Compounds > atazanavir sulfate
Page last updated: 2024-12-08

atazanavir sulfate

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Description

Atazanavir Sulfate: An azapeptide and HIV-PROTEASE INHIBITOR that is used in the treatment of HIV INFECTIONS and AIDS in combination with other ANTI-HIV AGENTS. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID158550
CHEMBL ID1200678
CHEBI ID31243
SCHEMBL ID341700
MeSH IDM0445555

Synonyms (66)

Synonym
bms-232632-05
atazanavir sulfate
CHEBI:31243 ,
229975-97-7
atazanavir sulfate (jan/usan)
D01276
2,5,6,10,13-pentaazatetradecanedioic acid, 3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((4-(2-pyridinyl)phenyl)methyl)-, dimethyl ester, (3s,8s,9s,12s)-, sulfate (1:1) (salt)
dimethyl (3s,8s,9s,12s)-9-benzyl-3,12,di-tert-butyl-8-hydroxy-4,11-dioxo-6-(p-2-pyridylbenzyl)-2,5,6,10,13-pentaazatetradecanedioate, sulfate (1:1) (salt)
atazanavir sulfate [usan]
2,5,6,10,13-pentaazatetradecanedioic acid, 3-12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((-4-(2-pyridinyl)phenyl)methyl)-, dimethyl ester, (3s,8s,9s,12s)-, sulfate (1:1) (salt)
CHEMBL1200678
atazanaviri sulfas
atazanavir so4
atazor
atazanavir sulphate
nsc-742546
methyl n-[(1s)-1-[[(1s,2s)-1-benzyl-2-hydroxy-3-[[[(2s)-2-(methoxycarbonylamino)-3,3-dimethyl-butanoyl]amino]-[(4-phenylphenyl)methyl]amino]propyl]carbamoyl]-2,2-dimethyl-propyl]carbamate; sulfuric acid;atazanavir sulfate
A816475
atazanavir sulfate (bms-232632-05)
unii-4mt4vie29p
nsc 742546
4mt4vie29p ,
AKOS016000176
MLS003915641
smr002544693
S1457
atazanaviri sulfas [who-ip latin]
atazanavir sulfate [orange book]
atazanavir sulfate [who-ip]
atazanavir sulfate [ep monograph]
2,5,6,10,13-pentaazatetradecanedioic acid, 3-12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((-4-(2-pyridinyl)phenyl)methyl)-, dimethyl ester, (3s,8s,9s,12s)-, sulphate (1:1) (salt)
atazanavir sulfate component of evotaz
dimethyl (3s,8s,9s,12s)-9-benzyl-3,12,di-tert-butyl-8-hydroxy-4,11-dioxo-6-(p-2-pyridylbenzyl)-2,5,6,10,13-pentaazatetradecanedioate, sulphate (1:1) (salt)
dimethyl (3s,8s,9s,12s)-9-benzyl-3,12-di-tert-butyl-8-hydroxy-4,11-dioxo-6-((4-(pyridin-2-yl)phenyl)methyl)-2,5,6,10,13-pentaazatetradecanedioate monosulfate
atazanavir sulphate [ema epar]
atazanavir so4 [vandf]
atazanavir sulfate [jan]
atazanavir sulfate [mi]
atazanavir sulfate [who-dd]
evotaz component atazanavir sulfate
atazanavir sulfate [mart.]
atazanavir sulfate [usp-rs]
CS-1890
atazanavir (sulfate)
HY-17367A
SCHEMBL341700
MLS006010199
DQSGVVGOPRWTKI-QVFAWCHISA-N
methyl ((5s,10s,11s,14s)-11-benzyl-5-(tert-butyl)-10-hydroxy-15,15-dimethyl-3,6,13-trioxo-8-(4-(pyridin-2-yl)benzyl)-2-oxa-4,7,8,12-tetraazahexadecan-14-yl)carbamate sulfate
mfcd08067748
bms-232632 sulfate
J-014934
SW220258-1
Q27114238
EX-A4010
AS-14954
3-amino-3-(3-benzyloxy-phenyl)-propionicacid
DTXSID401017206 ,
AMY36999
CCG-270493
229975-97-7 (sulfate)
atazanavir sulfate (ep monograph)
atazanavir sulfate (usp-rs)
dtxcid801475397
atazanavir sulfate (mart.)
bms-232632-05, reyataz

Research Excerpts

Treatment

Atazanavir sulfate + ritonavir treatment for 48 h completely prevented insulin stimulation of glucose uptake (P>0.05). Treatment with atazanvir sulfates, ritonovir, or ataz anavirsulfate and ritonivir for 24 or 48 h significantly increased basal glucose uptake.

ExcerptReferenceRelevance
"Atazanavir sulfate + ritonavir treatment for 48 h completely prevented insulin stimulation of glucose uptake (P>0.05)."( HIV protease inhibitors induce metabolic dysfunction in part via increased JNK1/2 pro-inflammatory signaling in L6 cells.
Bogachus, LD; Turcotte, LP, 2011)		1.09
"Treatment with atazanavir sulfate, ritonavir, or atazanavir sulfate + ritonavir for 24 or 48 h significantly increased basal glucose uptake (P<0.05) and atazanavir sulfate + ritonavir treatment increased basal glucose uptake significantly more than ritonavir or atazanavir sulfate treatment alone (P<0.05)."( HIV protease inhibitors induce metabolic dysfunction in part via increased JNK1/2 pro-inflammatory signaling in L6 cells.
Bogachus, LD; Turcotte, LP, 2011)		0.71

Toxicity

ExcerptReferenceRelevance
" No new safety issues were identified, and the overall incidence of treatment-emergent adverse events during BMS AI424-044 was comparable across treatment groups."( Long-term efficacy and safety of atazanavir with stavudine and lamivudine in patients previously treated with nelfinavir or atazanavir.
Cahn, P; Giordano, M; Kelleher, T; Mancini, M; Murphy, R; Pantaleo, G; Phanuphak, P; Pokrovskiy, V; Rozenbaum, W; Sension, M; Wood, R, 2004)		0.32
"ATV treatment of HIV-infected patients with or without a RTV booster was safe and effective in clinical routine."( Atazanavir for treatment of HIV infection in clinical routine: efficacy, pharmacokinetics and safety.
Feldt, T; Göbels, K; Häussinger, D; Kroidl, A; Kuschak, D; Leidel, R; Oette, M; Sagir, A, 2005)		0.33
" Treatment was not discontinued in any patient because of adverse effects."( Atazanavir and lopinavir/ritonavir: pharmacokinetics, safety and efficacy of a promising double-boosted protease inhibitor regimen.
Azuaje, C; Crespo, M; Curran, A; Diaz, M; Feijoo, M; Lopez, RM; Ocaña, I; Pahissa, A; Pou, L; Ribera, E, 2006)		0.33
" Four patients discontinued due to adverse experiences, three (2%) of the 133 patients across all raltegravir groups and one (2%) of the 45 patients on placebo."( Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial.
Chen, J; Gatell, JM; Gonzalez, CJ; Grinsztejn, B; Harvey, CM; Isaacs, RD; Katlama, C; Lazzarin, A; Nguyen, BY; Vittecoq, D, 2007)		0.34
"Of 25 subjects enrolled, scleral icterus was the most common adverse event (3 patients [12."( The safety, efficacy, and pharmacokinetic profile of a switch in antiretroviral therapy to saquinavir, ritonavir, and atazanavir alone for 48 weeks and a switch in the saquinavir formulation.
Cooper, DA; Emery, S; Law, M; MacRae, K; Mallon, PW; Satchell, C; Schutz, M; Williams, KM; Winston, A, 2007)		0.34
"001); patients receiving atazanavir had comparable rates of adverse event-related discontinuation and serious adverse events."( Efficacy and safety of atazanavir-based highly active antiretroviral therapy in patients with virologic suppression switched from a stable, boosted or unboosted protease inhibitor treatment regimen: the SWAN Study (AI424-097) 48-week results.
Antunes, F; Gatell, J; Gruber, C; Horban, A; Lazzarin, A; Ledesma, E; Leen, C; Odeshoo, L; Salmon-Ceron, D; Van den Dungen, M; Van Wijngaerden, E; Wirtz, V, 2007)		0.34
" The US Food and Drug Administration's Adverse Event Reporting System was searched for reports of nephrolithiasis in HIV-infected patients taking an atazanavir-based regimen."( Atazanavir-associated nephrolithiasis: cases from the US Food and Drug Administration's Adverse Event Reporting System.
Birnkrant, DB; Chan-Tack, KM; Struble, KA; Truffa, MM, 2007)		0.34
" Although safe and generally well tolerated, 300 mg or 400 mg atazanavir administered every 12 h did not maintain adequate plasma exposure when coadministered with rifampin."( Effect of concomitantly administered rifampin on the pharmacokinetics and safety of atazanavir administered twice daily.
Acosta, EP; Agarwala, S; Alston-Smith, B; Bertz, R; Child, M; Gerber, JG; Haas, DW; Hosey, L; Kendall, MA; Koletar, SL; Zolopa, AR, 2007)		0.34
" Adverse event-related discontinuations were 8% among ATV300/RTV-treated patients and <1% among ATV400-treated patients."( Efficacy and safety of atazanavir, with or without ritonavir, as part of once-daily highly active antiretroviral therapy regimens in antiretroviral-naive patients.
David, N; Hammond, J; Krantz, E; Malan, DR; McGrath, D; Wirtz, V, 2008)		0.35
" Serious adverse events were noted in 51 (12%) of 441 patients in the atazanavir/ritonavir group and in 42 (10%) of 437 patients in the lopinavir/ritonavir group."( Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study.
Andrade-Villanueva, J; Chetchotisakd, P; Corral, J; David, N; Echevarria, J; Mancini, M; McGrath, D; Molina, JM; Moyle, G; Percival, L; Thiry, A; Yang, R, 2008)		0.35
"100 patients were evaluated; 17 patients discontinued early including 6 for adverse events."( Evaluation of efficacy, safety, pharmacokinetics, and adherence in HIV-1-infected, antiretroviral-naïve patients treated with ritonavir-boosted atazanavir plus fixed-dose tenofovir DF/emtricitabine given once daily.
Cohen, C; Ebrahimi, R; Elion, R; Fisher, A; Flaherty, J; Kearney, B; McColl, D; Ortiz, R; Reddy, YS; Ruane, P; Ward, D, )		0.13
"Ritonavir-boosted atazanavir is associated with greater virologic control and immune response through 52 weeks compared to non-boosted atazanavir, without greater risk of adverse events except elevated bilirubin."( Efficacy and safety of ritonavir-boosted and unboosted atazanavir among antiretroviral-naïve patients.
Antoniskis, D; Blake, W; Dobrinich, R; Dodge, W; Horberg, M; Hurley, L; Klein, D; Kovach, D; Mogyoros, M; Silverberg, M; Towner, W, )		0.13
" Adverse event rate leading to study drug discontinuation was 5% in both arms."( Efficacy and safety of switching from boosted lopinavir to boosted atazanavir in patients with virological suppression receiving a LPV/r-containing HAART: the ATAZIP study.
Aranda, M; Arranz, JA; Blanco, JL; Clotet, B; Cosin, J; Cruceta, A; Dalmau, D; Domingo, P; Ferrer, E; García, I; Gatell, JM; Gutiérrez, F; Knobel, H; Lazzari, Ed; Llibre, JM; Mallolas, J; Martínez, E; Milinkovic, A; Murillas, J; Pedrol, E; Pich, J; Podzamczer, D; Ribera, E; Roca, V; Vidal, F, 2009)		0.35
" Data on CD4 cell count, HIV viral load, metabolic parameters and adverse events of grade 3-4 are collected through an on-line system every six months."( Efficacy and safety of boosted and unboosted atazanavir-containing antiretroviral regimens in real life: results from a multicentre cohort study.
Abeli, C; Bonfanti, P; Gianelli, E; Giuntini, R; Grosso, C; Madeddu, G; Marconi, P; Martinelli, C; Palvarini, L; Pellicano, G; Penco, G; Quirino, T; Ricci, E; Vichi, F, 2010)		0.36
"Our results suggest that, in unselected clinical settings, ATV-containing antiretroviral therapy is durable and safe in both its formulations."( Efficacy and safety of boosted and unboosted atazanavir-containing antiretroviral regimens in real life: results from a multicentre cohort study.
Abeli, C; Bonfanti, P; Gianelli, E; Giuntini, R; Grosso, C; Madeddu, G; Marconi, P; Martinelli, C; Palvarini, L; Pellicano, G; Penco, G; Quirino, T; Ricci, E; Vichi, F, 2010)		0.36
" We describe two patients who experienced serious quetiapine adverse effects potentially mediated through an interaction with ritonavir-boosted atazanavir."( Clinically significant adverse events from a drug interaction between quetiapine and atazanavir-ritonavir in two patients.
McCoy, C; Pollack, TM; Stead, W, 2009)		0.35
"Atazanavir (ATV) is a potent and safe protease inhibitor (PI) initially approved in adult HIV-1 infected patients in combination with other antiretroviral drugs with once daily administration."( Clinical pharmacology, efficacy and safety of atazanavir: a review.
Arvieux, C; Bellissant, E; Bentué-Ferrer, D; Ruffault, A; Tribut, O, 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)		0.36
" Atazanavir/ritonavir had a better lipid profile and fewer gastrointestinal adverse events than lopinavir/ritonavir."( Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study.
Absalon, J; Andrade-Villanueva, J; Chetchotisakd, P; Corral, J; David, N; Echevarria, J; Lataillade, M; Mancini, M; McGrath, D; Molina, JM; Moyle, G; Percival, L; Wirtz, V; Yang, R, 2010)		0.36
" Adverse event-related discontinuations occurred among 8% receiving ATV300/r and 3% receiving ATV400."( 96-week efficacy and safety of atazanavir, with and without ritonavir, in a HAART regimen in treatment-naive patients.
David, N; Iloeje, UH; Krantz, E; Malan, DR; Mathew, M; McGrath, D, )		0.13
" Secondary high plasma bilirubin and jaundice are its main adverse effect which only on rare occasions requires stopping the drug."( [Adverse effects of atazanavir].
González, M; Palacios, R; Ruiz, J; Santos, J, 2008)		0.35
" In patients co-infected with hepatitis B or C, the level of virological response to does not appear to be affected and the incidence of adverse effects, except the higher incidence of hepatotoxicity, is no higher than in non-coinfected subjects."( [Safety of atazanavir in patients with HIV and hepatitis B and/or C virus coinfection].
Camacho, A; Pérez-Camacho, I; Rivero, A; Torre-Cisneros, J, 2008)		0.35
" Hyperbilirubinemia (13%), diarrhea (4%), nausea (2%), and rash (2%) were the most frequent drug-related Grade 2-4 adverse events."( Safety and efficacy of a 36-week induction regimen of abacavir/lamivudine and ritonavir-boosted atazanavir in HIV-infected patients.
Bellos, N; DeJesus, E; Murphy, D; Patel, LG; Ross, LL; Shaefer, MS; Squires, KE; Sutherland-Phillips, DH; Wannamaker, PG; Young, B; Zhao, HH, )		0.13
" All adverse events were of mild or moderate intensity."( Pharmacokinetics and safety of twice-daily atazanavir 300 mg and raltegravir 400 mg in healthy individuals.
Bertz, R; Breidinger, S; Butterton, J; Comisar, W; Panebianco, D; Persson, A; Stonier, M; Zhang, J; Zhu, L, 2010)		0.36
" Atazanavir and raltegravir alone and coadministered appeared safe and well-tolerated."( Pharmacokinetics and safety of twice-daily atazanavir 300 mg and raltegravir 400 mg in healthy individuals.
Bertz, R; Breidinger, S; Butterton, J; Comisar, W; Panebianco, D; Persson, A; Stonier, M; Zhang, J; Zhu, L, 2010)		0.36
" Atazanavir (ATV) was well tolerated with no unanticipated adverse events."( Safety and exposure of once-daily ritonavir-boosted atazanavir in HIV-infected pregnant women.
Bertz, R; Botes, M; Child, M; Conradie, F; Eley, T; Hu, W; Josipovic, D; McGrath, D; Osiyemi, O; Vandeloise, E; Wirtz, V; Zorrilla, C, 2011)		0.37
" The most frequently reported adverse event was increased bilirubin (16."( Treatment durability, effectiveness, and safety with atazanavir/ritonavir-based HAART regimen in treatment-naïve HIV-infected patients.
Baril, JG; Boulerice, F; Lalonde, R; Loutfy, M; Rachlis, A; Sampalis, JS; Tremblay, C; Trottier, B, )		0.13
" Frequency of adverse events (AEs) was similar between arms, with 88."( A randomised comparison of safety and efficacy of nevirapine vs. atazanavir/ritonavir combined with tenofovir/emtricitabine in treatment-naïve patients.
Bhatti, L; Conner, C; Dejesus, E; Mills, A; Storfer, S, 2011)		0.37
" Three patients allocated elvitegravir had serious adverse events related to study drugs compared with seven assigned raltegravir; two and eight patients died, respectively."( Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study.
Andrade-Villanueva, J; Cheng, AK; Chuck, SL; Clotet, B; Clumeck, N; Lamarca, A; Liu, YP; Margot, N; Molina, JM; Zhong, L, 2012)		0.38
" There were no serious adverse events and no discontinuations due to adverse events over 48 weeks; HIV RNA remained undetectable."( A randomized study of pharmacokinetics, efficacy, and safety of 2 raltegravir plus atazanavir strategies in ART-treated adults.
Beileiter, K; Bloch, M; Boyd, MA; Carey, D; Cooper, DA; Emery, S; MacRae, K; Pett, SL; Ray, JE; Wand, H, 2012)		0.38
"During the study no serious adverse events were reported."( Efficacy and safety of a dual boosted protease inhibitor-based regimen, atazanavir and fosamprenavir/ritonavir, against HIV: experience in a pediatric population.
Adorni, F; Galli, M; Giacomet, V; Mameli, C; Rusconi, S; Viganò, A; Viganò, O; Zuccotti, GV, 2012)		0.38
" Although adverse events (AEs) were the main known reason for discontinuation, no unexpected AEs were observed."( Long-term efficacy and safety of atazanavir/ritonavir treatment in a real-life cohort of treatment-experienced patients with HIV type 1 infection.
Brockmeyer, N; Dupke, S; Eychenne, JL; Jansen, K; Jimenez-Exposito, MJ; Nakonz, T; Pugliese, P; Sönnerborg, A; Svedhem, V; Thalme, A, 2013)		0.39
" Seven moderate to severe adverse events were recorded (including four renal colics, possibly treatment-related) in six patients."( Safety and feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients on stable treatment with two nucleos(t)ide reverse transcriptase inhibitors + atazanavir/ritonavir with virological suppression (Atazanavir an
Cauda, R; Ciccarelli, N; Cingolani, A; Colafigli, M; D'Avino, A; De Luca, A; Di Giambenedetto, S; Fabbiani, M; Farina, S; Mondi, A; Murri, R; Navarra, P; Sidella, L; Tamburrini, E, 2013)		0.39
"Simplification to atazanavir/ritonavir + lamivudine was apparently safe and associated with rare virological failure, without resistance selection."( Safety and feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients on stable treatment with two nucleos(t)ide reverse transcriptase inhibitors + atazanavir/ritonavir with virological suppression (Atazanavir an
Cauda, R; Ciccarelli, N; Cingolani, A; Colafigli, M; D'Avino, A; De Luca, A; Di Giambenedetto, S; Fabbiani, M; Farina, S; Mondi, A; Murri, R; Navarra, P; Sidella, L; Tamburrini, E, 2013)		0.39
" Outcomes were incidence and health care costs of the following medically attended (International Classification of Diseases, Ninth Revision, Clinical Modification-coded or treated) adverse effects during the evaluation period: gastrointestinal, lipid abnormalities, diabetes/hyperglycemia, rash, and jaundice."( Comparative incidence and health care costs of medically attended adverse effects among U.S. Medicaid HIV patients on atazanavir- or darunavir-based antiretroviral therapy.
Chu, BC; Esker, S; Espindle, D; Hebden, T; Johnston, SS; Juday, T; Uy, J, )		0.13
"027) adverse events were less frequent in ATV/r arm."( Simplification to atazanavir/ritonavir monotherapy for HIV-1 treated individuals on virological suppression: 48-week efficacy and safety results.
Antinori, A; Carini, E; Castagna, A; D'Arminio Monforte, A; Di Biagio, A; Galli, L; Lazzarin, A; Montella, F; Nozza, S; Rusconi, S; Spagnuolo, V; Vinci, C, 2014)		0.4
" Overall, 12 (31%) patients stopped dual therapy: 7 patients because of adverse events, mostly clinical myositis (n = 3)."( Efficacy and safety of switching to raltegravir plus atazanavir dual therapy in pretreated HIV-1-infected patients over 144 weeks: a cohort study.
Batard, ML; Bernard-Henry, C; Cheneau, C; De Mautort, E; Fafi-Kremer, S; Gantner, P; Koeppel, C; Muret, P; Partisani, M; Priester, M; Rey, D; Sueur, C, 2014)		0.4
"Use of once-daily ATV, with/without RTV, was safe and well tolerated in children, with acceptable levels of viral suppression and CD4 count increase."( Long-term safety and efficacy of atazanavir-based therapy in HIV-infected infants, children and adolescents: the Pediatric AIDS Clinical Trials Group Protocol 1020A.
Aldrovani, G; Fenton, T; Fletcher, CV; Graham, B; Kiser, JJ; Mathew, M; Mofenson, LM; Rutstein, RM; Samson, P; Smith, E, 2015)		0.42
" Tolerance was good with one case of maternal grade 3 hyperbilirubinaemia, no cases in neonates at delivery and no clinically relevant adverse event."( Pharmacokinetics, safety and efficacy of ritonavir-boosted atazanavir (300/100 mg once daily) in HIV-1-infected pregnant women.
Bourgeois-Moine, A; Bourse, P; Calvez, V; Damond, F; Descamps, D; Dommergues, M; Duro, D; Faucher, P; Ichou, H; Landman, R; Lariven, S; Lê, MP; Legac, S; Mandelbrot, L; Matheron, S; Meier, F; Mortier, E; Peytavin, G; Soulié, C; Tubiana, R; Valantin, MA, 2015)		0.42
" Concerning safety, 10 moderate to severe adverse events were recorded in eight patients; overall seven cases of renal colic (possibly treatment related) were observed, leading to a discontinuation of treatment in two patients."( Efficacy and safety of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients with virological suppression: 144 week follow-up of the AtLaS pilot study.
Borghetti, A; Cauda, R; Ciccarelli, N; Colafigli, M; D'Avino, A; De Luca, A; Di Giambenedetto, S; Fabbiani, M; Gagliardini, R; Mondi, A, 2015)		0.42
"9%) discontinued due to adverse events (AEs); and 11 patients (19."( PRINCE-1: safety and efficacy of atazanavir powder and ritonavir liquid in HIV-1-infected antiretroviral-naïve and -experienced infants and children aged ≥3 months to <6 years.
Arce, PM; Biguenet, S; Cambilargiu, D; Correll, T; Donati, AP; Hardy, H; Lissens, J; Strehlau, R; Yang, R, 2015)		0.42
"Cohorts contributed individual patient data on adverse events (AE) in those aged <18 years taking DRV and ATV, respectively, to 02/2014."( Safety of darunavir and atazanavir in HIV-infected children in Europe and Thailand.
, 2016)		0.43
" Principal reasons for discontinuation were adverse events (15."( Long-Term Efficacy, Tolerability, and Renal Safety of Atazanavir/Ritonavir-based Antiretroviral Therapy in a Cohort of Treatment-Naïve Patients with HIV-1 Infection: the REMAIN Study.
Antela, A; Jiménez-Expósito, MJ; Knechten, H; Kuhlmann, B; Rocha-Pereira, N; Santos, J; Teófilo, E, 2016)		0.43
" Drug-related adverse events leading to discontinuation were 3 (6%) in the atazanavir/ritonavir monotherapy arm and 11 (21."( Atazanavir/ritonavir monotherapy: 96 week efficacy, safety and bone mineral density from the MODAt randomized trial.
Antinori, A; Bigoloni, A; Borderi, M; Caramatti, G; Castagna, A; D'Arminio Monforte, A; Di Biagio, A; Di Giambenedetto, S; Galli, L; Gibellini, D; Guaraldi, G; Lazzarin, A; Montella, F; Rusconi, S; Spagnuolo, V, 2016)		0.43
" In the atazanavir/ritonavir monotherapy arm, reintroduction of nucleosides, as needed, was always effective with no new resistance mutation; monotherapy was also associated with a lower incidence of adverse events and improvement in femur BMD."( Atazanavir/ritonavir monotherapy: 96 week efficacy, safety and bone mineral density from the MODAt randomized trial.
Antinori, A; Bigoloni, A; Borderi, M; Caramatti, G; Castagna, A; D'Arminio Monforte, A; Di Biagio, A; Di Giambenedetto, S; Galli, L; Gibellini, D; Guaraldi, G; Lazzarin, A; Montella, F; Rusconi, S; Spagnuolo, V, 2016)		0.43
" Adverse events occurred in 23 and 18 patients, respectively."( Efficacy and safety of once-daily ritonavir-boosted atazanavir or darunavir in combination with a dual nucleos(t)ide analogue backbone in HIV-1-infected combined ART (cART)-naive patients with severe immunosuppression: a 48 week, non-comparative, randomiz
Assoumou, L; Benalycherif, A; Cabié, A; Costagliola, D; Duvivier, C; Girard, PM; Joly, V; Lambert-Niclot, S; Landman, R; Marcelin, AG; Peytavin, G; Pialoux, G; Samri, A; Slama, L; Valin, N, 2016)		0.43
" To investigate safety, we compared adverse events (AE) among infants exposed to different maternal cART regimens."( Maternal Lopinavir/Ritonavir Is Associated with Fewer Adverse Events in Infants than Nelfinavir or Atazanavir.
Barr, E; Davies, J; Forster, JE; Kinzie, K; Levin, MJ; McFarland, EJ; Pappas, J; Paul, S; Smith, C; Weinberg, A, 2016)		0.43
" Before week 96, dual therapy was discontinued in 44 patients (16%) because of various adverse events, with no difference between the two groups."( Switch to Ritonavir-Boosted versus Unboosted Atazanavir plus Raltegravir Dual-Drug Therapy Leads to Similar Efficacy and Safety Outcomes in Clinical Practice.
Bani-Sadr, F; Gantner, P; Garraffo, R; Jovelin, T; Pugliese, P; Rey, D; Roger, PM; Treger, M, 2016)		0.43
"Emerging RAL-resistance and discontinuations for adverse events resulted in moderate efficacy rates of ATV and RAL dual therapy in heavily pretreated patients."( Switch to Ritonavir-Boosted versus Unboosted Atazanavir plus Raltegravir Dual-Drug Therapy Leads to Similar Efficacy and Safety Outcomes in Clinical Practice.
Bani-Sadr, F; Gantner, P; Garraffo, R; Jovelin, T; Pugliese, P; Rey, D; Roger, PM; Treger, M, 2016)		0.43
"Switch to atazanavir/raltegravir was safe and well tolerated allowing optimal drugs' plasma exposure."( Efficacy, safety and pharmacokinetics of atazanavir (200mg twice daily) plus raltegravir (400mg twice daily) dual regimen in the clinical setting.
Bonora, S; Bramato, C; Calcagno, A; Cenderello, G; D'Avolio, A; Di Perri, G; Marinaro, L; Orofino, G; Pirriatore, V; Ripamonti, D; Rizzi, M; Rusconi, S; Salassa, B; Trentini, L, 2017)		0.46
"Switching from ATV/r to unboosted ATV appears to be safe and effective in selected virologically suppressed patients receiving TDF-containing regimens, and may have favorable effects on bilirubin and renal function."( Efficacy and safety of "unboosting" atazanavir in a randomized controlled trial among HIV-infected patients receiving tenofovir DF.
Ganase, B; Guillemi, SA; Harrigan, PR; Harris, M; Hull, MW; Saeedi, R; Watson, B; Zhang, W, 2017)		0.46
" There were no deaths, adverse events leading to discontinuation, or serious adverse events."( Antiviral Activity, Safety, and Exposure-Response Relationships of GSK3532795, a Second-Generation Human Immunodeficiency Virus Type 1 Maturation Inhibitor, Administered as Monotherapy or in Combination With Atazanavir With or Without Ritonavir in a Phase
Boffito, M; Dicker, IB; Grasela, D; Hüser, A; Hwang, C; Keicher, C; Krystal, M; Lataillade, M; Ravindran, P; Ray, N; Schürmann, D; Sevinsky, H; Sobotha, C; Xiao, H, 2017)		0.46
" Through 48 weeks, the most common adverse events were upper respiratory tract infections (33."( Safety and Efficacy of Atazanavir Powder and Ritonavir in HIV-1-Infected Infants and Children From 3 Months to <11 Years of Age: The PRINCE-2 Study.
Cambilargiu, D; Correll, TA; Cotton, MF; Gonzalez-Tome, MI; Klauck, I; Liberty, A; Lissens, J; Pikora, C; Torres-Escobar, I; Zaru, L, 2018)		0.48
" Secondary outcomes were duration of hospital stay, length of intensive care unit stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects, and complications during the hospitalization."( A Randomized Clinical Trial of the Efficacy and Safety of Interferon β-1a in Treatment of Severe COVID-19.
Abbasian, L; Davoudi-Monfared, E; Hajiabdolbaghi, M; Kazemzadeh, H; Khalili, H; Rahmani, H; Salehi, M; Yekaninejad, MS, 2020)		0.56
" Among the focused drugs, Heparin and Atazanavir appear to cause more adverse reactions than other drugs."( Identifying side effects of commonly used drugs in the treatment of Covid 19.
Alhajj, R; Aygün, İ; Kaya, M, 2020)		0.56
"To examine clinical outcomes associated with colchicine drug interactions using the spontaneous reports of the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS)."( Drugs That Interact With Colchicine Via Inhibition of Cytochrome P450 3A4 and P-Glycoprotein: A Signal Detection Analysis Using a Database of Spontaneously Reported Adverse Events (FAERS).
Boyce, RD; Gómez-Lumbreras, A; Hansten, PD; Horn, J; Malone, DC; Tan, MS; Villa-Zapata, L, 2023)		0.91
" The reporting odds ratio (ROR) and observed-to-expected ratio (O/E) with shrinkage for adverse events related to colchicine's toxicity (ie, rhabdomyolysis/myopathy, agranulocytosis, hemorrhage, acute renal failure, hepatic failure, arrhythmias, torsade de pointes/QT prolongation, and cardiac failure) were compared between FAERS reports."( Drugs That Interact With Colchicine Via Inhibition of Cytochrome P450 3A4 and P-Glycoprotein: A Signal Detection Analysis Using a Database of Spontaneously Reported Adverse Events (FAERS).
Boyce, RD; Gómez-Lumbreras, A; Hansten, PD; Horn, J; Malone, DC; Tan, MS; Villa-Zapata, L, 2023)		0.91

