; Buzzi, M; Calmy, A; Cavassini, M; Decosterd, LA; Egger, M; Günthard, HF; Limacher, A; Marinosci, A; Metzner, KJ; Schmid, P; Sculier, D; Stoeckle, M; Vernazza, P; Wandeler, G; Yerly, S, 2020
)
0.82
" 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
)
0.78
"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
)
0.78
"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
)
0.88
" 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
)
0.89
" 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
)
1.13
" 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
)
1.22
" 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
)
0.86
" 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
)
0.86
"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
)
2.35
" 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
)
0.88
" 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
)
0.86
" Almost half the users (49%) presented an adverse event, although these were mild and transient, 30 days after starting prophylaxis."( HIV Pre-Exposure Prophylaxis (PrEP) in a Brazilian Clinical Setting: Adherence, Adverse Events, Sexual Behavior, and Sexually Transmitted Infections.
Barbosa, AKP; Batista, JDL; Montarroyos, UR; Monteiro, P; Montenegro, D, 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
)
0.87
"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
)
0.87
" 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,
)
0.53
"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,
)
0.37
"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,
)
0.37
" 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,
)
0.37
"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
)
0.99
"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
)
0.99
" 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
"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
" 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
" Only five participants experienced mild clinical adverse events attributed to the study drug (including headache, diarrhea, and nausea) and four participants had elevated serum creatinine (grade 1)."( An open-label evaluation of safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide for post-exposure prophylaxis following potential exposure to human immunodeficiency virus-1.
Bu Dou Re Xi Ti, GA; Dai, L; Gao, Y; Hua, W; Li, A; Li, J; Li, Z; Liu, A; Shao, Y; Sun, L; Wang, X; Wang, Z; Wu, RE; Xin, R; Ye, J; Zhang, H, 2022
)
0.95
"A once daily, STR of BIC/FTC/TAF used as PEP was safe and well-tolerated with a high rate of completion and adherence in Chinese."( An open-label evaluation of safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide for post-exposure prophylaxis following potential exposure to human immunodeficiency virus-1.
Bu Dou Re Xi Ti, GA; Dai, L; Gao, Y; Hua, W; Li, A; Li, J; Li, Z; Liu, A; Shao, Y; Sun, L; Wang, X; Wang, Z; Wu, RE; Xin, R; Ye, J; Zhang, H, 2022
)
0.95
" 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
" We assessed discontinuations and adverse events (AEs) that were considered related to the initial INSTI in the first year following initiation among treatment-naïve people living with HIV (PLWH)."( Treatment-related early discontinuations and adverse events among newly diagnosed people living with HIV initiating integrase inhibitors in a real-world setting.
Castano, J; DeJesus, E; Hinestrosa, F; Nguyen, V; Patel, K; Rolle, CP, 2023
)
0.91
" We analysed the incidence of adverse events (AEs), laboratory abnormalities, and changes in relevant tolerability parameters through 48 weeks."( Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials.
Avihingsanon, A; Chetchotisakd, P; Kiertiburanakul, S; Martin, H; Ratanasuwan, W; Siripassorn, K; Supparatpinyo, K; Wang, H; Wang, HY; Wong, T, 2023
)
1.16
" 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
)
1.11
"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
)
1.13
" Virological reactions and adverse events to the treatment were recorded, and patient subjective feelings in the form of Electronic Patient Reporting Outcome (ePRO) were collected."( Clinical efficacy, safety, and subjective experience based on ePRO in HIV-infected individuals administered Bictegravir/Emtricitabine/Tenofovir Alafenamide in southwest China.
Fu, Y; Gan, L; Kong, L; Long, H; Ma, S; Xie, X; Yang, X, 2023
)
1.12
" By Week 24, no patients had discontinued the BIC/FTC/TAF treatment due to adverse events."( Clinical efficacy, safety, and subjective experience based on ePRO in HIV-infected individuals administered Bictegravir/Emtricitabine/Tenofovir Alafenamide in southwest China.
Fu, Y; Gan, L; Kong, L; Long, H; Ma, S; Xie, X; Yang, X, 2023
)
1.12
" 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
)
1.14
" 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
)
1.14
" We also measured changes from baseline in CD4 + cell counts, CD4/CD8 ratio, lipid parameters, weight, creatinine (Cr), estimated glomerular filtration rate (eGFR), and drug-related adverse effects (DRAEs)."( Efficacy and safety profiles of dolutegravir plus lamivudine vs . bictegravir/emtricitabine/tenofovir alafenamide in therapy-naïve adults with HIV-1.
Deng, Y; He, L; Li, J; Wang, Y; Wei, Y; Wen, L; Xu, R; Zhong, H, 2023
)
1.14
" 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
)
1.12
" 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
)
1.12
"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

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.

ExcerptReferenceRelevance
" Pharmacokinetic parameters were generated by area/moment analysis."( Pharmacokinetics of 2',3'-dideoxy-5-fluoro-3'-thiacytidine in rats.
Abobo, CV; Boudinot, FD; Liotta, DC; Ni, L; Schinazi, RF, 1994
)
0.29
" An indirect response pharmacodynamic model was fitted to link the plasma pharmacokinetics from a 28 day treatment with the nucleoside reverse transcription inhibitor emtricitabine [(-)-FTC], with the resulting virus depletion and recovery profiles in woodchucks chronically infected with woodchuck hepatitis B virus."( Viral pharmacodynamic model for (-)-beta-2',3'-dideoxy-5-fluoro-3'-thiacytidine (emtricitabine) in chronically infected woodchucks.
Gerin, JL; Hurwitz, SJ; Korba, BE; Liberman, I; Schinazi, RF; Tennant, BC, 2002
)
0.74
" The following pharmacokinetic (PK) parameters were determined over 24 h at steady-state after 4 weeks of treatment: area under the plasma concentration vs."( Pharmacokinetics of emtricitabine, didanosine and efavirenz administered once-daily for the treatment of HIV-infected adults (pharmacokinetic substudy of the ANRS 091 trial).
Chene, G; Lascoux-Combes, C; Molina, JM; Perusat, S; Peytavin, G; Rozenbaum, W; Sereni, D, 2004
)
0.65
" EFV Cmax and Cmin were lower than expected, but the data may have been slightly underestimated in this study."( Pharmacokinetics of emtricitabine, didanosine and efavirenz administered once-daily for the treatment of HIV-infected adults (pharmacokinetic substudy of the ANRS 091 trial).
Chene, G; Lascoux-Combes, C; Molina, JM; Perusat, S; Peytavin, G; Rozenbaum, W; Sereni, D, 2004
)
0.65
" Plasma concentrations from a group of 54 rats, 12 pregnant rabbits and 60 dogs enrolled in large toxicity studies using a wide variety of oral doses, were compared using non-compartment pharmacokinetic modelling versus dose, treatment duration, species and gender."( Comparative pharmacokinetics of Racivir, (+/-)-beta-2',3'-dideoxy-5-fluoro-3'-thiacytidine in rats, rabbits, dogs, monkeys and HIV-infected humans.
Hurwitz, SJ; Otto, MJ; Schinazi, RF, 2005
)
0.33
" Pharmacokinetic parameters were dose proportional, and the maximum concentration of drug in serum at all doses exceeded the 90% effective concentration for wild-type HIV-1."( Safety, pharmacokinetics, and efficacy of (+/-)-beta-2',3'-dideoxy-5-fluoro-3'-thiacytidine with efavirenz and stavudine in antiretroviral-naïve human immunodeficiency virus-infected patients.
Arastèh, K; Beard, A; Cartee, L; Drauz, D; Herzmann, C; Kreckel, P; Murphy, RL; Otto, MJ; Schinazi, RF; Schulbin, H, 2005
)
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
)
0.66
" 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
)
0.8
" Several phase I studies were conducted in healthy volunteers over the course of clinical development to evaluate whether pharmacokinetic drug-drug interactions exist between emtricitabine and other nucleoside antivirals that are extensively eliminated by renal excretion."( Pharmacokinetic evaluation of emtricitabine in combination with other nucleoside antivirals in healthy volunteers.
Begley, JA; Blum, MR; Chittick, GE; Hui, J; Wang, LH; Zong, J, 2007
)
0.82
"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
)
0.88
" 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
)
0.67
"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
)
0.67
"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
)
0.89
"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
)
0.64
"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,
)
0.6
" 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,
)
0.4
"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
"The International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT), formerly Pediatric AIDS Clinical Trials Group (PACTG), study P1026s is a prospective pharmacokinetic study of HIV-infected pregnant women taking antiretrovirals for clinical indications, including a cohort taking emtricitabine 200 mg once daily."( Effect of pregnancy on emtricitabine pharmacokinetics.
Barr, E; Best, BM; Burchett, S; Capparelli, E; Hu, C; Jennings, A; Li, H; Luo, W; Mirochnick, M; Read, JS; Rossi, SS; Smith, E; Stek, AM, 2012
)
0.87
" Mean [90% confidence interval (CI)] emtricitabine pharmacokinetic parameters during the third trimester vs."( Effect of pregnancy on emtricitabine pharmacokinetics.
Barr, E; Best, BM; Burchett, S; Capparelli, E; Hu, C; Jennings, A; Li, H; Luo, W; Mirochnick, M; Read, JS; Rossi, SS; Smith, E; Stek, AM, 2012
)
0.96
" 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
)
0.63
"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
)
0.63
" 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
" 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
)
0.81
" 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
)
0.61
" Augmentation in the values of Cmax (1."( Pharmacokinetics and in vivo biodistribution of optimized PLGA nanoparticulate drug delivery system for controlled release of emtricitabine.
Pai, RS; Singh, G, 2014
)
0.61
" 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
)
0.83
" After a single dose, there were no differences in the mean AUC0-∞ values; however, there were significant differences in the mean Tmax values (1."( Pharmacokinetics of single- and multiple-dose emtricitabine in healthy male Chinese volunteers.
Han, WL; Huang, AL; Huang, WX; Shang, JC; Tan, R; Yan, B; Yang, JQ; Zhong, XN, 2014
)
0.66
"The aims were to describe emtricitabine (FTC) pharmacokinetics in a large population of pregnant women during the different trimesters of pregnancy, and to explain FTC pharmacokinetic variability during pregnancy."( Modified renal function in pregnancy: impact on emtricitabine pharmacokinetics.
Arrivé, E; Benaboud, S; Bouazza, N; Dabis, F; Fauchet, F; Foissac, F; Hirt, D; Pannier, E; Tréluyer, JM; Urien, S; Valade, E, 2014
)
0.96
"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
" 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
"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
" 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
)
0.7
" Physiologically based pharmacokinetic (PBPK) modeling offers an enhanced ability to predict age-related changes in pharmacokinetics in the pediatric population."( Physiologically Based Pharmacokinetic Prediction of Linezolid and Emtricitabine in Neonates and Infants.
Burckart, GJ; Duan, P; Fisher, JW; Wang, J; Yoshida, K; Zhang, L, 2017
)
0.69
" Based on this study, linezolid and emtricitabine pediatric PBPK models incorporating the ontogeny in renal maturation describe the pharmacokinetic differences between adult and pediatric populations, even though the contribution of renal clearance to the total clearance of two drugs was very different (30 % for linezolid vs."( Physiologically Based Pharmacokinetic Prediction of Linezolid and Emtricitabine in Neonates and Infants.
Burckart, GJ; Duan, P; Fisher, JW; Wang, J; Yoshida, K; Zhang, L, 2017
)
0.97
"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
)
0.65
"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
)
0.94
"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
" 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
"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
)
0.74
" 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
" Its clinical pharmacokinetic profile and influence on the cellular pharmacology of tenofovir diphosphate have not been reported."( Pharmacokinetics of tenofovir monoester and association with intracellular tenofovir diphosphate following single-dose tenofovir disoproxil fumarate.
Alexander, K; Anderson, PL; Brooks, KM; Bushman, LR; Castillo-Mancilla, JR; Ellison, L; Hosek, S; Huhn, GD; Ibrahim, ME; Kerr, BJ; Kiser, JJ; MaWhinney, S; McHugh, C; Tilden, S, 2019
)
0.51
"Tenofovir monoester Cmax and AUC0-4 were 59."( Pharmacokinetics of tenofovir monoester and association with intracellular tenofovir diphosphate following single-dose tenofovir disoproxil fumarate.
Alexander, K; Anderson, PL; Brooks, KM; Bushman, LR; Castillo-Mancilla, JR; Ellison, L; Hosek, S; Huhn, GD; Ibrahim, ME; Kerr, BJ; Kiser, JJ; MaWhinney, S; McHugh, C; Tilden, S, 2019
)
0.51
"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
)
0.77
" The goals of this study were to build maternal-fetal physiologically based pharmacokinetic (PBPK) models for acyclovir and emtricitabine, 2 anti(retro)viral drugs with active renal net secretion, and to (1) evaluate the predicted maternal PK at different stages of pregnancy; (2) predict the changes in PK target parameters following the current dosing regimen of these drugs throughout pregnancy; (3) evaluate the predicted concentrations of these drugs in the umbilical vein at delivery; (4) compare the model performance for predicting maternal PK of emtricitabine in the third trimester with that of previously published PBPK models; and (5) compare different previously published approaches for estimating the placental permeability of these 2 drugs."( Physiologically Based Pharmacokinetic Models to Predict Maternal Pharmacokinetics and Fetal Exposure to Emtricitabine and Acyclovir.
Best, BM; Burckart, GJ; Capparelli, EV; Dallmann, A; Green, DJ; Liu, XI; Mirochnick, M; Momper, JD; Rakhmanina, N; van den Anker, JN, 2020
)
0.98
"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
)
0.76
" 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
"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
" Our objective was to develop and evaluate a novel, physiologically based pharmacokinetic modeling workflow for predicting perinatal and postnatal disposition of commonly used antiretroviral drugs administered prenatally to pregnant women living with human immunodeficiency virus."( Physiologically Based Pharmacokinetic Modeling Framework to Predict Neonatal Pharmacokinetics of Transplacentally Acquired Emtricitabine, Dolutegravir, and Raltegravir.
Best, BM; Burckart, GJ; Cressey, TR; Dallmann, A; Green, DJ; Liu, XI; Mirochnick, M; Momper, JD; Rakhmanina, NY; van den Anker, JN, 2021
)
0.83
"Neonatal physiologically based pharmacokinetic models generally captured the initial plasma concentrations after delivery but underestimated concentrations in the terminal phase."( Physiologically Based Pharmacokinetic Modeling Framework to Predict Neonatal Pharmacokinetics of Transplacentally Acquired Emtricitabine, Dolutegravir, and Raltegravir.
Best, BM; Burckart, GJ; Cressey, TR; Dallmann, A; Green, DJ; Liu, XI; Mirochnick, M; Momper, JD; Rakhmanina, NY; van den Anker, JN, 2021
)
0.83
"These findings demonstrate the general feasibility of applying physiologically based pharmacokinetic models to predict washout concentrations of transplacentally acquired drugs in newborns."( Physiologically Based Pharmacokinetic Modeling Framework to Predict Neonatal Pharmacokinetics of Transplacentally Acquired Emtricitabine, Dolutegravir, and Raltegravir.
Best, BM; Burckart, GJ; Cressey, TR; Dallmann, A; Green, DJ; Liu, XI; Mirochnick, M; Momper, JD; Rakhmanina, NY; van den Anker, JN, 2021
)
0.83
" 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
)
1.03
" The objective of this study was to apply physiologically based pharmacokinetic (PBPK) models in pediatric patients to investigate the absorption and pharmacokinetics of 4 drugs belonging to the Biopharmaceutics Classification System (BCS) class I administered as oral liquid formulations."( Evaluation of Physiologically Based Pharmacokinetic Models to Predict the Absorption of BCS Class I Drugs in Different Pediatric Age Groups.
Burckart, GJ; Dallmann, A; Liu, XI; van den Anker, JN, 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
"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
)
1.13
" 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
)
0.97
"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
)
0.97
"Our objective was to predict maternal and fetal drug disposition using a physiologically based pharmacokinetic (PBPK) modeling approach."( Prediction of Maternal and Fetal Acyclovir, Emtricitabine, Lamivudine, and Metformin Concentrations during Pregnancy Using a Physiologically Based Pharmacokinetic Modeling Approach.
Abduljalil, K; Jamei, M; Ning, J; Pansari, A, 2022
)
0.98
" Predicted pharmacokinetic parameters were within twofold of the observed values."( Prediction of Maternal and Fetal Acyclovir, Emtricitabine, Lamivudine, and Metformin Concentrations during Pregnancy Using a Physiologically Based Pharmacokinetic Modeling Approach.
Abduljalil, K; Jamei, M; Ning, J; Pansari, A, 2022
)
0.98
"Because pharmacokinetic changes in antiretroviral drugs (ARV), due to their concurrent administration with food or nutritional products, have become a clinical challenge, it is necessary to monitor the therapeutic efficacy of ARV in people living with the human immunodeficiency virus (PLWH)."( Pharmacokinetic Outcomes of the Interactions of Antiretroviral Agents with Food and Supplements: A Systematic Review and Meta-Analysis.
Leelakanok, N; Methaneethorn, J; Siritientong, T; Thet, D, 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
)
1.2
" 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

Compound-Compound Interactions

Emtricitabine is a potent nucleoside reverse transcriptase inhibitor approved as a once-daily drug in combination with other antiretroviral agents for the treatment of HIV infection.

ExcerptReferenceRelevance
"Emtricitabine is a potent nucleoside reverse transcriptase inhibitor approved as a once-daily drug in combination with other antiretroviral agents for the treatment of HIV infection."( Pharmacokinetic evaluation of emtricitabine in combination with other nucleoside antivirals in healthy volunteers.
Begley, JA; Blum, MR; Chittick, GE; Hui, J; Wang, LH; Zong, J, 2007
)
2.07
" We evaluated the effect of preexisting drug-associated resistance mutations to the response in treatment-naive patients to therapy with emtricitabine (FTC) or stavudine (d4T) in combination with didanosine (ddI) and efavirenz (EFV)."( Baseline genotype as a predictor of virological failure to emtricitabine or stavudine in combination with didanosine and efavirenz.
Bae, AS; Borroto-Esoda, K; Harris, JL; Hinkle, JE; Quinn, JB; Rousseau, FS; Waters, JM, 2007
)
0.79
"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
)
0.85
" 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
)
3.24
"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
)
0.81
"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
)
0.75
"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
)
0.77
"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
)
0.81
" 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
)
0.76
"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
)
0.77
"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
)
0.59
" 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
)
0.57
"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
)
0.6
"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
)
0.81
"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
)
0.89
" 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
)
0.6
"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
)
0.87
" 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
)
0.78
"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
)
0.84
"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
)
0.82
" We compared the treatment responses to 3TC and FTC combined with TDF in boosted protease inhibitor (PI)-based cART for HIV-1-infected patients."( Virological responses to lamivudine or emtricitabine when combined with tenofovir and a protease inhibitor in treatment-naïve HIV-1-infected patients in the Dutch AIDS Therapy Evaluation in the Netherlands (ATHENA) cohort.
Gras, L; Rijnders, B; Rokx, C; van de Vijver, D; Verbon, A, 2016
)
0.7
" 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
)
0.82
"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
)
0.92
"We investigated whether a fixed-dose combination tablet of elvitegravir, cobicistat, emtricitabine, and tenofovirDF (Stribild) can be crushed and combined with enteral nutrition without influencing pharmacokinetics."( Brief Report: Pharmacokinetics of Crushed Elvitegravir Combination Tablet Given With or Without Enteral Nutrition.
Abbink, E; Burger, D; Colbers, A; Duisenberg-van Essenberg, M; Jongbloed-de Hoon, M; Kruijssen, M; van Crevel, R; Velthoven-Graafland, K, 2017
)
0.68
" 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
" 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,
)
0.35
" To evaluate potential drug-drug interactions between FHT and ART, we performed intensive measurements of the pharmacokinetic (PK) parameters of blood tenofovir (TFV), efavirenz (EFV), and estradiol (E2)."( Drug-drug Interactions Among Thai Transgender Women Living with Human Immunodeficiency Undergoing Feminizing Hormone Therapy and Antiretroviral Therapy: The iFACT Study.
Dalodom, T; Himmad, L; Hiransuthikul, A; Janamnuaysook, R; Kerr, SJ; Kongkapan, J; Mills, S; Pankam, T; Phanjaroen, K; Phanuphak, N; Phanuphak, P; Vannakit, R, 2021
)
0.62
" 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
"We assessed virological failure (VF) and resistance-associated mutations (RAMs) on dolutegravir maintenance regimens in combination with rilpivirine or with lamivudine or emtricitabine (xTC) and analysed the factors associated with VF."( Dolutegravir-based dual maintenance regimens combined with lamivudine/emtricitabine or rilpivirine: risk of virological failure in a real-life setting.
Allavena, C; Bani-Sadr, F; Cabie, A; Cuzin, L; Deschanvres, C; Duvivier, C; Hocqueloux, L; Joly, V; Lamaury, I; Palich, R; Raffi, F; Rey, D; Reynes, J; Robineau, O, 2021
)
1.05
"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
"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
" 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

The bioavailability of elvitegravir and tenofovir is not affected by the type of meal ingested. The single-tablet regimen of EFV/emtricitabine (FTC)/TDF is not approved as initial antiretroviral therapy in Europe by the European Medical Agency.