Pharmacokinetics

ExcerptReferenceRelevance
"BMS-232632 is a potent human immunodeficiency type 1 (HIV-1) protease inhibitor with a half-life that allows for once-daily dosing."( Hollow-fiber unit evaluation of a new human immunodeficiency virus type 1 protease inhibitor, BMS-232632, for determination of the linked pharmacodynamic variable.
Bilello, JA; Drusano, GL; Echols, R; Kaul, S; O'Mara, E; Preston, SL; Schnittman, S, 2001)		0.31
" Trough concentration of >80 ng/ml and peak concentration of 2000-6000 ng/ml were regarded as sufficient."( Atazanavir for treatment of HIV infection in clinical routine: efficacy, pharmacokinetics and safety.
Feldt, T; Göbels, K; Häussinger, D; Kroidl, A; Kuschak, D; Leidel, R; Oette, M; Sagir, A, 2005)		0.33
" Pharmacokinetic data are available for 32 patients, all patients had sufficient trough levels."( Atazanavir for treatment of HIV infection in clinical routine: efficacy, pharmacokinetics and safety.
Feldt, T; Göbels, K; Häussinger, D; Kroidl, A; Kuschak, D; Leidel, R; Oette, M; Sagir, A, 2005)		0.33
" The variability of pharmacokinetic results in our sample supports therapeutic drug monitoring in patients treated with ATV."( Atazanavir for treatment of HIV infection in clinical routine: efficacy, pharmacokinetics and safety.
Feldt, T; Göbels, K; Häussinger, D; Kroidl, A; Kuschak, D; Leidel, R; Oette, M; Sagir, A, 2005)		0.33
"To determine if atazanavir, a once-daily protease inhibitor and moderate inhibitor of P450 CYP3A4, exhibited pharmacokinetic interactions with (R)-methadone."( Lack of an effect of atazanavir on steady-state pharmacokinetics of methadone in patients chronically treated for opiate addiction.
Agarwala, S; Andrews, L; Child, M; Daley, L; Friedland, G; O'Mara, E; Schreibman, T; Shi, J; Wang, Y, 2005)		0.33
"Methadone pharmacokinetic parameters were measured in 16 patients on chronic methadone therapy prior to and after 14 days of daily administration of atazanavir."( Lack of an effect of atazanavir on steady-state pharmacokinetics of methadone in patients chronically treated for opiate addiction.
Agarwala, S; Andrews, L; Child, M; Daley, L; Friedland, G; O'Mara, E; Schreibman, T; Shi, J; Wang, Y, 2005)		0.33
"No clinically relevant pharmacokinetic interactions were found between atazanavir and methadone."( Lack of an effect of atazanavir on steady-state pharmacokinetics of methadone in patients chronically treated for opiate addiction.
Agarwala, S; Andrews, L; Child, M; Daley, L; Friedland, G; O'Mara, E; Schreibman, T; Shi, J; Wang, Y, 2005)		0.33
"To assess potential pharmacokinetic (PK) interactions between atazanavir (ATV, 300 mg, once daily) and lopinavir (LPV, 400 mg, twice daily), both boosted by ritonavir (RTV, 100 mg)."( Ritonavir-boosted atazanavir-lopinavir combination: a pharmacokinetic interaction study of total, unbound plasma and cellular exposures.
Biollaz, J; Buclin, T; Cavassini, M; Colombo, S; Decosterd, LA; Franc, C; Guignard, N; Khonkarly, M; Rochat, B; Tarr, PE; Telenti, A, 2006)		0.33
" We describe a 65-year-old man with HIV who underwent a 12-hour intensive pharmacokinetic study while receiving esomeprazole with atazanavir-ritonavir and subsequently, an 8-hour study while receiving esomeprazole with fosamprenavir-ritonavir."( Effects of esomeprazole on the pharmacokinetics of atazanavir and fosamprenavir in a patient with human immunodeficiency virus infection.
Anderson, PL; Fletcher, CV; Kiser, JJ; Lichtenstein, KA, 2006)		0.33
"A population pharmacokinetic analysis was performed in the context of therapeutic drug monitoring (87 patients, 121 samples)."( Influence of tenofovir, nevirapine and efavirenz on ritonavir-boosted atazanavir pharmacokinetics in HIV-infected patients.
Arvieux, C; Dailly, E; Jolliet, P; Perré, P; Raffi, F; Tattevin, P; Tribut, O, 2006)		0.33
"We evaluated the impact of modelling intra-subject variability on the likelihood ratio test (LRT) and the Wald test based on non-linear mixed effects models in pharmacokinetic interaction and bioequivalence cross-over trials."( Impact of modelling intra-subject variability on tests based on non-linear mixed-effects models in cross-over pharmacokinetic trials with application to the interaction of tenofovir on atazanavir in HIV patients.
Mentré, F; Panhard, X; Piketti, C; Taburet, AM, 2007)		0.34
"To assess the impact of baseline HIV-1 substitutions, individual pharmacokinetic (PK) parameters (Cmin, Cmax, area under the curve [AUC0-->24 h]) and genotype-inhibitory quotient (GIQ) on virological responses (VR) to atazanavir-ritonavir (300 mg/100 mg)-based highly active antiretroviral therapy (HAART) in 71 antiretroviral-experienced, atazanavir-naive patients in virological failure (VF) on HAART."( Virological responses to atazanavir-ritonavir-based regimens: resistance-substitutions score and pharmacokinetic parameters (Reyaphar study).
Boucher, S; Breilh, D; Fleury, H; Lazaro, E; Neau, D; Pellegrin, I; Pellegrin, JL; Ragnaud, JM; Saux, MC; Schrive, MH; Vray, M, 2006)		0.33
" Respective steady-state Cmin, Cmax and AUC0-->24 h were 300 (200; 700) ng/ml, 620 (430; 750) ng/ml and 78,000 (61,000; 94,000) ng."( Virological responses to atazanavir-ritonavir-based regimens: resistance-substitutions score and pharmacokinetic parameters (Reyaphar study).
Boucher, S; Breilh, D; Fleury, H; Lazaro, E; Neau, D; Pellegrin, I; Pellegrin, JL; Ragnaud, JM; Saux, MC; Schrive, MH; Vray, M, 2006)		0.33
" Atazanavir was increased to 200 mg and pharmacokinetic assessment repeated (day 30)."( Pharmacokinetics of saquinavir hard-gel/ritonavir and atazanavir when combined once daily in HIV Type 1-infected individuals administered different atazanavir doses.
Back, D; Boffito, M; Dickinson, L; Fletcher, C; Gazzard, B; Hill, A; Maitland, D; Moyle, G; Nelson, M; Pozniak, A, 2006)		0.33
" This study aimed to assess the ATV pharmacokinetic profile in a target population of HIV patients, to characterize interpatient and intrapatient variability, and to identify covariates that might influence ATV disposition."( Population pharmacokinetics of atazanavir in patients with human immunodeficiency virus infection.
Biollaz, J; Buclin, T; Cavassini, M; Colombo, S; Csajka, C; Décosterd, LA; Telenti, A, 2006)		0.33
" When comparing pharmacokinetic values in the nine patients receiving saquinavir/ritonavir with and without atazanavir, the median cellular saquinavir AUC0-24 was significantly increased (34."( Influence of atazanavir 200 mg on the intracellular and plasma pharmacokinetics of saquinavir and ritonavir 1600/100 mg administered once daily in HIV-infected patients.
Back, D; Boffito, M; Ford, J; Gazzard, B; Hill, A; Khoo, S; Maitland, D; Moyle, G; Nelson, M; Pozniak, A, 2006)		0.33
" Treatments were separated by 10 days, and pharmacokinetic analyses were performed on days 11, 32, and 53."( Pharmacokinetics of saquinavir with atazanavir or low-dose ritonavir administered once daily (ASPIRE I) or twice daily (ASPIRE II) in seronegative volunteers.
Acosta, EP; Becker, SL; Kakuda, TN; King, JR; Paul, S; Tse, MM, 2007)		0.34
" Patients were given a 12/24-h pharmacokinetic assessment at steady state."( Pharmacokinetics of saquinavir, atazanavir, and ritonavir in a twice-daily boosted double-protease inhibitor regimen.
Dauer, B; Harder, S; Klauke, S; Kurowski, M; Lutz, T; Müller, A; Oertel, B; Rottmann, C; Staszewski, S; von Hentig, N; Wolf, T, 2007)		0.34
" A complete pharmacokinetic evaluation of the steady-state concentrations of atazanavir and ritonavir was performed."( Pharmacokinetic interaction between rifampicin and ritonavir-boosted atazanavir in HIV-infected patients.
Blanco, JL; Gatell, JM; López-Púa, Y; Mallolas, J; Martínez, E; Nomdedeu, M; Sarasa, M; Soriano, A, 2007)		0.34
"In all three cases, more than 50% of the time the atazanavir level was below the minimum recommended trough plasma level (150 ng/mL according to current pharmacokinetic guidelines) to inhibit HIV wild-type replication."( Pharmacokinetic interaction between rifampicin and ritonavir-boosted atazanavir in HIV-infected patients.
Blanco, JL; Gatell, JM; López-Púa, Y; Mallolas, J; Martínez, E; Nomdedeu, M; Sarasa, M; Soriano, A, 2007)		0.34
" Ritonavir-boosted double-protease inhibitor (PI)-only regimens are such an option but are prone to pharmacokinetic interactions."( The safety, efficacy, and pharmacokinetic profile of a switch in antiretroviral therapy to saquinavir, ritonavir, and atazanavir alone for 48 weeks and a switch in the saquinavir formulation.
Cooper, DA; Emery, S; Law, M; MacRae, K; Mallon, PW; Satchell, C; Schutz, M; Williams, KM; Winston, A, 2007)		0.34
" The study also assessed the pharmacokinetic profile of a change in the SQV formulation, from 200 mg to 500 mg, in 2 regimens (SQV-RTV twice per day plus NRTIs [arm 1] and SQV-RTV-ATV once per day without NRTIs [arm 2]) in human immunodeficiency virus type 1-infected subjects (plasma human immunodeficiency virus RNA level, <50 copies/mL)."( The safety, efficacy, and pharmacokinetic profile of a switch in antiretroviral therapy to saquinavir, ritonavir, and atazanavir alone for 48 weeks and a switch in the saquinavir formulation.
Cooper, DA; Emery, S; Law, M; MacRae, K; Mallon, PW; Satchell, C; Schutz, M; Williams, KM; Winston, A, 2007)		0.34
" We performed an open-label, single-arm study to assess the safety and pharmacokinetic interactions of the HIV protease inhibitor atazanavir coadministered with rifampin."( Effect of concomitantly administered rifampin on the pharmacokinetics and safety of atazanavir administered twice daily.
Acosta, EP; Agarwala, S; Alston-Smith, B; Bertz, R; Child, M; Gerber, JG; Haas, DW; Hosey, L; Kendall, MA; Koletar, SL; Zolopa, AR, 2007)		0.34
"To investigate the potential for pharmacokinetic interactions between the protease inhibitors darunavir (DRV, TMC114) coadministered with low-dose ritonavir (darunavir/r), and atazanavir in HIV-negative, healthy volunteers."( Pharmacokinetics of darunavir (TMC114) and atazanavir during coadministration in HIV-negative, healthy volunteers.
De Marez, T; De Paepe, E; De Pauw, M; Hoetelmans, RM; Lefebvre, E; Sekar, VJ; Spinosa-Guzman, S; Vangeneugden, T, 2007)		0.34
"Atazanavir/ritonavir plasma concentrations were measured by liquid chromatography tandem mass spectrometry, and the geometric means of minimum and maximum concentrations (C(min), C(max)), the area under the time-concentration curve (AUC), half-life (t(1/2)) and total clearance (CL(tot)) were subject to a matched pairs-analysis."( Tenofovir comedication does not impair the steady-state pharmacokinetics of ritonavir-boosted atazanavir in HIV-1-infected adults.
Dauer, B; Haberl, A; Harder, S; Klauke, S; Lutz, T; Staszewski, S; von Hentig, N, 2007)		0.34
"The coadministration of tenofovir-DF did not impair the plasma concentrations of ritonavir-boosted atazanavir in a pharmacokinetic analysis of patient pairs matched for gender, ethnicity, weight and CDC status."( Tenofovir comedication does not impair the steady-state pharmacokinetics of ritonavir-boosted atazanavir in HIV-1-infected adults.
Dauer, B; Haberl, A; Harder, S; Klauke, S; Lutz, T; Staszewski, S; von Hentig, N, 2007)		0.34
"HIV-infected subjects on abacavir (600 mg once daily) plus two nucleoside reverse transcriptase inhibitors (NRTIs) (excluding tenofovir) underwent a 24 h pharmacokinetic assessment for plasma abacavir concentrations."( Abacavir plasma pharmacokinetics in the absence and presence of atazanavir/ritonavir or lopinavir/ritonavir and vice versa in HIV-infected patients.
Back, D; Boffito, M; Bonora, S; D'Avolio, A; Else, L; Gazzard, B; Mandalia, S; Moyle, G; Nelson, M; Pozniak, A; Waters, LJ, 2007)		0.34
"A prospective, open-label, single-site, two-period, crossover pharmacokinetic study was carried out in healthy volunteers."( Steady-state pharmacokinetics of once-daily fosamprenavir/ritonavir and atazanavir/ritonavir alone and in combination with 20 mg omeprazole in healthy volunteers.
Brower, R; Frank, I; Kim, D; Luber, AD; Peloquin, CA; Silverman, R, 2007)		0.34
" OMP reduced ATV exposure [area under the concentration curve at 0-24 h (AUC0-24 h)] and the minimum drug concentration (Cmin) by 27% each."( Steady-state pharmacokinetics of once-daily fosamprenavir/ritonavir and atazanavir/ritonavir alone and in combination with 20 mg omeprazole in healthy volunteers.
Brower, R; Frank, I; Kim, D; Luber, AD; Peloquin, CA; Silverman, R, 2007)		0.34
" HIV-infected subjects > or =18 to <25 years old receiving (> or =28 days) 300/100 mg atazanavir-ritonavir plus 300 mg tenofovir disoproxil fumarate (TDF) plus one or more other nucleoside analogs underwent intensive 24-h pharmacokinetic studies following a light meal."( Pharmacokinetics of antiretroviral regimens containing tenofovir disoproxil fumarate and atazanavir-ritonavir in adolescents and young adults with human immunodeficiency virus infection.
Cunningham, CK; Fletcher, CV; Flynn, PM; Harris, DR; Havens, PL; Kapogiannis, BG; Kiser, JJ; Liu, NX; Major-Wilson, H; Muenz, LR; Viani, RM; Wilson, CM, 2008)		0.35
"An intensive steady-state 24-h pharmacokinetic profile of atazanavir was performed in the third trimester of pregnancy and postpartum."( Atazanavir plus low-dose ritonavir in pregnancy: pharmacokinetics and placental transfer.
Airoldi, M; Bertuletti, P; Cattaneo, D; Frigerio, L; Maggiolo, F; Ripamonti, D; Ruggeri, M; Suter, F, 2007)		0.34
"96, indicating equivalence, whereas Cmax values were slightly although not significantly lower."( Atazanavir plus low-dose ritonavir in pregnancy: pharmacokinetics and placental transfer.
Airoldi, M; Bertuletti, P; Cattaneo, D; Frigerio, L; Maggiolo, F; Ripamonti, D; Ruggeri, M; Suter, F, 2007)		0.34
"Studies on the pharmacokinetic interaction between atazanavir and lopinavir with ritonavir (lopinavir/ritonavir) report contradictory results."( Atazanavir and lopinavir with ritonavir alone or in combination: analysis of pharmacokinetic interaction and predictors of drug exposure.
Bacarelli, A; Cauda, R; De Luca, A; Di Giambenedetto, S; Navarra, P; Ragazzoni, E; Regazzi, M; Villani, P, 2008)		0.35
" Rats received RTV-boosted ATV or ATV-SLS SD+G for 14 d in the pharmacokinetic study."( Long-term pharmacokinetic efficacy and safety of low-dose ritonavir as a booster and atazanavir pharmaceutical formulation based on solid dispersion system in rats.
Fukushima, K; Haraya, K; Ito, Y; Sugioka, N; Takada, K; Terasaka, S, 2008)		0.35
" The objective is to study the pharmacokinetic interaction of RSV with atazanavir/ritonavir (ATV/RTV) or fosamprenavir/ritonavir (FPV/RTV)."( Effects of atazanavir/ritonavir or fosamprenavir/ritonavir on the pharmacokinetics of rosuvastatin.
Bain, AM; Bedimo, RG; Busti, AJ; Hall, RG; Leff, RD; Meek, C; Mehvar, R, 2008)		0.35
"In a prospective pharmacokinetic drug interaction study, six HIV-seronegative, healthy adult volunteers received single 10-mg doses of RSV at baseline and after 6 days of ATV/RTV and FPV/RTV, with 6-day washout periods."( Effects of atazanavir/ritonavir or fosamprenavir/ritonavir on the pharmacokinetics of rosuvastatin.
Bain, AM; Bedimo, RG; Busti, AJ; Hall, RG; Leff, RD; Meek, C; Mehvar, R, 2008)		0.35
"Compared to baseline, the area under the plasma concentration-time curve (AUC 0-24h) and maximum plasma concentration (Cmax) of RSV increased by 213% and 600%, respectively, and the time to reach Cmax was shorter (1."( Effects of atazanavir/ritonavir or fosamprenavir/ritonavir on the pharmacokinetics of rosuvastatin.
Bain, AM; Bedimo, RG; Busti, AJ; Hall, RG; Leff, RD; Meek, C; Mehvar, R, 2008)		0.35
" Conclusions Unboosted atazanavir showed a favourable pharmacokinetic profile and was able to maintain or gain immuno-virological eligibility for OLT(x) in all patients."( A pilot study on the efficacy, pharmacokinetics and safety of atazanavir in patients with end-stage liver disease.
Baroncelli, S; Bertolini, A; Bonora, S; Ciaffi, S; Cocchi, S; Codeluppi, M; D'Avolio, A; Di Benedetto, F; Esposito, R; Floridia, M; Guaraldi, G; Masetti, M; Motta, A; Pinetti, D, 2008)		0.35
"The aim of this study was to determine the population pharmacokinetic (PK) parameters of atazanavir in adult human immunodeficiency virus-infected patients to build up a Bayesian strategy for dosage regimen individualization."( Population pharmacokinetics of atazanavir in human immunodeficiency virus-infected patients.
Drogoul, MP; Gagnieu, MC; Lacarelle, B; Lafeuillade, A; Mokhtari, S; Ravaux, I; Simon, N; Solas, C, 2008)		0.35
"The purposes of this study were to assess the pharmacokinetic (PK) properties and tolerability profiles of bevirimat administered as monotherapy and in combination with atazanavir."( Pharmacokinetic properties and tolerability of bevirimat and atazanavir in healthy volunteers: an open-label, parallel-group study.
Doto, J; Ellis, C; Galbraith, H; Martin, DE; Schettler, J, 2008)		0.35
"This was an open-label, three-session, pharmacokinetic trial."( Pharmacokinetics of atazanavir/ritonavir once daily and lopinavir/ritonavir twice and once daily over 72 h following drug cessation.
Back, D; Boffito, M; Else, L; Gazzard, B; Khoo, S; Moyle, G; Pozniak, A; Sousa, M; Taylor, J, 2008)		0.35
"This study investigated the pharmacokinetic forgiveness of two boosted protease inhibitors."( Pharmacokinetics of atazanavir/ritonavir once daily and lopinavir/ritonavir twice and once daily over 72 h following drug cessation.
Back, D; Boffito, M; Else, L; Gazzard, B; Khoo, S; Moyle, G; Pozniak, A; Sousa, M; Taylor, J, 2008)		0.35
"Several dose-finding studies of boosted protease inhibitors have demonstrated that doses lower than those recommended in Caucasian populations exhibit in the Thai population similar pharmacokinetic (PK) properties with sustained virological suppression but reduced toxicity."( A low dose of ritonavir-boosted atazanavir provides adequate pharmacokinetic parameters in HIV-1-infected Thai adults.
Avihingsanon, A; Burger, DM; Chanmano, S; Cooper, DA; Gorowara, M; Kerr, SJ; Lange, J; Ohata, P; Phanuphak, P; Ruxrungtham, K; van der Lugt, J, 2009)		0.35
"The aim of this study was to develop and validate a population pharmacokinetic model to: (i) describe ritonavir-boosted atazanavir concentrations (300/100 mg once daily) and identify important covariates; and (ii) evaluate the predictive performance of the model for lower, unlicensed atazanavir doses (150 and 200 mg once daily) boosted with ritonavir (100 mg once daily)."( Population pharmacokinetics of ritonavir-boosted atazanavir in HIV-infected patients and healthy volunteers.
Aarons, L; Back, D; Boffito, M; Davies, G; Dickinson, L; Else, L; Khoo, S; Pozniak, A; Waters, L, 2009)		0.35
"Non-linear mixed effects modelling was applied to determine atazanavir pharmacokinetic parameters, inter-individual variability (IIV) and residual error."( Population pharmacokinetics of ritonavir-boosted atazanavir in HIV-infected patients and healthy volunteers.
Aarons, L; Back, D; Boffito, M; Davies, G; Dickinson, L; Else, L; Khoo, S; Pozniak, A; Waters, L, 2009)		0.35
"A population pharmacokinetic model for ritonavir-boosted atazanavir has been developed and validated."( Population pharmacokinetics of ritonavir-boosted atazanavir in HIV-infected patients and healthy volunteers.
Aarons, L; Back, D; Boffito, M; Davies, G; Dickinson, L; Else, L; Khoo, S; Pozniak, A; Waters, L, 2009)		0.35
" We performed a population pharmacokinetic analysis with NONMEM and determined that the steady-state pharmacokinetics of saquinavir in 136 HIV type 1-infected adults was modulated by a decrease in saquinavir CL following coadministration of the cytochrome P450 3A inhibitors ritonavir and atazanavir."( Cytochrome P450 3A inhibition by atazanavir and ritonavir, but not demography or drug formulation, influences saquinavir population pharmacokinetics in human immunodeficiency virus type 1-infected adults.
Lötsch, J; von Hentig, N, 2009)		0.35
"A phase 1, open-label, randomized, crossover, drug interaction study was conducted to assess the pharmacokinetic effects of coadministration of posaconazole (400 mg twice daily), with atazanavir (ATV) (300 mg/d alone) and with ritonavir (100 mg/d) or with efavirenz (400 mg/d) in healthy volunteers."( Effects of oral posaconazole on the pharmacokinetics of atazanavir alone and with ritonavir or with efavirenz in healthy adult volunteers.
Krishna, G; Ma, L; Martinho, M; McLeod, J; Moton, A; Seiberling, M, 2009)		0.35
"Subjects underwent 24-hour pharmacokinetic sampling at baseline and on day 14 of each treatment period."( Pharmacokinetics of concurrent administration of fosamprenavir and atazanavir without ritonavir in human immunodeficiency virus-negative subjects.
Anderson, PL; Clay, PG; Glaros, AG; McRae, M, 2009)		0.35
" Participants received atazanavir 400 mg daily for 7 days followed by atazanavir/ritonavir 300 mg/100 mg daily for 7 days with pharmacokinetic studies on days 7 and 14."( Atazanavir pharmacokinetics in genetically determined CYP3A5 expressors versus non-expressors.
Anderson, PL; Aquilante, CL; Bushman, LR; Gardner, EM; MaWhinney, S; McDaneld, P; Predhomme, J; Ray, M; Zheng, JH, 2009)		0.35
" The aim of this study was to develop a population pharmacokinetic analysis to quantify the impact of 63396C→T and diurnal variation on ATV clearance."( Population pharmacokinetic modeling of the association between 63396C->T pregnane X receptor polymorphism and unboosted atazanavir clearance.
Back, DJ; Baietto, L; Bonora, S; Chierakul, N; Chuchuttaworn, C; Cuenca, L; D'Avolio, A; Davies, G; Di Perri, G; Dvorak, AM; Hoskins, JM; Khoo, S; McLeod, HL; Owen, A; Rodríguez Novoa, S; Saguenwong, N; Schipani, A; Siccardi, M; Simiele, M; Soriano, V, 2010)		0.36
" A pharmacokinetic study was performed in 22 HIV-infected adults treated with 400 mg RAL plus 300 mg ATV 300 twice a day."( Exposure-related effects of atazanavir on the pharmacokinetics of raltegravir in HIV-1-infected patients.
Baldelli, S; Cattaneo, D; Clementi, E; Conti, F; Cozzi, V; Ripamonti, D, 2010)		0.36
"Intensive steady-state 24-hour pharmacokinetic profiles were performed during the third trimester and at 6-12 weeks postpartum."( Atazanavir pharmacokinetics with and without tenofovir during pregnancy.
Basar, M; Best, BM; Burchett, SK; Capparelli, EV; Hawkins, E; Hu, C; Mirochnick, M; Read, JS; Rossi, SS; Smith, E; Stek, AM, 2011)		0.37
"S/GSK1349572 is an unboosted, once daily, next generation integrase inhibitor with potent activity, low pharmacokinetic (PK) variability and a novel resistance profile."( Effect of atazanavir and atazanavir/ritonavir on the pharmacokinetics of the next-generation HIV integrase inhibitor, S/GSK1349572.
Borland, J; Chen, S; Lou, Y; Min, S; Peppercorn, A; Piscitelli, SC; Song, I; Wajima, T, 2011)		0.37
" Intensive pharmacokinetic sampling occurred 7 days after starting ATV."( Atazanavir and atazanavir/ritonavir pharmacokinetics in HIV-infected infants, children, and adolescents.
Aldrovandi, G; Brundage, RC; Fenton, T; Fletcher, CV; Graham, B; Kiser, JJ; Mofenson, LM; Rutstein, RM; Samson, P; Schnittman, S; Smith, E, 2011)		0.37
"Cohorts satisfied protocol-defined pharmacokinetic criteria if the median ATV AUC0-24hr was 60 μg × h/ml or less, and AUC0-24hr and ATV concentrations 24-h postdose (C24) were more than 30 μg × h/ml and at least 60 ng/ml, respectively, in at least 80% of the children, with no individual AUC0-24hr less than 15 μg × h/ml."( Atazanavir and atazanavir/ritonavir pharmacokinetics in HIV-infected infants, children, and adolescents.
Aldrovandi, G; Brundage, RC; Fenton, T; Fletcher, CV; Graham, B; Kiser, JJ; Mofenson, LM; Rutstein, RM; Samson, P; Schnittman, S; Smith, E, 2011)		0.37
"Unboosted ATV capsules satisfied pharmacokinetic criteria at a dose of 520 mg/m for those aged more than 2 to 13 years or less and 620 mg/m for those aged more than 13 to 21 years or less."( Atazanavir and atazanavir/ritonavir pharmacokinetics in HIV-infected infants, children, and adolescents.
Aldrovandi, G; Brundage, RC; Fenton, T; Fletcher, CV; Graham, B; Kiser, JJ; Mofenson, LM; Rutstein, RM; Samson, P; Schnittman, S; Smith, E, 2011)		0.37
" A total of 151 ATV plasma concentrations were obtained, and a population pharmacokinetic model was developed with NONMEM."( Population pharmacokinetics of atazanavir/ritonavir in HIV-1-infected children and adolescents.
Blanche, S; Dollfus, C; Firtion, G; Foissac, F; Hirt, D; Laurent, C; Treluyer, JM; Urien, S, 2011)		0.37
" We report the pharmacokinetic parameters of tenofovir in combination with efavirenz, darunavir-ritonavir, or atazanavir-ritonavir in HIV-infected children."( Steady-state pharmacokinetics of tenofovir-based regimens in HIV-infected pediatric patients.
Acosta, EP; Britto, P; Carey, V; Graham, B; Hazra, R; Jean-Philippe, P; King, JR; Wiznia, A; Yogev, R, 2011)		0.37
" Full pharmacokinetic profiles were assessed for each phase for the 72 h following day 10."( Pharmacokinetics of once-daily darunavir-ritonavir and atazanavir-ritonavir over 72 hours following drug cessation.
Amara, A; Back, D; Boffito, M; Gazzard, B; Higgs, C; Jackson, A; Khoo, S; Moyle, G; Seymour, N, 2011)		0.37
"Significant pharmacokinetic interactions can result between acid-suppressing agents and some protease inhibitors (PIs) in the management of HIV infection."( Effects of the H2-receptor antagonist famotidine on the pharmacokinetics of atazanavir-ritonavir with or without tenofovir in HIV-infected patients.
Bertz, R; Boffito, M; Child, M; Chung, E; Kashuba, A; Mahnke, L; Patterson, K; Tebas, P; Wang, X; Wu, Y; Zhang, J; Zhu, L, 2011)		0.37
" ATV and RAL demonstrated considerable pharmacokinetic variability."( A randomized study of pharmacokinetics, efficacy, and safety of 2 raltegravir plus atazanavir strategies in ART-treated adults.
Beileiter, K; Bloch, M; Boyd, MA; Carey, D; Cooper, DA; Emery, S; MacRae, K; Pett, SL; Ray, JE; Wand, H, 2012)		0.38
"The objective of this study was to develop a simultaneous population pharmacokinetic (PK) model to describe atazanavir/ritonavir (ATV/RTV) PK (300/100 mg) and to assess the effect of RTV dose reduction on ATV PK."( Simultaneous population pharmacokinetic modelling of atazanavir and ritonavir in HIV-infected adults and assessment of different dose reduction strategies.
Austin, R; Back, D; Boffito, M; Davies, G; Dickinson, L; Khoo, S; Owen, A; Schipani, A, 2013)		0.39
"This is the first pharmacokinetic modelling of antiretroviral disposition in BP and CVF."( Pharmacokinetic modelling of efavirenz, atazanavir, lamivudine and tenofovir in the female genital tract of HIV-infected pre-menopausal women.
Cohen, MS; Dumond, JB; Forrest, A; Garonzik, SM; Kashuba, AD; Kendrick, RN; Nicol, MR; Patterson, KB, 2012)		0.38
"Boceprevir represents a new treatment option for hepatitis C (HCV)-infected patients, including those with HCV/human immunodeficiency virus coinfection; however, little is known about pharmacokinetic interactions between boceprevir and antiretroviral drugs."( Pharmacokinetic interactions between the hepatitis C virus protease inhibitor boceprevir and ritonavir-boosted HIV-1 protease inhibitors atazanavir, darunavir, and lopinavir.
Butterton, JR; Feng, HP; Hughes, EA; Hulskotte, EG; O'Mara, E; Treitel, MA; van Zutven, MG; Wagner, JA; Xuan, F; Youngberg, SP, 2013)		0.39
"A randomized, open-label study to assess the pharmacokinetic interactions between boceprevir and ritonavir-boosted protease inhibitors (PI/r) was conducted in 39 healthy adults."( Pharmacokinetic interactions between the hepatitis C virus protease inhibitor boceprevir and ritonavir-boosted HIV-1 protease inhibitors atazanavir, darunavir, and lopinavir.
Butterton, JR; Feng, HP; Hughes, EA; Hulskotte, EG; O'Mara, E; Treitel, MA; van Zutven, MG; Wagner, JA; Xuan, F; Youngberg, SP, 2013)		0.39
"International Maternal Pediatric Adolescent AIDS Clinical Trials Group 1026s is a prospective, nonblinded, pharmacokinetic study of HIV-infected pregnant women taking antiretrovirals for clinical indications, including 2 cohorts (with or without tenofovir) receiving atazanavir/ritonavir 300/100 mg once daily during the second trimester, 400/100 mg during the third trimester, and 300/100 mg postpartum (PP)."( Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy.
Best, BM; Burchett, SK; Byroads, M; Caparelli, E; Cressey, TR; Hawkins, E; Kreitchmann, R; Mirochnick, M; Rossi, S; Shapiro, DE; Smith, E; Stek, A; Wang, J; Watts, DH, 2013)		0.39
"Atazanavir pharmacokinetic data were available for 37 women without tenofovir, 35 with tenofovir; median (range) pharmacokinetic parameters are presented for second trimester, third trimester, and PP and number who met target/total."( Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy.
Best, BM; Burchett, SK; Byroads, M; Caparelli, E; Cressey, TR; Hawkins, E; Kreitchmann, R; Mirochnick, M; Rossi, S; Shapiro, DE; Smith, E; Stek, A; Wang, J; Watts, DH, 2013)		0.39
" Noncompartmental pharmacokinetic analysis was used to estimate PK parameters [area under the concentration-time curve over 24 h (AUC0-24h ) and maximal concentration (Cmax )]."( Pharmacokinetics of two common antiretroviral regimens in older HIV-infected patients: a pilot study.
Adams, JL; Corbett, AH; Dumond, JB; Forrest, A; Jennings, SH; Kashuba, AD; Kendrick, RL; Malone, S; Patterson, KB; Prince, HM; Sykes, C; Wang, R; White, N, 2013)		0.39
" Compared with the general population, these elderly subjects had 8-13% decreased TFV AUC0-24h and Cmax , and 19-78% increased FTC and RTV AUC0-24h and Cmax ."( Pharmacokinetics of two common antiretroviral regimens in older HIV-infected patients: a pilot study.
Adams, JL; Corbett, AH; Dumond, JB; Forrest, A; Jennings, SH; Kashuba, AD; Kendrick, RL; Malone, S; Patterson, KB; Prince, HM; Sykes, C; Wang, R; White, N, 2013)		0.39
"To investigate the pharmacokinetic and pharmacodynamic relationships of the human immunodeficiency virus (HIV)-protease inhibitor atazanavir (ATV) in the presence and absence of the pharmacokinetic booster ritonavir, utilizing ATV plasma trough concentrations (Ctrough ) and clinical biomarkers of antiviral efficacy and safety over 48 weeks."( Pharmacokinetics and pharmacodynamics of atazanavir-containing antiretroviral regimens, with or without ritonavir, in patients who are HIV-positive and treatment-naïve.
Bertz, RJ; Chung, E; Grasela, D; McGrath, D; Persson, A; Zhang, J; Zhu, L, 2013)		0.39
" Pharmacokinetics and drug-drug interaction were simulated using the full physiologically based pharmacokinetic model implemented in the Simcyp™ ADME simulator."( Prediction of drug-drug interactions between various antidepressants and efavirenz or boosted protease inhibitors using a physiologically based pharmacokinetic modelling approach.
Almond, L; Back, D; Khoo, S; Kirov, A; Marzolini, C; Owen, A; Seden, K; Siccardi, M, 2013)		0.39
" Although the simulated drug-drug interactions with antidepressants were overall weak to moderate according to the classification of the US FDA, fluoxetine and venlafaxine represent better candidates from a pharmacokinetic standpoint for patients on efavirenz and venlafaxine or citalopram for patients on boosted protease inhibitors."( Prediction of drug-drug interactions between various antidepressants and efavirenz or boosted protease inhibitors using a physiologically based pharmacokinetic modelling approach.
Almond, L; Back, D; Khoo, S; Kirov, A; Marzolini, C; Owen, A; Seden, K; Siccardi, M, 2013)		0.39
"A qd regimen of raltegravir 800 mg, atazanavir 600 mg and lamivudine or emtricitabine resulted in favourable pharmacokinetic profiles and good short-term safety and efficacy data."( Pharmacokinetics of the combination raltegravir/atazanavir in HIV-1-infected patients.
Burger, DM; Colbers, EP; Jansen, A; Richter, C; Rockstroh, JK; van der Ven, AJ; van Luin, M; Wasmuth, JC, 2013)		0.39
"The evidence to date does not support major pharmacokinetic changes in adults between ∼ 20 and 60 years of age."( Clinical pharmacokinetics of antiretroviral drugs in older persons.
Anderson, PL; Erlandson, KM; Schoen, JC, 2013)		0.39
" Although there were no significant changes in conjugated bilirubin, unconjugated bilirubin Cmax and AUC(0-24) of were lower (17 and 19%, phase 2; 20 and 23% during phase 3)."( Coadministration of atazanavir-ritonavir and zinc sulfate: impact on hyperbilirubinemia and pharmacokinetics.
Back, D; Boffito, M; Else, L; Gazzard, B; Jackson, A; Karolia, Z; Moyle, G; Ringner-Nackter, L; Seymour, N; Yapa, MH, 2013)		0.39
" We conducted a cross-sectional study of HIV-positive women to determine if protease inhibitor (PI) and non-nucleoside reverse transcriptase inhibitor (NNRTI) C(min) and Cmax values were significantly different than historical general population (predominantly male) averages and to evaluate correlates of higher concentrations."( Factors affecting antiretroviral pharmacokinetics in HIV-infected women with virologic suppression on combination antiretroviral therapy: a cross-sectional study.
Angel, JB; Blitz, SL; Burdge, D; Cohen, J; Conway, B; de Pokomandy, A; Gough, K; Haase, D; Klein, MB; la Porte, CJ; Loemba, H; Loutfy, MR; Pick, N; Raboud, J; Rachlis, AR; Smaill, FM; Trottier, S; Tseng, AL; Walmsley, SL, 2013)		0.39
" Timed blood samples for C(min) and Cmax were drawn weekly for 3 weeks."( Factors affecting antiretroviral pharmacokinetics in HIV-infected women with virologic suppression on combination antiretroviral therapy: a cross-sectional study.
Angel, JB; Blitz, SL; Burdge, D; Cohen, J; Conway, B; de Pokomandy, A; Gough, K; Haase, D; Klein, MB; la Porte, CJ; Loemba, H; Loutfy, MR; Pick, N; Raboud, J; Rachlis, AR; Smaill, FM; Trottier, S; Tseng, AL; Walmsley, SL, 2013)		0.39
"Compared to historical control data, C(min) in the women enrolled was significantly higher whereas Cmax was significantly lower."( Factors affecting antiretroviral pharmacokinetics in HIV-infected women with virologic suppression on combination antiretroviral therapy: a cross-sectional study.
Angel, JB; Blitz, SL; Burdge, D; Cohen, J; Conway, B; de Pokomandy, A; Gough, K; Haase, D; Klein, MB; la Porte, CJ; Loemba, H; Loutfy, MR; Pick, N; Raboud, J; Rachlis, AR; Smaill, FM; Trottier, S; Tseng, AL; Walmsley, SL, 2013)		0.39
"The pharmacokinetic data support coadministration of daclatasvir with atazanavir/ritonavir, efavirenz and/or tenofovir."( Assessment of pharmacokinetic interactions of the HCV NS5A replication complex inhibitor daclatasvir with antiretroviral agents: ritonavir-boosted atazanavir, efavirenz and tenofovir.
Bertz, R; Bifano, M; Grasela, D; Hartstra, J; Hwang, C; Kandoussi, H; Oosterhuis, B; Sevinsky, H; Tiessen, R; Velinova-Donga, M, 2013)		0.39
" They are characterized by highly cooperative dose-response curves that are not explained by current pharmacodynamic theory."( Multi-step inhibition explains HIV-1 protease inhibitor pharmacodynamics and resistance.
Bailey, JR; Chioma, S; Durand, CM; Laird, GM; Laskey, S; Moore, RD; Rabi, SA; Shan, L; Siliciano, RF, 2013)		0.39
"Cobicistat (Tybost™) is a mechanism-based inhibitor of cytochrome P450 (CYP) 3A enzymes that is indicated in the EU as a pharmacokinetic enhancer (i."( Cobicistat: a review of its use as a pharmacokinetic enhancer of atazanavir and darunavir in patients with HIV-1 infection.
Deeks, ED, 2014)		0.4
" Use of ritonavir as a pharmacokinetic enhancer may have abrogated genetic associations with atazanavir pharmacokinetics."( Genomewide association study of atazanavir pharmacokinetics and hyperbilirubinemia in AIDS Clinical Trials Group protocol A5202.
Daar, ES; Haas, DW; Johnson, DH; McLaren, PJ; Morse, GD; Ritchie, MD; Venuto, C, 2014)		0.4
" The authors studied ATV pharmacokinetic (PK) parameters among children who received atazanavir/ritonavir co-administered with TDF."( Pharmacokinetics of atazanavir/ritonavir among HIV-infected Thai children concomitantly taking tenofovir disoproxil fumarate.
Ananworanich, J; Bunupuradah, T; Keadpudsa, S; Prasitsuebsai, W; Puthanakit, T; Sahakijpicharn, T; Srimuan, A; Techasaensiri, C; Thammajaruk, N, 2014)		0.4
" Such formulations would serve to extend the drug half-life while improving the pharmacokinetic profile and biodistribution to reservoirs of human immunodeficiency virus (HIV) infection."( Pharmacokinetics, biodistribution, and toxicity of folic acid-coated antiretroviral nanoformulations.
Alnouti, Y; Balkundi, S; Fox, HS; Gautam, N; Gendelman, HE; Liu, XM; McMillan, J; Puligujja, P; Thakare, R, 2014)		0.4
"Long-acting nanoformulated antiretroviral therapy (nanoART) that targets monocyte-macrophages could improve the drug's half-life and protein-binding capacities while facilitating cell and tissue depots."( Pharmacodynamics of long-acting folic acid-receptor targeted ritonavir-boosted atazanavir nanoformulations.
Bade, AN; Baldridge, HM; Balkundi, SS; Dash, PK; Dimitrov, DS; Feng, Y; Gendelman, HE; Gorantla, S; Hilaire, JR; Kendrick, LM; Liu, XM; McMillan, JM; Poluektova, LY; Puligujja, P; Wang, Y; Ying, T; Zhang, G, 2015)		0.42
" From the interaction between atazanavir and DTG via CYP3A4 and UGT1A1 and placental efflux transporter inhibition and considering the infant's probable enzymatic immaturity, the DTG elimination half-life was estimated to be 4-fold longer in neonates than in adults."( Pharmacokinetics of dolutegravir in a premature neonate after HIV treatment intensification during pregnancy.
Amiel, C; Caseris, M; Charpentier, C; Descamps, D; Desnoyer, A; Farnoux, C; Lassel, L; Lê, MP; Pain, JB; Peytavin, G; Pialoux, G, 2015)		0.42
" Similarly, coadministration of BMS-663068 with RTV increased the BMS-626529 Cmax and AUCtau by 53% and 45%, respectively."( Pharmacokinetic interactions between BMS-626529, the active moiety of the HIV-1 attachment inhibitor prodrug BMS-663068, and ritonavir or ritonavir-boosted atazanavir in healthy subjects.
Bertz, R; Furlong, M; Hanna, GJ; Hruska, M; Hwang, C; Landry, IS; Shah, V; Zhu, L, 2015)		0.42
"Tenofovir is an efficacious drug with a long half-life and high activity against both HIV and HBV."( Population pharmacokinetics of tenofovir in HIV/HBV co-infected patients.
Avihingsanon, A; Burger, D; Lewin, SR; Matthews, G; Punyawudho, B; Ruxrungtham, K; Thammajaruk, N; Thongpeang, P, 2015)		0.42
" The population pharmacokinetic model of tenofovir was developed by a nonlinear mixed-effects modeling approach (NONMEM®)."( Population pharmacokinetics of tenofovir in HIV/HBV co-infected patients.
Avihingsanon, A; Burger, D; Lewin, SR; Matthews, G; Punyawudho, B; Ruxrungtham, K; Thammajaruk, N; Thongpeang, P, 2015)		0.42
"Population pharmacokinetic (PopPK) analyses often rely on steady state and full adherence to prescribed dosage regimen assumptions from data gathered during therapeutic drug monitoring (TDM)."( Comparison of Population Pharmacokinetics Based on Steady-State Assumption Versus Electronically Monitored Adherence to Lopinavir, Atazanavir, Efavirenz, and Etravirine: A Retrospective Study.
Buclin, T; Bugnon, O; Cavassini, M; Csajka, C; Fuchs, A; Rotzinger, A; Schneider, MP, 2016)		0.43
"The aim of the present study was to develop a simultaneous population pharmacokinetic model for atazanavir (ATV) incorporating the effect of ritonavir (RTV) on clearance to predict ATV concentrations under different dosing regimens in HIV-1-infected patients."( Population pharmacokinetic modelling of the changes in atazanavir plasma clearance caused by ritonavir plasma concentrations in HIV-1 infected patients.
Cedeño, S; Clotet, B; Estévez, JA; Miranda, C; Moltó, J; Valle, M, 2016)		0.43
" A population pharmacokinetic model was constructed using nonlinear mixed-effects modelling and used to simulate six dosing scenarios."( Population pharmacokinetic modelling of the changes in atazanavir plasma clearance caused by ritonavir plasma concentrations in HIV-1 infected patients.
Cedeño, S; Clotet, B; Estévez, JA; Miranda, C; Moltó, J; Valle, M, 2016)		0.43
"Different concentration decay patterns were seen for atazanavir and darunavir, which may be partially explained by cobicistat half-life (longer with atazanavir than darunavir)."( Once-daily atazanavir/cobicistat and darunavir/cobicistat exposure over 72 h post-dose in plasma, urine and saliva: contribution to drug pharmacokinetic knowledge.
Amara, A; Boffito, M; Elliot, ER; Else, L; Higgs, C; Khoo, S; Moyle, G; Pagani, N; Schoolmeesters, A, 2017)		0.46
"A literature search of MEDLINE was performed (1985 to April 2017) using the following search terms: cobicistat, ritonavir, pharmacokinetic, drug interactions, booster, pharmacokinetic enhancer, HIV, antiretrovirals."( Cobicistat Versus Ritonavir: Similar Pharmacokinetic Enhancers But Some Important Differences.
Hughes, CA; Phillips, EJ; Seet, J; Tseng, A; Wu, J, 2017)		0.46
" Pharmacokinetic properties of the boosted antiretroviral can also affect interaction outcome with comedications."( Cobicistat Versus Ritonavir: Similar Pharmacokinetic Enhancers But Some Important Differences.
Hughes, CA; Phillips, EJ; Seet, J; Tseng, A; Wu, J, 2017)		0.46
" Thus, we investigated the chronic inflammatory state associated with HIV infection as a source of pharmacokinetic variability of atazanavir."( Inflammation investigated as a source of pharmacokinetic variability of atazanavir in AIDS Clinical Trials Group protocol A5224s.
Hunt, PW; Lim, J; McComsey, GA; Messing, S; Morse, GD; Venuto, CS, 2018)		0.48
"Intensive 24-hour pharmacokinetic profiles at steady state compared ATV exposures (area under the concentration-time curve in one dosing interval) in 5 ATV + RTV baseline weight-band dosing categories, with historic data in adults receiving ATV + RTV 300/100 mg capsules."( Pharmacokinetics and Pharmacodynamics of Atazanavir in HIV-1-Infected Children Treated With Atazanavir Powder and Ritonavir: Combined Analysis of the PRINCE-1 and -2 Studies.
Correll, TA; Eley, T; Pikora, C; Sevinsky, H; Wang, R; Xu, X; Zaru, L, 2018)		0.48
" A chromatographic method coupled with tandem mass spectrometry was applied to analyze ATV plasma concentrations in a pharmacokinetic sub-study from the MODAt trial."( Potential associations between atazanavir exposure and clinical outcome: a pharmacokinetic sub-study from the MODAt randomized trial.
Baldelli, S; Castagna, A; Cattaneo, D; Clementi, E; Colella, E; Galli, L; Galli, M; Lazzarin, A; Rusconi, S; Spagnuolo, V, 2018)		0.48
"We did a parallel, three-group, pharmacokinetic evaluation at HIV clinics in Asia (two sites), South America (five), sub-Saharan Africa (three), and the USA (11) between Dec 30, 2014, and Sept 12, 2016."( Antiretroviral therapy and vaginally administered contraceptive hormones: a three-arm, pharmacokinetic study.
Akelo, V; Aweeka, F; Aziz, M; Berzins, B; Cohn, SE; Coombs, RW; Coughlin, K; Cramer, YS; Friedman, RK; Gingrich, D; Godfrey, C; Moran, LE; Rosenkranz, SL; Scarsi, KK; Swaminathan, S; Zorrilla, CD, 2019)		0.51
" Further studies designed to examine pharmacodynamic endpoints, such as ovulation, when intravaginal ring hormones are combined with efavirenz are warranted."( Antiretroviral therapy and vaginally administered contraceptive hormones: a three-arm, pharmacokinetic study.
Akelo, V; Aweeka, F; Aziz, M; Berzins, B; Cohn, SE; Coombs, RW; Coughlin, K; Cramer, YS; Friedman, RK; Gingrich, D; Godfrey, C; Moran, LE; Rosenkranz, SL; Scarsi, KK; Swaminathan, S; Zorrilla, CD, 2019)		0.51
" Pharmacokinetic modelling can explore utility of drug in hair."( A population pharmacokinetic model is beneficial in quantifying hair concentrations of ritonavir-boosted atazanavir: a study of HIV-infected Zimbabwean adolescents.
Chawana, TD; Ngara, B; Nhachi, CFB; Rusakaniko, S; Stray-Pedersen, B; Zvada, S, 2020)		0.56
" However, interaction of both drugs, with Cytochrome P 3A4 (CYP 3A4) isoenzyme, may spawn clinically significant pharmacokinetic interactions."( Evaluation of the effects of atazanavir-ritonavir on the pharmacokinetics of lumefantrine in patients living with HIV in Lagos University Teaching Hospital, South-Western Nigeria.
Abideen, G; Adewumi, OO; Agbaje, EO; Akanmu, AS; Akinleye, MO; Akinyede, A; Busari, AA; Hassan, OO; Kadri, MR; Oreagba, IA; Usman, SO, 2021)		0.62
" The concentration of lumefantrine in each sample was quantified with high-performance liquid chromatography (HPLC) and used to determine its pharmacokinetic parameters which were compared between the test and control groups."( Evaluation of the effects of atazanavir-ritonavir on the pharmacokinetics of lumefantrine in patients living with HIV in Lagos University Teaching Hospital, South-Western Nigeria.
Abideen, G; Adewumi, OO; Agbaje, EO; Akanmu, AS; Akinleye, MO; Akinyede, A; Busari, AA; Hassan, OO; Kadri, MR; Oreagba, IA; Usman, SO, 2021)		0.62
"3) ADVAN 13, based on a previously established pharmacokinetic model."( Pharmacokinetic-pharmacodynamic modelling of atazanavir in hair among adolescents on antiretroviral treatment in Zimbabwe.
Chawana, TD; Ngara, B; Nhachi, CFB; Rusakaniko, S; Zvada, S, 2021)		0.62
"Intensive steady-state 24-hour pharmacokinetic profiles were performed after administration of 300 mg of atazanavir and 150 mg of cobicistat orally in fixed-dose combination once daily during the second trimester, third trimester, and postpartum."( Pharmacokinetics of Atazanavir Boosted With Cobicistat in Pregnant and Postpartum Women With HIV.
Badell, ML; Best, BM; Browning, R; Capparelli, EV; Chakhtoura, N; Denson, K; George, K; Mirochnick, M; Momper, JD; Paul, ME; Powis, KM; Rungruengthanakit, K; Shapiro, DE; Stek, A; Wang, J, 2022)		0.72
"This is an open-label, randomized, fixed sequence single intravenous dosing study to assess pharmacokinetic interactions between remdesivir and TDF/3TC (Study A, crossover design) or TDF/3TC plus ATV/r (Study B)."( An open-label, randomized, single intravenous dosing study to investigate the effect of fixed-dose combinations of tenofovir/lamivudine or atazanavir/ritonavir on the pharmacokinetics of remdesivir in Ugandan healthy volunteers (RemTLAR).
Byakika-Kibwika, P; D'Avolio, A; Kaboggoza, JP; Lamorde, M; Waitt, C; Walimbwa, SI, 2021)		0.62
" Furthermore, this study will deliver pharmacokinetic datasets for remdesivir drug concentrations and demographic characteristics which could support pharmacometric approaches for simulation of remdesivir treatment regimens in patients concurrently using tenofovir/lamivudine and/or atazanavir/ritonavir."( An open-label, randomized, single intravenous dosing study to investigate the effect of fixed-dose combinations of tenofovir/lamivudine or atazanavir/ritonavir on the pharmacokinetics of remdesivir in Ugandan healthy volunteers (RemTLAR).
Byakika-Kibwika, P; D'Avolio, A; Kaboggoza, JP; Lamorde, M; Waitt, C; Walimbwa, SI, 2021)		0.62
" 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