ExcerptReferenceRelevance
" Absorption of FTC after oral administration was rapid, with bioavailability averaging 73 +/- 6%."( Pharmacokinetics and metabolism of racemic 2',3'-dideoxy-5-fluoro-3'-thiacytidine in rhesus monkeys.
Boudinot, FD; Ibrahim, SS; Liotta, DC; Manning, C; McClure, HM; Schinazi, RF, 1992
)
0.28
" The pharmacokinetics and bioavailability of 524W91 after oral dosing were studied in mice dosed with 10, 100, and 600 mg of 524W91 per kg of body weight by the oral and intravenous routes."( Pharmacokinetics, oral bioavailability, and metabolism in mice and cynomolgus monkeys of (2'R,5'S-)-cis-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl] cytosine, an agent active against human immunodeficiency virus and human hepatitis B virus.
Frick, LW; Lambe, CU; Nelson, DJ; St John, L; Taylor, LC, 1994
)
0.29
"1 liters/h/kg, and the oral bioavailability was 90% +/- 8%."( Pharmacokinetics, oral bioavailability, and metabolic disposition in rats of (-)-cis-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl] cytosine, a nucleoside analog active against human immunodeficiency virus and hepatitis B virus.
Frick, LW; Furfine, ES; Furman, PA; Liotta, DC; Nelson, DJ; Painter, GR; St John, L; Taylor, LC, 1993
)
0.29
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
"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
)
0.58
"39 fold) indicated significant enhancement in the rate and extent of bioavailability by the OPT-FTC NPs compared to pure drug."( Pharmacokinetics and in vivo biodistribution of optimized PLGA nanoparticulate drug delivery system for controlled release of emtricitabine.
Pai, RS; Singh, G, 2014
)
0.61
" 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
)
0.87
"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
)
0.88
" 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
" 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
"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
" 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
"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
)
0.95

Dosage Studied

HPTN 066 was conducted to establish objective, quantitative benchmarks for discrete, regular levels of adherence. HPTN 067 assessed the feasibility of daily and non-daily dosing of open-label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)

ExcerptRelevanceReference
"15 cells showed reductions in levels of HBV in serum and in intracellular levels of HBV when the mice were orally dosed with (-) cis-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine (FTC)."( Evaluation of the potent anti-hepatitis B virus agent (-) cis-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine in a novel in vivo model.
Condreay, LD; Daluge, SM; Ellis, MN; Furman, PA; Jansen, RW; Johnson, LC; Paff, MT; Painter, GR; Powdrill, TF; Selleseth, DW, 1994
)
0.29
" The pharmacokinetics and bioavailability of 524W91 after oral dosing were studied in mice dosed with 10, 100, and 600 mg of 524W91 per kg of body weight by the oral and intravenous routes."( Pharmacokinetics, oral bioavailability, and metabolism in mice and cynomolgus monkeys of (2'R,5'S-)-cis-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl] cytosine, an agent active against human immunodeficiency virus and human hepatitis B virus.
Frick, LW; Lambe, CU; Nelson, DJ; St John, L; Taylor, LC, 1994
)
0.29
" This methodology was successfully applied to the determination of FTC-TP in PBMCs of patients infected with human immunodeficiency virus after oral administration of various dosing regimens of FTC monotherapy."( Quantitation of intracellular triphosphate of emtricitabine in peripheral blood mononuclear cells from human immunodeficiency virus-infected patients.
Darque, A; Rousseau, F; Sommadossi, JP; Valette, G; Wang, LH; Zhou, XJ, 1999
)
0.56
" Using data on viral replication kinetics and dynamics, we designed an accelerated (14 day) open-label study of single agent emtricitabine (formerly known as FTC)--a nucleoside reverse transcriptase inhibitor--to select a dosing regimen for further therapeutic study."( Prototype trial design for rapid dose selection of antiretroviral drugs: an example using emtricitabine (Coviracil).
Delehanty, J; Kahn, JO; Mildvan, D; Quinn, JB; Rousseau, FS; Shepp, D; Simpson, JN; Sommadossi, JP; Thompson, M; van der Horst, C; Wakeford, C; Wang, LH, 2001
)
0.74
" Emtricitabine was well tolerated over the 2-month dosing period."( Dose range study of pharmacokinetics, safety, and preliminary antiviral activity of emtricitabine in adults with hepatitis B virus infection.
Delehanty, J; Fang, L; Gish, RG; Kessler, HA; Lang, W; Leung, NW; Mondou, E; Rigney, A; Rousseau, F; Snow, A; Trinh, H; Wang, LH; Wright, TL, 2002
)
1.45
" Potency, tolerability, convenient dosing and a low rate of side effects are some of the main characteristics of this new drug."( Emtricitabine: a new nucleoside analogue for once-daily antiretroviral therapy.
Cahn, P, 2004
)
1.77
" A phase I open-label trial was conducted in children to identify an FTC dosing regimen that would provide comparable plasma exposure to that observed in adults at 200 mg QD."( Pharmacokinetics and safety of single oral doses of emtricitabine in human immunodeficiency virus-infected children.
Bakshi, SS; Chittick, GE; Emmanuel, PJ; Flynn, PM; Rathore, MH; Wang, LH; Wiznia, AA, 2004
)
0.57
"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
)
1.98
" FTC may be dosed once daily and in vitro is less associated with the M184V mutation, which is classically associated with failure of treatment with lamivudine."( Emtricitabine (FTC) for the treatment of HIV infection.
Nelson, M; Schiavone, M, 2004
)
1.77
"Once daily (QD) dosing facilitates regimen simplification and adherence to antiretroviral therapy."( A randomized study of emtricitabine and lamivudine in stably suppressed patients with HIV.
Benson, CA; Haas, DW; Lamarca, A; McDonald, CK; Mondou, E; Quinn, JB; Rousseau, F; Rublein, J; Steinhart, CR; van der Horst, C, 2004
)
0.64
" This study highlights the importance of selecting animal species that demonstrate similar cytidine deaminase activity to humans when performing preclinical dosing studies on Racivir and other antiviral agents that are substrates for mammalian cytidine deaminases."( Comparative pharmacokinetics of Racivir, (+/-)-beta-2',3'-dideoxy-5-fluoro-3'-thiacytidine in rats, rabbits, dogs, monkeys and HIV-infected humans.
Hurwitz, SJ; Otto, MJ; Schinazi, RF, 2005
)
0.33
" In adult patients infected with HIV-1, emtricitabine has a convenient and simple dosing schedule of one 200-mg capsule once daily, and is as effective as lamivudine 150 mg twice daily and more effective than stavudine twice daily at suppressing plasma HIV-1 RNA when administered as part of a triple-drug regimen."( Emtricitabine: a novel nucleoside reverse transcriptase inhibitor.
Cox, SL; Molina, JM, 2005
)
2.04
"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
)
0.82
" 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
" 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
)
0.62
" 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
)
0.74
" 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
)
0.66
"A novel, once-daily dosing regimen of 3 antiretroviral drugs, emtricitabine, didanosine, and efavirenz, was tested in 37 therapy-naive HIV-infected children and adolescents between 3 and 21 years of age (inclusive)."( Long-term safety and efficacy of a once-daily regimen of emtricitabine, didanosine, and efavirenz in HIV-infected, therapy-naive children and adolescents: Pediatric AIDS Clinical Trials Group Protocol P1021.
Abrams, E; Blum, MR; Britto, P; Chittick, GE; Cunningham, C; Dickover, R; Draper, L; Flynn, P; Hu, C; Hughes, M; Kraimer, J; McKinney, RE; Ortiz, AA; Rathore, M; Reynolds, L; Rodman, J; Scites, M; Serchuck, LK; Smith, ME; Spector, S; Tran, P; Weinberg, A; Yogev, R, 2007
)
0.83
" 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
)
0.63
" 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
)
0.8
" FTC dose-linearity studies revealed that excretion parameters were not significantly different among dosing groups."( Renal excretion of emtricitabine I: effects of organic anion, organic cation, and nucleoside transport inhibitors on emtricitabine excretion.
Nakatani-Freshwater, T; Taft, DR, 2008
)
0.67
" The pharmacokinetic profile of GS-9160 in healthy human volunteers revealed that once-daily dosing was not likely to achieve antiviral efficacy; hence, the clinical development of this compound was discontinued."( Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
Chen, J; Chen, X; Geleziunas, R; Hesselgesser, J; Jin, H; Jones, GS; Kim, CU; Tsiang, M; Wright, M; Yu, F; Zeynalzadegan, A, 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
)
0.83
"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
)
0.55
" 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
)
0.83
" 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
)
0.57
" 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
)
0.85
" 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
)
0.59
"Among the 3 trials, 522 subjects were treated with FTC dosed once daily and 841 subjects were treated with 3TC dosed twice daily."( Reduced emergence of the M184V/I resistance mutation when antiretroviral-naïve subjects use emtricitabine versus lamivudine in regimens composed of two NRTIs plus the NNRTI efavirenz.
Borroto-Esoda, K; Chen, SS; Harris, J; Margot, N; McColl, DJ; Miller, MD,
)
0.35
" 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
" 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
)
0.6
"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
" 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
" 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
" 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
)
0.78
" 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
)
1.82
" 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
" 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
" 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
)
0.59
" 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
"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
" 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
" 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
)
0.63
"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
)
0.63
" 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
)
0.92
"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,
)
0.36
"The aims of this study were to describe emtricitabine concentration-time courses in a large population of HIV-1-infected adults, to evaluate the influence of renal function on emtricitabine disposition, and to assess current dosing adjustment recommendations."( Population pharmacokinetics of emtricitabine in HIV-1-infected adult patients.
Benaboud, S; Bouazza, N; Fauchet, F; Foissac, F; Ghosn, J; Hirt, D; Tréluyer, JM; Urien, S; Valade, E; Viard, JP, 2014
)
0.96
"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,
)
0.36
"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
)
0.65
" 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
" 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
" 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
)
0.81
" 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
" EFV area under the plasma concentration-time curve over 1 dosing interval from time 0 to 24 hours postdose values were generally suboptimal (<110 μM × h) in subjects younger than 3 years treated with oral solution; these subjects switched to capsule sprinkle."( Efavirenz Capsule Sprinkle and Liquid Formulations With Didanosine and Emtricitabine in HIV-1-infected Infants and Children 3 Months to 6 Years of Age: Study AI266-922.
Biguenet, S; Bunupuradah, T; Krystal, M; Lataillade, M; Pavia-Ruz, N; Rossouw, M; Sáez-Llorens, X; Seekins, D; Sevinsky, H; Taylor, M; Yang, R, 2015
)
0.65
" 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
)
0.87
"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,
)
0.32
"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
"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,
)
0.57
" 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
)
0.63
" 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
)
0.63
"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
"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
)
0.65
" 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
)
2.21
" 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
" 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
)
0.69
" 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
)
0.66
" 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
)
0.68
" 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
"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
" We conducted a prospective, randomized, crossover pharmacokinetic study of TFV-DP in DBS during 33%, 67%, or 100% of daily dosing under directly observed therapy (DOT)."( Intracellular Tenofovir-Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots following Directly Observed Therapy.
Anderson, PL; Buchbinder, S; Bushman, LR; Campbell, K; Castillo-Mancilla, JR; Gardner, EM; Ibrahim, M; Kiser, JJ; Liu, AY; MaWhinney, S; McHugh, C; Morrow, M; Seifert, SM; Wagner, T, 2018
)
0.75
"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
" 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
)
0.69
" 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
" 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
)
0.73
"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
)
0.69
"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
)
0.69
"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
"HPTN 067 assessed the feasibility of daily and non-daily dosing of open-label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)-based pre-exposure prophylaxis (PrEP)."( Factors Associated With Sex-Related Pre-exposure Prophylaxis Adherence Among Men Who Have Sex With Men in New York City in HPTN 067.
Amico, KR; Franks, J; Grant, RM; Hirsch-Moverman, Y; Hughes, JP; Li, M; Loquere, A; Mannheimer, S, 2019
)
0.74
"Factors associated with sex-related PrEP adherence were assessed among men who have sex with men (MSM) randomized to one of 3 PrEP dosing arms in HPTN 067 in New York City."( Factors Associated With Sex-Related Pre-exposure Prophylaxis Adherence Among Men Who Have Sex With Men in New York City in HPTN 067.
Amico, KR; Franks, J; Grant, RM; Hirsch-Moverman, Y; Hughes, JP; Li, M; Loquere, A; Mannheimer, S, 2019
)
0.51
" In the multivariable analyses, higher sex-related PrEP adherence was significantly associated with daily dosing arm, older age, employment, and higher PrEP adherence behavioral skills."( Factors Associated With Sex-Related Pre-exposure Prophylaxis Adherence Among Men Who Have Sex With Men in New York City in HPTN 067.
Amico, KR; Franks, J; Grant, RM; Hirsch-Moverman, Y; Hughes, JP; Li, M; Loquere, A; Mannheimer, S, 2019
)
0.51
" Lifelong antiretroviral (ARV) drug combination dosing allows management as a chronic condition by suppressing circulating viral load to allow for a near-normal life; however, the daily burden of oral administration may lead to non-adherence and drug resistance development."( Semi-solid prodrug nanoparticles for long-acting delivery of water-soluble antiretroviral drugs within combination HIV therapies.
Al-Khouja, A; Curley, P; Flexner, C; Hobson, JJ; Meyers, CF; Meyers, D; Owen, A; Rannard, SP; Siccardi, M, 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
)
0.7
" 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
" 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
)
0.84
"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 goals of this study were to build maternal-fetal physiologically based pharmacokinetic (PBPK) models for acyclovir and emtricitabine, 2 anti(retro)viral drugs with active renal net secretion, and to (1) evaluate the predicted maternal PK at different stages of pregnancy; (2) predict the changes in PK target parameters following the current dosing regimen of these drugs throughout pregnancy; (3) evaluate the predicted concentrations of these drugs in the umbilical vein at delivery; (4) compare the model performance for predicting maternal PK of emtricitabine in the third trimester with that of previously published PBPK models; and (5) compare different previously published approaches for estimating the placental permeability of these 2 drugs."( Physiologically Based Pharmacokinetic Models to Predict Maternal Pharmacokinetics and Fetal Exposure to Emtricitabine and Acyclovir.
Best, BM; Burckart, GJ; Capparelli, EV; Dallmann, A; Green, DJ; Liu, XI; Mirochnick, M; Momper, JD; Rakhmanina, N; van den Anker, JN, 2020
)
0.98
"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
)
0.7
" 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
)
0.81
" Beside the analytical profile, the degradation and stability of Emtricitabine, its pharmacology and pharmacokinetics, Pharmaceutical Applications, Mechanism of Action, dosage forms and dose, ADME profile, and interactions have been debated."( Emtricitabine.
Abdelhameed, AS; Al-Kahtani, HM; Al-Majed, AA; Al-Qahtani, BM; Bakheit, AHH, 2020
)
2.24
" 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
)
0.78
"\ 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
)
0.76
"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
)
0.83
" 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
)
0.83
" 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
"TGM and TGW on at least 6 months of stable sex hormone therapy containing testosterone or estradiol (respectively) were enrolled in a 4-week study of directly observed dosing of daily oral coformulated emtricitabine and tenofovir disoproxil fumarate (FTC/TDF)."( Sex Hormone Therapy and Tenofovir Diphosphate Concentration in Dried Blood Spots: Primary Results of the Interactions Between Antiretrovirals And Transgender Hormones Study.
Anderson, PL; Bhasin, S; Defechereux, PA; Deutsch, MB; Glidden, DV; Grant, RM; O'Neal, J; Pellegrini, M; Sevelius, J; Yager, J; Yu, M, 2021
)
0.81
"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)."(
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)
0.72
" Glans swab emtricitabine and darunavir concentrations peaked 24 h after dosing (emtricitabine 14 ng/swab, ( Antiretroviral drug exposure in urethral and glans surface sampling of the penis.
Conway-Washington, C; Dinh, C; Fountain, J; Garcia-Lerma, JG; Haaland, RE; Hall, L; Heneine, W; Kelley, CF; Lupo, LD; Martin, A, 2021
)
1
"We document ARV dosing in the urethra and on the glans surface with high drug concentrations noted for emtricitabine and darunavir and lower tenofovir and elvitegravir concentrations."( Antiretroviral drug exposure in urethral and glans surface sampling of the penis.
Conway-Washington, C; Dinh, C; Fountain, J; Garcia-Lerma, JG; Haaland, RE; Hall, L; Heneine, W; Kelley, CF; Lupo, LD; Martin, A, 2021
)
0.84
" 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
)
0.62
"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
)
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
)
0.62
" 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
)
0.84
"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
)
1.05
" Daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) has been the flagship PrEP regimen, and data support a pericoital/on-demand "2-1-1" dosing schedule for men who have sex with men."( Challenges and Opportunities for Preexposure Prophylaxis.
Cambou, MC; Landovitz, RJ,
)
0.4
" There are only 200 mg and 600 mg dosage forms of EFV in China."( Efficacy and safety of Efavirenz 400 mg-based regimens switching from 600 mg-based regimens in people living with HIV with virological suppression in China: a randomized, open-label, non-inferiority study.
Han, J; Li, B; Liu, Y; Xiao, J; Zhang, L; Zhao, H, 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
)
0.99
" 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
)
0.99
"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
)
0.96
" 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
" 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
)
0.97
" 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
)
0.97
"To assess the impact on the estimated glomerular filtration rate (eGFR) of different tenofovir disoproxil/emtricitabine dosing regimens for HIV pre-exposure prophylaxis (PrEP)."( Impact on renal function of daily and on-demand HIV pre-exposure prophylaxis in the ANRS-PREVENIR study.
Assoumou, L; Beniguel, L; Costagliola, D; Duvivier, C; El Mouhebb, M; Genin, M; Ghosn, J; Goldwirt, L; Liegeon, G; Molina, JM; Palacios, C; Palich, R; Rojas Castro, D; Slama, L; Surgers, L, 2022
)
0.93
"On-demand PrEP dosing had a smaller impact on eGFR evolution than daily PrEP, but the difference was not clinically relevant."( Impact on renal function of daily and on-demand HIV pre-exposure prophylaxis in the ANRS-PREVENIR study.
Assoumou, L; Beniguel, L; Costagliola, D; Duvivier, C; El Mouhebb, M; Genin, M; Ghosn, J; Goldwirt, L; Liegeon, G; Molina, JM; Palacios, C; Palich, R; Rojas Castro, D; Slama, L; Surgers, L, 2022
)
0.72
" The availability of long-acting injectable PrEP that does not require daily dosing has the potential to improve uptake and adherence, particularly in high-risk individuals."( Cabotegravir Extended-Release Injectable Suspension: A Review in HIV-1 Pre-Exposure Prophylaxis.
Blair, HA, 2022
)
0.72
" Due to binding interactions between polyvalent cations and bictegravir and the potential impact on antiretroviral efficacy, construction of a daily medication schedule to avoid interactions between the antiretroviral regimen and the supplements while promoting optimal dosing of each supplement was necessary; however there is currently no guidance on twice-daily cation dosing with coadministered bictegravir and limited guidance on multivitamin coadministration in this context."( Achievement of virologic suppression with HIV antiretroviral therapy in a patient also taking multiple daily cation supplement doses: A case report and review of the literature.
Buscemi, L; Mossholder, B, 2023
)
0.91
" To better understand INSTI distribution and inform dosing selection we compared the pharmacology of two-dose boosted elvitegravir and unboosted bictegravir regimens in MSM."( Pharmacology of boosted and unboosted integrase strand transfer inhibitors for two-dose event-driven HIV prevention regimens among men.
Conway-Washington, C; Dinh, C; Edwards, TE; Fountain, J; García-Lerma, JG; Haaland, RE; Hall, L; Heneine, WM; Holder, A; Kelley, CF; Lupo, LD; Martin, A; Massud, I, 2023
)
0.91
"Mean bictegravir plasma concentrations remained above the 95% protein-adjusted effective concentration 96 h after dosing [273 (95% CI: 164-456) ng/mL] whereas elvitegravir plasma concentrations became undetectable 48 h after the second dose."( Pharmacology of boosted and unboosted integrase strand transfer inhibitors for two-dose event-driven HIV prevention regimens among men.
Conway-Washington, C; Dinh, C; Edwards, TE; Fountain, J; García-Lerma, JG; Haaland, RE; Hall, L; Heneine, WM; Holder, A; Kelley, CF; Lupo, LD; Martin, A; Massud, I, 2023
)
0.91
" Differing elvitegravir and bictegravir distribution may result in variable mucosal and systemic antiviral activity and can inform dosing strategies for event-driven HIV prevention."( Pharmacology of boosted and unboosted integrase strand transfer inhibitors for two-dose event-driven HIV prevention regimens among men.
Conway-Washington, C; Dinh, C; Edwards, TE; Fountain, J; García-Lerma, JG; Haaland, RE; Hall, L; Heneine, WM; Holder, A; Kelley, CF; Lupo, LD; Martin, A; Massud, I, 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
"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
" 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
" 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
)
1.13
"As topical pre-exposure prophylaxis (PrEP) has been shown to cause immune modulation in rectal or cervical tissue, our aim was to examine the impact of oral PrEP on lymphoid and myeloid changes in the foreskin in response to dosing and timing of drug administration."( A randomized clinical trial of on-demand oral pre-exposure prophylaxis does not modulate lymphoid/myeloid HIV target cell density in the foreskin.
Alinde, B; Besethi, A; Chiodi, F; Else, L; Fox, J; Gray, CM; Herrera, C; Kaleebu, P; Khoo, S; Leach, L; Lebina, L; Malhangu, B; Martinson, N; Mbangiwa, T; Motaung, B; Mugaba, S; Namubiru, P; Odoch, G; Opoka, D; Petkov, S; Pillay, AAP; Rametse, CL; Sebaa, S; Seiphetlo, TB; Serwanga, J; Ssemata, AS; Webb, EL, 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
)
1.37
"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
"The efficacy of on-demand HIV pre-exposure prophylaxis (PrEP) for men in sub-Saharan Africa has not been evaluated, and the on-demand PrEP dosing requirement for insertive sex remains unknown."( Dose finding study for on-demand HIV pre-exposure prophylaxis for insertive sex in sub-Saharan Africa: results from the CHAPS open label randomised controlled trial.
Alieu, A; Alinde, B; Callebaut, C; Chiodi, F; Else, L; Fox, J; Gray, CM; Herrera, C; Kaleebu, P; Khoo, S; Limakatso, L; Martinson, N; Mugaba, S; Muhumuza, R; Namubiru, P; O'Hagan, K; Odoch, G; Opoka, D; Penchala, SD; Petkov, S; Pillay, AD; Seatlholo, P; Seeley, J; Seiphetlo, TB; Serwanga, J; Ssemata, AS; Webb, EL; Weiss, H, 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
)
1.11
" 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
)
1.29
"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
)
1.11
" Serum oestradiol concentrations were measured prior to medication dosing and 2, 4, 6 and 8 h post-dose."( Oestradiol concentrations in trans women with HIV suppressed on unboosted integrase inhibitor regimens versus trans women without HIV taking oral oestradiol: a pilot study.
Armstrong, I; Bourns, A; Chan, LYL; Fung, R; Halpenny, R; Hranilovic, S; Iyer, H; Jeyarajah, N; Kennedy, VL; Kia, H; Kovchazov, G; Lacombe-Duncan, A; Loutfy, M; McCully, J; Nguyen, Q; Persad, Y; Scarsi, KK; Tseng, A; Underhill, A; Weisdorf, T, 2023
)
0.91
" Regimen Optimization in the setting of HIV suppression may reduce pill burden, and/or dosing frequency, enhance tolerability and/or decrease toxicity, prevent or mitigate DDIs, eliminate food/fluid requirements, relieve pill fatigue, decrease stigma or concerns associated with taking oral med, allow pregnancy, reduce costs (DHHS 2023)."( Optimizing Antiretroviral Therapy with Bictegravir/Emtricitabine/Tenofovir Alafenamide in virologically suppressed PLWH.
Andreoni, M, 2023
)
1.16
" 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 (2)

RoleDescription
antiviral drugA substance used in the prophylaxis or therapy of virus diseases.
HIV-1 reverse transcriptase inhibitorAn entity which inhibits the activity of HIV-1 reverse transcriptase.
[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 (4)

ClassDescription
pyrimidoneA pyrimidine carrying one or more oxo substituents.
organofluorine compoundAn organofluorine compound is a compound containing at least one carbon-fluorine bond.
monothioacetalA thioacetal having the structure R2C(OR')(SR'). The term includes monothioketals, R =/= H, as a subclass.
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]

Protein Targets (6)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
TDP1 proteinHomo sapiens (human)Potency21.13600.000811.382244.6684AID686978
[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)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)133.00000.11007.190310.0000AID1473738
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[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)
AlbuminHomo sapiens (human)Kd44.00000.08933.31358.0000AID1238542
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (46)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
cellular response to starvationAlbuminHomo sapiens (human)
negative regulation of mitochondrial depolarizationAlbuminHomo sapiens (human)
cellular response to calcium ion starvationAlbuminHomo sapiens (human)
cellular oxidant detoxificationAlbuminHomo sapiens (human)
transportAlbuminHomo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (35)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
oxygen bindingAlbuminHomo sapiens (human)
DNA bindingAlbuminHomo sapiens (human)
fatty acid bindingAlbuminHomo sapiens (human)
copper ion bindingAlbuminHomo sapiens (human)
protein bindingAlbuminHomo sapiens (human)
toxic substance bindingAlbuminHomo sapiens (human)
antioxidant activityAlbuminHomo sapiens (human)
pyridoxal phosphate bindingAlbuminHomo sapiens (human)
identical protein bindingAlbuminHomo sapiens (human)
protein-folding chaperone bindingAlbuminHomo sapiens (human)
exogenous protein bindingAlbuminHomo sapiens (human)
enterobactin bindingAlbuminHomo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (26)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
extracellular regionAlbuminHomo sapiens (human)
extracellular spaceAlbuminHomo sapiens (human)
nucleusAlbuminHomo sapiens (human)
endoplasmic reticulumAlbuminHomo sapiens (human)
endoplasmic reticulum lumenAlbuminHomo sapiens (human)
Golgi apparatusAlbuminHomo sapiens (human)
platelet alpha granule lumenAlbuminHomo sapiens (human)
extracellular exosomeAlbuminHomo sapiens (human)
blood microparticleAlbuminHomo sapiens (human)
protein-containing complexAlbuminHomo sapiens (human)
cytoplasmAlbuminHomo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (217)