ExcerptReferenceRelevance
" To assess the potential of this inhibitor when used in combination with other antiretrovirals, BMS-232632 was evaluated for anti-HIV activity in two-drug combination studies."( BMS-232632, a highly potent human immunodeficiency virus protease inhibitor that can be used in combination with other available antiretroviral agents.
Blair, WS; Colonno, RJ; Deminie, CA; Djang, F; Gong, YF; Guo, Q; Lin, PF; Riccardi, KA; Robinson, BS; Stock, DA; Terry, BJ, 2000)		0.31
"Three dose levels of the protease inhibitor (PI) atazanavir (200, 400, and 500 mg once daily) were compared with nelfinavir (750 mg three times daily) when given both as monotherapy and in combination with didanosine and stavudine in 420 antiretroviral-naive subjects infected with HIV-1."( Results of a phase 2 clinical trial at 48 weeks (AI424-007): a dose-ranging, safety, and efficacy comparative trial of atazanavir at three doses in combination with didanosine and stavudine in antiretroviral-naive subjects.
Piliero, P; Sanne, I; Schnittman, S; Squires, K; Thiry, A, 2003)		0.32
"A randomized, double-blind, double-dummy, active-controlled, 2-arm study comparing the antiviral efficacy and safety of atazanavir 400 mg administered once daily with efavirenz 600 mg administered once daily in combination with open-label fixed-dose zidovudine plus lamivudine twice daily."( Comparison of once-daily atazanavir with efavirenz, each in combination with fixed-dose zidovudine and lamivudine, as initial therapy for patients infected with HIV.
Delfraissy, JF; Gatell, JM; Giordano, M; Jemsek, J; Lazzarin, A; Pokrovskiy, V; Powderly, WG; Rivero, A; Rozenbaum, W; Schrader, S; Sension, M; Squires, K; Thiry, A; Vibhagool, A, 2004)		0.32
"The aim of this pilot study was to examine the pharmacokinetics of atazanavir (ATV) when given in combination with amprenavir (APV) or saquinavir hard-gel capsules (SQV) to human immunodeficiency virus (HIV)-positive patients."( Steady-state pharmacokinetics of atazanavir given alone or in combination with saquinavir hard-gel capsules or amprenavir in HIV-1-infected patients.
Castagna, A; Cusato, M; Fusetti, G; Galli, A; Gianotti, N; Guffanti, M; Lazzarin, A; Regazzi, M; Seminari, E; Villani, P, 2005)		0.33
"Of the patients, 12 received ATV as a single protease inhibitor; 12 received ATV in combination with APV; and 10 in combination with SQV."( Steady-state pharmacokinetics of atazanavir given alone or in combination with saquinavir hard-gel capsules or amprenavir in HIV-1-infected patients.
Castagna, A; Cusato, M; Fusetti, G; Galli, A; Gianotti, N; Guffanti, M; Lazzarin, A; Regazzi, M; Seminari, E; Villani, P, 2005)		0.33
"HIV-positive patients with CD4 cell counts > or = 100 cells/mm3 were randomized to 1 of 2 treatment arms: (1) atazanavir, 400 mg given once daily, plus efavirenz placebo; or (2) efavirenz, 600 mg given once daily, plus atazanavir placebo; each drug was administered with fixed-dose zidovudine (300 mg) and lamivudine (150 mg) given twice daily, and patients were treated for at least 48 weeks."( Body fat and other metabolic effects of atazanavir and efavirenz, each administered in combination with zidovudine plus lamivudine, in antiretroviral-naive HIV-infected patients.
Arathoon, E; Arlotti, M; Giordano, M; Jemsek, JG; Noor, MA; Perez, C; Pokrovskiy, V; Soccodato, M; Sosa, N; Thiry, A, 2006)		0.33
" The purpose of this study was to determine the steady-state pharmacokinetics of once-daily (qd) fosamprenavir/ritonavir (FPV/r) and atazanavir/ritonavir (ATV/r) alone and in combination with 20 mg qd omeprazole (OMP) in healthy volunteers."( Steady-state pharmacokinetics of once-daily fosamprenavir/ritonavir and atazanavir/ritonavir alone and in combination with 20 mg omeprazole in healthy volunteers.
Brower, R; Frank, I; Kim, D; Luber, AD; Peloquin, CA; Silverman, R, 2007)		0.34
"To characterize the cytochrome P450 enzyme(s) responsible for the N-dealkylation of maraviroc in vitro, and predict the extent of clinical drug-drug interactions (DDIs)."( Maraviroc: in vitro assessment of drug-drug interaction potential.
Collins, C; Dickins, M; Hyland, R; Jones, B; Jones, H, 2008)		0.35
"In this open-label, international non-inferiority study, 883 antiretroviral-naive, HIV-1-infected patients were randomly assigned to receive atazanavir/ritonavir 300/100 mg once daily (n=440) or lopinavir/ritonavir 400/100 mg twice daily (n=443), in combination with fixed-dose tenofovir/emtricitabine 300/200 mg once daily."( Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study.
Andrade-Villanueva, J; Chetchotisakd, P; Corral, J; David, N; Echevarria, J; Mancini, M; McGrath, D; Molina, JM; Moyle, G; Percival, L; Thiry, A; Yang, R, 2008)		0.35
"This 96-week, open-label, randomized study assessed changes in body composition in treatment-naive patients infected with human immunodeficiency virus type 1 who were treated with either atazanavir or ritonavir-boosted atazanavir, in combination with stavudine and lamivudine."( Changes in body composition with ritonavir-boosted and unboosted atazanavir treatment in combination with Lamivudine and Stavudine: a 96-week randomized, controlled study.
Mathew, M; McComsey, G; McGrath, D; Rightmire, A; Wirtz, V; Yang, R, 2009)		0.35
"Clinicians caring for patients infected with the human immunodeficiency virus (HIV) and diagnosed with psychiatric comorbidities must be aware of potential drug-drug interactions, particularly with protease inhibitor-based antiretroviral therapy."( Clinically significant adverse events from a drug interaction between quetiapine and atazanavir-ritonavir in two patients.
McCoy, C; Pollack, TM; Stead, W, 2009)		0.35
"International, multicenter, open-label, 96-week noninferiority randomized trial of atazanavir/ritonavir 300/100 mg once daily vs lopinavir/ritonavir 400/100 mg twice daily, each in combination with fixed-dose tenofovir/emtricitabine 300/200 mg once daily, in antiretroviral-naive, HIV-1-infected patients."( Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study.
Absalon, J; Andrade-Villanueva, J; Chetchotisakd, P; Corral, J; David, N; Echevarria, J; Lataillade, M; Mancini, M; McGrath, D; Molina, JM; Moyle, G; Percival, L; Wirtz, V; Yang, R, 2010)		0.36
" We report the results of an open-label pilot trial with unboosted atazanavir in combination with lamivudine and didanosine as first-line therapy conducted in Senegal."( Efficacy and safety of unboosted atazanavir in combination with lamivudine and didanosine in naive HIV type 1 patients in Senegal.
Benalycherif, A; Bennai, Y; Diallo, MB; Fall, MB; Girard, PM; Gueye, NF; Kane, CT; Landman, R; Mboup, S; Ndiaye, B; Peytavin, G; Sow, PS, 2010)		0.36
" Because OATP2B1 exhibits an increasing number of drug substrates, including several statins, alterations of its function by PIs could result in clinically significant drug-drug interactions in the intestine."( pH dependence of organic anion-transporting polypeptide 2B1 in Caco-2 cells: potential role in antiretroviral drug oral bioavailability and drug-drug interactions.
Bendayan, R; Kis, O; Ramaswamy, M; Zastre, JA, 2010)		0.36
" nevirapine on the same background, in naïve HIV-1-infected patients) study compared prospectively ritonavir-boosted atazanavir (ATZ/r) 300 mg/100 mg once daily (qd) with immediate release nevirapine (NVP) 200 mg twice daily or 400 mg qd, each combined with fixed-dose tenofovir 300 mg/emtricitabine 200 mg qd in 569 ARV-naïve HIV-1-infected patients."( Lipid profiles for nevirapine vs. atazanavir/ritonavir, both combined with tenofovir disoproxil fumarate and emtricitabine over 48 weeks, in treatment-naïve HIV-1-infected patients (the ARTEN study).
Andrade-Villanueva, J; Cairns, V; Clotet, B; de Rossi, L; Domingo, P; Gellermann, HJ; Podzamczer, D; Reiss, P; Rockstroh, JK; Soriano, V; Taylor, S, 2011)		0.37
"ARTEN is a randomized, open-label, non-inferiority trial that compares nevirapine (NVP) 200 mg twice daily or 400 mg once daily to atazanavir/ritonavir (ATZ/r) 300 mg/100 mg once daily, each combined with fixed-dose tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg once daily, in antiretroviral-naive HIV-1 patients with CD4(+) T-cell counts <400 (men) and <250 cells/mm(3) (women)."( Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial.
Andrade-Villanueva, J; Antunes, F; Arastéh, K; de Rossi, L; Di Perri, G; Domingo, P; Gellermann, H; Lutz, T; Migrone, H; Opravil, M; Podzamczer, D; Soriano, V; Taylor, S, 2011)		0.37
"NVP demonstrated at week 48 non-inferior antiviral efficacy compared with ATZ/r when given along with TDF/FTC, despite more drug-related discontinuations with NVP than ATZ/r."( Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial.
Andrade-Villanueva, J; Antunes, F; Arastéh, K; de Rossi, L; Di Perri, G; Domingo, P; Gellermann, H; Lutz, T; Migrone, H; Opravil, M; Podzamczer, D; Soriano, V; Taylor, S, 2011)		0.37
" In order to improve ATV exposure, plasma and intracellular (IC) PK of ATV in patients administered with ATV 400 mg once daily and TDF/emtricitabine (FTC) and switched to ATV 200 mg twice daily were studied."( Pharmacokinetics of switching unboosted atazanavir coadministered with tenofovir disoproxil fumarate from 400 mg once daily to 200 mg twice daily in HIV-positive patients.
Baietto, L; Bonora, S; Calcagno, A; D'Avolio, A; Di Perri, G; Gonzalez de Requena, D; Siccardi, M; Simiele, M; Tettoni, M; Trentini, L, 2011)		0.37
"Treatment of HIV/tuberculosis (TB) co-infected patients is complex due to drug-drug interactions for these chronic diseases."( Determination of rifabutin dosing regimen when administered in combination with ritonavir-boosted atazanavir.
Arikan, D; Bertz, R; Coumbis, J; Farajallah, A; Stonier, M; Wu, Y; Xu, X; Zhang, J; Zhu, L, 2011)		0.37
" The study was stopped because subjects experienced more severe declines in neutrophil counts when rifabutin was given with atazanavir/ritonavir than alone."( Determination of rifabutin dosing regimen when administered in combination with ritonavir-boosted atazanavir.
Arikan, D; Bertz, R; Coumbis, J; Farajallah, A; Stonier, M; Wu, Y; Xu, X; Zhang, J; Zhu, L, 2011)		0.37
"Limited data are available on the use of unboosted atazanavir in combination with nucleoside reverse transcriptase inhibitors (NRTIs) in treatment-experienced HIV-infected patients."( Efficacy and safety of a switch to unboosted atazanavir in combination with nucleoside analogues in HIV-1-infected patients with virological suppression under antiretroviral therapy.
Ammassari, A; Castagna, A; Delaugerre, C; Ghosn, J; Medrano, J; Molina, JM; Pavie, J; Porcher, R; Rusconi, S; Torti, C; Valin, N, 2011)		0.37
" NRTIs used in combination with atazanavir were tenofovir, abacavir and emtricitabine/lamivudine in 36."( Efficacy and safety of a switch to unboosted atazanavir in combination with nucleoside analogues in HIV-1-infected patients with virological suppression under antiretroviral therapy.
Ammassari, A; Castagna, A; Delaugerre, C; Ghosn, J; Medrano, J; Molina, JM; Pavie, J; Porcher, R; Rusconi, S; Torti, C; Valin, N, 2011)		0.37
"In patients with virological suppression and no prior history of virological failure, a switch to unboosted atazanavir in combination with NRTIs is associated with a low probability of virological failure and a good safety profile."( Efficacy and safety of a switch to unboosted atazanavir in combination with nucleoside analogues in HIV-1-infected patients with virological suppression under antiretroviral therapy.
Ammassari, A; Castagna, A; Delaugerre, C; Ghosn, J; Medrano, J; Molina, JM; Pavie, J; Porcher, R; Rusconi, S; Torti, C; Valin, N, 2011)		0.37
"Efficacy results were consistent with the ARTEN study demonstrating that NVP was non-inferior to ATV/r when taken in combination with TDF/FTC."( A randomised comparison of safety and efficacy of nevirapine vs. atazanavir/ritonavir combined with tenofovir/emtricitabine in treatment-naïve patients.
Bhatti, L; Conner, C; Dejesus, E; Mills, A; Storfer, S, 2011)		0.37
" Mean plasma concentration-time profiles for atazanavir, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), darunavir (DRV, administered with ritonavir [RTV]), and drospirenone/ethinylestradiol were similar following co-administration of GSK2248761."( Drug interaction profile for GSK2248761, a next generation non-nucleoside reverse transcriptase inhibitor.
de Serres, M; Gould, E; Johnson, M; Kim, J; Lou, Y; Mayers, D; Pietropaolo, K; Piscitelli, S; White, S; Zhou, XJ, 2012)		0.38
"To explore the durability of three first-line tenofovir/emtricitabine-based regimens in combination with atazanavir/ritonavir, efavirenz or lopinavir/ritonavir in HIV-1-infected patients."( Duration of first-line antiretroviral therapy with tenofovir and emtricitabine combined with atazanavir/ritonavir, efavirenz or lopinavir/ritonavir in the Italian ARCA cohort.
Borghi, V; Capetti, A; Cicconi, P; Di Biagio, A; Di Giambenedetto, S; Francisci, D; Giacometti, A; Giannarelli, D; Maggiolo, F; Monno, L; Penco, G; Prinapori, R; Sterrantino, G; Zoncada, A, 2013)		0.39
"Drug transporters such as P-glycoprotein and OATPs regulate intestinal permeability of atazanavir and may contribute to its poor oral bioavailability and drug-drug interactions with other protease inhibitors and TDF."( Role of drug efflux and uptake transporters in atazanavir intestinal permeability and drug-drug interactions.
Bendayan, R; Hoque, MT; Kis, O; Walmsley, SL; Zastre, JA, 2013)		0.39
" Although antidepressants are prescribed to a significant proportion of patients treated with antiretrovirals, there are limited clinical data on drug-drug interactions."( Prediction of drug-drug interactions between various antidepressants and efavirenz or boosted protease inhibitors using a physiologically based pharmacokinetic modelling approach.
Almond, L; Back, D; Khoo, S; Kirov, A; Marzolini, C; Owen, A; Seden, K; Siccardi, M, 2013)		0.39
" Pharmacokinetics and drug-drug interaction were simulated using the full physiologically based pharmacokinetic model implemented in the Simcyp™ ADME simulator."( Prediction of drug-drug interactions between various antidepressants and efavirenz or boosted protease inhibitors using a physiologically based pharmacokinetic modelling approach.
Almond, L; Back, D; Khoo, S; Kirov, A; Marzolini, C; Owen, A; Seden, K; Siccardi, M, 2013)		0.39
"Simulated pharmacokinetics and drug-drug interactions were in concordance with available clinical data."( Prediction of drug-drug interactions between various antidepressants and efavirenz or boosted protease inhibitors using a physiologically based pharmacokinetic modelling approach.
Almond, L; Back, D; Khoo, S; Kirov, A; Marzolini, C; Owen, A; Seden, K; Siccardi, M, 2013)		0.39
" These findings indicate that IVIVE is a useful tool for predicting drug-drug interactions and designing prospective clinical trials, giving insight into the variability of exposure, sample size and time-dependent induction or inhibition."( Prediction of drug-drug interactions between various antidepressants and efavirenz or boosted protease inhibitors using a physiologically based pharmacokinetic modelling approach.
Almond, L; Back, D; Khoo, S; Kirov, A; Marzolini, C; Owen, A; Seden, K; Siccardi, M, 2013)		0.39
" The objective of this study was to compare changes in body composition between ritonavir-boosted atazanavir (ATV/r) and ritonavir-boosted lopinavir (LPV/r) over 96 weeks using data from a substudy of CASTLE, which compared once-daily ATV/r with twice-daily LPV/r, both in combination with tenofovir disoproxil fumarate/emtricitabine in treatment-naïve patients with HIV-1 infection."( Comparison of body composition changes between atazanavir/ritonavir and lopinavir/ritonavir each in combination with tenofovir/emtricitabine in antiretroviral-naïve patients with HIV-1 infection.
DeGrosky, M; Farajallah, A; Hardy, H; McGrath, D; Moyle, GJ, 2014)		0.4
" When ATV-LNPs were prepared with ritonavir (RTV), a metabolic and cellular membrane exporter inhibitor, and tenofovir (TFV), an HIV reverse-transcriptase inhibitor, stable, scalable, and reproducible anti-HIV drug combination LNPs were produced."( Evaluation of atazanavir and darunavir interactions with lipids for developing pH-responsive anti-HIV drug combination nanoparticles.
Duan, J; Freeling, JP; Ho, RJ; Koehn, J; Shu, C, 2014)		0.4
"International, randomized double-blind active-controlled trial to evaluate the efficacy and safety of COBI vs ritonavir (RTV) as a pharmacoenhancer of atazanavir in combination with emtricitabine/tenofovir disoproxil fumarate in HIV treatment-naive patients followed through week 144."( Brief Report: Cobicistat Compared With Ritonavir as a Pharmacoenhancer for Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate: Week 144 Results.
Abram, ME; Andrade-Villanueva, JF; Antunes, F; Arastéh, K; Cao, H; Chetchotisakd, P; DeJesus, E; Fehr, J; Gallant, JE; Koenig, E; Liu, HC; Rizzardini, G; Szwarcberg, J, 2015)		0.42
"25 when administered in combination with probenecid."( Assessment of pharmacokinetic drug-drug interaction between pradigastat and atazanavir or probenecid.
Chen, J; Hanna, I; Koo, P; Majumdar, T; Mendonza, A; Meyers, D; Neelakantham, S; Rebello, S; Sunkara, G; Zhu, B, 2016)		0.43
" We report a case of an atazanavir-precipitated drug-drug interaction that led to elevated serum concentrations of lurasidone and associated clinical symptoms of drug toxicity."( A case of a probable drug interaction between lurasidone and atazanavir-based antiretroviral therapy.
Carvalhal, A; Hall, E; Naccarato, M; Ostrowski, M; Wai, A, 2016)		0.43
"Dolutegravir plasma trough concentrations were measured in 78 HIV-infected patients given the drug in combination with a protease inhibitor, a non-nucleoside reverse transcriptase inhibitor or abacavir/lamivudine."( Dolutegravir plasma concentrations according to companion antiretroviral drug: unwanted drug interaction or desirable boosting effect?
Cattaneo, D; Clementi, E; Cozzi, V; Galli, M; Gervasoni, C; Meraviglia, P; Minisci, D; Riva, A, 2017)		0.46
" Hence, potential drug-drug interactions (DDIs) may occur between these 2 drugs and antiretrovirals."( Drug-Drug Interactions Between Antiretrovirals and Carbamazepine/Oxcarbazepine: A Real-Life Investigation.
Atzori, C; Baldelli, S; Cattaneo, D; Cozzi, V; Filice, C; Fusi, M; Gervasoni, C; Micheli, V, 2020)		0.56
"This was a Phase I, open-label, two cohort (n=18/cohort), fixed-sequence study in healthy females that evaluated the drug-drug interaction (DDI) between multiple-dose ATV+COBI or DRV+COBI and single-dose drospirenone/ethinyl estradiol (EE)."( Confirmation of the drug-drug interaction potential between cobicistat-boosted antiretroviral regimens and hormonal contraceptives.
Das, M; Kearney, BP; Ling, KH; Majeed, SR; West, S, 2019)		0.51
" We confirmed that ATV inhibits SARS-CoV-2 replication, alone or in combination with ritonavir (RTV) in Vero cells and a human pulmonary epithelial cell line."( Atazanavir, Alone or in Combination with Ritonavir, Inhibits SARS-CoV-2 Replication and Proinflammatory Cytokine Production.
Alves, CR; Bozza, FA; Bozza, PT; Cardoso Soares, V; Carels, N; da Silva Gomes Dias, S; de Freitas, CS; Ferreira, AC; Fintelman-Rodrigues, N; Matos, AR; Mattos, M; Miranda, MD; Ribeiro Lima, C; Sacramento, CQ; Siqueira, MM; Souza da Silva, F; Souza, TML; Temerozo, JR, 2020)		0.56
"The aim of this study was to simulate the drug-drug interaction (DDI) between ritonavir-boosted atazanavir (ATV/r) and rifampicin (RIF) using physiologically based pharmacokinetic (PBPK) modelling, and to predict suitable dose adjustments for ATV/r for the treatment of people living with HIV (PLWH) co-infected with tuberculosis."( Predicting Drug-Drug Interactions between Rifampicin and Ritonavir-Boosted Atazanavir Using PBPK Modelling.
Bunglawala, F; Cottura, N; Denti, P; Fabrega, F; Howarth, A; Kinvig, H; Lloyd, A; Montanha, MC; Siccardi, M; Waitt, C, 2022)		0.72
"Previous use of a mechanistic static model to accurately quantify the increased rosuvastatin exposure due to drug-drug interaction (DDI) with coadministered atazanavir underpredicted the magnitude of area under the plasma concentration-time curve ratio (AUCR) based on inhibition of breast cancer resistance protein (BCRP) and organic anion transporting polypeptide (OATP) 1B1."( Mechanistic in vitro studies indicate that the clinical drug-drug interactions between protease inhibitors and rosuvastatin are driven by inhibition of intestinal BCRP and hepatic OATP1B1 with minimal contribution from OATP1B3, NTCP and OAT3.
Atkinson, H; Coghlan, H; Edgerton, J; Elsby, R; Hodgson, D; Outteridge, S, 2023)		0.91

Bioavailability

ExcerptReferenceRelevance
"Acid suppression markedly reduced the bioavailability of atazanavir in this group of healthy volunteers."( Inhibition of atazanavir oral absorption by lansoprazole gastric acid suppression in healthy volunteers.
Bednarczyk, E; Berenson, CS; Difrancesco, R; Eberhardt, E; Morse, GD; Ogundele, AB; Smith, PF; Tomilo, DL, 2006)		0.33
"Atazanavir (ATV) is a low oral bioavailability (BA) compound and, clinically, is generally coadministrated with ritonavir (RTV), which boosts the oral BA of ATV by inhibiting cytochrome P450 (CYP) 3A, and P-glycoprotein (Pgp) via the same metabolic pathway."( Pharmaceutical approach to HIV protease inhibitor atazanavir for bioavailability enhancement based on solid dispersion system.
Fukushima, K; Haraya, K; Ito, Y; Kodera, S; Seki, Y; Shibata, N; Sugioka, N; Takada, K; Terasaka, S; Wada, A, 2007)		0.34
" The results indicated that lopinavir bioavailability was not affected by the coadministration of omeprazole or ranitidine."( Effects of acid-reducing agents on the pharmacokinetics of lopinavir/ritonavir and ritonavir-boosted atazanavir.
Beck, K; Cai, Y; Causemaker, SJ; Chiu, YL; Doan, T; Esslinger, HU; Hanna, GJ; King, KR; Klein, CE; Podsadecki, TJ, 2008)		0.35
"Atazanavir (ATV) is clinically coadministered with low-dose ritonavir (RTV), which boosts the oral bioavailability (BA) of ATV by inhibiting cytochrome P450 (CYP) 3A, and P-glycoprotein (Pgp) via the same metabolic pathway; however, it is well known that in the chronic phase, the inhibition effect of RTV on Pgp and CYP3A becomes an induction effect."( Long-term pharmacokinetic efficacy and safety of low-dose ritonavir as a booster and atazanavir pharmaceutical formulation based on solid dispersion system in rats.
Fukushima, K; Haraya, K; Ito, Y; Sugioka, N; Takada, K; Terasaka, S, 2008)		0.35
" Ritonavir boosting of atazanavir enhances the bioavailability of atazanavir but may result in some elevation of lipids and is recommended for treatment-experienced patients and those receiving efavirenz or tenofovir."( Atazanavir: its role in HIV treatment.
Wood, R, 2008)		0.35
" Evening dosing was associated with 34% higher bioavailability than morning dosing."( Population pharmacokinetic modeling of the association between 63396C->T pregnane X receptor polymorphism and unboosted atazanavir clearance.
Back, DJ; Baietto, L; Bonora, S; Chierakul, N; Chuchuttaworn, C; Cuenca, L; D'Avolio, A; Davies, G; Di Perri, G; Dvorak, AM; Hoskins, JM; Khoo, S; McLeod, HL; Owen, A; Rodríguez Novoa, S; Saguenwong, N; Schipani, A; Siccardi, M; Simiele, M; Soriano, V, 2010)		0.36
" The relative bioavailability (F(rel)) of ATV was 132% higher with RTV comedication and was 35."( Model-based approach for optimization of atazanavir dose recommendations for HIV-infected pediatric patients.
Bertz, R; Hong, Y; Horga, M; Kowalski, KG; Pfister, M; Roy, A; Zhang, J; Zhu, L, 2011)		0.37
" These interactions may have important implications on the absorption and metabolism and thus the overall oral bioavailability of atazanavir."( Interactions between phytochemical components of Sutherlandia frutescens and the antiretroviral, atazanavir in vitro: implications for absorption and metabolism.
Bendayan, R; Kanfer, I; Kis, O; Müller, AC; Patnala, S, 2012)		0.38
" The absorption rate constant (0."( Pharmacokinetic-pharmacodynamic modeling of unboosted Atazanavir in a cohort of stable HIV-infected patients.
Baudry, T; Boibieux, A; Chidiac, C; Ferry, T; Gagnieu, MC; Goutelle, S; Livrozet, JM; Peyramond, D; Tod, M, 2013)		0.39
"Drug transporters such as P-glycoprotein and OATPs regulate intestinal permeability of atazanavir and may contribute to its poor oral bioavailability and drug-drug interactions with other protease inhibitors and TDF."( Role of drug efflux and uptake transporters in atazanavir intestinal permeability and drug-drug interactions.
Bendayan, R; Hoque, MT; Kis, O; Walmsley, SL; Zastre, JA, 2013)		0.39
" The objective of this animal study was to determine whether pre-treatment with antibiotics affects the intestinal bioavailability of Atazanavir (ATV) and Ritonavir (RTV)."( Metronidazole or Cotrimoxazole therapy is associated with a decrease in intestinal bioavailability of common antiretroviral drugs.
Desjeux, JF; Dossou-Yovo, F; Eto, B; Limas-Nzouzi, N; Mamadou, G; Miantezila, J; Soudy, ID, 2014)		0.4
"57-fold) indicated significant enhancement in the rate and extent of bioavailability by the OPT formulation compared to pure drug."( Optimized self-nanoemulsifying drug delivery system of atazanavir with enhanced oral bioavailability: in vitro/in vivo characterization.
Pai, RS; Singh, G, 2014)		0.4
"The studies, therefore, indicate the successful formulation development of SNEDDS with distinctly improved bioavailability of ATV."( Optimized self-nanoemulsifying drug delivery system of atazanavir with enhanced oral bioavailability: in vitro/in vivo characterization.
Pai, RS; Singh, G, 2014)		0.4
"91-fold) indicated significant enhancement in the rate and extent of bioavailability by the OPT formulation compared to pure drug."( Atazanavir-loaded Eudragit RL 100 nanoparticles to improve oral bioavailability: optimization and in vitro/in vivo appraisal.
Pai, RS; Singh, G, 2016)		0.43
" FA receptor-targeted poloxamer 407 nanocrystals, containing ritonavir-boosted atazanavir (ATV/r), significantly increased drug bioavailability and PD by five and 100 times, respectively."( Pharmacodynamics of long-acting folic acid-receptor targeted ritonavir-boosted atazanavir nanoformulations.
Bade, AN; Baldridge, HM; Balkundi, SS; Dash, PK; Dimitrov, DS; Feng, Y; Gendelman, HE; Gorantla, S; Hilaire, JR; Kendrick, LM; Liu, XM; McMillan, JM; Poluektova, LY; Puligujja, P; Wang, Y; Ying, T; Zhang, G, 2015)		0.42
" According to the in silico model, pre-absorptive and absorptive factors had less impact on atazanavir bioavailability compared to post-absorptive parameters, although active drug efflux and extraction appear to account for the sub-proportional pharmacokinetic response to lower atazanavir doses in the fasted state."( Advances and challenges in PBPK modeling--Analysis of factors contributing to the oral absorption of atazanavir, a poorly soluble weak base.
Berlin, M; Dressman, JB; Kesisoglou, F; Ruff, A; Wang, MH; Xu, W, 2015)		0.42
" However, they are characterized by poor oral bioavailability and a need for boosting with a pharmacokinetic enhancer, which results in additional drug-drug interactions that are sometimes difficult to manage."( Coupling of an Acyl Migration Prodrug Strategy with Bio-activation To Improve Oral Delivery of the HIV-1 Protease Inhibitor Atazanavir.
Annadurai, M; Arla, R; Bhutani, P; Desai, SD; Jenkins, SM; Kadow, JF; Krystal, MR; Mandlekar, S; Meanwell, NA; Padmanabhan, S; Ramar, T; Sarabu, R; Sinha, S; Sridhar, S; Subbaiah, MAM; Subramani, L; Subramanian, M; Wang, C, 2018)		0.48
" The model suggested that the mechanism by which SF reduced the overall bioavailability of ATV may be modulated via the inhibition of the "active" absorption process."( Identification of Mechanism and Pathway of the Interaction between the African Traditional Medicine, Sutherlandia Frutescens, and the Antiretroviral Protease Inhibitor, Atazanavir, in Human Subjects Using Population Pharmacokinetic (PK) Analysis.
Ducharme, MP; Kanfer, I; Muller, AC, 2018)		0.48
" These findings have important consequences for modeling and prediction of supersaturation impact on the absorption rate as well as for better defining the thermodynamic driving force for crystallization in complex media."( Interplay of Supersaturation and Solubilization: Lack of Correlation between Concentration-Based Supersaturation Measurements and Membrane Transport Rates in Simulated and Aspirated Human Fluids.
Augustijns, P; Brouwers, J; Elkhabaz, A; Moseson, DE; Taylor, LS, 2019)		0.51
" Extensive use of atazanavir (ATV) as antiretroviral and previous evidence suggesting its bioavailability within the respiratory tract prompted us to study this molecule against SARS-CoV-2."( Atazanavir, Alone or in Combination with Ritonavir, Inhibits SARS-CoV-2 Replication and Proinflammatory Cytokine Production.
Alves, CR; Bozza, FA; Bozza, PT; Cardoso Soares, V; Carels, N; da Silva Gomes Dias, S; de Freitas, CS; Ferreira, AC; Fintelman-Rodrigues, N; Matos, AR; Mattos, M; Miranda, MD; Ribeiro Lima, C; Sacramento, CQ; Siqueira, MM; Souza da Silva, F; Souza, TML; Temerozo, JR, 2020)		0.56
" The main objective of the present work was to fabricate ATV-loaded nanostructured lipid carriers (NLCs) employing quality by design (QbD) approach to address the challenges of bioavailability and their safety after oral administration."( Quality by design (QbD)-based fabrication of atazanavir-loaded nanostructured lipid carriers for lymph targeting: bioavailability enhancement using chylomicron flow block model and toxicity studies.
Bari, SB; Gurumukhi, VC, 2022)		0.72
" Thus, the current work describes the systematic development, optimization, and evaluation of hydroxypropyl methylcellulose acetate succinate (HPMC-AS)-based supersaturable preconcentrate isotropic mixture (SP-IM) containing long-chain triglyceride to improve intestinal lymphatic transport and augment oral bioavailability of atazanavir (ATZ)."( In silico-assisted development of supersaturable preconcentrated isotropic mixture of atazanavir for augmenting biopharmaceutical performance in the presence of H2-receptor antagonist.
Rana, V; Sethi, S, 2023)		0.91