Assay IDTitleYearJournalArticle
AID404908Cytotoxicity against human HL60 cells after 3 days by MTT assay2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
Strong and selective inhibitors of hepatitis B virus replication among novel N4-hydroxy- and 5-methyl-beta-L-deoxycytidine analogues.
AID541132Selectivity ratio of EC50 for antiviral activity against NNRTI-resistant HIV1 harboring RTK103N mutant gene to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
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.
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.
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).
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.
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).
AID582411Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen positive hepatocytes at 15 mg/kg, po qd measured on 36th week on 48 weeks study (Rvb = 41 +/- 25 %)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
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.
AID1298355Antiviral activity against VSV-G pseudotyped HIV-1 NL4-3 infected in human U373-MAGI cells assessed as reduction in U5-gag level measured at 6 to 72 hrs post infection by qPCR method2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
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.
AID582405Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral DNA replicative intermediate level per ug of total cell DNA at 15 mg/kg, po qd for 48 weeks measured on 60th week (Rvb = 979 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID217731Cytotoxicity was determined in the vero cells infected with HIV-I1993Journal of medicinal chemistry, Jan-22, Volume: 36, Issue:2
Asymmetric synthesis and biological evaluation of beta-L-(2R,5S)- and alpha-L-(2R,5R)-1,3-oxathiolane-pyrimidine and -purine nucleosides as potential anti-HIV agents.
AID541130Selectivity ratio of EC50 for antiviral activity against NRTI-resistant HIV1 harboring RTM184V mutant gene to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID404912Antiviral activity against HBV in HepG2.2.15 cells assessed as decrease in extracellular viral DNA level by RT-PCR2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
Strong and selective inhibitors of hepatitis B virus replication among novel N4-hydroxy- and 5-methyl-beta-L-deoxycytidine analogues.
AID369218Antiviral activity against woodchuck hepatitis virus infected woodchucks assessed as log reduction of serum viral DNA per ml of serum after 4 weeks2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
Antiviral effect of orally administered (-)-beta-D-2-aminopurine dioxolane in woodchucks with chronic woodchuck hepatitis virus infection.
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.
AID154956Anti-HIV-1 activity against human peripheral blood mononuclear (PBM) cells infected with HIV-1 strain LAV1993Journal of medicinal chemistry, Jan-22, Volume: 36, Issue:2
Asymmetric synthesis and biological evaluation of beta-L-(2R,5S)- and alpha-L-(2R,5R)-1,3-oxathiolane-pyrimidine and -purine nucleosides as potential anti-HIV agents.
AID541169Selectivity ratio of EC50 for antiviral activity against HIV1 harboring N155H mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID541163Selectivity ratio of EC50 for antiviral activity against HIV1 harboring E92Q mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
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.
AID46361In vitro concentration required to decrease 50% of mitochondrial DNA content in CEM cells1996Journal of medicinal chemistry, Apr-26, Volume: 39, Issue:9
Design and synthesis of 2',3'-dideoxy-2',3'-didehydro-beta-L-cytidine (beta-L-d4C) and 2',3'-dideoxy 2',3'-didehydro-beta-L-5-fluorocytidine (beta-L-Fd4C), two exceptionally potent inhibitors of human hepatitis B virus (HBV) and potent inhibitors of human
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.
AID1447284Cytotoxicity against human P4R5 MAGI cells after 2 hrs by MTT assay2017Bioorganic & medicinal chemistry letters, 05-01, Volume: 27, Issue:9
Synthesis and anti-HIV activities of unsymmetrical long chain dicarboxylate esters of dinucleoside reverse transcriptase inhibitors.
AID582431Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as increase of liver alkaline phosphatase activity at 15 mg/kg, po qd for 48 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
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.
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.
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).
AID572768Antiviral activity against HIV1 infected in human MT2 cells assessed as inhibition of viral replication2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
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.
AID582429Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as increase of liver alanine aminotransferase activity at 15 mg/kg, po qd for 48 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID541109Antiviral activity against HIV1 3B infected in human MT-2 cells by two fold dilution method in presence of 10% FBS2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID147705Inhibition of Newcastles disease virus replication by 50% (no effect at this concentration)2000Bioorganic & medicinal chemistry letters, Dec-04, Volume: 10, Issue:23
Phenylpropenamide derivatives as inhibitors of hepatitis B virus replication.
AID1238542Binding affinity to human serum albumin with excitation at 280 nm after 2 hrs by spectrofluorimetric analysis2015Bioorganic & medicinal chemistry letters, Aug-15, Volume: 25, Issue:16
Ionic derivatives of betulinic acid exhibit antiviral activity against herpes simplex virus type-2 (HSV-2), but not HIV-1 reverse transcriptase.
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.
AID541174Selectivity ratio of EC50 for antiviral activity against HIV1 harboring E92V, G140S and V151A mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
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).
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.
AID582409Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral RNA level per ug of total cell DNA at 15 mg/kg, po qd for 48 weeks measured on 60th week (Rvb = 27 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1447282Inhibition of HIV1 3B dinucleoside reverse transcriptase infected in human P4R5 MAGI cells assessed as reduction in viral infection after 2 hrs by Galacto-Star beta-galactosidase reporter gene assay2017Bioorganic & medicinal chemistry letters, 05-01, Volume: 27, Issue:9
Synthesis and anti-HIV activities of unsymmetrical long chain dicarboxylate esters of dinucleoside reverse transcriptase inhibitors.
AID582417Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as absent of lesion in portal hepatitis at 15 mg/kg, po qd for 48 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID582396Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral DNA replicative intermediate level per ug of total cell DNA at 15 mg/kg, po qd measured on 12th week on 48 weeks study (Rvb = 1495 +/- 890 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID582424Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as effect on hematological parameters at 15 mg/kg, po qd for 48 weeks measured up to 60 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID541168Selectivity ratio of EC50 for antiviral activity against HIV1 harboring V151A mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID1447283Inhibition of HIV1 BaL dinucleoside reverse transcriptase infected in human P4R5 MAGI cells assessed as reduction in viral infection after 2 hrs by Galacto-Star beta-galactosidase reporter gene assay2017Bioorganic & medicinal chemistry letters, 05-01, Volume: 27, Issue:9
Synthesis and anti-HIV activities of unsymmetrical long chain dicarboxylate esters of dinucleoside reverse transcriptase inhibitors.
AID664467Antiviral activity against HIV1 BaL infected in HeLa P4/R5 cells assessed as reduction of viral infection incubated for 2 hrs followed by incubated in drug-free medium for 46 hrs by single round infection beta-galactosidase reporter gene assay2012Journal of medicinal chemistry, Mar-22, Volume: 55, Issue:6
Synthesis and anti-HIV activities of glutamate and peptide conjugates of nucleoside reverse transcriptase inhibitors.
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.
AID1652587Antiviral activity against HIV2 ROD infected in human TK-deficient CEM/TK(-) cells assessed as inhibition of viral-induced giant cell formation incubated for 4 to 5 days by microscopy
AID541129Selectivity ratio of EC50 for antiviral activity against NRTI-resistant HIV1 harboring RTK65R mutant gene to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
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.
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).
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.
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.
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.
AID582426Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as increase of liver alanine aminotransferase activity at 15 mg/kg, po qd measured on 4 to 24 weeks on 48 week study2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
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.
AID1587128Half-life in human serum administered once daily2019Journal of medicinal chemistry, 05-09, Volume: 62, Issue:9
A Survey of the Structures of US FDA Approved Combination Drugs.
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.
AID664466Antiviral activity against HIV1 3B infected in HeLa P4/R5 cells assessed as reduction of viral infection incubated for 2 hrs followed by incubated in drug-free medium for 46 hrs by single round infection beta-galactosidase reporter gene assay2012Journal of medicinal chemistry, Mar-22, Volume: 55, Issue:6
Synthesis and anti-HIV activities of glutamate and peptide conjugates of nucleoside reverse transcriptase inhibitors.
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.
AID541135Selectivity ratio of EC50 for antiviral activity against PI-resistant HIV1 harboring RTG48V, V82A and L90M mutant gene to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID541131Selectivity ratio of EC50 for antiviral activity against NRTI-resistant HIV1 harboring RT-6TAMs mutant gene to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID1780695Therapeutic index, ratio of CC50 for human CEM-GXR cells infected with wild type HIV1 NL4-3 to EC50 for wild type HIV1 NL4-3 infected in human CEM-GXR cells
AID3033Concentration required to inhibit 50% of extracellular circular replication of HBV DNA using 2215 cell line1996Journal of medicinal chemistry, Apr-26, Volume: 39, Issue:9
Design and synthesis of 2',3'-dideoxy-2',3'-didehydro-beta-L-cytidine (beta-L-d4C) and 2',3'-dideoxy 2',3'-didehydro-beta-L-5-fluorocytidine (beta-L-Fd4C), two exceptionally potent inhibitors of human hepatitis B virus (HBV) and potent inhibitors of human
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.
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.
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.
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).
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.
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.
AID1780689Cytotoxicity against human CEM-GXR cells infected with wild type HIV1 NL4-3 assessed as cell viability measured after 72 hrs by Flow cytometry assay
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.
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.
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).
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.
AID404909Cytotoxicity against human HepG2 cells after 3 days by MTT assay2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
Strong and selective inhibitors of hepatitis B virus replication among novel N4-hydroxy- and 5-methyl-beta-L-deoxycytidine analogues.
AID1587129Oral bioavailability in human administered once daily2019Journal of medicinal chemistry, 05-09, Volume: 62, Issue:9
A Survey of the Structures of US FDA Approved Combination Drugs.
AID86846Inhibition of Duck HBV replication by 50% (no effect at this concentration)2000Bioorganic & medicinal chemistry letters, Dec-04, Volume: 10, Issue:23
Phenylpropenamide derivatives as inhibitors of hepatitis B virus replication.
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.
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.
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.
AID572767Antiviral activity against HIV1 infected in human HeLa P4/R5 cells assessed as inhibition of viral replication2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID423283Selectivity ratio of EC50 for wild type HIV2 ROD to EC50 for wild type HIV1 NL4-3 M184V variant2008Antimicrobial 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.
AID541134Selectivity ratio of EC50 for antiviral activity against PI-resistant HIV1 harboring RTI84V, L90M mutant gene to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
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.
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.
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.
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.
AID582398Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as frequency of hepatocytes expressing viral antigen at 15 mg/kg, po qd for 48 weeks measured on 60th week2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID582427Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as increase of liver sorbitol dehydrogenase activity at 15 mg/kg, po qd measured on 28 to 48 weeks on 48 week study2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
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.
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.
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.
AID541166Selectivity ratio of EC50 for antiviral activity against HIV1 harboring G140S mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
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.
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.
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).
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).
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.
AID1652586Antiviral activity against HIV2 ROD infected in human CEM/0 cells assessed as inhibition of viral-induced giant cell formation incubated for 4 to 5 days by microscopy
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.
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.
AID1780701Cytotoxicity against human PBMC cells assessed as cell viability measured after 11 days by Viacount assay
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.
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.
AID582428Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as increase of serum gamma-glutamyltransferase activity at 15 mg/kg, po qd for 48 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID582399Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as absent of lesion in portal hepatitis at 15 mg/kg, po qd measured on 12th week on 48 weeks study2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
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.
AID86856Inhibition of Woodchuck HBV replication by 50% (no effect at this concentration)2000Bioorganic & medicinal chemistry letters, Dec-04, Volume: 10, Issue:23
Phenylpropenamide derivatives as inhibitors of hepatitis B virus replication.
AID1652588Cytotoxicity in human CEM/0 cells assessed as reduction in cell viability incubated for 4 to 5 days
AID582414Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as frequency of hepatocytes expressing viral antigen at 15 mg/kg, po qd measured on 36th week on 48 weeks study2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
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.
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.
AID152644Cytotoxicity against human peripheral blood mononuclear (PBM) cells infected with HIV-I1993Journal of medicinal chemistry, Jan-22, Volume: 36, Issue:2
Asymmetric synthesis and biological evaluation of beta-L-(2R,5S)- and alpha-L-(2R,5R)-1,3-oxathiolane-pyrimidine and -purine nucleosides as potential anti-HIV agents.
AID1298361Antiviral activity against VSV-G pseudotyped HIV-1 NL4-3 infected in human U373-MAGI cells assessed as reduction in gag level measured at 6 to 72 hrs post infection by qPCR method2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID86024Inhibition of HSV-1 replication by 50% (no effect at this concentration)2000Bioorganic & medicinal chemistry letters, Dec-04, Volume: 10, Issue:23
Phenylpropenamide derivatives as inhibitors of hepatitis B virus replication.
AID1780683Antiviral activity against wild type HIV1 NL4-3 infected in human CEM-GXR cells assessed as inhibition of viral replication measured after 3 days by Flowcytometry assay
AID582403Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen level in serum at 15 mg/kg, po qd for 48 weeks measured on 60th week (Rvb = 3.3 +/- 1.6 log10 ng/ml)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID216378Inhibition of Vesicular stomatis virus replication by 50% (no effect at this concentration)2000Bioorganic & medicinal chemistry letters, Dec-04, Volume: 10, Issue:23
Phenylpropenamide derivatives as inhibitors of hepatitis B virus replication.
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.
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.
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.
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.
AID582404Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral DNA replicative intermediate level per ug of total cell DNA at 15 mg/kg, po qd for 48 weeks (Rvb = 995 +/- 736 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
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.
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).
AID572769Antiviral activity against HIV1 infected in human PBMC assessed as inhibition of viral replication2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
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.
AID541162Selectivity ratio of EC50 for antiviral activity against HIV1 harboring L74M mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID582397Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as frequency of hepatocytes expressing viral antigen at 15 mg/kg, po qd measured on 12th week on 48 weeks study2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID86358Inhibition of hepatitis B virus replication in the HepAD38 cell line.2000Bioorganic & medicinal chemistry letters, Dec-04, Volume: 10, Issue:23
Phenylpropenamide derivatives as inhibitors of hepatitis B virus replication.
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).
AID541175Selectivity ratio of EC50 for antiviral activity against HIV1 harboring G140S and Q148H mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID81419Inhibition of HIV-1 replication by 50% (no effect at this concentration)2000Bioorganic & medicinal chemistry letters, Dec-04, Volume: 10, Issue:23
Phenylpropenamide derivatives as inhibitors of hepatitis B virus replication.
AID582423Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as change in body weight at 15 mg/kg, po qd for 48 weeks measured up to 60 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID582395Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral DNA replicative intermediate level per ug of total cell DNA at 15 mg/kg, po qd measured on 36th week on 48 weeks study (Rvb = 1132 +/- 738 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID582425Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as increase of liver sorbitol dehydrogenase activity at 15 mg/kg, po qd measured on 4 to 24 weeks on 48 week study2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
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.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
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.
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.
AID582402Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen level in serum at 15 mg/kg, po qd for 48 weeks (Rvb = 3.8 +/- 1.3 log10 ng/ml)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1290154Antiviral activity against subtype B X4 tropic HIV1 3B infected in GFP-positive human CEM cells expressing CD4+,CXCR4 and CCR5 after 3 days2016Journal of medicinal chemistry, Mar-10, Volume: 59, Issue:5
A Parallel Synthesis Approach to the Identification of Novel Diheteroarylamide-Based Compounds Blocking HIV Replication: Potential Inhibitors of HIV-1 Pre-mRNA Alternative Splicing.
AID541173Selectivity ratio of EC50 for antiviral activity against HIV1 harboring E138K and Q148K mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID588997Inhibitors of transporters of clinical importance in the absorption and disposition of drugs, MPR32010Nature reviews. Drug discovery, Mar, Volume: 9, Issue:3
Membrane transporters in drug development.
AID588996Inhibitors of transporters of clinical importance in the absorption and disposition of drugs, MRP22010Nature reviews. Drug discovery, Mar, Volume: 9, Issue:3
Membrane transporters in drug development.
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.
AID46362In vitro concentration required to inhibit 50% of CEM cell growth1996Journal of medicinal chemistry, Apr-26, Volume: 39, Issue:9
Design and synthesis of 2',3'-dideoxy-2',3'-didehydro-beta-L-cytidine (beta-L-d4C) and 2',3'-dideoxy 2',3'-didehydro-beta-L-5-fluorocytidine (beta-L-Fd4C), two exceptionally potent inhibitors of human hepatitis B virus (HBV) and potent inhibitors of human
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.
AID582430Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as increase of liver aspartate aminotransferase activity at 15 mg/kg, po qd for 48 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1780702Anti-HIV activity against HIV1 Bal infected in human PBMC assessed as inhibition of viral infection measured after 11 days by ELISA method
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.
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.
AID582400Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen level in serum at 15 mg/kg, po qd measured on 12th week on 48 weeks study (Rvb = 4.3 +/- 1.5 log10 ng/ml)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
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.
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.
AID106908Concentration required to inhibit 50% of HIV activity in MT-2 cells1996Journal of medicinal chemistry, Apr-26, Volume: 39, Issue:9
Design and synthesis of 2',3'-dideoxy-2',3'-didehydro-beta-L-cytidine (beta-L-d4C) and 2',3'-dideoxy 2',3'-didehydro-beta-L-5-fluorocytidine (beta-L-Fd4C), two exceptionally potent inhibitors of human hepatitis B virus (HBV) and potent inhibitors of human
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.
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.
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.
AID3034Concentration required to inhibit 50% of intracellular circular replication of HBV DNA using 2215 cell line1996Journal of medicinal chemistry, Apr-26, Volume: 39, Issue:9
Design and synthesis of 2',3'-dideoxy-2',3'-didehydro-beta-L-cytidine (beta-L-d4C) and 2',3'-dideoxy 2',3'-didehydro-beta-L-5-fluorocytidine (beta-L-Fd4C), two exceptionally potent inhibitors of human hepatitis B virus (HBV) and potent inhibitors of human
AID423282Selectivity ratio of EC50 for wild type HIV2 ROD 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.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
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.
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
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.
AID582401Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen level in serum at 15 mg/kg, po qd measured on 36th week on 48 weeks study (Rvb = 3.8 +/- 1.3 log10 ng/ml)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID582413Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen positive hepatocytes at 15 mg/kg, po qd for 48 weeks measured on 60th week (Rvb = 26 %)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
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.
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.
AID582408Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral RNA level per ug of total cell DNA at 15 mg/kg, po qd for 48 weeks (Rvb = 34 +/- 20 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
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.
AID1780703Anti-HIV activity against HIV1 3B infected in human PBMC assessed as inhibition of viral infection measured after 11 days by ELISA method
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.
AID541133Selectivity ratio of EC50 for antiviral activity against NNRTI-resistant HIV1 harboring RTY181C mutant gene to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID541170Selectivity ratio of EC50 for antiviral activity against HIV1 harboring N155S mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
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.
AID582415Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as frequency of hepatocytes expressing viral antigen at 15 mg/kg, po qd for 48 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
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.
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.
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.
AID1780690Cytotoxicity against human CEM-GXR cells infected with wild type HIV1 97USSN54 assessed as cell viability measured after 72 hrs by Flow cytometry assay
AID541167Selectivity ratio of EC50 for antiviral activity against HIV1 harboring Q148K mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID582412Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen positive hepatocytes at 15 mg/kg, po qd for 48 weeks study (Rvb = 35 +/- 27 %)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID541165Selectivity ratio of EC50 for antiviral activity against HIV1 harboring E138K mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID582410Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen positive hepatocytes at 15 mg/kg, po qd measured on 12th week on 48 weeks study (Rvb = 55 +/- 32 %)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
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).
AID541171Selectivity ratio of EC50 for antiviral activity against HIV1 harboring L74M and E92V mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
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.
AID541164Selectivity ratio of EC50 for antiviral activity against HIV1 harboring E92V mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID582406Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral RNA level per ug of total cell DNA at 15 mg/kg, po qd measured on 12th week on 48 weeks study (Rvb = 46 +/- 25 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
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.
AID1780696Therapeutic index, ratio of CC50 for human CEM-GXR cells infected with wild type HIV1 97USSN54 to EC50 for wild type HIV1 97USSN54 infected in human CEM-GXR cells
AID541161Selectivity ratio of EC50 for antiviral activity against HIV1 harboring T66I mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
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.
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).
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.
AID1780684Antiviral activity against wild type HIV1 97USSN54 infected in human CEM-GXR cells assessed as inhibition of viral replication measured after 3 days by Flowcytometry assay
AID541172Selectivity ratio of EC50 for antiviral activity against HIV1 harboring E92V and V151A mutation in catalytic core domain of integrase to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID86359The concentration of compound which inhibits hepatitis B virus replication in the HepAD38 cell line.2000Bioorganic & medicinal chemistry letters, Dec-04, Volume: 10, Issue:23
Phenylpropenamide derivatives as inhibitors of hepatitis B virus replication.
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).
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.
AID664468Cytotoxicity against human HeLa P4/R5 cells after 48 hrs by MTT assay2012Journal of medicinal chemistry, Mar-22, Volume: 55, Issue:6
Synthesis and anti-HIV activities of glutamate and peptide conjugates of nucleoside reverse transcriptase inhibitors.
AID1652585Antiviral activity against HIV1 3B infected in human CEM/0 cells assessed as inhibition of viral-induced giant cell formation incubated for 4 to 5 days by microscopy
AID582407Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral RNA level per ug of total cell DNA at 15 mg/kg, po qd measured on 36th week on 48 weeks study (Rvb = 33 +/- 21 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
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.
AID310045Cytotoxicity against 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.
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.
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.
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.
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.
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.
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.
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.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,638)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's25 (1.53)18.2507
2000's228 (13.92)29.6817
2010's915 (55.86)24.3611
2020's470 (28.69)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 85.28