Dosage Studied

ExcerptRelevanceReference
" Atazanavir [Reyataz] is a new protease inhibitors with once-daily dosing and minimal lipid and glycemic effects."( Atazanavir: improving the HIV protease inhibitor class.
Becker, S, 2003)		0.32
" It has a pharmacokinetic profile that supports once-daily dosing and has demonstrated a unique resistance profile and superior virologic potency compared with other antiretrovirals in vitro."( Atazanavir: A novel once-daily protease inhibitor.
Piliero, PJ, 2004)		0.32
"Individuals established on an atazanavir-containing regimen, completed an interviewer-administered questionnaire recording atazanavir dosing characteristics, concomitant medication use and adherence."( Atazanavir trough plasma concentration monitoring in a cohort of HIV-1-positive individuals receiving highly active antiretroviral therapy.
Amin, J; Bloch, M; Carr, A; Cooper, DA; Emery, S; Mallon, PW; Marriott, D; Ray, J; Winston, A, 2005)		0.33
" Dosing characteristics (including food taken), concomitant medications (including drugs used for dyspepsia) and HIV RNA were not significantly associated with trough atazanavir concentrations."( Atazanavir trough plasma concentration monitoring in a cohort of HIV-1-positive individuals receiving highly active antiretroviral therapy.
Amin, J; Bloch, M; Carr, A; Cooper, DA; Emery, S; Mallon, PW; Marriott, D; Ray, J; Winston, A, 2005)		0.33
"In this cohort, despite the wide inter-individual variability of atazanavir trough concentrations, no significant association with dosing characteristics, concomitant medication (with the exception of nevirapine and lopinavir/ritonavir) or virological response was observed."( Atazanavir trough plasma concentration monitoring in a cohort of HIV-1-positive individuals receiving highly active antiretroviral therapy.
Amin, J; Bloch, M; Carr, A; Cooper, DA; Emery, S; Mallon, PW; Marriott, D; Ray, J; Winston, A, 2005)		0.33
" When atazanavir 300 mg was coadministered with ritonavir 100 mg on a once-daily dosage regimen, atazanavir AUC from 0 to 24 hours and minimum plasma concentration were increased by 3- to 4-fold and approximately 10-fold, respectively, compared with atazanavir 300 mg alone."( Clinical pharmacokinetics and summary of efficacy and tolerability of atazanavir.
Barrail, A; Goujard, C; Le Tiec, C; Taburet, AM, 2005)		0.33
" Dosage adjustment need not be recommended for either methadone or atazanavir when co-administered to patients treated for opiate abuse and HIV disease."( Lack of an effect of atazanavir on steady-state pharmacokinetics of methadone in patients chronically treated for opiate addiction.
Agarwala, S; Andrews, L; Child, M; Daley, L; Friedland, G; O'Mara, E; Schreibman, T; Shi, J; Wang, Y, 2005)		0.33
" The Ccell/Ctot and Cu/Ctot ratio was unaffected by the addition of the second PI and remained stable throughout dosing interval."( Ritonavir-boosted atazanavir-lopinavir combination: a pharmacokinetic interaction study of total, unbound plasma and cellular exposures.
Biollaz, J; Buclin, T; Cavassini, M; Colombo, S; Decosterd, LA; Franc, C; Guignard, N; Khonkarly, M; Rochat, B; Tarr, PE; Telenti, A, 2006)		0.33
" The clinical significance of this decrease is unknown and warrants further investigation to determine the need for tailoring LPV dosage in selected cases."( Ritonavir-boosted atazanavir-lopinavir combination: a pharmacokinetic interaction study of total, unbound plasma and cellular exposures.
Biollaz, J; Buclin, T; Cavassini, M; Colombo, S; Decosterd, LA; Franc, C; Guignard, N; Khonkarly, M; Rochat, B; Tarr, PE; Telenti, A, 2006)		0.33
"Atazanavir (ATV) is recommended to be dosed at 400 mg once daily or 300 mg daily coadministered with 100 mg ritonavir (RTV)."( Atazanavir plasma concentrations vary significantly between patients and correlate with increased serum bilirubin concentrations.
Jeganathan, S; Ray, J; Smith, DE, )		0.13
" 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
" Since ATV plasma levels are highly variable and seem to be correlated with both viral response and toxicity, dosage individualization based on plasma concentration monitoring might be indicated."( Population pharmacokinetics of atazanavir in patients with human immunodeficiency virus infection.
Biollaz, J; Buclin, T; Cavassini, M; Colombo, S; Csajka, C; Décosterd, LA; Telenti, A, 2006)		0.33
" The single daily dosing was expected to improve adherence to treatment."( Change to a once-daily combination including boosted atazanavir in HIV-1-infected children.
Blanche, S; Delaugerre, C; Jullien, V; Macassa, E; Rouzioux, C; Teglas, JP; Tréluyer, JM; Veber, F, 2006)		0.33
" PPIs and dosing regimens varied among subjects."( Clinical outcomes associated with concomitant use of atazanavir and proton pump inhibitors.
Duggan, JM; Sahloff, EG, 2006)		0.33
" Atazanavir (ATV) has clinical efficacy comparable to a standard of care regimen in naive patients and, when dosed with low-dose ritonavir (RTV), also in treatment-experienced patients."( Effect of rifampin on steady-state pharmacokinetics of atazanavir with ritonavir in healthy volunteers.
Agarwala, S; Been-Tiktak, A; Bertz, R; Burger, DM; Child, M; Wang, Y, 2006)		0.33
" SQV pharmacokinetics were significantly higher when dosed with RTV compared to ATV (P < ."( Pharmacokinetics of saquinavir with atazanavir or low-dose ritonavir administered once daily (ASPIRE I) or twice daily (ASPIRE II) in seronegative volunteers.
Acosta, EP; Becker, SL; Kakuda, TN; King, JR; Paul, S; Tse, MM, 2007)		0.34
"Most antiretrovirals are metabolized in the liver, and lower dosing could be advisable in patients with severe liver insufficiency."( Influence of liver fibrosis stage on plasma levels of antiretroviral drugs in HIV-infected patients with chronic hepatitis C.
Barreiro, P; Gonzalez-Lahoz, J; Jiménez-Nácher, I; Labarga, P; Martín-Carbonero, L; Rodríguez-Novoa, S; Ruiz, A; Soriano, V, 2007)		0.34
" The method quantitates BUP and NBUP plasma concentrations within the range of expected values from current BUP dosing guidelines."( Buprenorphine assay and plasma concentration monitoring in HIV-infected substance users.
DiFrancesco, R; Donnelly, J; Fischl, MA; Gripshover, B; McCance-Katz, EF; Moody, DE; Morse, GD; Reichman, RC; Zingman, BS, 2007)		0.34
" The ATV area under the concentration-time curve from dosing to 24 hours after the dose (AUC0-24; GM: 36."( Beneficial pharmacokinetic interaction between atazanavir and lopinavir/ritonavir.
Agarwala, S; Barditch-Crovo, P; Carson, K; Flexner, C; Fuchs, E; Parsons, T; Pham, PA; Vasist, L, 2007)		0.34
" Individuals established on ATV (300 mg and 100 mg ritonavir daily) or LPV (400 mg and 100 mg ritonavir twice daily)-containing regimens completed two clinical visits (trough and directly observed therapy) during which dosing characteristics, concomitant medication, and substance use were recorded."( Assessing the impact of substance use and hepatitis coinfection on atazanavir and lopinavir trough concentrations in HIV-infected patients during therapeutic drug monitoring.
Boston, NS; Brazeau, D; Catanzaro, L; DiFrancesco, R; Fischl, MA; Forrest, A; Gripshover, B; Ma, Q; Morse, GD; Reichman, RC; Slish, J; Zingman, BS, 2007)		0.34
" Over the whole dosing interval, therapeutic drug concentrations well above the wild-type HIV 90% inhibitory concentration are maintained."( Atazanavir plus low-dose ritonavir in pregnancy: pharmacokinetics and placental transfer.
Airoldi, M; Bertuletti, P; Cattaneo, D; Frigerio, L; Maggiolo, F; Ripamonti, D; Ruggeri, M; Suter, F, 2007)		0.34
" These data indicate that chronic HIV treatment may be assisted with plasma concentration monitoring to identify those patients who may require dosage modification and/or regimen adjustment in order to optimize antiretroviral effects."( Factors associated with altered pharmacokinetics in substance users and non-substance users receiving lopinavir and atazanavir.
Boston, N; Brazeau, D; Catanzaro, LM; DiFrancesco, R; Fischl, MA; Forrest, A; Gripshover, B; Higgins, N; Lliguicota, F; Ma, Q; Morse, GD; Reichman, RC; Slish, J; Tooley, K; Zingman, BS, )		0.13
" In this study, we investigated the long-term efficacy and safety of RTV-boosted ATV in rats with a clinical relevant dosage of ATV and RTV, 7 mg/kg and 2 mg/kg, respectively, and drew a direct comparison with RTV-boosted ATV and the previously reported ATV pharmaceutical formulation based on a solid dispersion system (ATV-SLS SD+G)."( Long-term pharmacokinetic efficacy and safety of low-dose ritonavir as a booster and atazanavir pharmaceutical formulation based on solid dispersion system in rats.
Fukushima, K; Haraya, K; Ito, Y; Sugioka, N; Takada, K; Terasaka, S, 2008)		0.35
" The subjects had 11 plasma samples drawn over a dosing interval on days 1, 15, and 30."( Effects of minocycline and valproic acid coadministration on atazanavir plasma concentrations in human immunodeficiency virus-infected adults receiving atazanavir-ritonavir.
Cruttenden, K; DiCenzo, R; Gelbard, H; Hochreiter, J; Mariuz, P; Peterson, DR; Rezk, NL; Schifitto, G, 2008)		0.35
"The aim of this study was to determine the population pharmacokinetic (PK) parameters of atazanavir in adult human immunodeficiency virus-infected patients to build up a Bayesian strategy for dosage regimen individualization."( Population pharmacokinetics of atazanavir in human immunodeficiency virus-infected patients.
Drogoul, MP; Gagnieu, MC; Lacarelle, B; Lafeuillade, A; Mokhtari, S; Ravaux, I; Simon, N; Solas, C, 2008)		0.35
" Dosing was discontinued in 4 subjects (atazanavir-induced hyperbilirubinemia, 3; atazanavir-induced rash, 1)."( Pharmacokinetic properties and tolerability of bevirimat and atazanavir in healthy volunteers: an open-label, parallel-group study.
Doto, J; Ellis, C; Galbraith, H; Martin, DE; Schettler, J, 2008)		0.35
" These values were lower compared with the half-life over the respective dosing intervals (7."( Pharmacokinetics of atazanavir/ritonavir once daily and lopinavir/ritonavir twice and once daily over 72 h following drug cessation.
Back, D; Boffito, M; Else, L; Gazzard, B; Khoo, S; Moyle, G; Pozniak, A; Sousa, M; Taylor, J, 2008)		0.35
" The PK parameters of ATV/RTV at a dosage of 200/100 mg once daily, plus two nucleoside reverse transcriptase inhibitors, were significantly lower than those associated with a dosage of 300/100 mg once daily in the same patients."( A low dose of ritonavir-boosted atazanavir provides adequate pharmacokinetic parameters in HIV-1-infected Thai adults.
Avihingsanon, A; Burger, DM; Chanmano, S; Cooper, DA; Gorowara, M; Kerr, SJ; Lange, J; Ohata, P; Phanuphak, P; Ruxrungtham, K; van der Lugt, J, 2009)		0.35
" After intravenous (iv), oral (po) and intraportal (ip) administration of ATV at a dosage of 7 mg/kg, AUCs in HL rats were 12."( Effect of serum lipids on the pharmacokinetics of atazanavir in hyperlipidemic rats.
Aoyama, H; Fukushima, K; Kobuchi, S; Mizuhara, K; Shibata, M; Sugioka, N; Takada, K; Uchisako, R, 2009)		0.35
" The model was used to investigate other, particularly lower, ritonavir-boosted atazanavir dosing strategies."( Population pharmacokinetics of ritonavir-boosted atazanavir in HIV-infected patients and healthy volunteers.
Aarons, L; Back, D; Boffito, M; Davies, G; Dickinson, L; Else, L; Khoo, S; Pozniak, A; Waters, L, 2009)		0.35
"HIV-1-infected adults receiving a regimen containing ritonavir-boosted atazanavir or fosamprenavir were recruited into a prospective study of adherence and dosage timing of both agents."( Occurrence of selective ritonavir nonadherence and dose-staggering in recipients of boosted HIV-1 protease inhibitor therapy.
Rode, RA; Sarlo, JA; Shuter, J; Zingman, BS, )		0.13
"Atazanavir 400 mg/day plus fosamprenavir 1400 mg/day significantly decreased concentrations of atazanavir compared with standard dosing regimens of each drug alone."( Pharmacokinetics of concurrent administration of fosamprenavir and atazanavir without ritonavir in human immunodeficiency virus-negative subjects.
Anderson, PL; Clay, PG; Glaros, AG; McRae, M, 2009)		0.35
"Atazanavir (ATV) is a protease inhibitor (PI) in which its main qualities, compared to other PI are dosing convenience, good tolerability and excellent metabolic profile."( [Clinical utility of atazanavir].
Curran, A; Ribera Pascuet, E, 2008)		0.35
" The primary outcome was the ratio of plasma raltegravir C(tau), or concentration at the end of the dosing interval, for arm B (24 h) versus arm A (12 h)."( Pharmacokinetics and pharmacogenomics of once-daily raltegravir and atazanavir in healthy volunteers.
Calmy, A; Decosterd, L; di Iulio, J; Fayet, A; Jelliffe, R; Kanani, M; Lee, JS; Margol, A; Neely, M; von Schoen-Angerer, T, 2010)		0.36
" Evening dosing was associated with 34% higher bioavailability than morning dosing."( Population pharmacokinetic modeling of the association between 63396C->T pregnane X receptor polymorphism and unboosted atazanavir clearance.
Back, DJ; Baietto, L; Bonora, S; Chierakul, N; Chuchuttaworn, C; Cuenca, L; D'Avolio, A; Davies, G; Di Perri, G; Dvorak, AM; Hoskins, JM; Khoo, S; McLeod, HL; Owen, A; Rodríguez Novoa, S; Saguenwong, N; Schipani, A; Siccardi, M; Simiele, M; Soriano, V, 2010)		0.36
" In turn, ART commonly requires complex dosing schedules and leads to the emergence of viral resistance and treatment failures."( Analyses of nanoformulated antiretroviral drug charge, size, shape and content for uptake, drug release and antiviral activities in human monocyte-derived macrophages.
Balkundi, S; Bronich, T; Gendelman, HE; Kabanov, AV; Kanmogne, G; Martinez-Skinner, A; McMillan, J; Mosley, RL; Nowacek, AS; Roy, U, 2011)		0.37
" Because of the potential for a significant interaction between tacrolimus and atazanavir, the tacrolimus dosage was to be based on serum tacrolimus concentrations."( Managing the atazanavir-tacrolimus drug interaction in a renal transplant recipient.
Aull, MJ; Figueiro, JM; Saal, SD; Tsapepas, DS; Webber, AB, 2011)		0.37
"In a 53-year-old man with HIV infection who underwent renal transplantation, the drug interaction between atazanavir and tacrolimus was managed by modifying the tacrolimus dosage regimen after determining the patient's blood tacrolimus concentration profile."( Managing the atazanavir-tacrolimus drug interaction in a renal transplant recipient.
Aull, MJ; Figueiro, JM; Saal, SD; Tsapepas, DS; Webber, AB, 2011)		0.37
" Co-administration with ATV/RTV resulted in increased plasma S/GSK1349572 area under the concentration-time curve during a dosing interval (AUC(0,τ)), observed maximal concentration (C(max) ), and concentration at the end of dosing interval at steady state (C(τ) ) by 62%, 34% and 121%, respectively."( Effect of atazanavir and atazanavir/ritonavir on the pharmacokinetics of the next-generation HIV integrase inhibitor, S/GSK1349572.
Borland, J; Chen, S; Lou, Y; Min, S; Peppercorn, A; Piscitelli, SC; Song, I; Wajima, T, 2011)		0.37
"ATV/RTV with dose-normalized EE/NGM resulted in geometric mean reductions of 16% in EE peak plasma concentration (C(max)), 19% in EE area under the concentration-time curve for a dosing interval (AUC([τ])) and 37% in EE lowest plasma concentration (C(min)), compared with EE 35 μg with NGM in the absence of ATV/RTV."( The effect of atazanavir/ritonavir on the pharmacokinetics of an oral contraceptive containing ethinyl estradiol and norgestimate in healthy women.
Bertz, R; Chung, E; Eley, T; Mahnke, L; Persson, A; Xu, X; Yones, C; Zhang, J, 2011)		0.37
"Adequate plasma trough concentrations (Ctrough) of protease inhibitors are required to maintain antiviral activity throughout the dosing interval."( Therapeutic monitoring and variability of atazanavir in HIV-infected patients, with and without HCV coinfection, receiving boosted or unboosted regimens.
Barassi, A; Brandolini, M; Cusato, M; D'Arminio Monforte, A; Gulminetti, R; Maserati, R; Melzi D'Eril, GV; Regazzi, M; Sighinolfi, L; Tinelli, C; Villani, P, 2011)		0.37
" The purpose of this study was to assess the safety, efficacy and appropriate dosing regimen for ritonavir (RTV)-boosted atazanavir in HIV-1-infected pregnant women."( Safety and exposure of once-daily ritonavir-boosted atazanavir in HIV-infected pregnant women.
Bertz, R; Botes, M; Child, M; Conradie, F; Eley, T; Hu, W; Josipovic, D; McGrath, D; Osiyemi, O; Vandeloise, E; Wirtz, V; Zorrilla, C, 2011)		0.37
"In this nonrandomized, open-label study, HIV-infected pregnant women were dosed with either 300/100 mg (n=20) or 400/100 mg (n=21) atazanavir/RTV once-daily (qd) in combination with zidovudine (300 mg) and lamivudine (150 mg) twice daily in the third trimester."( Safety and exposure of once-daily ritonavir-boosted atazanavir in HIV-infected pregnant women.
Bertz, R; Botes, M; Child, M; Conradie, F; Eley, T; Hu, W; Josipovic, D; McGrath, D; Osiyemi, O; Vandeloise, E; Wirtz, V; Zorrilla, C, 2011)		0.37
" Dosage of 200 mg might provide an option to patients showing suboptimal ATV exposure with standard unboosted dosing."( Pharmacokinetics of switching unboosted atazanavir coadministered with tenofovir disoproxil fumarate from 400 mg once daily to 200 mg twice daily in HIV-positive patients.
Baietto, L; Bonora, S; Calcagno, A; D'Avolio, A; Di Perri, G; Gonzalez de Requena, D; Siccardi, M; Simiele, M; Tettoni, M; Trentini, L, 2011)		0.37
"The object of this study was to investigate the pharmacokinetics of darunavir-ritonavir and atazanavir-ritonavir once-daily dosing over 72 h (h) following drug intake cessation."( Pharmacokinetics of once-daily darunavir-ritonavir and atazanavir-ritonavir over 72 hours following drug cessation.
Amara, A; Back, D; Boffito, M; Gazzard, B; Higgs, C; Jackson, A; Khoo, S; Moyle, G; Seymour, N, 2011)		0.37
" Therapeutic drug monitoring (TDM) is occasionally used to guide chronic dosing to achieve target trough concentrations, but its clinical success assumes minimal intrasubject variability."( Within-patient atazanavir trough concentration monitoring in HIV-1-infected patients.
Crutchley, RD; Hochreitter, J; Ma, Q; Morse, GD; Sulaiman, A, 2011)		0.37
" This study evaluates an intermittent dosing regimen for rifabutin when it is co-administered with ritonavir-boosted atazanavir."( Determination of rifabutin dosing regimen when administered in combination with ritonavir-boosted atazanavir.
Arikan, D; Bertz, R; Coumbis, J; Farajallah, A; Stonier, M; Wu, Y; Xu, X; Zhang, J; Zhu, L, 2011)		0.37
"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
" However, some patients may have received atazanavir at a suboptimal dosage or had suboptimal susceptibility to BT agents."( Atazanavir: in pediatric patients with HIV-1 infection.
Deeks, ED, 2012)		0.38
" We also collected data on dosing of atazanavir, and on demographic (age, gender, and ethnicity), physiological (weight and body mass index), and clinical parameters (CD4+ cell count, HIV-RNA viremia, co-medication, and hepatitis C co-infection)."( Effects of hepatitis C virus infection on the pharmacokinetics of ritonavir-boosted atazanavir in HIV-1-infected patients.
Cenderello, G; Di Biagio, A; Loregian, A; Pagni, S; Palù, G; Rosso, R; Sormani, MP; Viscoli, C, 2012)		0.38
"003) from their corresponding baseline value during the 100 mg dosing period; there were no significant changes on 50 mg."( Ritonavir boosting dose reduction from 100 to 50 mg does not change the atazanavir steady-state exposure in healthy volunteers.
Antonijoan, RM; Barbanoj, MJ; Cedeño, S; Clotet, B; Domingo, P; Estévez, JA; Mangues, MA; Moltó, J; Puntes, M; Tuneu, L; Valle, M, 2012)		0.38
"In this highly adherent population, the number of daily pills was related to self-reported health status but not to self-reported adherence, whereas the dosing interval did not influence self-reported adherence or health status."( Number of daily pills, dosing schedule, self-reported adherence and health status in 2010: a large cross-sectional study of HIV-infected patients on antiretroviral therapy.
Bocchiola, B; Cahua, T; Castagna, A; Danise, A; Galli, L; Gianotti, N; Lazzarin, A; Maillard, M; Panzini, P; Pazzi, A; Salpietro, S; Zandonà, D, 2013)		0.39
" This suggests that 300/50 mg and 200/100 mg dosing are preferred candidate regimens in future clinical studies."( Simultaneous population pharmacokinetic modelling of atazanavir and ritonavir in HIV-infected adults and assessment of different dose reduction strategies.
Austin, R; Back, D; Boffito, M; Davies, G; Dickinson, L; Khoo, S; Owen, A; Schipani, A, 2013)		0.39
" Use of exact dosing data halved unexplained variability in ATV clearance."( Effect of adherence as measured by MEMS, ritonavir boosting, and CYP3A5 genotype on atazanavir pharmacokinetics in treatment-naive HIV-infected patients.
Barrail-Tran, A; Descamps, D; Duval, X; Goujard, C; Mentré, F; Nembot, G; Panhard, X; Savic, RM; Taburet, AM; Verstuyft, C; Vrijens, B, 2012)		0.38
" Model-predicated area under the concentration-time curve during the dosing interval (AUC(τ)) and exposure ratios of CVF AUC(τ):BP AUC(τ) were calculated for each drug."( Pharmacokinetic modelling of efavirenz, atazanavir, lamivudine and tenofovir in the female genital tract of HIV-infected pre-menopausal women.
Cohen, MS; Dumond, JB; Forrest, A; Garonzik, SM; Kashuba, AD; Kendrick, RN; Nicol, MR; Patterson, KB, 2012)		0.38
" Coadministration with boceprevir decreased RTV AUC during a dosing interval τ (AUC(τ)) by 22%-36%."( Pharmacokinetic interactions between the hepatitis C virus protease inhibitor boceprevir and ritonavir-boosted HIV-1 protease inhibitors atazanavir, darunavir, and lopinavir.
Butterton, JR; Feng, HP; Hughes, EA; Hulskotte, EG; O'Mara, E; Treitel, MA; van Zutven, MG; Wagner, JA; Xuan, F; Youngberg, SP, 2013)		0.39
" Blood plasma (for TFV, FTC, EFV, ATV and RTV concentrations) and peripheral blood mononuclear cells [PBMCs; for tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) concentrations] were collected at 11 time-points over a 24-hour dosing interval."( Pharmacokinetics of two common antiretroviral regimens in older HIV-infected patients: a pilot study.
Adams, JL; Corbett, AH; Dumond, JB; Forrest, A; Jennings, SH; Kashuba, AD; Kendrick, RL; Malone, S; Patterson, KB; Prince, HM; Sykes, C; Wang, R; White, N, 2013)		0.39
" The MEMS-defined adherence for correct dosing (-0."( Adherence profiles and therapeutic responses of treatment-naive HIV-infected patients starting boosted atazanavir-based therapy in the ANRS 134-COPHAR 3 trial.
Barrail-Tran, A; Descamps, D; Duval, X; Goujard, C; Mentré, F; Nembot, G; Panhard, X; Parienti, JJ; Taburet, AM; Vigan, M; Vrijens, B, 2013)		0.39
" Until then, guidelines for drug-drug interactions and dosing in renal and hepatic impairment should be followed in older HIV-infected individuals."( Clinical pharmacokinetics of antiretroviral drugs in older persons.
Anderson, PL; Erlandson, KM; Schoen, JC, 2013)		0.39
" We assessed the changes in total, conjugated, and unconjugated bilirubin and the effect on ATV pharmacokinetics (PK) after single and 14-day dosing of ZnSO(4)."( Coadministration of atazanavir-ritonavir and zinc sulfate: impact on hyperbilirubinemia and pharmacokinetics.
Back, D; Boffito, M; Else, L; Gazzard, B; Jackson, A; Karolia, Z; Moyle, G; Ringner-Nackter, L; Seymour, N; Yapa, MH, 2013)		0.39
" No clinically relevant interactions between daclatasvir and tenofovir disoproxil fumarate were observed for either drug, and no dosing adjustments were indicated."( Assessment of pharmacokinetic interactions of the HCV NS5A replication complex inhibitor daclatasvir with antiretroviral agents: ritonavir-boosted atazanavir, efavirenz and tenofovir.
Bertz, R; Bifano, M; Grasela, D; Hartstra, J; Hwang, C; Kandoussi, H; Oosterhuis, B; Sevinsky, H; Tiessen, R; Velinova-Donga, M, 2013)		0.39
" They are characterized by highly cooperative dose-response curves that are not explained by current pharmacodynamic theory."( Multi-step inhibition explains HIV-1 protease inhibitor pharmacodynamics and resistance.
Bailey, JR; Chioma, S; Durand, CM; Laird, GM; Laskey, S; Moore, RD; Rabi, SA; Shan, L; Siliciano, RF, 2013)		0.39
" D-atazanavir analogs were dosed to human in parallel with atazanavir."( Revealing the metabolic sites of atazanavir in human by parallel administrations of D-atazanavir analogs.
Braman, V; Cheng, C; Harbeson, S; Tung, R; Vedananda, S; Wu, L, 2013)		0.39
" These results suggest that hepatic metabolism decreased and that dosing regimens should be carefully evaluated in obese patients."( Effects of obesity induced by high-fat diet on the pharmacokinetics of atazanavir in rats.
Aoyama, H; Fukushima, K; Ito, Y; Kobuchi, S; Sugioka, N; Takada, K, 2013)		0.39
"06 μg/ml), suggesting that the RBT dosage may be inadequate."( Pharmacokinetics of rifabutin during atazanavir/ritonavir co-administration in HIV-infected TB patients in India.
Bhavani, PK; Chandrasekaran, C; Hemanth Kumar, AK; Raja, K; Ramachandran, G; Srinivasan, R; Sudha, V; Swaminathan, S; Venkatesh, S, 2013)		0.39
"Atazanavir/ritonavir 200/100 mg dosing provided adequate ATV AUC 0-24 when used with TDF in HIV-infected Thai children weighing between 25 and 50 kg."( Pharmacokinetics of atazanavir/ritonavir among HIV-infected Thai children concomitantly taking tenofovir disoproxil fumarate.
Ananworanich, J; Bunupuradah, T; Keadpudsa, S; Prasitsuebsai, W; Puthanakit, T; Sahakijpicharn, T; Srimuan, A; Techasaensiri, C; Thammajaruk, N, 2014)		0.4
" Blood sampling was performed at the end of the dosing interval (Ctrough)."( Intracellular accumulation of atazanavir/ritonavir according to plasma concentrations and OATP1B1, ABCB1 and PXR genetic polymorphisms.
Allegra, S; Bonora, S; Calcagno, A; Carcieri, C; Cusato, J; D'Avolio, A; Di Perri, G; Sciandra, M; Simiele, M; Trentini, L, 2014)		0.4
" Most patients (70%) received a 400 mg ATV dosing per day, once (26%) or twice daily (44%)."( Efficacy and safety of switching to raltegravir plus atazanavir dual therapy in pretreated HIV-1-infected patients over 144 weeks: a cohort study.
Batard, ML; Bernard-Henry, C; Cheneau, C; De Mautort, E; Fafi-Kremer, S; Gantner, P; Koeppel, C; Muret, P; Partisani, M; Priester, M; Rey, D; Sueur, C, 2014)		0.4
"Atazanavir (ATV) is an attractive option for the treatment of Pediatric HIV infection, based on once-daily dosing and the availability of a formulation appropriate for younger children."( Long-term safety and efficacy of atazanavir-based therapy in HIV-infected infants, children and adolescents: the Pediatric AIDS Clinical Trials Group Protocol 1020A.
Aldrovani, G; Fenton, T; Fletcher, CV; Graham, B; Kiser, JJ; Mathew, M; Mofenson, LM; Rutstein, RM; Samson, P; Smith, E, 2015)		0.42
"We document our experience with therapeutic drug monitoring (TDM) of antiretroviral agents (1807 determinations) carried out as day-by-day clinical practice for the optimization of drug dosing in HIV-infected patients."( Is it time to revise antiretrovirals dosing? a pharmacokinetic viewpoint.
Baldelli, S; Castoldi, S; Cattaneo, D; Charbe, N; Clementi, E; Cozzi, V; Fucile, S, 2014)		0.4
" Compared with the results obtained by administration of BMS-663068 alone, coadministration of BMS-663068 with ATV/r increased the BMS-626529 maximum concentration in plasma (Cmax) and the area under the concentration-time curve in one dosing interval (AUCtau) by 68% and 54%, respectively."( Pharmacokinetic interactions between BMS-626529, the active moiety of the HIV-1 attachment inhibitor prodrug BMS-663068, and ritonavir or ritonavir-boosted atazanavir in healthy subjects.
Bertz, R; Furlong, M; Hanna, GJ; Hruska, M; Hwang, C; Landry, IS; Shah, V; Zhu, L, 2015)		0.42
" Pre-absorptive factors are those related to dosage form disintegration, drug dissolution, supersaturation, precipitation and gastric emptying."( Advances and challenges in PBPK modeling--Analysis of factors contributing to the oral absorption of atazanavir, a poorly soluble weak base.
Berlin, M; Dressman, JB; Kesisoglou, F; Ruff, A; Wang, MH; Xu, W, 2015)		0.42
"We investigated the distribution of ATV plasma trough concentrations according to drug dosage and the potential relationship between ATV plasma trough concentrations and drug-related adverse events in a consecutive series of 240 HIV-infected patients treated with ATV/r 300/100 mg (68%) or ATV 400 mg (32%)."( Metabolic and kidney disorders correlate with high atazanavir concentrations in HIV-infected patients: is it time to revise atazanavir dosages?
Cattaneo, D; Charbe, N; Clementi, E; Cozzi, V; Ferraris, L; Galli, M; Gervasoni, C; Landonio, S; Meraviglia, P; Minisci, D; Molinari, L; Riva, A; Rizzardini, G, 2015)		0.42
"A significant proportion of patients treated with the conventional dosage of ATV (300/100) had plasma concentrations exceeding the upper therapeutic threshold."( Metabolic and kidney disorders correlate with high atazanavir concentrations in HIV-infected patients: is it time to revise atazanavir dosages?
Cattaneo, D; Charbe, N; Clementi, E; Cozzi, V; Ferraris, L; Galli, M; Gervasoni, C; Landonio, S; Meraviglia, P; Minisci, D; Molinari, L; Riva, A; Rizzardini, G, 2015)		0.42
"Atazanavir/ritonavir (ATV/r) recently became the preferred protease inhibitor (PI) for use in Nigeria since it is dosed once daily, which may improve treatment adherence and has fewer side effects than lopinavir/ritonavir (LPV/r)--the most widely available PI in resource-limited settings."( Immunological and Virological Outcomes of Patients Switched from LPV/r to ATV/r-Containing Second- Line Regimens.
Adeyemo, T; Akanmu, AS; Awolola, A; Bello, FO; Kanki, PJ; Lesi, F; Ogunsola, FT; Okonkwo, P; Okwuegbuna, K; Oloko, K, 2015)		0.42
" The dosing regimen improved treatment outcomes more than two fold from untargeted nanoATV/r."( Pharmacodynamics of folic acid receptor targeted antiretroviral nanotherapy in HIV-1-infected humanized mice.
Araínga, M; Dash, P; Gendelman, HE; Gorantla, S; McMillan, J; Mosley, RL; Palandri, D; Poluektova, L; Puligujja, P, 2015)		0.42
" The dosing of ATV powder, boosted with 80 mg RTV liquid, was based on three baseline weight bands (5 to <10 kg=150 mg, 10 to <15 kg=200 mg and 15 to <25 kg=250 mg)."( PRINCE-1: safety and efficacy of atazanavir powder and ritonavir liquid in HIV-1-infected antiretroviral-naïve and -experienced infants and children aged ≥3 months to <6 years.
Arce, PM; Biguenet, S; Cambilargiu, D; Correll, T; Donati, AP; Hardy, H; Lissens, J; Strehlau, R; Yang, R, 2015)		0.42
" This study confirmed that patients with kidney impairment and the concurrent use of atazanavir/ritonavir will require the dosage of tenofovir to be adjusted to ensure efficacy and prevent unwanted toxicities."( Population pharmacokinetics of tenofovir in HIV/HBV co-infected patients.
Avihingsanon, A; Burger, D; Lewin, SR; Matthews, G; Punyawudho, B; Ruxrungtham, K; Thammajaruk, N; Thongpeang, P, 2015)		0.42
" Prices in nominal values for both dosage forms remained virtually constant between 2011 (the signature of the Partnership for Productive Development Agreement), 2012 and 2013 (after the establishment of the Partnership)."( Strategies for price reduction of HIV medicines under a monopoly situation in Brazil.
Chaves, GC; Hasenclever, L; Oliveira, MA; Osorio-de-Castro, CG, 2015)		0.42
"Twenty-nine subjects completed both dosing cohorts."( Efavirenz but Not Atazanavir/Ritonavir Significantly Reduces Atovaquone Concentrations in HIV-Infected Subjects.
Alfaro, RM; Calderón, MM; Kovacs, JA; Kumar, P; McManus, M; Pau, AK; Penzak, SR, 2016)		0.43
"Population pharmacokinetic (PopPK) analyses often rely on steady state and full adherence to prescribed dosage regimen assumptions from data gathered during therapeutic drug monitoring (TDM)."( Comparison of Population Pharmacokinetics Based on Steady-State Assumption Versus Electronically Monitored Adherence to Lopinavir, Atazanavir, Efavirenz, and Etravirine: A Retrospective Study.
Buclin, T; Bugnon, O; Cavassini, M; Csajka, C; Fuchs, A; Rotzinger, A; Schneider, MP, 2016)		0.43
"Published PopPK models for lopinavir, atazanavir, efavirenz, and etravirine were applied to estimate PK parameters and individual concentrations in 140 HIV patients taking part in a medication adherence program using 2 dosing data sets."( Comparison of Population Pharmacokinetics Based on Steady-State Assumption Versus Electronically Monitored Adherence to Lopinavir, Atazanavir, Efavirenz, and Etravirine: A Retrospective Study.
Buclin, T; Bugnon, O; Cavassini, M; Csajka, C; Fuchs, A; Rotzinger, A; Schneider, MP, 2016)		0.43
"Clearance estimates and likewise predicted concentrations did not markedly differ between the 2 dosing histories."( Comparison of Population Pharmacokinetics Based on Steady-State Assumption Versus Electronically Monitored Adherence to Lopinavir, Atazanavir, Efavirenz, and Etravirine: A Retrospective Study.
Buclin, T; Bugnon, O; Cavassini, M; Csajka, C; Fuchs, A; Rotzinger, A; Schneider, MP, 2016)		0.43
"PopPK analysis assuming steady state with full adherence produced similar results to those based on detailed electronic dosing history reconciled with patients' allegations."( Comparison of Population Pharmacokinetics Based on Steady-State Assumption Versus Electronically Monitored Adherence to Lopinavir, Atazanavir, Efavirenz, and Etravirine: A Retrospective Study.
Buclin, T; Bugnon, O; Cavassini, M; Csajka, C; Fuchs, A; Rotzinger, A; Schneider, MP, 2016)		0.43
" Thus, co-medications should be systematically reviewed when switching the pharmacokinetic enhancer to anticipate potential dosage adjustments."( Cobicistat versus ritonavir boosting and differences in the drug-drug interaction profiles with co-medications.
Back, D; Gibbons, S; Khoo, S; Marzolini, C, 2016)		0.43
" This study sheds light on the complex dissolution and solution phase behavior of multicomponent amorphous dosage forms, in particular those containing poorly water soluble drugs, which may undergo supersaturation in vivo."( Compromised in vitro dissolution and membrane transport of multidrug amorphous formulations.
Alhalaweh, A; Bergström, CAS; Taylor, LS, 2016)		0.43
"The aim of the present study was to develop a simultaneous population pharmacokinetic model for atazanavir (ATV) incorporating the effect of ritonavir (RTV) on clearance to predict ATV concentrations under different dosing regimens in HIV-1-infected patients."( Population pharmacokinetic modelling of the changes in atazanavir plasma clearance caused by ritonavir plasma concentrations in HIV-1 infected patients.
Cedeño, S; Clotet, B; Estévez, JA; Miranda, C; Moltó, J; Valle, M, 2016)		0.43
" A population pharmacokinetic model was constructed using nonlinear mixed-effects modelling and used to simulate six dosing scenarios."( Population pharmacokinetic modelling of the changes in atazanavir plasma clearance caused by ritonavir plasma concentrations in HIV-1 infected patients.
Cedeño, S; Clotet, B; Estévez, JA; Miranda, C; Moltó, J; Valle, M, 2016)		0.43
"There were higher rates of clinical TB cure in individuals on a boosted protease inhibitor-based ART regimen with daily RBT compared to intermittently dosed RBT."( Improved tuberculosis outcomes with daily vs. intermittent rifabutin in HIV-TB coinfected patients in India.
Ambrose, P; Benson, CA; Devaraj, C; Ezhilarasi, C; Jenks, JD; Kumarasamy, N; Poongulali, S; Yepthomi, T, 2016)		0.43
" When combined with the CYP3A4 substrate daclatasvir, the daclatasvir dosage should be reduced from 60 to 30 mg once daily."( Daclatasvir 30 mg/day is the correct dose for patients taking atazanavir/cobicistat.
Burger, DM; Colbers, EP; de Kanter, CT; Drenth, JP; Smolders, EJ; Velthoven-Graafland, K, 2017)		0.46
" This boosting effect of atazanavir could be used to optimize dolutegravir dosing in particular clinical settings."( Dolutegravir plasma concentrations according to companion antiretroviral drug: unwanted drug interaction or desirable boosting effect?
Cattaneo, D; Clementi, E; Cozzi, V; Galli, M; Gervasoni, C; Meraviglia, P; Minisci, D; Riva, A, 2017)		0.46
" This in turn hinders understanding of the driving force for phase transformations and membrane transport, which is essential to better understand supersaturating dosage forms."( Impact of Micellar Surfactant on Supersaturation and Insight into Solubilization Mechanisms in Supersaturated Solutions of Atazanavir.
Gao, Y; Indulkar, AS; Mo, H; Raina, SA; Taylor, LS; Zhang, GGZ, 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 phase 2b trial AI438011 investigated the safety, efficacy, and dose-response of fostemsavir vs ritonavir-boosted atazanavir (ATV/r) in treatment-experienced, HIV-1-infected subjects."( Viral Drug Resistance Through 48 Weeks, in a Phase 2b, Randomized, Controlled Trial of the HIV-1 Attachment Inhibitor Prodrug, Fostemsavir.
Hanna, GJ; Joshi, SR; Krystal, M; Lataillade, M; Lee, S; Stock, DA; Zhou, N, 2018)		0.48
"Intensive 24-hour pharmacokinetic profiles at steady state compared ATV exposures (area under the concentration-time curve in one dosing interval) in 5 ATV + RTV baseline weight-band dosing categories, with historic data in adults receiving ATV + RTV 300/100 mg capsules."( Pharmacokinetics and Pharmacodynamics of Atazanavir in HIV-1-Infected Children Treated With Atazanavir Powder and Ritonavir: Combined Analysis of the PRINCE-1 and -2 Studies.
Correll, TA; Eley, T; Pikora, C; Sevinsky, H; Wang, R; Xu, X; Zaru, L, 2018)		0.48
"Weight-band dosing of ATV + RTV plus optimized dual nucleos(t)ide reverse transcriptase inhibitors in young HIV-1-infected children achieved similar ATV exposure to that in adults; no unexpected safety findings occurred, and with the exception of lower virologic suppression in the lowest ATV CCQ, there was no apparent trend in virologic suppression across ATV CCQs."( Pharmacokinetics and Pharmacodynamics of Atazanavir in HIV-1-Infected Children Treated With Atazanavir Powder and Ritonavir: Combined Analysis of the PRINCE-1 and -2 Studies.
Correll, TA; Eley, T; Pikora, C; Sevinsky, H; Wang, R; Xu, X; Zaru, L, 2018)		0.48
" The developed stability indicating method is capable for determination of impurities of Atazanavir and Ritonavir in combined tablet dosage form as well as individual dosage forms also."( Simultaneous Determination of Impurities of Atazanavir and Ritonavir in Tablet Dosage Form by Using Reversed-Phase Ultra Performance Liquid Chromatographic Method.
Mantena, BPV; Mantripragada, MKVVN; Nutulapati, VVS; Rao, SV, 2018)		0.48
" We investigated a chemo-activated, acyl migration-based prodrug design approach to improve the pharmacokinetic profile of 1 but failed to obtain improved oral bioavailability over dosing the parent drug in rats."( Coupling of an Acyl Migration Prodrug Strategy with Bio-activation To Improve Oral Delivery of the HIV-1 Protease Inhibitor Atazanavir.
Annadurai, M; Arla, R; Bhutani, P; Desai, SD; Jenkins, SM; Kadow, JF; Krystal, MR; Mandlekar, S; Meanwell, NA; Padmanabhan, S; Ramar, T; Sarabu, R; Sinha, S; Sridhar, S; Subbaiah, MAM; Subramani, L; Subramanian, M; Wang, C, 2018)		0.48
" Data collected included demographic data, laboratory tests, antiretroviral treatment history, methadone dosing and drug abstinence."( Risk factors for kidney disease among HIV-1 positive persons in the methadone program.
Firląg-Burkacka, E; Grycner, E; Horban, A; Kowalska, JD; Matłosz, B; Pietraszkiewicz, E, 2019)		0.51
" 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
"Standard atazanavir/cobicistat dosing during pregnancy results in lower exposure which may increase the risk of virologic failure and perinatal transmission."( Pharmacokinetics of Atazanavir Boosted With Cobicistat in Pregnant and Postpartum Women With HIV.
Badell, ML; Best, BM; Browning, R; Capparelli, EV; Chakhtoura, N; Denson, K; George, K; Mirochnick, M; Momper, JD; Paul, ME; Powis, KM; Rungruengthanakit, K; Shapiro, DE; Stek, A; Wang, J, 2022)		0.72
"This is an open-label, randomized, fixed sequence single intravenous dosing study to assess pharmacokinetic interactions between remdesivir and TDF/3TC (Study A, crossover design) or TDF/3TC plus ATV/r (Study B)."( An open-label, randomized, single intravenous dosing study to investigate the effect of fixed-dose combinations of tenofovir/lamivudine or atazanavir/ritonavir on the pharmacokinetics of remdesivir in Ugandan healthy volunteers (RemTLAR).
Byakika-Kibwika, P; D'Avolio, A; Kaboggoza, JP; Lamorde, M; Waitt, C; Walimbwa, SI, 2021)		0.62
"Drug solubility in intestinal fluid is a key parameter controlling absorption after the administration of a solid oral dosage form."( Structured solubility behaviour in bioequivalent fasted simulated intestinal fluids.
Abuhassan, Q; Augustijns, P; Brouwers, J; Halbert, GW; Khadra, I; Pyper, K, 2022)		0.72
" Daily emtricitabine/TAF was dosed according to World Health Organization (WHO)-recommended weight bands: 120/15 mg in children weighing 14 to <25 kg and 200/25 mg in those weighing ≥25 kg."( First Pharmacokinetic Data of Tenofovir Alafenamide Fumarate and Tenofovir With Dolutegravir or Boosted Protease Inhibitors in African Children: A Substudy of the CHAPAS-4 Trial.
Bamford, A; Burger, DM; Bwakura-Dangarembizi, M; Chabala, C; Colbers, A; Denti, P; Doerholt, K; Gibb, DM; Griffiths, AL; Makumbi, S; McIlleron, HM; Monkiewicz, LN; Mulenga, V; Mumbiro, V; Musiime, V; Nangiya, J; Szubert, AJ; Waalewijn, H; Wasmann, RE; Wiesner, L, 2023)		0.91
"In children, TAF combined with boosted PIs or dolutegravir and dosed according to WHO-recommended weight bands provides TAF and tenofovir concentrations previously demonstrated to be well tolerated and effective in adults."( First Pharmacokinetic Data of Tenofovir Alafenamide Fumarate and Tenofovir With Dolutegravir or Boosted Protease Inhibitors in African Children: A Substudy of the CHAPAS-4 Trial.
Bamford, A; Burger, DM; Bwakura-Dangarembizi, M; Chabala, C; Colbers, A; Denti, P; Doerholt, K; Gibb, DM; Griffiths, AL; Makumbi, S; McIlleron, HM; Monkiewicz, LN; Mulenga, V; Mumbiro, V; Musiime, V; Nangiya, J; Szubert, AJ; Waalewijn, H; Wasmann, RE; Wiesner, L, 2023)		0.91
" Compared with capsules, tablets are more preferred dosage forms due to its ease of manufacturing and tamper proof nature."( Spherical crystal agglomeration technique for improved flow properties and oral bioavailability of atazanavir sulphate.
Rawat, J; Shah, D; Thakkar, H, 2023)		0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
organic sulfate salt
[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]