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index85.28 (24.57)
Research Supply Index7.68 (2.92)
Research Growth Index5.60 (4.65)
Search Engine Demand Index153.63 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (85.28)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials464 (27.20%)5.53%
Reviews194 (11.37%)6.00%
Case Studies120 (7.03%)4.05%
Observational52 (3.05%)0.25%
Other876 (51.35%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (372)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
An Open-label Study of Liquid and Sprinkled Formulations of Efavirenz Administered in Combination With Didanosine and Emtricitabine in HIV-infected Infants and Children 3 Months to 6 Years of Age. [NCT00364793]Phase 1/Phase 256 participants (Actual)Interventional2007-02-28Completed
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
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
Bictegravir in the Elderly Living With HIV: Impact of Polypharmacy and Multimorbidity (BICEP) [NCT05064020]162 participants (Anticipated)Observational2020-08-01Active, not recruiting
DOT Diary Longitudinal Pilot: A Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men [NCT03771638]Phase 4100 participants (Actual)Interventional2019-02-01Completed
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
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
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
The Effect of Biktarvy (B/F/TAF) on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers [NCT04950530]Phase 120 participants (Anticipated)Interventional2022-12-22Recruiting
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
Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression [NCT01174914]Phase 2171 participants (Actual)Interventional2008-03-31Completed
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
Bioequivalence of Tenofovir and Emtricitabine Following Overencapsulation [NCT02968576]25 participants (Actual)Interventional2016-12-31Completed
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
I-BrEATHe - Interactions Between Antiretrovirals And Transgender Hormones [NCT04050371]Phase 448 participants (Actual)Interventional2017-08-03Completed
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
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
"Assessment of a New Boosting Strategy for HIV Pre-exposure Prophylaxis in Healthy Volunteers" [NCT03202511]Early Phase 115 participants (Actual)Interventional2017-06-23Completed
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
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
"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
Study on the Drug Interaction of HS-10234 and Emtricitabine in Healthy Subjects [NCT04477096]Phase 136 participants (Actual)Interventional2020-08-03Completed
Body Composition Sub-study of the D2EFT Trial [NCT03675815]Phase 4155 participants (Actual)Interventional2019-12-05Active, not recruiting
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
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
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 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
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
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
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
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
"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
The Cellular Pharmacology of F-TAF in Dried Blood Spots [NCT02962739]Phase 138 participants (Actual)Interventional2016-03-31Completed
Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients [NCT02327702]Phase 4200 participants (Anticipated)Interventional2015-01-31Not yet recruiting
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
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
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
Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD [NCT04500847]Phase 135 participants (Anticipated)Interventional2021-12-17Recruiting
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 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
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)
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
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)
Effect of SwitChing AtriPla to Eviplera on Neurocognitive and Emotional Functioning, ESCAPE Study [NCT02308332]Phase 458 participants (Actual)Interventional2015-02-28Completed
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.)
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum [NCT00042289]1,578 participants (Actual)Observational2003-06-09Completed
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
Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3 [NCT04880395]Phase 4230 participants (Anticipated)Interventional2021-05-20Recruiting
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
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 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
"Prevention of HIV in Île-de-France" [NCT03113123]3,257 participants (Anticipated)Interventional2017-05-03Recruiting
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
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
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
Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study [NCT01003990]Phase 3710 participants (Actual)Interventional2002-10-31Completed
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
An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects [NCT00642291]Phase 216 participants (Actual)Interventional2002-11-30Completed
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
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 Study of Bioequivalence When Administering Biktarvy® (TAF/FTC/BIC) in the Form of a Solid/Crushed/Dissolved Tablet to Healthy Volunteers - SOLUBIC Study [NCT04244448]Phase 118 participants (Actual)Interventional2019-12-02Completed
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
Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Antiretroviral Strategy in Persistently Non-adherent Children, Adolescents, and Young Adults Who Are Failing HAART and Have the M184V Resistance Mutation. [NCT01338025]Phase 433 participants (Actual)Interventional2011-03-31Terminated(stopped due to Study was halted for lack of accrual)
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
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
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
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
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
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
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
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
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
Phase IV, Randomized, Multicenter and Double Clinical Trial Blind Designed to Assess Safety and Convenience of the Change From DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control and Neuropsychiatric Vulnerabilities: MIND Study [NCT05549180]Phase 484 participants (Actual)Interventional2022-10-06Active, not recruiting
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
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
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
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
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
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
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
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
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
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
Implication for Strategies of Long Term Control of Viral Replication in Patient With Primary HIV Infection (PHI) Treated With Multitarget Antiviral Therapy (MT-ART) [NCT04225325]Phase 4112 participants (Anticipated)Interventional2018-05-07Recruiting
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
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
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
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
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
COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry [NCT00705419]180 participants (Actual)Observational2007-07-31Completed
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
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
A Rollover Protocol to Provide Subjects Completing the FTC-203 Study in South Africa With Continued Access to Emtricitabine [NCT00743340]Phase 250 participants (Actual)Interventional2005-11-22Completed
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
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, 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
Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg. [NCT02583464]Phase 124 participants (Actual)Interventional2014-09-30Completed
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
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
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
Pharmacokinetics and Safety of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants [NCT04862975]200 participants (Anticipated)Observational2024-01-08Not yet recruiting
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
Pharmacokinetic and Safety Pilotstudy of RAltegravir and Atazanavir in a Once DAily Dose Regimen in HIV-1 Infected Patients (PRADA) [NCT00943540]Phase 220 participants (Anticipated)Interventional2009-07-31Completed
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
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
Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine [NCT03218085]50 participants (Anticipated)Observational2017-07-14Recruiting
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
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 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 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
A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/Ritonavir With Lopinavir/Ritonavir, Each in Combination With Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment in Naive Subjects [NCT00272779]Phase 31,057 participants (Actual)Interventional2005-11-30Completed
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)
A Phase II Exploratory Study Examining Immunologic and Virologic Indices in Two Age-Differentiated Cohorts of HIV-Infected Subjects to Explore the Basis of Accelerated HIV-Disease Progression Associated With Aging [NCT00006144]Phase 290 participants Interventional2000-10-31Completed
An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV-Infected Pediatric Patients [NCT00017992]Phase 2100 participants InterventionalRecruiting
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
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
Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM) [NCT01033760]Phase 390 participants (Actual)Interventional2010-04-30Completed
A Pilot Study of Lopinavir/Ritonavir in Participants Experiencing Virologic Relapse on NNRTI-Containing Regimens [NCT00357552]123 participants (Actual)Interventional2008-01-31Completed
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
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
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)
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
Switch to Tenofovir Alafenamide (TAF), Emtricitabine (FTC), Bictegravir (BIC)(Biktarvy®) in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication [NCT04222283]Phase 427 participants (Anticipated)Interventional2020-08-17Recruiting
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project. [NCT01989611]400 participants (Anticipated)Interventional2014-06-30Active, not recruiting
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
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, Double-Blind, Equivalence Trial Comparing Emtricitabine to Stavudine Within a Triple Drug Combination Containing Didanosine Plus Efavirenz in Antiretroviral-Drug Naive HIV-1 Infected Patients [NCT00006208]Phase 30 participants Interventional2000-08-31Active, not recruiting
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
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
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)
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
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
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
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
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
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 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
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
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women [NCT01394133]0 participants (Actual)Observational2011-07-31Withdrawn(stopped due to Lack of enrollment)
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
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 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
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
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)
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
Entecavir Intensification for Persistent Hepatitis B Virus (HBV) Viremia in HIV-HBV Infection [NCT00662545]Phase 410 participants (Actual)Interventional2008-04-30Completed
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
Treating HIV-infected Elite Controllers as a Model of HIV Remission [NCT01025427]Phase 416 participants (Actual)Interventional2009-12-31Completed
ENLIGHTEN: Establishing Novel Antiretroviral (ARV) Imaging for Hair to Elucidate Non-Adherence [NCT03218592]Phase 436 participants (Actual)Interventional2017-06-28Completed
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
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
Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naive Patients With HIV/HBV Co-infection [NCT00476463]Phase 224 participants (Actual)Interventional2005-04-30Completed
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
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
Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study [NCT00537966]2,017 participants (Anticipated)Interventional2002-01-31Recruiting
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
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
Exploratory Pharmacokinetic and Pharmacodynamic Study of Oral F/TAF for the Prevention of HIV Acquisition [NCT02904369]Phase 173 participants (Actual)Interventional2016-10-06Completed
Phase IV, Open Label, Randomized, Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir Alafenamide/Emtricitabine/Darunavir/Cobicistat [NCT03685500]Phase 478 participants (Actual)Interventional2018-12-04Completed
A Pilot Study of Rapid HIV Treatment Initiation, Access and Engagement in Care (RHAE) [NCT03512964]32 participants (Actual)Interventional2016-11-29Completed
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
Comparison Atazanavir/Ritonavir (ATV/r) vs Nevirapine (NVP) Twice a Day (Bid) on Truvada Backbone [NCT00552240]Phase 4154 participants (Actual)Interventional2007-09-30Completed
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 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
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
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)
Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department [NCT03711253]Phase 440 participants (Anticipated)Interventional2019-10-14Active, 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
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 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
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
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)
Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy [NCT01285050]Phase 420 participants (Actual)Interventional2011-01-31Completed
Pilot Study on Efficacy and Safety of a Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults. ANRS 091 MONTANA [NCT00196599]Phase 239 participants Interventional1999-02-28Completed
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 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)
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
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
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
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 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 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 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
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 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 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
Phase II Randomized Trial Comparing Efficacy and Safety of the Maintenance of a HAART Association Protease Inhibitor Containing Versus a Once Daily Antiretroviral Triple Association, in HIV Adult Patients With Undetectable Viral Load.ANRS 099 ALIZE [NCT00196612]Phase 3350 participants Interventional2001-04-30Completed
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
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 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
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
Acute HIV Infection - A Key Link for Transmission Prevention: A Randomized Pilot Study [NCT01450189]46 participants (Actual)Interventional2011-10-31Completed
Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals [NCT02251236]14 participants (Actual)Interventional2016-01-31Completed
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 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
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
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 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 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
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
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
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
Defining the Rectal Mucosa in Men Who Have Sex With Men at Risk of HIV Infection [NCT02401230]Phase 486 participants (Actual)Interventional2015-03-31Completed
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
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
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
Implementation of Onsite, Rapid Antiretroviral Therapy (ART) Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program [NCT04650269]Phase 427 participants (Actual)Interventional2021-03-04Active, not recruiting
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
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
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
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
A Randomized, Open-Label Superiority Trial Comparing Emtricitabine to Abacavir Within a Triple Drug Combination in Antiretroviral-Drug Naive HIV-1 Infected Patients [NCT00002362]Phase 30 participants Interventional1999-08-31Suspended
A Randomized, Open-Label Equivalence Study of FTC Versus Lamivudine in Patients on a Stable Triple Antiretroviral Therapy Regimen Containing Lamivudine, Stavudine or Zidovudine, and a Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor [NCT00002416]Phase 3390 participants InterventionalCompleted
An Open-Label Study to Evaluate the Safety, Tolerance, Antiviral Activity, and Pharmacokinetics of Emtricitabine in Combination With Efavirenz and Didanosine in a Once-Daily Regimen in HIV Infected, Antiretroviral Therapy Naive or Very Limited Antiretrovi [NCT00016718]Phase 1/Phase 243 participants (Actual)Interventional2001-08-31Completed
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
Efficacy, Tolerability and Acceptability of the Single Table Regimen (STR) Biktarvy® by Trans People Living With HIV (TPLWH) [NCT04944654]Phase 41 participants (Actual)Interventional2023-01-07Terminated(stopped due to Trial set up was delayed, funding support no longer available)
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
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
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
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
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
Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (Genvoya) as Maintenance Treatment of HIV-1/Hepatitis B Virus (HBV)-Coinfected Patients: an Observational Study [NCT03425994]275 participants (Actual)Observational [Patient Registry]2018-02-06Active, not recruiting
A Phase I, Randomized, Single-Dose, Placebo-Controlled Trial to Evaluate the Safety and Pharmacokinetics of 524W91 [NCT00002335]Phase 118 participants InterventionalCompleted
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
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
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
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
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
An Open-Label, 48-Week Extension Study of Elvucitabine Administered In Combination With Background Antiretroviral Agents in Participants Who Have Completed 14 Days of Treatment in Protocol ACH443-014A. [NCT00380159]Phase 24 participants (Actual)Interventional2006-09-30Completed
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
Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients [NCT02327676]Phase 4200 participants (Anticipated)Interventional2015-01-31Not yet recruiting
Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial [NCT03327155]Phase 3900 participants (Actual)Interventional2017-11-16Completed
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.)
MARaviroc-based Treatment Switch in HIV-positive Patients With HAND: Consequences of Reducing Antiretroviral-associated Neurotoxicity [NCT03163277]Phase 438 participants (Actual)Interventional2017-05-15Terminated(stopped due to Sloww accrual and COVID-19 related problems (impossible to perform LPs))
Emtricitabine for Naive Chinese Chronic Hepatitis B Patients [NCT02327663]Phase 42,000 participants (Anticipated)Interventional2014-12-31Not yet recruiting
Comprehensive HIV Prevention Package for MSM in Port Elizabeth [NCT02449733]101 participants (Actual)Interventional2015-05-31Completed
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 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
Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients [NCT02327689]Phase 4400 participants (Anticipated)Interventional2015-01-31Not yet recruiting
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
The Efficacy, Safety, and Tolerability of Switching to a Bictegravir (BIC)/Emtricitabine(FTC)/Tenofovir Alafenamide (TAF) Regimen in Virally Suppressed HIV-Positive Patients Post-Renal Transplant [NCT04530630]Phase 420 participants (Actual)Interventional2020-11-09Active, not recruiting
Emtricitabine for Prevention of Vertical Transmission of HBV in Chinese Pregnant HBsAg Positive Patients [NCT02327715]Phase 4200 participants (Anticipated)Interventional2015-01-31Not yet recruiting
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
Dose-Proportionality and Intra-Individual Variability of Intracellular Tenofovir Diphosphate and Emtricitabine Triphosphate In Healthy Volunteers [NCT01276600]Phase 132 participants (Actual)Interventional2011-01-31Completed
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
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
Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth) [NCT01571128]1,215 participants (Actual)Interventional2014-11-30Completed
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
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
Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women [NCT03060785]Phase 116 participants (Actual)Interventional2016-03-08Completed
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
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
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 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 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
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 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
Parrying the Pitfalls of PrEP: Preventing Premature PrEP Discontinuation and STIs Among MSM [NCT05072093]Phase 4200 participants (Anticipated)Interventional2021-11-20Recruiting
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
Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART [NCT01869634]Phase 437 participants (Actual)Interventional2013-06-30Completed
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
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
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
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 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 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
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
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)
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
"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
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV in Brazilian Transgender Women [NCT03220152]Phase 4120 participants (Anticipated)Interventional2017-07-10Recruiting
Decrease of Neuropsychiatric and Neurocognitive Side Effects Prevalence [NCT02447016]Phase 425 participants (Actual)Interventional2015-05-31Terminated(stopped due to no more participants taking atripla)
Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection [NCT04483674]Phase 266 participants (Anticipated)Interventional2020-12-04Recruiting
PrEP Adherence Monitoring Using Dried Blood Spots [NCT02022657]Phase 1/Phase 252 participants (Actual)Interventional2014-04-30Completed
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
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00016718 (3) [back to overview]Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment.
NCT00016718 (3) [back to overview]Proportion of Participants With Suppression of HIV Viral Load to Less Than 400 Copies/ml at Week 16
NCT00016718 (3) [back to overview]Proportion of Participants With Suppression of HIV Viral Load to Less Than 50 Copies/ml at Week 16
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]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]Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of 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]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: 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]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 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 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 (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]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]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 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)
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 Treatment Failure (PI Comparison)
NCT00084136 (18) [back to overview]Time to Treatment Failure (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 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]Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)
NCT00084136 (18) [back to overview]Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)
NCT00084136 (18) [back to overview]Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI 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)
NCT00089505 (9) [back to overview]Percent of Participants Who Experienced Virologic Failure or Died
NCT00089505 (9) [back to overview]Number of Participants Who Experienced HIV-related Disease Progression or Death
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]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 Who Had SD NVP Exposure Prior to Study Entry
NCT00089505 (9) [back to overview]Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry
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
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]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]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]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]Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
NCT00090779 (9) [back to overview]Number of Participants in IT Arm Off Treatment Before 36 Weeks
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%.
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
NCT00105079 (6) [back to overview]Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters
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 Participants Assessed for Adverse Events (AEs)
NCT00105079 (6) [back to overview]Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
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 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 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]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]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 < 50 c/mL) at 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 From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144
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 96
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 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 96
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 in Limb Fat (kg) From Week 48 to Week 144
NCT00112047 (53) [back to overview]Change in Limb Fat (kg) From Week 48 to 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]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 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 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)
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]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]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 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) at Week 96
NCT00118898 (22) [back to overview]Number of Participants With Treatment Modification
NCT00118898 (22) [back to overview]Number of Participants With Regimen Failure
NCT00118898 (22) [back to overview]Amount of Study Follow-up
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing Treatment Modification
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 a Grade 3/4 Safety Event
NCT00118898 (22) [back to overview]Time From Randomization to Virologic Failure
NCT00118898 (22) [back to overview]Time From Treatment Dispensation to Treatment Modification
NCT00118898 (22) [back to overview]The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
NCT00118898 (22) [back to overview]Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event
NCT00118898 (22) [back to overview]Change in Fasting Triglyceride Level From Baseline
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 Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline
NCT00118898 (22) [back to overview]Number of Participants With a Grade 3/4 Safety Event
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]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 Virologic Failure
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing Regimen Failure
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]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]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 <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]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 <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 <400 Copies/mL at Weeks 48 and 96
NCT00272779 (88) [back to overview]Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48
NCT00272779 (88) [back to overview]Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24
NCT00272779 (88) [back to overview]Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)
NCT00272779 (88) [back to overview]Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679
NCT00272779 (88) [back to overview]Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309
NCT00272779 (88) [back to overview]Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734
NCT00272779 (88) [back to overview]Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598
NCT00272779 (88) [back to overview]Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265
NCT00272779 (88) [back to overview]Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097
NCT00272779 (88) [back to overview]Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R
NCT00272779 (88) [back to overview]Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C
NCT00272779 (88) [back to overview]Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097
NCT00272779 (88) [back to overview]Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)
NCT00272779 (88) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
NCT00272779 (88) [back to overview]Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
NCT00272779 (88) [back to overview]Reduction of log10 HIV RNA Levels From Baseline to Week 48
NCT00272779 (88) [back to overview]Reduction of log10 HIV RNA Levels From Baseline at Week 96
NCT00272779 (88) [back to overview]Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4
NCT00272779 (88) [back to overview]Percentage of Participants With Lipoatrophy at Week 96
NCT00272779 (88) [back to overview]Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48
NCT00272779 (88) [back to overview]Number of Participants With HIV RNA < 50 c/mL) at Week 96
NCT00272779 (88) [back to overview]Number of Participants With HIV RNA < 400 c/mL) at Week 96
NCT00272779 (88) [back to overview]Number of Participants With HIV RNA < 400 c/mL at Week 48
NCT00272779 (88) [back to overview]Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)
NCT00272779 (88) [back to overview]Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48
NCT00272779 (88) [back to overview]Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
NCT00272779 (88) [back to overview]Mean Changes in Fasting Insulin at Week 96
NCT00272779 (88) [back to overview]Mean Changes in Fasting Glucose at Week 96
NCT00272779 (88) [back to overview]Mean Changes From Baseline in Body Weight at Week 96
NCT00272779 (88) [back to overview]Mean Change in Weight From Baseline at Week 48
NCT00272779 (88) [back to overview]Mean Change in Fasting Insulin at Week 48
NCT00272779 (88) [back to overview]Mean Change in Fasting Glucose at Week 48
NCT00272779 (88) [back to overview]Mean Change in Body Mass Index (BMI) in Participants at Week 48
NCT00272779 (88) [back to overview]Mean Change From Baseline in Waist-to-hip-ratio at Week 96
NCT00272779 (88) [back to overview]Mean Change From Baseline in Waist-to-hip-ratio at Week 48
NCT00272779 (88) [back to overview]Mean Change From Baseline in Waist Circumference at Week 96
NCT00272779 (88) [back to overview]Mean Change From Baseline in Waist Circumference at Week 48
NCT00272779 (88) [back to overview]Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48
NCT00272779 (88) [back to overview]Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96
NCT00272779 (88) [back to overview]Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48
NCT00272779 (88) [back to overview]Mean Change From Baseline in CD4 Cell Count at Week 96
NCT00272779 (88) [back to overview]Mean Change From Baseline in Body Weight at Week 96
NCT00272779 (88) [back to overview]Mean Change From Baseline in Body Weight at Week 48
NCT00272779 (88) [back to overview]Mean Change From Baseline in BMI at Week 96
NCT00272779 (88) [back to overview]Mean Change From Baseline in BMI at Week 96
NCT00272779 (88) [back to overview]Mean Change From Baseline in BMI at Week 48
NCT00272779 (88) [back to overview]Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4
NCT00272779 (88) [back to overview]Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4
NCT00272779 (88) [back to overview]Cmin of Tenofovir at Week 4
NCT00272779 (88) [back to overview]Cmin of RTV at Week 4
NCT00272779 (88) [back to overview]Cmax of Tenofovir at Week 4
NCT00272779 (88) [back to overview]Cmax of RTV at Week 4
NCT00272779 (88) [back to overview]AUC (TAU) of Tenofovir at Week 4
NCT00272779 (88) [back to overview]AUC (0-24) of RTV at Week 4
NCT00272779 (88) [back to overview]Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
NCT00272779 (88) [back to overview]Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)
NCT00272779 (88) [back to overview]Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48
NCT00272779 (88) [back to overview]Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96
NCT00272779 (88) [back to overview]Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48
NCT00272779 (88) [back to overview]Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96
NCT00272779 (88) [back to overview]Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96
NCT00272779 (88) [back to overview]Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48
NCT00272779 (88) [back to overview]Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA
NCT00272779 (88) [back to overview]Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96
NCT00272779 (88) [back to overview]Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48
NCT00272779 (88) [back to overview]Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48
NCT00272779 (88) [back to overview]Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96
NCT00272779 (88) [back to overview]Mean Changes in Fasting Lipids at Week 96
NCT00272779 (88) [back to overview]Mean Change in Fasting Lipid at Week 48
NCT00272779 (88) [back to overview]Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842
NCT00272779 (88) [back to overview]Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980
NCT00272779 (88) [back to overview]Mean Change From Baseline in VAT Associated With RETN_730
NCT00272779 (88) [back to overview]Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980
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 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 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
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 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 96
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 Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48
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]Median Change in MELD Score From Baseline at Week 144
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 96
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 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 Plasma HBV DNA < 400 Copies/mL at Week 144
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 48
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 a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48
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 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]Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96
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 HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline)
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]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]Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48
NCT00307489 (19) [back to overview]Hepatitis B Early Antigen (HBeAg) Loss at Week 168
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 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]HBsAg Loss at Week 168
NCT00307489 (19) [back to overview]Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48
NCT00307489 (19) [back to overview]Percentage of Participants With Normalized ALT at Week 48
NCT00307489 (19) [back to overview]HBeAg Seroconversion at Week 48
NCT00307489 (19) [back to overview]Change From Baseline in log10 Plasma HBV DNA Levels at Week 48
NCT00307489 (19) [back to overview]Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168
NCT00307489 (19) [back to overview]HBsAg Loss at Week 48
NCT00307489 (19) [back to overview]Percentage of Participants With Plasma HBV DNA < 169 Copies/mL 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]Percentage of Participants With Normalized ALT at Week 168
NCT00307489 (19) [back to overview]Percentage of Participants With Normal ALT at Week 48
NCT00307489 (19) [back to overview]Percentage of Participants With Normal ALT at Week 168
NCT00307489 (19) [back to overview]Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 48
NCT00307489 (19) [back to overview]Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 168
NCT00307489 (19) [back to overview]Hepatitis B Early Antigen (HBeAg) Loss 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.
NCT00357552 (11) [back to overview]Number of Participants With Study-targeted Diagnoses and Clinical Events
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]Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.
NCT00357552 (11) [back to overview]Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma
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]Percentage of Subjects Reporting Not Skipping Medications in the Last Month.
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 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]Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification
NCT00357552 (11) [back to overview]Change in CD4+ Cell Counts From Study Entry to Week 104
NCT00364793 (28) [back to overview]Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population
NCT00364793 (28) [back to overview]Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population
NCT00364793 (28) [back to overview]AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
NCT00364793 (28) [back to overview]CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
NCT00364793 (28) [back to overview]CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
NCT00364793 (28) [back to overview]Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
NCT00364793 (28) [back to overview]CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants
NCT00364793 (28) [back to overview]Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
NCT00364793 (28) [back to overview]Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants
NCT00364793 (28) [back to overview]The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants
NCT00364793 (28) [back to overview]The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants
NCT00364793 (28) [back to overview]The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants
NCT00364793 (28) [back to overview]The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants
NCT00364793 (28) [back to overview]Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants
NCT00364793 (28) [back to overview]Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants
NCT00364793 (28) [back to overview]Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population
NCT00364793 (28) [back to overview]Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound
NCT00364793 (28) [back to overview]Number of Participants With Serum Chemistry Abnormalities - Treated Participants
NCT00364793 (28) [back to overview]Number of Participants With On-Treatment Adverse Events (AEs), Related Adverse Events, Serious Adverse Events (SAEs), Death, Discontinuation Due to Adverse Events, and CDC Class C AIDS Events
NCT00364793 (28) [back to overview]Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population
NCT00364793 (28) [back to overview]CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants
NCT00364793 (28) [back to overview]Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants
NCT00364793 (28) [back to overview]Number of Participants With Hematologic Abnormalities - Treated Participants
NCT00364793 (28) [back to overview]Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population
NCT00364793 (28) [back to overview]Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population
NCT00364793 (28) [back to overview]The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants
NCT00364793 (28) [back to overview]Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants
NCT00364793 (28) [back to overview]The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants
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 240
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 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 96
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156
NCT00369941 (73) [back to overview]Change From Baseline in CD4 Cell Count at Week 156
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 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 With Serious LAEs 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 With Serious 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
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
NCT00442962 (11) [back to overview]Time to First Safety Event
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 Early Virologic Suppression
NCT00442962 (11) [back to overview]Percentage of Participants With Early Virologic Response
NCT00442962 (11) [back to overview]Time to Initial Virological Failure
NCT00442962 (11) [back to overview]Time to Initial Virologic Response
NCT00442962 (11) [back to overview]Time to First Dose Modification
NCT00442962 (11) [back to overview]Early Changes in CD4 Count From Baseline
NCT00442962 (11) [back to overview]Percentage of Participants With Late Virologic Suppression
NCT00442962 (11) [back to overview]Percentage of Participants With Late Virologic Response
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
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
NCT00524173 (4) [back to overview]Number of Subjects With Hepatitis b Virus (HBV) DNA <1000 IU/ml at Week 48
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)
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 24
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]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 Type 1 Collagen Cross-linked C-telopeptide at Week 96
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]Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) 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]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]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]Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48
NCT00549198 (58) [back to overview]Change From Baseline in Cluster Difference 4 (CD4+) Cell Count 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 24
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Osteocalcin 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 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 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 24
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 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 24
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 the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96
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 24
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]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 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 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 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 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 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 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 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 Total Cholesterol 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 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 96
NCT00549198 (58) [back to overview]Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96
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 48 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 36 of Treatment
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 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]Proportion of Patients Reporting Hepatic Events of Any Severity
NCT00552240 (46) [back to overview]Proportion of Patients Reporting CNS Side Effects of Any Severity
NCT00552240 (46) [back to overview]Percentage Adherence by Pill Count
NCT00552240 (46) [back to overview]Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48
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]Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
NCT00552240 (46) [back to overview]Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities
NCT00552240 (46) [back to overview]Number of Patients With Virologic Rebound to >400 Copies/ml
NCT00552240 (46) [back to overview]Number of Participants With Virologic Success (FDA Definition)
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 Response (VR)
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 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 48 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 4 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 < 50 Copies/ml at Week 24 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 12 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
NCT00557245 (11) [back to overview]Head Circumference 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]Weight Among Infants Born to Female Participants Taking Study Drug
NCT00557245 (11) [back to overview]Study Drug Adherence: Self-reported Missed Doses of 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]Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.
NCT00557245 (11) [back to overview]Prevalence of Unprotected Sex During Follow-up
NCT00557245 (11) [back to overview]Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up
NCT00557245 (11) [back to overview]Number of Participants With Serious Adverse Events (SAEs)
NCT00557245 (11) [back to overview]Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.
NCT00594646 (2) [back to overview]Number of HIV-1 Infected Participants
NCT00594646 (2) [back to overview]Medication Regimen Completion Rates
NCT00608569 (8) [back to overview]Confirmed Virologic Failure at or Prior to Week 48
NCT00608569 (8) [back to overview]Confirmed Virologic Failure at or Prior to Week 24
NCT00608569 (8) [back to overview]CD8 Count at Follow-up Visits
NCT00608569 (8) [back to overview]Time to First Grade 3 or 4 Sign or Symptom
NCT00608569 (8) [back to overview]Time to First Grade 3 or 4 Lab or Sign/Symptom Event
NCT00608569 (8) [back to overview]CD4 Count at Follow-up Visits
NCT00608569 (8) [back to overview]Adherence to Second Line HAART Regimen
NCT00608569 (8) [back to overview]Time to First Grade 3 or 4 Lab Event
NCT00625404 (12) [back to overview]Confirmed Grade 3 or Higher ALT Elevation
NCT00625404 (12) [back to overview]FTC and/or Tenofovir Resistance
NCT00625404 (12) [back to overview]HIV Infection
NCT00625404 (12) [back to overview]Participant Report of Change in Number of Sexual Partners
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)
NCT00625404 (12) [back to overview]Pregnancy Complications
NCT00625404 (12) [back to overview]Confirmed Grade 3 or Higher Reduction in Phosphorus
NCT00625404 (12) [back to overview]Confirmed Grade 3 or Higher AST Elevation
NCT00625404 (12) [back to overview]Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration
NCT00625404 (12) [back to overview]CD4+ T-cell Count
NCT00625404 (12) [back to overview]Confirmed Grade 2 or Higher Serum Creatinine Toxicity
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]Study Medication Toxicity-related Discontinuation .
NCT00654147 (6) [back to overview]Time to Confirmed Virologic Failure
NCT00654147 (6) [back to overview]Time to Virologic Failure
NCT00654147 (6) [back to overview]Change From Baseline CD4+ and CD8+ Cell Counts
NCT00654147 (6) [back to overview]Weeks to HIV-1 RNA <200 Copies/ml
NCT00654147 (6) [back to overview]Study Medication Tolerability
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]Person-years of Follow-up of Oral TDF 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]Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms
NCT00705679 (11) [back to overview]Number of HIV-1 Infections of Oral TDF 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]Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo 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]Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
NCT00705679 (11) [back to overview]Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms
NCT00705679 (11) [back to overview]Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms
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
NCT00711009 (82) [back to overview]Mean Change From Baseline in Lactate (Millimoles/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]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 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 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 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 Interleukin-6 (Nanograms/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Insulin (Picomoles/Liter)
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 Hemoglobin (Grams/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Hematocrit (Fraction)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)
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 Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (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]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 Trunk Mass (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 Fat (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 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 Fat (Grams)
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 Lower Extremity Fat (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 Bone Mineral Content (Grams)
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 Creatinine (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 Cholesterol (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Chloride (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Chest Measurement (cm)
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 Calcium (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 Bicarbonate (Micromoles/Liter)
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 Aspartate Aminotransferase (Units/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Albumin (Grams/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)
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 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 Magnesium (Millimoles/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]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]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]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)
NCT00724711 (14) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL 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 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]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 Fasting Glucose at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Fibrinogen at Week 48
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 Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at 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 Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48
NCT00724711 (14) [back to overview]Change From Baseline Fasting Lipid Parameters 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]Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48
NCT00743340 (1) [back to overview]Number of Participants Who Had Access to, and Received the Intervention
NCT00752856 (4) [back to overview]Viral Suppression Efficacy at 48 Weeks
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.
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 Insulin at Week 12 and 48.
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]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 Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48
NCT00757783 (16) [back to overview]Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.
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]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 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 Glucose 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 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 CD4 Cell Count at Week 12 and 48, Observed Values.
NCT00762892 (5) [back to overview]Change From Baseline in Log HIV Viral Load 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 Homocysteine at 6 Months
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 CD4 Count at 48 Weeks
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]Raltegravir AUC (0-12h) in 1 Dosing Interval
NCT00768989 (28) [back to overview]Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count
NCT00768989 (28) [back to overview]Baseline and Mean Change From Baseline in Total Cholesterol Levels
NCT00768989 (28) [back to overview]Raltegravir Tmax
NCT00768989 (28) [back to overview]Raltegravir Terminal Elimination Half Life
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]Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4
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]Raltegravir Cmin Prior to the Morning Dose
NCT00768989 (28) [back to overview]Raltegravir Cmin 12 Hours Postdose
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 Total Bilirubin Level
NCT00768989 (28) [back to overview]Mean Change From Baseline in Electrocardiogram Findings
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]Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval
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]Atazanavir Cmin Prior to the Morning Dose
NCT00768989 (28) [back to overview]Atazanavir Individual Inhibitory Quotient (IQ)
NCT00768989 (28) [back to overview]Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval
NCT00768989 (28) [back to overview]Atazanavir Terminal Elimination Half Life
NCT00768989 (28) [back to overview]Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)
NCT00768989 (28) [back to overview]Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose
NCT00768989 (28) [back to overview]Number of Nonresponders at Week 8
NCT00768989 (28) [back to overview]Raltegravir Cmax in 1 Dosing Interval
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 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
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]Incidence of Death or AIDS Defining Events (CDC Category C)
NCT00811954 (19) [back to overview]CD4+ T-cell Count
NCT00811954 (19) [back to overview]Change in Fasting Plasma Glucose Level From Baseline
NCT00811954 (19) [back to overview]Change in Fasting Total Cholesterol Level From Baseline
NCT00811954 (19) [back to overview]Change in Fasting Triglycerides Level 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 Waist Circumference From Baseline
NCT00811954 (19) [back to overview]Change in Waist:Height Ratio From Baseline
NCT00811954 (19) [back to overview]Self-reported Adherence
NCT00811954 (19) [back to overview]Presence of Mutations Associated With NRTI Resistance
NCT00811954 (19) [back to overview]Presence of Mutations Associated With INI Resistance
NCT00811954 (19) [back to overview]Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance
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]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
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 Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
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]Average Observed Plasma Concentration (Cavg) of Maraviroc
NCT00827112 (16) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Maraviroc
NCT00827112 (16) [back to overview]HIV-1 RNA Levels at Baseline
NCT00827112 (16) [back to overview]Time-Averaged Difference (TAD) in log10 Viral Load
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 Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
NCT00827112 (16) [back to overview]Time to Loss of Virological Response (TLOVR)
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]Number of Participants With Phenotypic Resistance
NCT00827112 (16) [back to overview]Number of Participants With Genotypic Resistance
NCT00827112 (16) [back to overview]Minimum Observed Plasma Concentration (Cmin) of Maraviroc
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
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]Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT)
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]Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 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]Percent Change in Lean Mass From Study Entry to Week 96
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 Total Limb Fat From Study Entry to Week 96
NCT00851799 (27) [back to overview]Percent Change in Trunk Fat From Study Entry to Week 96
NCT00851799 (27) [back to overview]Percent Change in Visceral Abdominal Fat (VAT) 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]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]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]Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 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]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]Fold Change in D-dimer From Study Entry to Weeks 48 and 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]Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 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
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
NCT00856323 (4) [back to overview]Self-reported Methamphetamine Use in Previous 30 Days.
NCT00856323 (4) [back to overview]Description of Incident STI Infections.
NCT00856323 (4) [back to overview]Post-Exposure Prophylaxis Medication Adherence
NCT00856323 (4) [back to overview]HIV-related Sexual Risk Behaviors in Previous 30 Days.
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]Ritonavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
NCT00869960 (8) [back to overview]Tenofovir 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]Atazanavir 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]Tenofovir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
NCT00869960 (8) [back to overview]Atazanavir 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)
NCT00885664 (11) [back to overview]SF-12 Physical Capacity Score
NCT00885664 (11) [back to overview]INF Gamma
NCT00885664 (11) [back to overview]IL-8
NCT00885664 (11) [back to overview]IL-7
NCT00885664 (11) [back to overview]IL-6
NCT00885664 (11) [back to overview]IL-4
NCT00885664 (11) [back to overview]IL-10
NCT00885664 (11) [back to overview]IL-1 Beta
NCT00885664 (11) [back to overview]SF-12 Mental Capacity Score
NCT00885664 (11) [back to overview]TNF Alpha
NCT00885664 (11) [back to overview]Symptom Score
NCT00924898 (6) [back to overview]Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications
NCT00924898 (6) [back to overview]Number of Participants Without Virologic Failure at Week 24
NCT00924898 (6) [back to overview]Number of Participants Without Virologic Failure at Week 48
NCT00924898 (6) [back to overview]Number of Participants With HIV RNA Suppression at Week 96
NCT00924898 (6) [back to overview]Time to HIV RNA Suppression <50 Copies/mL
NCT00924898 (6) [back to overview]Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment
NCT00928187 (13) [back to overview]Development of Metabolic Syndrome
NCT00928187 (13) [back to overview]Adherence
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]Number of Patients With HIV Plasma Viral Load < 200 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 Plasma HIV RNA < 50 Copies/mL
NCT00928187 (13) [back to overview]Number of Patients With Resistance Mutations
NCT00928187 (13) [back to overview]Patients With Plasma HIV RNA < 200 Copies/ml
NCT00928187 (13) [back to overview]Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)
NCT00928187 (13) [back to overview]Tolerance: Gastrointestinal Complains
NCT00928187 (13) [back to overview]Tolerance: Neuropathies (Grade 1 to 4)
NCT00928187 (13) [back to overview]Number of Patients With WHO Stage 3 and 4 HIV Related Events
NCT00931801 (4) [back to overview]Maintenance of Virologic Suppression
NCT00931801 (4) [back to overview]Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
NCT00931801 (4) [back to overview]The Difference in CD4 From Baseline to Week 48
NCT00931801 (4) [back to overview]The Change in Adherence to Study Treatment Arm From Baseline to Week 48
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 <200 Copies/mL at Week 24 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]Probability of Remaining Free of a Safety/Tolerability Event at 96 Weeks
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 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
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]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]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]Tolerability of Etravirine in HIV-1 Infected Adults Initiating Antiretroviral Therapy
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
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 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]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]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
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
NCT00960622 (1) [back to overview]Change in Peak Oxygen Uptake.
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]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 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 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]Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4
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]Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in 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 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]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]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]Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline
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]Frequency of Missing Study Pills Because Participant Ran Out of Study Pills
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 Had a Change in Daily Routine
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Felt Sick or Ill
NCT01033942 (96) [back to overview]Acceptability of Risk Reduction Counseling at Every Visit
NCT01033942 (96) [back to overview]Acceptability of Questions About Sexual Behavior at Every Visit
NCT01033942 (96) [back to overview]Acceptability of Physical Examination by a Doctor
NCT01033942 (96) [back to overview]Acceptability of Participating in Group Sessions
NCT01033942 (96) [back to overview]Acceptability of Health Clinic for Study Visits
NCT01033942 (96) [back to overview]Acceptability of Having an HIV Test at Every Visit
NCT01033942 (96) [back to overview]Acceptability of Being Randomly Assigned to a Group
NCT01033942 (96) [back to overview]Acceptability of Being Contacted by the Research Team in Between Visits
NCT01033942 (96) [back to overview]Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed
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 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 Did Not Want Others to Notice Participant Was Taking Medications
NCT01033942 (96) [back to overview]Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful
NCT01033942 (96) [back to overview]Acceptability of the Taste of the Pill
NCT01033942 (96) [back to overview]Acceptability of the Color of the Pill
NCT01033942 (96) [back to overview]Acceptability of Taking the Pill Everyday
NCT01033942 (96) [back to overview]Acceptability of Taking Part in the Study
NCT01033942 (96) [back to overview]Acceptability of Size of Pill
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Simply Forgot
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]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]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]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 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 20
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 4
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]Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects
NCT01033942 (96) [back to overview]Frequency of Missing Study Pills Because Participant Was Away From Home
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
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
NCT01061151 (28) [back to overview]Antepartum Component: Number of Mothers With Obstetrical Complications
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]Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of Tuberculosis
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence Rate of Cardiovascular or Other Metabolic 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 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 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]Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery
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
NCT01061151 (28) [back to overview]Postpartum Component: Incidence of Confirmed Infant HIV Infection
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of HIV/AIDS-related Events
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: 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 of HIV/AIDS-related Event or Death
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]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]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]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)
NCT01140880 (4) [back to overview]Course Completion
NCT01140880 (4) [back to overview]Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)
NCT01140880 (4) [back to overview]Time From Exposure to Truvada Initiation
NCT01140880 (4) [back to overview]Medication Adherence
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 12 Weeks on Treatment
NCT01195467 (2) [back to overview]The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 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
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
NCT01285050 (1) [back to overview]HCV RNA
NCT01327651 (28) [back to overview]The Total Pills Actually Used Over the Follow-up Period
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
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]Self-reported Side Effect or Symptom Scores
NCT01327651 (28) [back to overview]Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing
NCT01327651 (28) [back to overview]Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)
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, 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
NCT01332227 (7) [back to overview]Percentage of Participants With HIV-1 RNA Level <40 c/mL 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
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 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]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 48
NCT01335620 (2) [back to overview]Drug Levels in Blood
NCT01335620 (2) [back to overview]Cerebral Function; Changes in Global Cognitive Z-score
NCT01338025 (4) [back to overview]Number of Participants Non-adherent as Measured by 3-day Recall
NCT01338025 (4) [back to overview]Number of Participants With Immunologic Deterioration
NCT01338025 (4) [back to overview]Change in CD4+ T Cell Count
NCT01338025 (4) [back to overview]Change in HIV-1 RNA Levels
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]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]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL.
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 Treatment-related AEs
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]Frequency of Adverse Events (AE).
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]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]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]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]Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [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]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]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]Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)
NCT01345630 (25) [back to overview]Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin
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 Who Discontinued Due to AEs
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 ARV Dose Modification
NCT01352117 (12) [back to overview]Percentage of Participants With HIV-1 RNA Suppression
NCT01352117 (12) [back to overview]Percentage of Participants With Etoposide 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]Percentage of Participants With HIV-1 RNA Suppression
NCT01352117 (12) [back to overview]Cumulative Incidence of Initial KS Progressive Disease by Week 96
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]Percentage of Time Spent in Hospital
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]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]Cumulative Probability of Virologic Failure by Week 48
NCT01352715 (9) [back to overview]Change in CD4+ Cell Count From Baseline to Week 48
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
NCT01400412 (20) [back to overview]Number of Participants Who Died During the Study
NCT01400412 (20) [back to overview]Number of Participants Who Experienced Bone Fractures
NCT01400412 (20) [back to overview]Percent Change From Baseline in Total Hip Bone Mineral Density (BMD)
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 in Expression of CD28+/CD57+ 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 RANKL+ on CD8+ 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]Percentage Change in Expression of CD38+/HLA-DR+ on CD4+ T Cells From Baseline to Week 48
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]CD8+ T-cell Change From Baseline to Week 48
NCT01400412 (20) [back to overview]Change in CD4 Count From Baseline to Week 24
NCT01400412 (20) [back to overview]Change in CD4 Count 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]Cumulative Probability of Virologic Failure by Week 48
NCT01400412 (20) [back to overview]Change in Levels of sCD163 From Baseline to Week 48
NCT01400412 (20) [back to overview]Number of Participants Who Developed Grade 3 or 4 Primary Adverse Events
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 HIV-1 RNA Virologic Failure by Week 48 for BV+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]Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) 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 Objective Response 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]Time to IERC-confirmed KS Progression or Death 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]Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART
NCT01435018 (37) [back to overview]Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART
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]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 4
NCT01435018 (37) [back to overview]Number of Participants With Peripheral Neuropathy (PN)
NCT01435018 (37) [back to overview]Number of Participants With Symptomatic Peripheral Neuropathy (SPN)
NCT01435018 (37) [back to overview]Number of Participants With Treatment-related Toxicities and Adverse Events (AEs)
NCT01435018 (37) [back to overview]Self-reported Adherence to ART Therapy
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]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]Prevalence of AHI Among Persons Screened
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]Blood HIV RNA Concentration at Week 52
NCT01450189 (30) [back to overview]Cumulative Incidence Herpes Simplex Virus Type 2
NCT01450189 (30) [back to overview]Unprotected Sex Acts in Previous One Week - 26 Weeks
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 12, Men
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 Month - 52 Weeks
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]Genital HIV RNA Concentration - Week 12, Women
NCT01450189 (30) [back to overview]Cumulative Incidence Herpes Simplex Virus Type 2
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 26, Men
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 26, Women
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 52, Men
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 52, Women
NCT01450189 (30) [back to overview]Blood HIV RNA Concentration at Week 26
NCT01450189 (30) [back to overview]Number of Adverse Events
NCT01450189 (30) [back to overview]Blood HIV RNA Concentration at Week 12
NCT01505114 (1) [back to overview]Occurrence of Grade 3 or Higher Adverse Events (AEs)
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]Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24
NCT01605890 (12) [back to overview]Number of Virological Failure Participants With Resistance Mutations
NCT01605890 (12) [back to overview]Number of Participants With Treatment Switch or Discontinuation
NCT01605890 (12) [back to overview]Number of Clinical and Biological Events
NCT01605890 (12) [back to overview]Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL
NCT01605890 (12) [back to overview]Number of Participants With Clinical Progression
NCT01605890 (12) [back to overview]Median Change in CD4 Lymphocytes Count at Week 12
NCT01605890 (12) [back to overview]Percentage of Participants in Therapeutic Success
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
NCT01605890 (12) [back to overview]Median Change of CD4 Lymphocytes at Week 48
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]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]Log10(Pf Parasite Density)
NCT01632891 (7) [back to overview]Change in log10(Pf Gametocyte Density) From Entry to Day 30
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
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]Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks
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]Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 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]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 72 Weeks [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Change From Baseline in CD4+ T-cell Count
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 Fasting Values of Triglycerides [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 Total Cholesterol [CPI+SOC v SOC]
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]Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [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]Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Glucose
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.
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 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]Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol
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 Treatment Modification or Discontinuation [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to 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
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 First Dose Modification Due to Grade 3 or 4 Toxicity
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]Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC]
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 Death or Hospitalization by Week 48
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 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]Time From Study Entry/Randomization to the First of Death or Hospitalization.
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 Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [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]Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC]
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 Death
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]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]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, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Number of Weeks of Follow-up
NCT01641367 (60) [back to overview]Number of Weeks of Follow-up [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants Experiencing Death 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, AIDS-defining Event or a Non-AIDS-defining Event 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 That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48
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]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 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]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]Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count 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 With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm
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]Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2
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 Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
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]Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
NCT01641809 (57) [back to overview]Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96
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]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 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 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 Estimated Creatinine Clearance 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]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 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]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]Number of Participants With Adherence to Study Treatment
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 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]Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase
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]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]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]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]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
NCT01687218 (12) [back to overview]Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma
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]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]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 Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?
NCT01687218 (12) [back to overview]Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge
NCT01687218 (12) [back to overview]Safety: Grade 2 or Higher Adverse Events
NCT01687218 (12) [back to overview]Pharmacokinetics: End Period Tenofovir-Diphosphate (TFV-DP) Concentrations (log10 ng/mg) in Rectal Tissue
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: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma
NCT01687218 (12) [back to overview]Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge
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/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 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.
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
NCT01769456 (12) [back to overview]Total Body 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]Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48
NCT01769456 (12) [back to overview]Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
NCT01769456 (12) [back to overview]Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
NCT01769456 (12) [back to overview]Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners
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]Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48
NCT01769456 (12) [back to overview]Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study
NCT01772823 (15) [back to overview]Total Body Bone Mineral Density at Baseline and at Week 48
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]Number of Participants With Unprotected Sex Acts
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]Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)
NCT01772823 (15) [back to overview]Lumbar Spine Bone Mineral Density at Baseline and at Week 48
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 Serum Creatinine Event of Grade 1 or Higher
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)
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]Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age)
NCT01772823 (15) [back to overview]Number of Sex Partners
NCT01772823 (15) [back to overview]Total Hip Bone Mineral Density at Baseline and at Week 48
NCT01772823 (15) [back to overview]Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders
NCT01772823 (15) [back to overview]Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders
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 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]Change in Levels of Interleukin (IL)-6
NCT01777997 (9) [back to overview]Change in Quality of Life (QoL) Index
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 Levels of D-dimer
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 CD8+ T-cell Activation
NCT01781806 (3) [back to overview]Cohort H PrEP Engagement by Study Visit
NCT01781806 (3) [back to overview]Number of HIV Seroconversions by Cohort.
NCT01781806 (3) [back to overview]Number of Participants With a Grade 2 or Higher Adverse Event by Cohort
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]Plasma Concentration 24 Hours Post-Dose (C24) - Part B
NCT01803074 (28) [back to overview]Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline
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]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]Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11
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]Plasma Half-life: Part A and C
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 Maximum Decline in Log 10 HIV-1 RNA - 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]Accumulation Index (AI): Part A and C
NCT01803074 (28) [back to overview]Plasma Concentration 24 Hours Post-Dose (C24) - 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]Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C
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 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]Time to Reach Maximum Plasma Concentration (Tmax) - Part B
NCT01803074 (28) [back to overview]Maximum Observed Plasma Concentrations (Cmax) - Part B
NCT01803074 (28) [back to overview]Number of Participants With Abnormal Changes in Physical Examination
NCT01803074 (28) [back to overview]Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
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]Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C
NCT01855867 (3) [back to overview]Number of Participants With Self-Reported Missed Doses
NCT01855867 (3) [back to overview]Number of Adverse Event Occurrences
NCT01855867 (3) [back to overview]nPEP Failure (HIV Infection During Study Participation)
NCT01869634 (4) [back to overview]Change in Systemic Immune Activation
NCT01869634 (4) [back to overview]Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV
NCT01869634 (4) [back to overview]Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV
NCT01869634 (4) [back to overview]Change in Percentage of Total Artery Diameter
NCT01910402 (48) [back to overview]Number of Participants Who Withdrew From Treatment Due to AEs-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]Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
NCT01910402 (48) [back to overview]Absolute Values in CD4+ Cell Count at Indicated Timepoints-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]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 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-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]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]Number of Participants With Maximum Post-Baseline Emergent Hematology 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 Chemistry Toxicities-Continuation 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 Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With AEs by Maximum Toxicity-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With AEs by Maximum Toxicity-Continuation Phase
NCT01910402 (48) [back to overview]HIVTSQs Total Score at Indicated Timepoints
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]Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points
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 Total CHLS/HDL CHLS Ratio at Indicated Timepoints
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 Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
NCT01910402 (48) [back to overview]Change From Baseline in Hematocrit Count 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 Erythrocyte Mean Corpuscular Volume 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 CD4+ Cell Count at Indicated Timepoints-Randomized Phase
NCT01910402 (48) [back to overview]Change From Baseline in CD4+ Cell Count at Indicated Timepoints-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 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 Lipase 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]Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS
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
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]Sleep Quality
NCT01929759 (8) [back to overview]Neurocognitive Changes
NCT01929759 (8) [back to overview]Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)
NCT01929759 (8) [back to overview]Markers of Immune Activation
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)
NCT02180438 (12) [back to overview]Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events
NCT02180438 (12) [back to overview]Grade 3 or 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]Switching Off Stribild Prior to 48 Weeks
NCT02180438 (12) [back to overview]Death
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
NCT02180438 (12) [back to overview]Interim 24 Weeks Analysis of Death
NCT02180438 (12) [back to overview]Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF
NCT02180438 (12) [back to overview]CD4 T-cell Count at 48 Weeks < Baseline
NCT02180438 (12) [back to overview]< 50 CD4 T-cell Increase at 48 Weeks From Baseline
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]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]Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP
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 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]Number of Participants With Acceptability as Per Questionnaire Administered at Week 48
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
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]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
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 Baseline
NCT02251236 (4) [back to overview]Concentration of Tenofovir in Cerebrospinal Fluid at Week 24
NCT02401230 (13) [back to overview]Median Plasma Emtricitabine (FTC) Concentration
NCT02401230 (13) [back to overview]Median Plasma Tenofovir (TDF) Concentration
NCT02401230 (13) [back to overview]Median Percentage of CD4 Positive T-Cells
NCT02401230 (13) [back to overview]Median Rectal Tissue Tenofovir (TDF) Concentration
NCT02401230 (13) [back to overview]Median Cumulative Amount of p24
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 Emtricitabine (FTC) Concentration
NCT02401230 (13) [back to overview]Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration
NCT02401230 (13) [back to overview]Median Rectal Secretion Emtricitabine (FTC) Concentration
NCT02401230 (13) [back to overview]Median Rectal Secretion Tenofovir (TDF) Concentration
NCT02401230 (13) [back to overview]Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration
NCT02401230 (13) [back to overview]Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration
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]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]Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD)
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]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]Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count 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 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 Cystatin C (eGFRcyst) by CKD-EPI Formula 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 Serum Creatinine 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 Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) 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 Retinol Binding Protein To Creatinine Ratio (URBPCR) at Week 48
NCT02431247 (64) [back to overview]Change From Reference in ALP Levels
NCT02431247 (64) [back to overview]Change From Reference in CD4+ Cell Count at Week 96
NCT02431247 (64) [back to overview]Change From Reference in eGFRcr by CKD-EPI Formula
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 Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula
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 PTH
NCT02431247 (64) [back to overview]Change From Reference in Levels of Serum CTX
NCT02431247 (64) [back to overview]Change From Reference in Levels of Serum P1NP
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 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 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
NCT02495779 (1) [back to overview]Number of Participants With PrEP Adherence
NCT02556333 (1) [back to overview]HIV RNA Change From Baseline to Day 10
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 of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm
NCT02603120 (7) [back to overview]Spine Bone Mineral Density (BMD) at Baseline
NCT02603120 (7) [back to overview]Change From Baseline in CD4+ Cell Count at Week 48
NCT02603120 (7) [back to overview]Hip Bone Mineral Density at Baseline
NCT02603120 (7) [back to overview]Percentage Change From Baseline in Hip BMD at Week 48
NCT02603120 (7) [back to overview]Percentage Change From Baseline in Spine BMD at Week 48
NCT02815566 (2) [back to overview]Percent Change in Bone Mineral Density From Baseline at the Lumbar Spine
NCT02815566 (2) [back to overview]% Change in Bone Mineral Density From Baseline at the Femoral Neck
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 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]Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96
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]CD4+ Cell Counts at Week 144
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]Changes From Baseline in CD4+ Cell Counts at Week 96
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at 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]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]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]Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities 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 Any Drug Related AEs and Drug Related AEs by Maximum Grade 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 AEs by Maximum Severity Grades up to 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 96 by Subgroups
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 144
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]Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48
NCT02831673 (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]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 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]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]Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144
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
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]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 HIV-1 Disease Progression 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 Maximum Post-Baseline Emergent Hematology Toxicities 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 Any Adverse Event (AE) and Serious AE (SAE) up to Week 148
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]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]Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144
NCT02831764 (64) [back to overview]CD4+ Cell Counts at Week 96
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]Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144
NCT02831764 (64) [back to overview]CD4+ Cell Counts at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Bone Biomarker-Serum Vitamin D 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 EQ-5D-5L Thermometer Scores at Week 144
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]Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96
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 Utility Score at Week 96
NCT02859558 (4) [back to overview]HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
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]Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation
NCT02962739 (1) [back to overview]Steady State Concentrations of TFV-DP for Different Dosing Patterns of Descovy
NCT02968576 (2) [back to overview]Peak Plasma Concentration (Cmax)
NCT02968576 (2) [back to overview]Area Under the Concentration-time Curve (AUC)
NCT03048422 (23) [back to overview]Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery
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]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 HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory
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 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure
NCT03048422 (23) [back to overview]Percentage of Mother-Infant Pairs With Preterm Deliveries
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 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 Infants Born Small for Gestational Age
NCT03048422 (23) [back to overview]Maternal Change in Creatinine Clearance
NCT03048422 (23) [back to overview]Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event
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
NCT03048422 (23) [back to overview]Cumulative Probability of Infant HIV-infection
NCT03048422 (23) [back to overview]Cumulative Probability of Infant Deaths
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]Change in Maternal Weight Postpartum
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]Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery
NCT03048422 (23) [back to overview]Infant Creatinine Clearance
NCT03126370 (6) [back to overview]Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: eGFR
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 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 in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: B2M/Cr Ratio, and RBP/Cr Ratio
NCT03126370 (6) [back to overview]Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: UPCR
NCT03164564 (2) [back to overview]Number of Pariicipants With Documented Incident HIV Infections
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
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
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]DOT Diary Mobile App Acceptability
NCT03387462 (4) [back to overview]Assessment of Situations and Reasons for Sub-optimal Use of the App
NCT03512964 (4) [back to overview]Number of Patients Offered Rapid HIV Treatment Initiation
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
NCT03593655 (4) [back to overview]Number of Participant-Visits With No Product Use
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]Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets
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 (NT-proBNP (in pg/mL))
NCT03656783 (5) [back to overview]Change in Myocyte Injury and Strain (hs Troponin (in ng/L))
NCT03656783 (5) [back to overview]Change in Global CFR
NCT03656783 (5) [back to overview]Change in Peak Stress Global MBF
NCT03717129 (9) [back to overview]FTC Cmax
NCT03717129 (9) [back to overview]EVG Half-life
NCT03717129 (9) [back to overview]AUC0-∞ for Tenofovir (TFV)
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]FTC Half-life
NCT03717129 (9) [back to overview]TFV Half-life
NCT03717129 (9) [back to overview]TFV Cmax
NCT03717129 (9) [back to overview]EVG Cmax
NCT03797014 (10) [back to overview]HBV DNA at Week 48
NCT03797014 (10) [back to overview]CD4 Cell Count Change at Week 48
NCT03797014 (10) [back to overview]HBeAg Loss at Week 48
NCT03797014 (10) [back to overview]HIV-1 RNA at Week 24
NCT03797014 (10) [back to overview]HBsAg Loss at Week 48
NCT03797014 (10) [back to overview]CD4 Cell Count Change at Week 24
NCT03797014 (10) [back to overview]HIV-1 RNA at Week 48
NCT03797014 (10) [back to overview]ALT Normalization at Week 24
NCT03797014 (10) [back to overview]ALT Normalization at Week 48
NCT03797014 (10) [back to overview]HBV DNA at Week 24
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 MCV
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 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 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 Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
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: 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 Heart Rate
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Pulse Rate
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Specific Gravity of Urine
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Temperature
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 the Hematology Parameter: Erythrocytes
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: Hemoglobin
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: MCV
NCT03836729 (107) [back to overview]Period 1: Absolute Values of Urine Urobilinogen
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 Volume (MCV)
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 Respiratory Rate
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 Pulse 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 1: Absolute Values of pH of Urine
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 1: Absolute Values of Respiratory Rate
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: 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 2: Ctau of GSK3640254
NCT03836729 (107) [back to overview]Period 2: Ctau of TFV
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]Period 2:Cmax of FTC
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
NCT03917420 (11) [back to overview]Average Testosterone Concentrations in Serum.
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 Concentrations in Plasma.
NCT03917420 (11) [back to overview]Average Emtricitabine Concentrations in Peripheral Blood Mononuclear Cells.
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 Estradiol Concentrations in Serum.
NCT03917420 (11) [back to overview]Average Progesterone Concentrations in Serum.
NCT03917420 (11) [back to overview]Average Tenofovir Concentrations in Plasma.
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 Tenofovir Diphosphate Concentrations in Peripheral Blood Mononuclear Cells.
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.
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]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]Rectal Tissue Concentration of Tenofovir (TFN)
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]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]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)
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 Tenofovir-diphosphate (TFV-DP)
NCT03976752 (40) [back to overview]Plasma Concentration of Elvitegravir (EVG)
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]Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
NCT03998176 (4) [back to overview]Percentage of Participants With Grade 3 or Greater Adverse Events
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
NCT04050371 (3) [back to overview]Total Testosterone
NCT04050371 (3) [back to overview]Estradiol Concentration
NCT04050371 (3) [back to overview]Tenofovir Diphosphate Concentration in Dried Blood Spots (DBS)
NCT04140266 (26) [back to overview]Geometric Mean of Maternal DPV 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]Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit
NCT04140266 (26) [back to overview]Geometric Mean of Infant DPV Concentrations From Plasma by Visit
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]Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) 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]Geometric Mean of Infant FTC-TP Concentration by Visit
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]Number of Mother Participants With Serious Adverse Events (SAEs) Including Maternal Deaths in Both Study Arms
NCT04140266 (26) [back to overview]Number of Infant Participants With Grade 3 or Higher AEs in Both Study Arms
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]Geometric Mean of Maternal FTC-TP Concentrations by Visit
NCT04140266 (26) [back to overview]Number of Infant Participants With SAEs Including Infant Deaths in Both Study Arms
NCT04140266 (26) [back to overview]Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations
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 TFV Concentrations
NCT04140266 (26) [back to overview]Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations
NCT04140266 (26) [back to overview]Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations
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]Geometric Mean of Infant 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 TFV-DP Concentrations by Visit
NCT04140266 (26) [back to overview]Number and Proportion of Infants With Detectable FTC-TP Concentrations
NCT04233879 (8) [back to overview]Percentage of Participants Who Experienced an Adverse Event (AE) up to 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 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]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
NCT04318210 (7) [back to overview]Extracellular Tenofovir (TFV) for Recent Drug Exposure
NCT04318210 (7) [back to overview]Self-reported Drug Adherence Over the Past 3 Days
NCT04318210 (7) [back to overview]Number of Sex Partners
NCT04318210 (7) [back to overview]Number of Sex Acts by Condom Usage
NCT04318210 (7) [back to overview]Intracellular Tenofovir-diphosphate (TFV-DP)
NCT04318210 (7) [back to overview]HIV Seroconversion
NCT04318210 (7) [back to overview]Serious Adverse Events

Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment.

"Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). Adverse Events of Grade 3 or 4 laboratory abnormalities or signs and symptoms that were judged by the study team to be possibly or probably related to the study treatment.~Comparisons between age groups were not required as per protocol." (NCT00016718)
Timeframe: At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Groups 2 and 3

Interventionproportion of participants (Number)
Age Group 10.17
Age Group 20.1
Age Group 30.19

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Proportion of Participants With Suppression of HIV Viral Load to Less Than 400 Copies/ml at Week 16

Proportion was calculated as number of participants with HIV-1 RNA <= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point. (NCT00016718)
Timeframe: At week 16

Interventionproportion of participants (Number)
Age Group 10.83
Age Group 20.86
Age Group 30.81

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Proportion of Participants With Suppression of HIV Viral Load to Less Than 50 Copies/ml at Week 16

Proportion was calculated as number of participants with HIV-1 RNA <= 50 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point. (NCT00016718)
Timeframe: At week 16

Interventionproportion of participants (Number)
Age Group 10.50
Age Group 20.76
Age Group 30.75

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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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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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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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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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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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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: 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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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 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 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 (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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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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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 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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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 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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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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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 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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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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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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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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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 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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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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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 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 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 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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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 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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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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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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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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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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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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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 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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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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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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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 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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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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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 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 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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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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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 < 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 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 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 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 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 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 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 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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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 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 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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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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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 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 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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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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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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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 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) 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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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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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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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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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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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 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 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 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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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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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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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 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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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 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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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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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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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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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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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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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 <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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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 <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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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 <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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Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48

MOS-HIV is developed to assess a participant's health and functional status associated with HIV infection. The questionnaire is applied to participants with adequate linguistic skills and consists of 35 items. The questionnaire derives an overall health score and 10 subscale scores (health transitions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy/fatigue, health distress and quality of life).The subscale and summary scores range from 0-100 with a higher score indicating better health. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48

,
InterventionUnits on Scale (Mean)
Physical Health Summary (296, 287)Mental Health Summary (296, 287)Overall Health Perception Subscale (305, 297)Physical Function Subscale (303, 298)Role Function Subscale (307, 298)Social Function Subscale (308, 295)Cognitive Function Subscale (307, 300)Pain Subscale (308, 297)Mental Health Subscale (306, 300)Energy/Fatigue Subscale (304, 300)Health Distress Subscale (304, 300)Quality of Life Subscale (308, 300)Health Transition Subscale (308, 300)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD3.86.015.65.88.59.24.88.38.38.414.312.911.0
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD3.35.613.75.38.17.45.68.08.77.915.08.48.8

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Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24

Medical Outcomes Study HIV Health Survey (MOS-HIV) is developed to assess a patient's health and functional status associated with HIV infection. The MOS-HIV questionnaire is applied to participants with adequate linguistic skills. The subscale and summary scores range from 0-100 with a higher score indicating better health. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 24.

,
InterventionUnits on Scale (Mean)
Physical Health Summary (317, 314)Mental Health Summary (317, 314)Overall Health Perception Subscale (325, 320)Physical Function Subscale (324, 325)Role Function Subscale (325, 325)Social Function Subscale (327, 322)Cognitive Function Subscale (326, 324)Pain Subscale (327, 325)Mental Health Subscale (325, 326)Energy/Fatigue Subscale (323, 326)Health Distress Subscale (323, 326)Quality of Life Subscale (327, 326)Health Transition Subscale (327, 326)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD4.15.315.27.610.68.55.67.46.47.114.49.913.1
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD3.34.813.05.06.57.13.08.67.47.513.97.110.7

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Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)

The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction. (NCT00272779)
Timeframe: IBS-QoL is administered at baseline (Day 1) and Week 12.

,
InterventionUnits on Scale (Mean)
Overall (301. 310)Dysphoria (308, 319)Interference with activity (310, 320)Body image (316, 321)Health worry (312, 320)Food avoidance (316, 322)Social reaction (311, 316)Sexual (317, 321)Relationships (313, 320)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD4.64.75.12.17.95.63.34.73.5
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD0.21.2-0.4-0.13.6-0.6-0.4-0.40.0

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Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.

,
Interventionpg/mL (Mean)
Fasting TNF-alpha: RS11030679 WTFasting TNF-alpha: RS11030679 MAC
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD7.580.02
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD-0.131.27

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Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.

,
Interventionpg/mL (Mean)
Fasting TNF-alpha: IL6_5309 WTFasting TNF-alpha: IL6_5309 MAC
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD-1.196.01
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD-2.681.41

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Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.

,
Interventionmg/dL (Mean)
Fasting Triglycerides: RETN_734 WTFasting Triglycerides: RETN_734 MAC
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD23.3521.16
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD75.12155.28

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Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.

,
Interventionmg/dL (Mean)
Fasting Triglycerides: RETN_598 WTFasting Triglycerides: RETN_598 MAC
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD20.2325.78
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD61.66123.28

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Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.

,
Interventionmg/dL (Mean)
Fasting Triglycerides: RETN_2265 WTFasting Triglycerides: RETN_2265 MAC
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD19.6128.70
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD65.83148.95

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Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.

,
Interventionmg/dL (Mean)
Fasting Triglycerides: RETN_097 WTFasting Triglycerides: RETN_097 MAC
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD21.4127.21
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD68.06157.87

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Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.

,
Interventionmg/dL (Mean)
Fasting Triglycerides: APOE_C130R WTFasting Triglycerides: APOE_C130R MAC
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD23.2713.92
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD70.71131.56

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Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.

,
Interventionng/dL (Mean)
Fasting PAI-1: APOE_R176C WT
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD5.98-117.27
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD7.30-5.94

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Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted (adj) p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.

,
Interventionmg/dL (Mean)
Fasting Non-HDL Cholesterol: RETN_097 WTFasting Non-HDL Cholesterol: RETN_097 MAC
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD12.5013.23
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD26.9852.28

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Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)

The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction. (NCT00272779)
Timeframe: IBS-QoL is administered at baseline (Day 1) and Week 4.

,
InterventionUnits on Scale (Mean)
Overall (306, 316)Dysphoria (317, 325)Interference with activity (319, 327)Body image (321, 329)Health worry (319, 330)Food avoidance (319, 329)Social reaction (316, 327)Sexual (320, 329)Relationships (321, 328)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD3.23.33.11.66.04.01.93.71.2
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD-0.7-0.1-1.9-1.32.0-1.7-0.8-0.1-0.6

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Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4

Tmax was derived from the plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

InterventionHr (Median)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD3.00
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD4.00

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Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4

T-half was derived from the plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

InterventionHr (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD10.31
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD13.89

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Reduction of log10 HIV RNA Levels From Baseline to Week 48

Changes from baseline in log10 HIV RNA levels were calculated. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48

Interventionc/mL (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD-3.09
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD-3.13

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Reduction of log10 HIV RNA Levels From Baseline at Week 96

Changes from baseline in log10 HIV RNA levels were calculated. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96

Interventionc/mL (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD-3.21
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD-3.19

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Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4

EC90/50=concentration of drug inducing 90%/50% of its maximal response. Protein binding adjusted EC90 for ATV and LPV were derived from phenotypically measured individual EC50 values at baseline using the following formula: Protein binding adjusted EC90 (ng/mL) = scale factor × molecular weight of the free base × EC50 micrometer(μM)/ unbound fraction (fu). Scale factor relates EC50 to EC90 (value of 3 and 2 for ATV and LPV, respectively); fu: estimated unbound fraction of ATV and LPV in vivo (0.14 and 0.02 for ATV and LPV respectively). (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Interventionng/mL (Geometric Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD19.01
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD162.7

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Percentage of Participants With Lipoatrophy at Week 96

Lipoatrophy, redistribution of body fat was defined as >= 20% decrease in limb fat. The percentage of participants with lipoatrophy from baseline was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96

Interventionpercentage of participants (Number)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD5
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD7

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Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48

HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant responded to treatment. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48

InterventionParticipants (Number)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD343
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD338

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Number of Participants With HIV RNA < 50 c/mL) at Week 96

HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant has responded to treatment. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96

InterventionParticipants (Number)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD327
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD302

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Number of Participants With HIV RNA < 400 c/mL) at Week 96

HIV RNA <400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant has responded to treatment. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96

InterventionParticipants (Number)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD350
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD330

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Number of Participants With HIV RNA < 400 c/mL at Week 48

HIV RNA < 400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant responded to treatment. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48

InterventionParticipants (Number)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD377
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD365

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

TLOVR defines responders at Week 48 as participants with confirmed HIV RNA <400 c/mL through Week 48 without intervening virologic rebound or treatment discontinuation. Virologic rebound is defined as confirmed on-treatment HIV RNA <400 c/mL or last on-treatment HIV RNA <400 c/mL followed by discontinuation. Participants are considered failures in this analysis if they experienced virologic rebound at or before Week 48, discontinued before Week 48, never responded by Week 48, never received study therapy or had missing HIV RNA at Week 48 and beyond. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48

InterventionParticipants (Number)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD377
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD363

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Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48

The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Adherence to regimen was defined as taking 100% of medicine (all doses and numbers of pills as prescribed for each medicine). 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. (NCT00272779)
Timeframe: Week 48

InterventionParticipants (Number)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD330
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD316

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Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4

Cmin was derived from the plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Interventionng/mL (Geometric Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD526.4
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD5944

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Mean Changes in Fasting Insulin at Week 96

Mean change from baseline in fasting insulin at Week 96. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96.

InterventionµU/mL (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD0.1
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD-0.8

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Mean Changes in Fasting Glucose at Week 96

Mean change from baseline in fasting glucose at Week 96 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96

Interventionmg/dL (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD4.0
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD1.0

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Mean Changes From Baseline in Body Weight at Week 96

Mean change in body weight from baseline was determined. (NCT00272779)
Timeframe: Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96.

Interventionkg (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD6
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD3

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Mean Change in Weight From Baseline at Week 48

Mean change in body weight from baseline was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48

Interventionkg (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD4.0
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD2.0

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Mean Change in Fasting Insulin at Week 48

Mean change from baseline in fasting insulin at Week 48. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48.

Interventionmicro units (µU)/mL (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD2.5
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD0.2

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Mean Change in Fasting Glucose at Week 48

Mean change from baseline in fasting glucose at Week 48. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48.

Interventionmg/dL (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD2
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD0

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Mean Change in Body Mass Index (BMI) in Participants at Week 48

Mean change in BMI from baseline at Week 48 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48

Interventionkg/m^2 (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD1.3
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD0.8

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Mean Change From Baseline in Waist-to-hip-ratio at Week 96

Mean change from baseline in waist-to-hip-ratio at Week 96 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96

Interventionratio (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD0.02
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD0.01

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Mean Change From Baseline in Waist-to-hip-ratio at Week 48

Mean change from baseline in waist-to-hip-ratio at Week 48 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48

Interventionratio (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD0.02
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD0.01

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Mean Change From Baseline in Waist Circumference at Week 96

Mean change From baseline in waist circumference at Week 96 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96.

Interventioncm (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD6
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD2

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Mean Change From Baseline in Waist Circumference at Week 48

Mean change from baseline in waist circumference at Week 48 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48

Interventioncm (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD4
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD2

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Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48

Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement was associated with a decrease in values. (NCT00272779)
Timeframe: DEXA scans were taken at Baseline (Day 1) and at Weeks 48.

InterventionRatio (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD0.04
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD-0.02

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Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96

Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96.

InterventionRatio (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD0.05
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD0.00

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Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48

Mean change from baseline in CD4 cell counts was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48.

Interventionc/mm^3 (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD203
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD219

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Mean Change From Baseline in CD4 Cell Count at Week 96

Mean change from baseline in CD4 count among treated participants was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96

Interventioncells/mm^3 (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD268
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD290

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Mean Change From Baseline in Body Weight at Week 96

Mean change from baseline in weight at Week 96 (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96

Interventionkg (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD5
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD3

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Mean Change From Baseline in Body Weight at Week 48

Mean change from baseline in body weight at Week 48 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48

Interventionkg (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD4
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD3

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Mean Change From Baseline in BMI at Week 96

Mean change From baseline in BMI at Week 96 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96

Interventionkg/m^2 (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD2.0
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD1.2

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Mean Change From Baseline in BMI at Week 96

(NCT00272779)
Timeframe: Baseline (Day 1) and Week 96

Interventionkg/m^2 (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD1.6
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD1.0

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Mean Change From Baseline in BMI at Week 48

Mean change from baseline in BMI at Week 48 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48.

Interventionkg/m^2 (Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD1.5
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD1.1

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Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4

Cmax was derived from plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD.

Interventionnanogram(ng)/mL (Geometric Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD2897
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD10654

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Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4

IQ defined as Cmin at week 4 divided by protein binding adjusted EC90 values for the respective protease inhibitor (ATV or LPV) derived from individual participant clinical isolates. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Interventionng/mL (Geometric Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD27.33
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD35.91

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Cmin of Tenofovir at Week 4

Cmin was derived from plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Interventionng/mL (Geometric Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD72.46
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD84.98

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Cmin of RTV at Week 4

Cmin was derived from plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Interventionng/mL (Geometric Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD50.52
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD179.0

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Cmax of Tenofovir at Week 4

Cmax was derived from plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Interventionng/mL (Geometric Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD352.0
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD380.7

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Cmax of RTV at Week 4

Cmax was derived from plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Interventionng/mL (Geometric Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD959.8
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD657.4

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AUC (TAU) of Tenofovir at Week 4

AUC (TAU) was derived from plasma concentration versus time data.It was calculated from time 0-24 hours for tenofovir in LPV/RPV and ATV/RTV regimen at Week 4. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Interventionng*h/mL (Geometric Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD3272
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD3675

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AUC (0-24) of RTV at Week 4

AUC (0-24) was derived from plasma concentration versus time data. It was estimated as 2 times the AUC(TAU) based on 12-hour PK. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Interventionng*h/mL (Geometric Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD6724
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD8011

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Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4

AUC(TAU) was derived from the plasma concentration versus time data. It was calculated from time 0 to 12 hours for LPV and RTV in the LPV/RTV regimen, 0-24 hours for ATV and RTV in the ATV/RTV regimen, and 0-24 hours for tenofovir in both regimens at Week 4. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Interventionng*h/mL (Geometric Mean)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD28605
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD90945

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Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)

The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 24

,
InterventionUnits on a scale (Mean)
Overall (290, 289)Dysphoria (295, 298)Interference with activity (294, 297)Body image (299, 300)Health worry (297, 300)Food avoidance (299, 300)Social reaction (295, 297)Sexual (299, 299)Relationships (297, 297)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD4.34.44.41.87.55.63.24.33.3
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD1.41.80.01.15.30.40.40.81.2

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Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48

Participants with virologic failure are those who never suppressed (HIV RNA <400 c/mL) and were on study through Week 48, or who rebounded to HIV RNA >= 400 c/mL and those who discontinued due to insufficient viral load response. IAS=International AIDS Society, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48

,
InterventionParticipants (Number)
Virologic Failure, Week 48 (HIV RNA >= 400 c/mL)Paired Genotypes (n = 27, 26)Paired Phenotypes (n= 27, 26)IAS-defined major PI substitutions (n = 17, 15)Other IAS-defined PI substitutions (n = 17, 15)PI phenotypic resistance (ATV/RTV FC>5.2 (n=18,16)PI phenotypic resistance (LPV/RTV FC >9 (n=18, 16)PI phenotypic resistance (Other PIs )(n=18, 16)RTI Substitutions , TAMS (n= 17,15)RTI Substitutions , M184V (n = 17,15)RTI phenotypic resistance, FTC FC>3.5 (n = 18, 16)RTI phenotypic resistance, TDF FC >1.4(n = 18, 16)RTI phenotypic resistance, Other NRTIs(n = 18, 16)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD2717181610413405
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD2615160200413315

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Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96

Virologic failure participants defined as participants who were never suppressed (HIV RNA < 400 c/mL) and on study through Week 48, or who rebounded to HIV RNA ≥ 400 c/mL, and those who discontinued due to insufficient viral load response using CVR (NC=F). IAS-USA=International AIDS Society-United States of America, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184/V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96.

,
InterventionParticipants (Number)
Virologic Failure, Week 96 (HIV RNA >= 400 c/mL)Paired Genotypes (n = 28, 29)Paired Phenotypes (n= 28, 29)IAS-USA major PI substitutions (n = 26, 26)IAS-USA minor PI substitutions (n = 26, 26)PI polymorphisms without IAS-USA (n=26, 26)PI phenotypic resistance (ATV/RTV FC >5.2 (25, 23)PI phenotypic resistance (LPV/RTV FC>9 (25,23)PI phenotypic resistance (Other PIs [25, 23])NRTI substitutions (TAMS [26, 26])NRTI substitutions (M184I/V [26, 26])RTI phenotypic resistance (FC [n = 25, 23])RTI phenotypic resistance (TDF [n = 25, 23])RTI phenotypic resistance (Other NRTI [n =25, 23])
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD282625111110315505
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD292623011401637526

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Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis

19 genes of interest were selected from previous results or literature, and 34 SNPs were genotyped. Phenotype-Genotype analysis was performed using 31 of the SNPs. The genotypes of each SNP were further classified as either a minor allele carrier (MAC) group composed of heterozygous and rare homozygous genotypes, or wild type [WT, common homozygous]. (NCT00272779)
Timeframe: Baseline visit

Interventionparticipants (Number)
RETN_097 WTRETN_097 MACAPOE_R176C WTAPOE_R176C MACCCDC122_5980 WTCCDC122_5980 MACIL6_5309 WTIL6_5309 MACRS11030679 WTRS11030679 MACAPOE_C130R WTAPOE_C130R MACRETN_2265 WTRETN_2265 MACRETN_598 WTRETN_598 MACRETN_734 WTRETN_734 MACBRUNOL_1842 WTBRUNOL_1842 MACRETN_730 WTRETN_730 MAC
All Participants With Pharmacogenetic Blood Samples1643518216126715714111287169301465311980175221217799100

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Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96

Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

,
InterventionParticipants (Number)
Glycosuria (n = 434, 431)Proteinuria (n = 434, 431)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD65
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD56

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Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48

Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day. (NCT00272779)
Timeframe: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.

,
InterventionParticipants (Number)
Glycosuria (n = 434, 431)Proteinuria (n = 434, 431)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD43
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD31

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Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48

Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: Creatine phosphokinase (CPK): Grade 3: 5.1 - 10.0 * upper limit of normal (ULN), Grade 4: >10* ULN; Lipase: Grade 3: 2.10 - 5.0* ULN, Grade 4: 5.0* ULN. (NCT00272779)
Timeframe: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.

,
InterventionParticipants (Number)
CPK (n = 435, 430)Lipase (n = 435, 430)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD226
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD206

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Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96

Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: CPK: Grade 3: 5.1 - 10.0 * ULN, Grade 4: >10* ULN; Lipase: Grade 3: 2.10 - 5.0* ULN, Grade 4: 5.0* ULN. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

,
InterventionParticipants (Number)
CPK (n=435, 430)Lipase (n=435, 430)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD349
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD289

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Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96

Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: BUN: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 - 15.0 mg/dL, Grade 4: >15.0 mg/dL. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

,
InterventionParticipants (Number)
BUN (n = 435,431)Creatine (n = 435, 431)Phosphorous (n = 435, 431)Uric acid (n = 435, 431)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD0101
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD0214

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Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48

Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Blood urea nitrogen (BUN): Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 - 15.0 mg/dL, Grade 4: >15.0 mg/dL. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48.

,
InterventionParticipants (Number)
BUN (n = 435, 431)Creatinine (n = 435, 431)Phosphorus (n = 435, 431)Uric acid (n = 435, 431)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD0100
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD0113

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Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96

Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per NCI-CTCAE. Grade 3 and 4 criteria were: ALT, AST, alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

,
InterventionParticipants (Number)
ALT (n= 435, 431)AST (n = 435, 430)Albumin (n = 435, 431)Alkaline Phosphatase (n= 435, 430)Total Bilirubin (n = 435, 431)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD111101192
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD75013

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Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48

Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 3 and 4 criteria were: alanine aminotransferase (ALT), aspartate aminotransferase(AST), alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL. (NCT00272779)
Timeframe: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.

,
InterventionParticipants (Number)
ALT (n= 435, 431)AST (n = 435, 430)Albumin (n = 435, 431)Alkaline Phosphatase (n= 435, 430)Direct Bilirubin (n = 435, 430)Total Bilirubin (n = 435, 431)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD890137146
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD620141

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Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96

Hematology abnormalities were graded per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 - 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 - 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

,
InterventionParticipants (Number)
Hematocrit (n= 434, 431)Hemoglobin (n= 434, 431)INR (n= 435, 431)Neutrophils (n = 434, 431)Platelets ( n= 433, 431)Prothrombin time (n = 435, 431)WBC (n = 434, 431)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD03721590
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD671871241

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Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)

Hematology abnormalities were graded per modified World Health Organization (WHO) criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 - 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 - 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3. (NCT00272779)
Timeframe: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.

,
InterventionParticipants (Number)
Hematocrit (n= 434, 431)Hemoglobin (n= 434, 431)INR (n= 435, 431)Neutrophils (n = 434, 431)Platelets ( n= 433, 430)PT (n = 435, 431)WBC (n = 434, 431)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD02614560
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD661131160

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Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48

Laboratory measurements marked as abnormal, as per National Cholesterol Education Program (NCEP)- Adult Treatment Panel (ATP)-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL. (NCT00272779)
Timeframe: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.

,
InterventionParticipants (Number)
Total Cholesterol (n = 434, 428)Triglycerides (n = 434, 428)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD302
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD7715

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Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96

Laboratory measurements marked as abnormal, as per NCEP-ATP-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

,
InterventionParticipants (Number)
Total Cholesterol (n = 434, 428)Triglycerides (n = 434, 428)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD473
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD10818

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Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48

Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL. (NCT00272779)
Timeframe: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.

,
InterventionParticipants (Number)
Hyperglycemia (n = 434, 428)Hypoglycemia (n = 434, 428)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD10
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD10

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Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96

Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

,
InterventionParticipants (Number)
Hyperglycemia (n = 434, 428)Hypoglycemia (n = 434, 428)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD31
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD20

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Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48

Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 - 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1-6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L. (NCT00272779)
Timeframe: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.

,
InterventionParticipants (Number)
Hypercarbia (n = 435, 431)Hypocarbia (n = 435, 431)Hypercalcemia (n = 435, 431)Hypocalcemia (n = 435, 431)Hyperchloremia (n = 435, 431)Hypochloremia (n = 435, 431)Hyperkalemia (n = 435, 430)Hypokalemia (n = 435, 430)Hypernatremia (n = 435, 431)Hyponatremia (n = 435, 431)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD0101000000
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD0704001101

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Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96

Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 - 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1-6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

,
InterventionParticipants (Number)
Hypercarbia (n = 435, 431)Hypocarbia (n = 435, 431)Hypercalcemia (n = 435, 431)Hypocalcemia (n = 435, 431)Hyperchloremia (n = 435, 431)Hypochloremia (n = 435, 431)Hyperkalemia (n = 435, 430)Hypokalemia (n = 435, 430)Hypernatremia (n = 435, 431)Hyponatremia (n = 435, 431)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD0401000010
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD0804021122

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Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96

AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match. (NCT00272779)
Timeframe: From Day 1 through Week 96

,
InterventionParticipants (Number)
DeathsSerious Adverse Events (SAEs)Adverse Events (AEs) leading to discontinuation
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD66313
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD65022

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Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48

AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match. (NCT00272779)
Timeframe: From baseline (Day 1) to Week 48.

,
InterventionParticipants (Number)
DeathsOther SAEsAEsAEs leading to discontinuation
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD65140011
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD64239915

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Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA

(NCT00272779)
Timeframe: Baseline (Day 1) and Week 96.

,
InterventionRatio (Mean)
VAT-to-TAT Ratio (n = 95,68)VAT-to-SAT Ratio (n = 95, 68)Trunk-to-Limb Fat Ratio (n = 106, 71)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD-0.04-0.220.05
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD-0.02-0.090.00

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Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96

The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96.

,
InterventionPercentage (Mean)
Trunk FatLimb FatTotal Body Fat
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD342729
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD161515

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Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48

The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: a physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values. (NCT00272779)
Timeframe: DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48.

,
InterventionPercentage (Mean)
Trunk FatLimb FatTotal Body Fat
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD262223
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD161715

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Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48

Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique. (NCT00272779)
Timeframe: DEXA scans were taken at Baseline (Day 1) and Week 48.

,
Interventiongrams/ centimeters ^2 (g/cm^2) (Mean)
Bone Mineral Density of Both ArmsBone Mineral Density of Both LegsBone Mineral Density of TrunkBone Mineral Density of Total Body
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD-1-2-4-2
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD-1-2-4-3

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Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96

Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96

,
Interventiong/cm^2 (Mean)
Bone Mineral Density of Both ArmsBone Mineral Density of Both LegsBone Mineral Density of TrunkBone Mineral Density of Total Body
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD-1-2-3-3
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD-2-3-5-4

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Mean Changes in Fasting Lipids at Week 96

Mean change from baseline in fasting lipids at Week 96 was determined. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

,
Interventionmg/dL (Mean)
Fasting total Cholesterol (n=342, 291)Fasting HDL Cholesterol (n=341, 291)Fasting Non-HDL Cholesterol (n=341, 291)Fasting LDL Cholesterol (n=342, 291)Fasting Triglycerides (n=342, 291)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD207.013.012.016.0
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD3710.027.017.063.0

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Mean Change in Fasting Lipid at Week 48

Mean change from baseline in fasting lipids, for fasting total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, and triglycerides at Week 48 were determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48.

,
Interventionmilligrams/deciliter (mg/dL) (Mean)
Fasting total Cholesterol (n=373, 337)Fasting HDL Cholesterol (n=371, 335)Fasting Non-HDL Cholesterol (n=371, 335)Fasting LDL Cholesterol (n=372, 335)Fasting Triglycerides (n=373, 337)
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD199101220
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD3812261870

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Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT). (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.

,
Interventioncm^2 (Mean)
VAT: BRUNOL_1842 WTVAT: BRUNOL_1842 MAC
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD23.45-3.20
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD10.38-1.76

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Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT and TAT were measured by computed tomography (CT). (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.

,
Interventioncm^2 (Mean)
VAT-to-TAT Ratio: CCDA122_5980 WTVAT-to-TAT Ratio: CCDA122_5980 MAC
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD-0.03-0.11
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD-0.03-0.02

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Mean Change From Baseline in VAT Associated With RETN_730

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT). (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.

,
Interventioncm^2 (Mean)
VAT: RETN_730 WTVAT: RETN_730 MAC
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD-2.9523.29
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD13.69-1.05

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Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. SAT and TAT were measured by computed tomography (CT). (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.

,
Interventioncm^2 (Mean)
SAT-to-TAT Ratio: CCDC122_5980 WTSAT-to-TAT Ratio: CCDC122_5980 MAC
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD0.030.11
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD0.030.02

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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 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 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 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 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 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

[back to top]

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 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 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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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

[back to top]

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 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 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 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 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

[back to top]

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

[back to top]

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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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 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 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

[back to top]

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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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 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 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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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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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

[back to top]

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

[back to top]

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

[back to top]

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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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

[back to top]

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 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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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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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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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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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

[back to top]

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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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

[back to top]

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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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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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

[back to top]

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 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 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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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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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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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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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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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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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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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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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 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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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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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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Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population

Plasma concentrations of EFV were determined using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg). (NCT00364793)
Timeframe: Week 2

InterventionL/h/kg (Geometric Mean)
EFV+ddI+FTC in Infants >=3 Months to < 6 Months2.07
EFV+ddI+FTC in Infants >=6 Months to < 2 Years2.36
EFV+ddI+FTC in Children >= 2 Years to < 3 Years1.44
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years0.66

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Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population

Plasma concentrations were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was < LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in micromolars*time (µM•h). (NCT00364793)
Timeframe: Week 2

InterventionµM•h (Geometric Mean)
EFV+ddI+FTC in Infants >=3 Months to < 6 Months129.5
EFV+ddI+FTC in Infants >=6 Months to < 2 Years71.4
EFV+ddI+FTC in Children >= 2 Years to < 3 Years93.8
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years130.8

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AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population

Plasma concentrations were obtained using a validated LC-MS/MS at Week 2. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was < LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in nanograms*time per milliliter (ng•h/mL). (NCT00364793)
Timeframe: Week 2

Interventionng•h/mL (Geometric Mean)
EFV+ddI+FTC in Infants >=3 Months to < 6 Months1445
EFV+ddI+FTC in Infants >=6 Months to < 2 Years2848
EFV+ddI+FTC in Children >= 2 Years to < 3 Years1038
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years1000

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CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population

Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F was calculated by dividing the dose of ddI by AUC(TAU) of ddI. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h). (NCT00364793)
Timeframe: Week 2

InterventionL/h (Geometric Mean)
EFV+ddI+FTC in Infants >=3 Months to < 6 Months40.7
EFV+ddI+FTC in Infants >=6 Months to < 2 Years35.6
EFV+ddI+FTC in Children >= 2 Years to < 3 Years113.9
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years143.0

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CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population

Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg). (NCT00364793)
Timeframe: Week 2

InterventionL/h/kg (Geometric Mean)
EFV+ddI+FTC in Infants >=3 Months to < 6 Months7.88
EFV+ddI+FTC in Infants >=6 Months to < 2 Years4.26
EFV+ddI+FTC in Children >= 2 Years to < 3 Years11.36
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years10.34

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Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population

Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the T-HALF was summarized using a mean. Terminal elimination plasma half-life=ln2 divided by K where K is the absolute value of the slope of the terminal phase of the plasma profile as determined by log-linear regression of at least three data points. T-HALF was measured in hours (h). (NCT00364793)
Timeframe: Week 2

Interventionh (Mean)
EFV+ddI+FTC in Infants >=3 Months to < 6 Months0.92
EFV+ddI+FTC in Infants >=6 Months to < 2 Years1.41
EFV+ddI+FTC in Children >= 2 Years to < 3 Years1.73
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years1.14

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CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants

A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1). (NCT00364793)
Timeframe: Baseline to Weeks 24 and 48

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Interventioncells/mm^3 (Median)
Baseline (n=10, 9, 3, 6, 28)Week 24 (n=6, 7, 3, 6, 22)Week 48 (n=7, 8, 2, 5, 22)
EFV+ddI+FTC in All Participants1144177196
EFV+ddI+FTC in Children >= 2 Years to < 3 Years51731971
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years413283284
EFV+ddI+FTC in Infants >=3 Months to < 6 Months1518259-258
EFV+ddI+FTC in Infants >=6 Months to < 2 Years156982346

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Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population

Cmax and Cmin were derived from plasma concentration versus time. Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. All reportable Cmin values were =6 months to < 2 years (Group 2); LLOQ/2 was imputed for those summary statistics;in Group 2, 9 of 10 Cmin values were NCT00364793)
Timeframe: Week 2

,,,
Interventionng/mL (Geometric Mean)
Cmax (n=12, 10, 4, 6)Cmin (n=4, 10, 4, 3)
EFV+ddI+FTC in Children >= 2 Years to < 3 Years3561.25
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years3761.25
EFV+ddI+FTC in Infants >=3 Months to < 6 Months8501.25
EFV+ddI+FTC in Infants >=6 Months to < 2 Years11931.54

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Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants

HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1). (NCT00364793)
Timeframe: Baseline through Weeks 60, 72, 84, and 96

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Interventionlog10 c/mL (Median)
Baseline (n=13,10,4,7,34)Week 60 (n=7, 8, 3, 4, 22)Week 72 (n=7, 6, 1, 3, 17)Week 84 (n=7, 7, 2, 4, 20)Week 96 (n=7, 6, 2, 4, 19)
EFV+ddI+FTC in All Participants5.88-3.50-3.45-3.37-3.45
EFV+ddI+FTC in Children >= 2 Years to < 3 Years5.88-3.26-3.20-2.18-2.15
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years5.50-3.48-4.18-3.51-3.57
EFV+ddI+FTC in Infants >=3 Months to < 6 Months5.88-3.92-4.08-4.08-3.82
EFV+ddI+FTC in Infants >=6 Months to < 2 Years5.88-3.44-2.75-3.28-3.73

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The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants

Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 50 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 50 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were < 50 c/mL; denominator was all who remained on treatment through Week 24. (NCT00364793)
Timeframe: Week 24

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Interventionparticipants (Number)
CVR (n=15, 10, 4, 8, 37)VR-OC (n=11, 10, 4, 7, 32)
EFV+ddI+FTC in All Participants1516
EFV+ddI+FTC in Children >= 2 Years to < 3 Years32
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years44
EFV+ddI+FTC in Infants >=3 Months to < 6 Months45
EFV+ddI+FTC in Infants >=6 Months to < 2 Years45

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The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants

Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 50 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 50 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were < 50 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA < 50 c/mL in the predefined Week 48 visit window; denominator was all treated participants. (NCT00364793)
Timeframe: Week 48

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Interventionparticipants (Number)
CVR (NC=F) n=15, 10, 4, 8, 37VR-OC n=9, 9, 3, 6, 27SNAPSHOT n=15, 10, 4, 8, 37
EFV+ddI+FTC in All Participants181717
EFV+ddI+FTC in Children >= 2 Years to < 3 Years222
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years444
EFV+ddI+FTC in Infants >=3 Months to < 6 Months666
EFV+ddI+FTC in Infants >=6 Months to < 2 Years655

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The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants

Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 400 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 400 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were < 400 c/mL; denominator was all who remained on treatment through Week 24. (NCT00364793)
Timeframe: Week 24

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Interventionparticipants (Number)
CVR (n=15, 10, 4, 8, 37)VR-OC(n=11,10 ,4, 7, 32)
EFV+ddI+FTC in All Participants2625
EFV+ddI+FTC in Children >= 2 Years to < 3 Years44
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years76
EFV+ddI+FTC in Infants >=3 Months to < 6 Months88
EFV+ddI+FTC in Infants >=6 Months to < 2 Years77

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The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants

Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 400 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 400 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were < 400 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA < 400 c/mL in the predefined Week 48 visit window; denominator was all treated participants. (NCT00364793)
Timeframe: Week 48

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Interventionparticipants (Number)
CVR (NC=F) n=15, 10, 4, 8, 37VR-OC n=9, 9, 3, 6, 27SNAPSHOT n=15, 10, 4, 8, 37
EFV+ddI+FTC in Children >= 2 Years to < 3 Years333
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years555
EFV+ddI+FTC in Infants >=3 Months to < 6 Months777
EFV+ddI+FTC in Infants >=6 Months to < 2 Years666
Total Participants212121

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Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants

A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1). (NCT00364793)
Timeframe: Baseline to Weeks 60, 72, 84, and 96

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Interventionpercentage of CD4 cells (Median)
Baseline (n=7,9,3,5,24)Week 60 (n=3,6,2,3,14)Week 72 (n=2,7,1,3,13)Week 84 (n=3,7,1,3,14)Week 96 (n=3,6,1,3,13)
EFV+ddI+FTC in All Participants247177
EFV+ddI+FTC in Children >= 2 Years to < 3 Years127-1215
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years713121214
EFV+ddI+FTC in Infants >=3 Months to < 6 Months2810-14-3-2
EFV+ddI+FTC in Infants >=6 Months to < 2 Years263187

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Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants

A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1). (NCT00364793)
Timeframe: Baseline to Weeks 24 and 48

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Interventionpercentage of CD4 cells (Median)
Baseline (n=7, 9, 3, 5, 24)Week 24 (n=3, 7, 3, 5, 18)Week 48 (n=5, 8, 2, 5, 20)
EFV+ddI+FTC in All Participants2496
EFV+ddI+FTC in Children >= 2 Years to < 3 Years1298
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years71011
EFV+ddI+FTC in Infants >=3 Months to < 6 Months28145
EFV+ddI+FTC in Infants >=6 Months to < 2 Years2624

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Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population

PK parameters were evaluated 2 weeks post start of dosing. Based on observed AUC, measured in micromoles (μM)*h, dosing was increased, remained the same, or decreased at next visit to achieve the desired AUC (110-380 μM*h). Number of participants who became resistant was categorized by those who required additional dosing after Week 2 (AUC<110 μM*h) and those who did not. AUC: derived from plasma concentration of EFV versus time. Plasma concentrations for determination of AUC were obtained using a validated LC-MS/MS method. LLOQ for EFV = 10.0 ng/mL and ULOQ = 8,000 ng/mL. AUC calculated by log- and linear trapezoidal summations. Genotypic resistance=presence of substitutions in the RT gene and/or presence of mutations that confer resistance to entire nucleoside reverse transcriptase inhibitor class. Phenotypic resistance=EFV: > 3.3* IC50 of control strain. Assays: Monogram Biosciences Phenosense™ GT (EFV biologic cutoff=3) and VircoTYPE™ HIV-1 v 4.3.01( EFV biologic cutoff=3.3). (NCT00364793)
Timeframe: Baseline to Week 48

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Interventionparticipants (Number)
Resistant; AUC<110 µM•h(n=2,7,2,3,14)Resistant; AUC>=110 µM•h(n=10,3,2,4,19)
EFV+ddI+FTC in All Participants64
EFV+ddI+FTC in Children >= 2 Years to < 3 Years10
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years10
EFV+ddI+FTC in Infants >=3 Months to < 6 Months12
EFV+ddI+FTC in Infants >=6 Months to < 2 Years32

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Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound

At baseline, treatment-naïve screened by genotype; treatment-experienced screened by genotype and phenotype. Genotypic resistance: presence of substitutions in reverse transcriptase (RT) gene and/or presence of mutations that confer resistance to nucleoside reverse transcriptase inhibitor class. Phenotype resistance: FTC: > 3.1* the 50% inhibitory concentration (IC50) of the control strain; EFV: > 3.3* IC50 ; ddI: > 2.6*IC50. Virologic failure: <1 log10 decrease in HIV RNA from Week 16 on; confirmatory HIV RNA within 14-35 days; HIV RNA > 10,000 c/mL with prior value < 400 c/mL; confirmatory HIV RNA 14-35 days. Monogram Biosciences Phenosense™ assay ( EFV and FTC: biologic cutoffs=3 and 3.5, respectively; ddI: clinical cutoff: lower limit=1.39; upper limit = 2.2.); VircoTYPE™ HIV-1 v 4.3.01( EFV, FTC: biologic cutoffs=3.3 and 3.1, respectively;ddI: clinical cutoff: lower limit = 0.9; upper limit = 2.6. No genotypic/phenotypic changes in presence of virologic failure=no resistance. (NCT00364793)
Timeframe: Baseline to Week 48

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Interventionparticipants (Number)
Lack of suppression with Changes (PP)Viral Load Rebound with Changes(PP)Viral Failure with Changes (outside 35 day limit)
EFV+ddI+FTC in All Participants325
EFV+ddI+FTC in Children >= 2 Years to < 3 Years001
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years001
EFV+ddI+FTC in Infants >=3 Months to < 6 Months210
EFV+ddI+FTC in Infants >=6 Months to < 2 Years113

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Number of Participants With Serum Chemistry Abnormalities - Treated Participants

Central/local laboratory. DAIDS v 2004. Bicarbonate, low: Gr 1: 16 milliequivalents per liter (mEq/L) - < LLN; Gr 2: 11.0-15.9 mEq/L; Gr 3: 8.0-10.9 mEq/L; Gr 4: <8.0 mEq/L; calcium, high Gr 1: 10.6-11.5 mg/dL; Gr 2: 11.6-12.5 mg/dL; Gr 3 12.6-13.5 mg/dL; Gr 4: >13.5 mg/dL; calcium, low Gr1: 7.8-8.4 mg/dL; Gr2: 7.0-7.7 mg/dL; Gr3: 6.1-6.9 mg/dL; Gr 4: <6.1 mg/dL; creatinine Gr1: 1.1-1.3*ULN; Gr 2: 1.4-1.8*ULN; Gr 3: 1.9-3.4*ULN; Gr 4: >=3.5*ULN; lipase Gr 1: 1.1-1.5*ULN; Gr 2: 1.6-3.0*ULN; Gr 3: 3.1-5.0*ULN; Gr 4: >5.0*ULN; potassium high (low) Gr 1: 5.6-6.0 (3.0-3.4) mEq/L; Gr 2: 6.1-6.5 (2.5-2.9) mEq/L; Gr 3: 6.6-7.0 (2.0-2.4) mEq/L; Gr 4: >7.0 (<2.0) mEq/L; sodium, high (low) Gr 1: 146-150 (130-135) mEq/L; Gr 2: 151-154 (125-129) mEq/L; Gr 3: 155-159 (121-124) mEq/L; Gr 4: >=160 (<=120) mEq/L; uric acid Gr 1: 7.5-10.0 mg/dL; Gr 2: 10.1-12.0 mg/dL; Gr 3: 12.1-15.0 mg/dL; Gr 4: >15.0 mg/dL. Baseline within 50 days post screening, prior to start of study medication. (NCT00364793)
Timeframe: Baseline to Week 96

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Interventionparticipants (Number)
Bicarbonate, low (n=12, 10, 4, 7, 33)Sodium, low (n=12, 10, 4, 7, 33)Sodium High (n=12, 10, 4, 7, 33)Uric Acid (n=12, 10, 4, 7, 33)Calcium High (n= 12, 10, 4, 7, 33)Calcium Low (n= 12, 10, 4, 7, 33)Potassium High (n= 12, 10, 4, 7, 33)Potassium Low (n= 12, 10, 4, 7, 33)Lipase Total (n= 12, 10, 4, 7, 33)
EFV+ddI+FTC in All Participants28153236933
EFV+ddI+FTC in Children >= 2 Years to < 3 Years420101010
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years541011012
EFV+ddI+FTC in Infants >=3 Months to < 6 Months1051000511
EFV+ddI+FTC in Infants >=6 Months to < 2 Years941124400

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Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population

Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. Division of AIDS Table (DAIDS) for Grading Severity of Adult and Pediatric AEs version (v) Dec 2004. Upper limit of normal (ULN): lower limit of normal (LLN), alanine transaminase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). ALT Grade (Gr) 1: 1.25 to 2.5*ULN; Gr 2: 2.6 to 5.0*ULN; Gr 3: 5.1 to 10.0*ULN; Gr 4: >10.0*ULN. AST Gr 1: 1.25 to 2.5*ULN; Gr 2: 2.6 to 5.0*ULN; Gr 3: 5.1 to 10.0*ULN; Gr 4: >10.0*ULN. Total bilirubin Gr 1: 1.25 to 1.5*ULN; Gr 2: 1.6 to 2.5*ULN; Gr 3: 2.6 to 5.0*ULN; Gr 4: >5.0*ULN. ALP (U/L) Gr 1: 1.25 to 2.5*ULN, Gr 2: 2.6 to 5.0*ULN, Gr 3: 5.1 to 10.0*ULN, Gr 4: >10.0*ULN. Albumin (low) Gr 1: 3 grams per deciliter (g/dL) to NCT00364793)
Timeframe: Baseline to Week 96

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Interventionparticipants (Number)
Albumin (n=12, 10, 4, 7, 33)ALP (n=12, 10, 4, 7, 33)ALT (n=12, 10, 4, 7, 33)AST (n=12, 10, 4, 7, 33)
EFV+ddI+FTC in All Participants1171210
EFV+ddI+FTC in Children >= 2 Years to < 3 Years1221
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years0500
EFV+ddI+FTC in Infants >=3 Months to < 6 Months0878
EFV+ddI+FTC in Infants >=6 Months to < 2 Years0231

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CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants

A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1). (NCT00364793)
Timeframe: Baseline to Weeks 60, 72, 84, and 96

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Interventioncells/mm^3 (Median)
Baseline (n=10,9,3,6,28)Week 60 (n=6, 6, 2,3,17)Week 72 (n=5, 7, 1, 3, 16)Week 84 (n=6, 7, 1, 3, 17)Week 96 (n=6, 6, 1, 3, 16)
EFV+ddI+FTC in All Participants1144-3159259-40
EFV+ddI+FTC in Children >= 2 Years to < 3 Years517580-50101402
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years413676620497744
EFV+ddI+FTC in Infants >=3 Months to < 6 Months1518-870-1178-937-834
EFV+ddI+FTC in Infants >=6 Months to < 2 Years1569-91423459-43

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Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants

Abnormalities were determined from measurements analyzed at central or local laboratory. DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Total Cholesterol (fasting) Gr 1: 170 - 199 mg/dL; Gr 2: 200 - 300 mg/dL; Gr 3 >300 mg/dL; Gr 4 Not Applicable(NA). LDL cholesterol, fasting: Gr 1: 110-129 mg/dL; Gr 2: 130-189 mg/dL; Gr 3 >=190 mg/dL; Gr 4 NA. Triglycerides, fasting: Gr 1: NA; Gr 2 500-750 mg/dL; Gr 3: 751-1,200 mg/dL; Gr 4: >1,200 mg/dL. Glucose, serum, high, fasting and (non-fasting): Gr 1: 110 - 125 (116-160) mg/dL; Gr 2: 126-250 (161- 250) mg/dL; Gr 3: 251-500 (251-500) mg/dL; Gr 4: >500 (> 500) mg/dL. Glucose, serum, low, >=1 month of age (<1 month): Gr 1: 55-64 (50-54) mg/dL; Gr 2: 40-54 (40-49) mg/dL; Gr 3: 30-39 (30-39) mg/dL; Gr 4: <30 (<30) mg/dL. Baseline: within 50 days after the screening visit and was prior to start of study medication (Week 1). Only those in 4th arm were old enough to fast prior to testing; other arms did not have fasting samples taken. (NCT00364793)
Timeframe: Baseline to Week 96

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Interventionparticipants (Number)
Total Cholesterol (n=9,10,4,0,23)Total Cholesterol Fasting (n=0,0,0,7,7)Glucose High (n=11,10,3,0,24)Glucose Low (n=11,10,3,0,24)Glucose High Fasting (n=0,0,0,7,7)LDL cholesterol (n=9,10,4,0,23)LDL cholesterol fasting (n=0,0,0,7,7)
EFV+ddI+FTC in All Participants7113141
EFV+ddI+FTC in Children >= 2 Years to < 3 Years1NA00NA0NA
EFV+ddI+FTC in Children >= 3 Years to <= 6 YearsNA1NANA1NA1
EFV+ddI+FTC in Infants >=3 Months to < 6 Months2NA12NA0NA
EFV+ddI+FTC in Infants >=6 Months to < 2 Years4NA01NA4NA

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Number of Participants With Hematologic Abnormalities - Treated Participants

Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. DAIDS DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Hemoglobin Gr 1: 8.5-10.0 g/dL; Gr 2: 7.5-8.4 g/dL; Gr 3: 6.50-7.4 g/dL; Gr 4: <6.5 g/dL; Platelets, decreased: Gr 1: 100.000-124.999*10^9/L; Gr 2: 50.000-99.999*10^9/L; Gr 3: 25.000-49.999*10^9/L; Gr 4: <25.000*10^9/L; White blood cell count (WBC) decreased Gr 1: 2.000-2.500*10^9/L; Gr 2: 1.500-1.999*10^9/L; Gr 3: 1.000-1.499*10^9/L; Gr 4: <1.000*10^9/L. Baseline visit was within 50 days post screening and was prior to start of study drug (Week 1). (NCT00364793)
Timeframe: Baseline to Week 96

,,,,
Interventionparticipants (Number)
Hemoglobin (n=11, 10, 4, 7, 32)Platelet (n=11, 10, 4, 7, 32)Neutrophils (n=11, 10, 4, 7, 32)
EFV+ddI+FTC in All Participants12210
EFV+ddI+FTC in Children >= 2 Years to < 3 Years200
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years101
EFV+ddI+FTC in Infants >=3 Months to < 6 Months417
EFV+ddI+FTC in Infants >=6 Months to < 2 Years512

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Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population

Plasma concentrations of EFV were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F was calculated by dividing the dose of EFV by AUC(TAU) of EFV. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h). (NCT00364793)
Timeframe: Week 2

InterventionL/h (Geometric Mean)
EFV+ddI+FTC in Infants >=3 Months to < 6 Months9.54
EFV+ddI+FTC in Infants >=6 Months to < 2 Years19.69
EFV+ddI+FTC in Children >= 2 Years to < 3 Years13.16
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years9.11

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Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population

Cmax and Cmin were derived from plasma concentrations versus time using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL. (NCT00364793)
Timeframe: Week 2

,,,
Interventionng/mL (Geometric Mean)
CmaxCmin
EFV+ddI+FTC in Children >= 2 Years to < 3 Years2167648
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years26321185
EFV+ddI+FTC in Infants >=3 Months to < 6 Months3790391
EFV+ddI+FTC in Infants >=6 Months to < 2 Years1998445

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The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants

Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA < 400 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were < 400 c/mL; denominator was all who remained on treatment through the specific week. (NCT00364793)
Timeframe: Weeks 60, 72, 84, and 96

,,,,
Interventionparticipants (Number)
Week 60 (n=7, 8, 3, 4, 22)Week 72 (n=7, 7, 2, 4, 20)Week 84 (n=7, 7, 2, 4, 20)Week 96 (n=7, 6, 2, 4, 19)
EFV+ddI+FTC in All Participants19171717
EFV+ddI+FTC in Children >= 2 Years to < 3 Years2111
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years4444
EFV+ddI+FTC in Infants >=3 Months to < 6 Months7777
EFV+ddI+FTC in Infants >=6 Months to < 2 Years6555

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Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants

HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1). (NCT00364793)
Timeframe: Baseline through Week 48

,,,,
Interventionlog10 c/mL (Median)
Baseline (n=13,10,4,7,34)Week 2 (n=12, 9, 4, 5, 30)Week 4 (n=11, 8, 4, 6, 29)Week 8 (n=11, 10, 3, 7, 31)Week 12 (n=10, 10, 3, 6, 29)Week 16 (n=10, 10, 4, 7, 31)Week 24 (n=10, 9, 3, 7, 29)Week 32 (n=9, 9, 4, 6, 28)Week 40 (n=7, 9, 4 ,6, 26)Week 48 (n=9, 9, 3, 6, 27)
EFV+ddI+FTC in All Participants5.88-2.11-2.63-2.92-3.14-3.27-3.28-3.27-3.93-3.18
EFV+ddI+FTC in Children >= 2 Years to < 3 Years5.88-2.42-2.86-2.92-4.02-4.11-4.18-3.73-4.02-3.27
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years5.50-1.93-3.04-3.27-3.31-3.44-2.95-2.93-2.93-2.93
EFV+ddI+FTC in Infants >=3 Months to < 6 Months5.88-1.89-2.18-2.73-2.48-2.72-3.46-2.75-4.01-2.92
EFV+ddI+FTC in Infants >=6 Months to < 2 Years5.88-2.26-2.49-2.91-3.19-3.17-3.92-3.28-4.17-3.27

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The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants

Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA < 50 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were < 50 c/mL; denominator was all who remained on treatment through the specific week. (NCT00364793)
Timeframe: Weeks 60, 72, 84, and 96

,,,,
Interventionparticipants (Number)
Week 60 (n=7, 8, 3, 4, 22)Week 72 (n=7, 7, 2, 4, 20)Week 84 (n=7, 7, 2, 4, 20)Week 96 (n=7, 6, 2, 4, 19)
EFV+ddI+FTC in All Participants14171615
EFV+ddI+FTC in Children >= 2 Years to < 3 Years2110
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years3434
EFV+ddI+FTC in Infants >=3 Months to < 6 Months4776
EFV+ddI+FTC in Infants >=6 Months to < 2 Years5555

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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 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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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 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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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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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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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 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 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 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 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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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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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 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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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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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 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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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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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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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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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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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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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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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 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 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 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

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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 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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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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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

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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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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

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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

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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

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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

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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

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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

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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

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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 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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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

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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 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 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 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 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 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 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

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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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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 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 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

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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

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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

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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

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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

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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

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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

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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 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 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 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 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 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 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 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 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 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

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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 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 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 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 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 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 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

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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 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

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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]

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

[back to top]

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

[back to top]

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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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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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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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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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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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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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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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 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

[back to top]

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

[back to top]

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 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 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

[back to top]

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

[back to top]

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

[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 < 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]

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

[back to top]

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

[back to top]

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

[back to top]

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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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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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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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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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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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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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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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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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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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 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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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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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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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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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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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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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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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 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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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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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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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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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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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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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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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 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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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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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 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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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 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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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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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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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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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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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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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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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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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 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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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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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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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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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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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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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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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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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 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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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 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 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 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 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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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 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 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 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 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 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 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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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 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 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 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 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 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 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 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 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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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 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 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 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 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 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 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 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 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 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 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 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 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 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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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 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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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 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 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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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 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 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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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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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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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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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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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 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 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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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 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 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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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 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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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 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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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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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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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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Number of Participants Who Had Access to, and Received the Intervention

This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study. (NCT00743340)
Timeframe: Up to 586 weeks

InterventionParticipants (Count of Participants)
Emtricitabine50

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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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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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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 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 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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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 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 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 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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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 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 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 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 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 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 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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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 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 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 CD4 Count at 48 Weeks

(NCT00762892)
Timeframe: Baseline and 48 weeks

Interventioncells/uL (Mean)
Raltegravir192
Atazanavir205

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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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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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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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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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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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Raltegravir Terminal Elimination Half Life

(NCT00768989)
Timeframe: At Week 2 from Baseline

InterventionHours (Mean)
Atazanavir + Raltegravir2.9

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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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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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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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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 Cmin 12 Hours Postdose

(NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng•h/mL (Geometric Mean)
Atazanavir + Raltegravir76.2

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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 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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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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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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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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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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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 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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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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Atazanavir Terminal Elimination Half Life

(NCT00768989)
Timeframe: At Week 2 from Baseline

InterventionHours (Mean)
Atazanavir + Raltegravir5.0

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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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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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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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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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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 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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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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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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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 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 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 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 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 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 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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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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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 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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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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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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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 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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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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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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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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HIV-1 RNA Levels at Baseline

(NCT00827112)
Timeframe: Baseline

Interventioncopies/mL (Mean)
Maraviroc+ Atazanavir / Ritonavir84982
Atazanavir / Ritonavir + Emtricitabine / Tenofovir114827

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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 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 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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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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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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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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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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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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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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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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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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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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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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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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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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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 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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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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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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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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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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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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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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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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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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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 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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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-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-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-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-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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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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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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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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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 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 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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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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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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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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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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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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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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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 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 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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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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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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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: 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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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 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 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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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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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 <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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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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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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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 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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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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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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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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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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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

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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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 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 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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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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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 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 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 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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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

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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

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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

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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 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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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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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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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

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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 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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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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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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[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 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 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 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

[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 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 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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[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]

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]

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]

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 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 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 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]

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]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[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]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[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]

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

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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

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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

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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

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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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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

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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

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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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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: 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 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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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 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 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 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 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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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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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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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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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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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 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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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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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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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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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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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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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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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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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 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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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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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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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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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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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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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 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 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 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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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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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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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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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)
EnrollmentDay 3Week 4Week 5Week 10
Cape Town, South Africa, Seroconverted Participant #12040034605732050416070

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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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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

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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 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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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 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 4Week 5Week 6
Cape Town, South Africa, Seroconverted Participant #20000

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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 6
Bangkok, Thailand, Seroconverted Participant #1000

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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

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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 22Week 26Week 30
Cape Town, South Africa, Seroconverted Participant #80000000000

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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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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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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 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 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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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 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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Drug Levels in Blood

rategravir concentration (NCT01335620)
Timeframe: Day 28

Interventionng/ml (Geometric Mean)
Truvada Plus Raltegravir1732

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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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Number of Participants Non-adherent as Measured by 3-day Recall

Number of participants reporting a missed medication dose in the past 3 days. (NCT01338025)
Timeframe: 28 Weeks

Interventionparticipants (Number)
Arm A, Non-suppressive HAART Regimen3
Arm B, 3TC or FTC Monotherapy1

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Number of Participants With Immunologic Deterioration

"Immunologic deterioration was declared for a participant if any one of the following conditions is observed within the first 28 weeks:~greater than or equal to 30% decline in absolute CD4+ T cell count from entry, or~development of CDC class C events.~Results report number of participants with immunologic deterioration at week 28 calculated." (NCT01338025)
Timeframe: From entry to week 28

Interventionparticipants (Number)
Arm A, Non-suppressive HAART Regimen0
Arm B, 3TC or FTC Monotherapy5

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Change in CD4+ T Cell Count

Change in CD4+ T cell count from entry to Week 28 (CD4+ at entry - CD4+ at Week 28). (NCT01338025)
Timeframe: Entry to week 28

InterventionCD4+ T cell count/mL (Median)
Arm A, Non-suppressive HAART Regimen27.5
Arm B, 3TC or FTC Monotherapy76

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Change in HIV-1 RNA Levels

Change in HIV-1 RNA levels from Entry to Week 28 (NCT01338025)
Timeframe: 28 Weeks

Interventioncopies/mL (Median)
Arm A, Non-suppressive HAART Regimen3087
Arm B, 3TC or FTC Monotherapy-2241

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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 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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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 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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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 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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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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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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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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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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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 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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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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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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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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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 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 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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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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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 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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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 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 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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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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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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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 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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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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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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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 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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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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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 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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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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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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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 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 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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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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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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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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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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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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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 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 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 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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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 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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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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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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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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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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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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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)

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 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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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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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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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 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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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 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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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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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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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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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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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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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 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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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 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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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 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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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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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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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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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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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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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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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 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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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

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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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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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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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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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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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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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 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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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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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 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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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 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 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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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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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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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

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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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.

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 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 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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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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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 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 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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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, 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 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 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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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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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 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 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 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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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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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 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 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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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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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 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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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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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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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, 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 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 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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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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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, 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, 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 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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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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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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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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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 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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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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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 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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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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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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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 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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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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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 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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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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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 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 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 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 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 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 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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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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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 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 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 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 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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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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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, 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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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 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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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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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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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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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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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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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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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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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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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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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 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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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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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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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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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: 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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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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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/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 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 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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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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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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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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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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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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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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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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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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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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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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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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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 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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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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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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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 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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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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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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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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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 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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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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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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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 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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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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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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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 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 (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 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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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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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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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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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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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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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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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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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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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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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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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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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 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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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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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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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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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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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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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 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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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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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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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 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 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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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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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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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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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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Change in Systemic Immune Activation

Change in systemic immune activation, as measured by change in plasma cytokine levels (IL-6). (NCT01869634)
Timeframe: Baseline, 12 months

Interventionpg/ml (Median)
HIV Positive Naive to ART1.74
Normal Control Volunteers0.66

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Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV

CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV. (NCT01869634)
Timeframe: Baseline, 12 months

Interventioncells / mm^2 (Median)
Entry
Normal Control Volunteers478

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Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV

CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV. (NCT01869634)
Timeframe: Baseline, 12 months

Interventioncells / mm^2 (Median)
Entry12-months after ART
HIV Positive Naive to ART80213

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Change in Percentage of Total Artery Diameter

computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy (NCT01869634)
Timeframe: Baseline, 12 months

Intervention% of total artery diameter (Median)
HIV Positive Naive to ART57
Normal Control Volunteers53

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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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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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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 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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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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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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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-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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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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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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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 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 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 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 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 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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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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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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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 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 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 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 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 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 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 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 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 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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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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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 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 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 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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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 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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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 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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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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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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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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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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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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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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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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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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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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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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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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Interim 24 Weeks Analysis of Death

(NCT02180438)
Timeframe: 24 weeks

Interventionparticipants (Number)
Open Label Prospective Single Arm Study of Stribild0

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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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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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< 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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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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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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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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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 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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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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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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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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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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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 Baseline

(NCT02251236)
Timeframe: Baseline

Interventionng/mL (Median)
Stribild Arm3.03
Genvoya Arm0.49

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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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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 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 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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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 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 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 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 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 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 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 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 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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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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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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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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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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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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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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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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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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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 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 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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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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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 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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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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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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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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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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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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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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% 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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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 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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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 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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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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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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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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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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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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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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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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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 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 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 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 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 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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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 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) 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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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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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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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 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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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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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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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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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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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 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 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 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 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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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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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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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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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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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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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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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 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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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 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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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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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 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 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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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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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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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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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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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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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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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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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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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 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 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 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 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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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 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

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 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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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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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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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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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 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 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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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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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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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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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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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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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 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 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 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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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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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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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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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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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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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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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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Number of Patients Offered Rapid HIV Treatment Initiation

(NCT03512964)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Rapid HIV Treatment Initiation32

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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 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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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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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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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 (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 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 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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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 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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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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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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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 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: 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 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 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 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 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: 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 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 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 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 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 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 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: 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: 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: 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: 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 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: 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 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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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 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 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 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 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 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 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 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: 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: 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 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 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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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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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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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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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 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 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 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 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 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 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 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 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 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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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)
Baseline2 hours48 hours
Genvoya - 2 and 48 Hours Specimen Collection051.231.03

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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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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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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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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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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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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 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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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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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 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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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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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 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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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 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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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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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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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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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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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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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 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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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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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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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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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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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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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 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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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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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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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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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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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 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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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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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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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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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 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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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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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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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 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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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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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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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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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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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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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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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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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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