Research

Studies (1,035)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's390 (37.68)29.6817
2010's554 (53.53)24.3611
2020's91 (8.79)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 28.06

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 moderate demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index28.06 (24.57)
Research Supply Index7.21 (2.92)
Research Growth Index6.91 (4.65)
Search Engine Demand Index36.71 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (28.06)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials246 (22.32%)5.53%
Reviews86 (7.80%)6.00%
Case Studies94 (8.53%)4.05%
Observational37 (3.36%)0.25%
Other639 (57.99%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (172)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
[NCT01274780]Phase 4180 participants (Actual)Interventional2011-05-31Completed
An Open-label, Randomised Pilot Study Comparing the Efficacy, Safety and Tolerability of Raltegravir With Protease Inhibitor-based Therapy in Treatment-naïve, HIV/Hepatitis C Co-infected Injecting Drug Users Receiving Methadone [NCT01105611]Phase 440 participants (Anticipated)Interventional2010-08-31Recruiting
Microboosting of Atazanavir 300 mg With 50 mg Versus 100 mg Ritonavir Daily in HIV-infected Patients: a Pharmacokinetic Study [NCT02034838]Phase 112 participants (Actual)Interventional2014-01-31Completed
A Multicenter Phase III Trial of Second-line Antiretroviral Treatment Strategies in African Adults (Tanzania Ans South Africa) Using Atazanavir or Lopinavir/Ritonavir [NCT01255371]Phase 30 participants (Actual)Interventional2012-03-31Withdrawn(stopped due to drug procurement issues)
Two Randomized, Open-labeled, Parallel Designed Multiple-dose Clinical Trials to Evaluate Pharmacokinetics of Ritonavir-unboosted and Ritonavir-boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunte [NCT01368783]Phase 132 participants (Anticipated)Interventional2011-06-30Not yet recruiting
Assessment of the Taste Properties of Atazanavir and Cobicistat and Pediatric Oral Test Formulations Containing Both Atazanavir and Cobicistat in Healthy Adults [NCT02307656]Phase 16 participants (Actual)Interventional2014-12-12Completed
ATAGLU: Study of Glucose Metabolism in HIV Positive Patients That Switch From Another Protease Inhibitor to Boosted or Unboosted Atazanavir [NCT02102048]300 participants (Anticipated)Interventional2009-01-31Active, not recruiting
A Single-Centre Open-Label Study in Healthy Adult Volunteers to Assess the Pharmacokinetic Interactions Between Steady-State TPV (500 mg) and Single-Dose and Steady-State Atazanavir (300 mg QD) in the Presence of Ritonavir (100 mg) [NCT02253836]Phase 121 participants (Actual)Interventional2005-01-31Completed
Efficacy of Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy in Patients With Viral Suppression. Randomized, Open-label 96 Weeks Non-inferiority Trial [NCT01307488]Phase 4286 participants (Actual)Interventional2011-09-30Completed
Metabolic Effects of Switching Kaletra to Boosted Reyataz [NCT00413153]15 participants (Actual)Interventional2006-05-31Completed
A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing a Reyataz-Based Substitution Approach in the Management of Lipodystrophy Syndrome. Research Into Atazanavir in Lipodystrophy (The REAL Study) [NCT00135356]Phase 4219 participants (Actual)Interventional2005-07-31Completed
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
Randomized, Open Label Study Evaluating the Lipid Profile Difference and Efficacy of a Combined Therapy Including Tenofovir, Emtricitabine + Atazanavir / r or NVP in Naive HIV - 1 Infected Patients. [NCT00389207]Phase 3576 participants (Actual)Interventional2006-10-31Completed
A Pilot Phase II Study of a Nucleoside Sparing Regimen of Dolutegravir + Atazanavir/r in HIV-1 Infected Patients With Detectable Viremia (DOLATAV Study) [NCT02542852]Phase 210 participants (Actual)Interventional2015-09-30Completed
Non-comparative Phase II Open Study Evaluating the Efficacy of a Reduced Dose Atazanavir / Ritonavir 200/100 mg + 2 NRTI in HIV-1-infected Patients With Virological Success With Atazanavir / Ritonavir 300/100 mg + 2 NRTI [NCT02473328]Phase 290 participants (Actual)Interventional2015-06-30Completed
A Phase IIIB, Open-label, Randomized, Multi-center Study Evaluating the Effect on Serum Lipids Following a Switch to ATV/r in HIV-1 Infected Subjects Who Have Achieved Virologic Suppression on a LPV/r Based Regimen. [NCT00120393]Phase 3192 participants (Anticipated)Interventional2004-01-31Completed
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
A Randomized, Open Label Trial to Investigate the Efficacy and Safety of Nitazoxanide Plus Atazanavir/Ritonavir for the Treatment of COVID-19: a Pilot Study [NCT04459286]Phase 257 participants (Actual)Interventional2020-10-09Terminated(stopped due to IDSMB recommendation)
Evaluation of the Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, Alone and in Combination With d4T and ddI as Compared to a Reference Combination Regimen [NCT00002240]Phase 20 participants Interventional1999-03-31Completed
Intensive Pharmacokinetic Studies of Antiretroviral Drug Combinations in Children [NCT00260078]Phase 1/Phase 275 participants (Actual)Interventional2006-02-28Completed
An Open Study to Investigate the Effect of Different Boosting Agents on Pharmacokinetics of Single Doses of BILR 355 BS (Dose Steps: 5 and 12.5 mg) Dissolved in 5 mL PEG 400 After Oral Administration in Healthy Male Volunteers [NCT02257008]Phase 144 participants (Actual)Interventional2003-03-31Completed
[NCT00067782]Phase 30 participants Interventional2002-12-31Completed
Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects [NCT00004584]Phase 20 participants Interventional1999-12-31Completed
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum [NCT00042289]1,578 participants (Actual)Observational2003-06-09Completed
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine With or Without Tenofovir on the Pharmacokinetics of Atazanavir When Given With Ritonavir in HIV-Infected Subjects [NCT00384904]Phase 440 participants (Actual)Interventional2006-12-31Completed
An Open, Prospective Study to Compare the Safety and Efficacy of Raltegravir vs. Atazanavir / Ritonavir, Both in Combination With Tenofovir DF and Emtricitabine, in the Treatment of HIV-infection in ART Naive Subjects With HCV Co-infection. [NCT01225705]Phase 40 participants (Actual)Interventional2010-10-31Withdrawn(stopped due to no pts recruited)
Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population [NCT01180075]85 participants (Actual)Observational2010-05-31Completed
Investigation of the Pharmacokinetics of Atazanavir in Pregnant Women, Individuals at Extremes of BMI, Children, and Adolescents: An Observational Study Nested Within the VirTUAL Consortium [NCT03923231]32 participants (Actual)Observational2019-09-02Completed
A Randomized Prospective Open Label Study of Switching to Raltegravir Based ART Compared to Maintaining Ritonavir Boosted PI-based ART on Liver Fibrosis Progression in HIV-HCV Coinfected Patients [NCT01231685]Phase 29 participants (Actual)Interventional2011-12-31Completed
Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients [NCT03708861]Phase 30 participants (Actual)Interventional2016-01-31Withdrawn
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine on the Pharmacokinetics of Atazanavir in HIV-Infected Subjects Receiving Atazanavir With Ritonavir and Tenofovir [NCT01232127]Phase 425 participants (Actual)Interventional2011-02-28Completed
Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study [NCT01003990]Phase 3710 participants (Actual)Interventional2002-10-31Completed
Randomized, Open-label Study of Switch From Lopinavir/Ritonavir (LPV/r) or Fosamprenavir/Ritonavir (FPV/r) to Either Once Daily Atazanavir/Ritonavir (ATV/r) or Once Daily Darunavir/Ritonavir (DRV/r) (Plus Background Nucleoside Reverse Transcriptase Inhibi [NCT00756730]Phase 449 participants (Actual)Interventional2008-09-30Completed
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
Open Label Phase 4, 48 Week Pilot Study of the Antiviral Efficacy and Tolerability of the Combination of Isentress™ and ReyatazTM When Substituted for Current Antiviral Regimen in Patients With Viral Suppression But Who Are Experiencing Adverse Events Rel [NCT00751153]Phase 440 participants (Anticipated)Interventional2008-03-31Recruiting
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
An Open-label, Randomized Crossover Study to Obtain a Preliminary Estimate of the Bioavailability of Atazanavir and Cobicistat When Administered in an Age-appropriate Fixed-Dose Combination Formulation Compared With Coadministration of the Age-appropriate [NCT04263350]Phase 134 participants (Actual)Interventional2020-02-26Completed
IMPAACT P1058A: Intensive Pharmacokinetic Studies of New Classes of Antiretroviral Drug Combinations in Children, Adolescents and Young Adults [NCT00977756]168 participants (Actual)Observational2002-08-31Completed
A 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
"PIQD: The Once a Day Protease Inhibitor Regimens. Ritonavir Boosted Atazanavir vs. Ritonavir Boosted Fosamprenavir Used in Combination With Tenofovir and Emtricitabine in HIV-1 Infected Antiretroviral Treatment-Naïve Patients." [NCT00242216]Phase 476 participants (Actual)Interventional2004-05-31Completed
Phase III Open Label Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV [NCT00035932]Phase 3571 participants (Actual)Interventional2001-11-30Completed
A Prospective Longitudinal Pilot Study to Measure the Effect of Intensification With Raltegravir +/- a Protease Inhibitor (PI) or Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) on HIV-1 Levels in the Gut [NCT00884793]8 participants (Actual)Interventional2008-09-30Completed
TMC125-TiDP2-C238: A Randomized, Exploratory, Open-label 48-week Trial to Investigate the Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Etravirine (ETR) in Combination With Ritonavir-boosted Atazanavir (ATV/Rtv) and 1 NRTI in Treatment- [NCT00896051]Phase 250 participants (Actual)Interventional2009-08-31Completed
A Randomised, Open-label, Cross-over Study to Examine the Pharmacokinetics and Short-term Safety and Efficacy of Two Dosing Strategies of Raltegravir Plus Atazanavir in HIV-infected Patients [NCT00874523]Phase 326 participants (Actual)Interventional2009-07-31Completed
A Study of the Pharmacokinetics of Atazanavir (ATV)/Ritonavir(RTV) Administered as Part of Highly Active Antiretroviral Therapy (HAART) in HIV-1 Infected Pregnant Women [NCT00326716]Phase 169 participants (Actual)Interventional2006-06-30Completed
Phase IIIb Multicenter, Single Arm, Open-Label Pilot Study to Evaluate the Effectiveness and Safety of Maintenance With Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in HIV-Infected Patients Evidencing Virologic Suppression OREY (Only [NCT00337467]Phase 361 participants (Actual)Interventional2006-06-30Completed
Influence of Atazanavir Treatment on Endothelial Dysfunction, Vascular Inflammation and Heme Oxygenase Activity in Type 2 Diabetes Mellitus [NCT00696722]Phase 216 participants (Anticipated)Interventional2008-06-30Completed
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women [NCT00869960]Phase 424 participants (Actual)Interventional2009-03-31Completed
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
The Effects of Atazanavir-induced Hyperbilirubinemia on the Innate Immune Response During Human Endotoxemia. A Parallel Double Blind Placebo Controlled Pilot Study. [NCT00916448]30 participants (Actual)Interventional2009-05-31Completed
Pharmacokinetics, Safety and Efficacy of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen in Patients With Intolerance and/or Resistance to NRTIs, NNRTIs and RTV: A Pilot Study [NCT02566707]Phase 29 participants (Actual)Interventional2015-08-31Terminated(stopped due to due to introduction of another integrase inhibitor, recruitement was not feasible anymore.)
Steady-state Pharmacokinetics of Atazanavir/Cobicistat and Darunavir/Cobicistat Once Daily Over 72 Hours in Healthy Volunteers [NCT02589158]Phase 116 participants (Actual)Interventional2015-11-30Completed
See Detailed Description [NCT00440947]Phase 3515 participants (Actual)Interventional2007-03-31Completed
Simplification From Tenofovir Plus Lamivudine or Emtricitabine Plus Ritonavir-Boosted-Protease Inhibitor to Ritonavir-Boosted-Atazanavir Plus Lamivudine in Virologically-Suppressed-HIVInfected Adults With Osteopenia [NCT02652793]45 participants (Anticipated)Interventional2015-07-31Recruiting
CID 0708 - Sex, Aging and Antiretroviral Pharmacokinetics [NCT00666055]11 participants (Actual)Observational2008-03-31Completed
A Drug-drug Interaction Study Between the Novel Anti-HCV Agent Daclatasvir and the Antiretroviral Agents Atazanavir/Ritonavir or Atazanavir/Cobicistat in Healthy Volunteers [NCT02565888]Phase 116 participants (Actual)Interventional2015-11-30Completed
A Pilot Randomized, Open Label Study to Evaluate Efficacy and Safety of the Combination of RAL+ATV/r in Comparison With TDF/FTC+ATV/r in HIV Infected Patients, Who Failed an Initial NNRTI Containing Regimen [NCT01829802]Phase 450 participants (Anticipated)Interventional2014-05-31Active, not recruiting
Phase I, Open Label, Randomized, Drug-Drug Interaction Study in Healthy Subjects to Investigate the Effects of Co-Administered Atazanavir/Ritonavir (300mg/100mg) or Atazanavir 400mg Administered Once Daily on the Steady-State Plasma Pharmacokinetics of GS [NCT00883935]Phase 124 participants (Actual)Interventional2009-04-30Completed
A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9350-boosted Atazanavir (ATV/GS-9350) Compared to Ritonavir-boosted Atazanavir (ATV/r) in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in HIV-1 Infected [NCT00892437]Phase 285 participants (Actual)Interventional2009-05-31Completed
Study to Assess the Pharmacokinetic Drug - Drug Interactions Between Atazanavir Plus Ritonavir Coadministered With Voriconazole in Healthy Subjects [NCT00833482]Phase 1185 participants (Actual)Interventional2009-09-30Completed
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 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 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
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
Pharmacokinetics of Darunavir/Ritonavir Once Daily and Atazanavir/Ritonavir Once Daily Over 72 Hours Following Drug Intake Cessation [NCT01073761]Phase 125 participants (Anticipated)Interventional2010-04-30Completed
ARNS 141 TIPI : A Pilot Trial to Assess the Ability of an Intermittent Antiretroviral Therapy in Maintaining an Immunological Stability in Antiretroviral naïve HIV Infected Adults, With CD4 Count Above 500/mm3 [NCT00820118]Phase 245 participants (Actual)Interventional2009-05-31Completed
A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing the Efficacy of a Treatment Maintenance Phase With Unboosted vs. Boosted Reyataz After an Induction Phase With Reyataz and Ritonavir in Treatment Naive HIV Patients (the INDUMA Study) [NCT00207142]Phase 4252 participants (Actual)Interventional2005-11-30Completed
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
Comparison Atazanavir/Ritonavir (ATV/r) vs Nevirapine (NVP) Twice a Day (Bid) on Truvada Backbone [NCT00552240]Phase 4154 participants (Actual)Interventional2007-09-30Completed
Randomized, Open-Label Evaluation of Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Persons From Resource-Limited Settings (PE [NCT00084136]Phase 41,571 participants (Actual)Interventional2005-05-31Completed
A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen [NCT00135343]Phase 360 participants Interventional2004-04-30Completed
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)
A Phase IV, Prospective, Multicenter , Randomized Open Label, 48 Weeks Study to Evaluate the Antiretroviral Efficacy and Safety of Atazanavir or Darunavir,Each in Combination With a Fixed Dose of Tenofovir Emtricitabine in HIV-1-infected Treatment-naïve S [NCT01928407]Phase 4120 participants (Actual)Interventional2011-02-23Completed
Boosted Atazanavir and Truvada Given Once-Daily (BATON Study): A Phase 4 Study of Safety, Efficacy & Adherence in HIV Infected, Antiretroviral Naïve Subjects Treated With a Simple Once-Daily Regimen [NCT00224445]Phase 4100 participants (Actual)Interventional2005-09-30Completed
Open-labeled, Randomized, Crossover, Single-dose Study in Healthy Male Subjects to Evaluate the Pharmacokinetics, Safety & Tolerability of Stable Isotopologs of Atazanavir (ATV), Administered as Single Agents or as Combinations of Two Isotopologs, With a [NCT01458769]Phase 147 participants (Actual)Interventional2010-12-31Completed
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)
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment- [NCT01108510]Phase 3698 participants (Actual)Interventional2010-04-30Completed
A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in Human Immunodeficiency Virus [NCT01335698]Phase 3160 participants (Actual)Interventional2011-05-27Completed
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
A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in HIV Infected Pediatric Patie [NCT01099579]Phase 382 participants (Actual)Interventional2010-10-13Completed
A Prospective, Randomized, Multicenter, Open-Label Study to Compare the Efficacy and Safety of Simplifying From a Regimen of Atazanavir (ATV) + Ritonavir (RTV) + Tenofovir/Emtricitabine to ATV + Abacavir/Lamivudine Without RTV in Virologically Suppressed, [NCT01102972]Phase 4297 participants (Actual)Interventional2010-04-30Completed
Effect of HIV-1 Protease Inhibitors on Endothelial Function and Glucose Metabolism in Normal, HIV-Uninfected Subjects: Atazanavir or Lopinavir/Ritonavir or Placebo [NCT00720590]30 participants (Actual)Interventional2003-11-30Completed
Study to Evaluate the Exposure of Rifabutin Administered in an Alternate Regimen in Combination With Atazanavir and Ritonavir Healthy Subjects [NCT00646776]Phase 185 participants (Actual)Interventional2008-04-30Completed
Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Atazanavir/Ritonavir + Lamivudine in Patients Stably Treated With Two NRTIs + Atazanavir/Ritonavir With Optimal Virologic Response. [NCT00885482]Phase 440 participants (Actual)Interventional2009-05-31Completed
Cardiovascular, Anthropometric, and Skeletal Effects of Antiretroviral Therapy (ART) Initiation With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Plus Atazanavir/Ritonavir (ATV/r), Darunavir/Ritonavir (DRV/r), or Raltegravir (RAL): Metabolic Subs [NCT00851799]334 participants (Actual)Observational2009-06-30Completed
The Effect of Atazanavir/Cobicistat on the Pharmacokinetics of an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (Microgynon 30®) in Healthy Women [NCT02697851]Phase 113 participants (Actual)Interventional2016-07-31Terminated(stopped due to "Insufficient enrolment and business reasons")
A Pilot Randomized, Open-Label Study Comparing the Safety and Efficacy of a Raltegravir Based NRTI Sparing Regimen [NCT00814879]60 participants (Actual)Interventional2009-05-31Completed
Randomized Controlled Phase 2/3 Clinical Trial of NA-831 Alone or With Atazanavir, or NA-831 With Dexamethasone, or Atazanavir With Dexamethasone in the Treatment of COVID-19 Infection [NCT04452565]Phase 2/Phase 3525 participants (Anticipated)Interventional2022-06-15Recruiting
A Randomised Prospective Study Assessing Changes in Neurocognitive Function, Using a Computerised Test Battery, in Treatment Naïve HIV-1 Positive Subjects Commencing Two Different Antiretroviral Regimens [NCT00540137]Phase 421 participants (Actual)Interventional2007-07-31Completed
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women [NCT01394133]0 participants (Actual)Observational2011-07-31Withdrawn(stopped due to Lack of enrollment)
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Nevirapine on the Pharmacokinetics of Atazanavir in HIV-Infected Individuals [NCT00162149]Phase 146 participants Interventional2005-10-31Completed
Bioequivalence Study of Atazanavir Single 300 mg Capsule Relative to Two Atazanavir 150 mg Capsules in Healthy Subjects [NCT00393328]Phase 146 participants Interventional2006-11-30Completed
A Prospective, Open-Label, Pilot Trial of Regimen Simplification to Atazanavir/Ritonavir Alone as Maintenance Antiretroviral Therapy After Sustained Virologic Suppression [NCT00084019]36 participants (Actual)Interventional2004-07-31Completed
Safety, Tolerability, and Pharmacokinetic Interactions of Atazanavir and Rifampin in Healthy Volunteers [NCT00096850]18 participants (Actual)InterventionalCompleted
Disulfiram Interactions With HIV Medications: Clinical Implications [NCT00878306]Phase 140 participants (Actual)Interventional2008-11-30Completed
The Pharmacokinetics of Atazanavir / Ritonavir 200/100 OD Versus 300/100 mg OD in Combination With 2 NRTIs in HIV Pre-treated Patients [NCT00411957]Phase 1/Phase 222 participants (Actual)Interventional2007-01-31Completed
An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of a Fixed-Dose Combination of Abacavir 600 mg/Lamivudine 300 mg Once-Daily in Combination With Atazanavir 300 mg + Ritonavir 100 mg Once-Daily in Antiretroviral-Naïve HIV-1 Infected Sub [NCT00426296]Phase 40 participants Interventional2006-08-31Recruiting
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
Open Label, Multiple Dose, Sequential, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of Atazanavir and Raltegravir Co-Administered Twice Daily in Healthy Subjects [NCT00518297]Phase 122 participants (Actual)Interventional2007-08-31Completed
[NCT00525239]60 participants (Anticipated)Interventional2004-03-31Recruiting
Randomized, Non-inferiority Trial Comparing a Dual Maintenance Therapy Strategy With Dolutegravir + Lamivudine (DTG/3TC) or Atazanavir/Ritonavir + Lamivudine (ATV/r+3TC) Versus the Standard WHO First Line Triple Therapy Tenofovir + Lamivudine + Efavirenz [NCT04022967]Phase 3480 participants (Actual)Interventional2020-09-21Active, not recruiting
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
The Study of Atazavanir/Ritonavir-based HAART in Thai HIV-infected Children [NCT01656109]Phase 220 participants (Actual)Interventional2011-07-31Completed
Phase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients [NCT00084253]Phase 4200 participants (Anticipated)Interventional2004-06-30Completed
Monotherapy in Africa: Evaluation of New Therapy [NCT02155101]Phase 3120 participants (Actual)Interventional2014-05-31Completed
Genetic-determinants of Protease Inhibitor Pharmacology [NCT01388543]Phase 431 participants (Actual)Interventional2006-09-30Completed
Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Omeprazole 20 mg on the Pharmacokinetics of Atazanavir Administered With Ritonavir in Healthy Subjects [NCT00357240]Phase 156 participants Interventional2006-06-30Completed
Open-label Randomized Multicenter Study of Once Daily Antiretroviral Treatment Regimen Comparing Ritonavir Boosted Atazanavir to Efavirenz [NCT00280969]Phase 371 participants (Actual)Interventional2005-09-30Completed
A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety, Tolerability and Efficacy of Trizivir (Abacavir 300mg, Lamivudine 150mg, and Zidovudine 300mg) BID vs Combivir (Lamivudine 150mg and Zidovudine 300mg) BID Plus Atazanavir 400mg QD [NCT00082394]Phase 40 participants Interventional2004-04-26Completed
A Phase IV, One-arm, Open-label, Multicenter Study Evaluating Effect of Treatment Change to Atazanavir/Ritonavir on Brachial Endothelial Function of HIV Infected Patient Receiving Function in HIV Infected Patient Receiving Potent Antiretroviral Combinatio [NCT00312754]Phase 470 participants Interventional2005-06-30Terminated(stopped due to insufficient enrollment)
Randomized Open Label Study Assessing the Antiviral Activity, Toxicity and Pharmacologic Interaction of Tenofovir DF/Atazanavir Enhanced With Low Dose of Ritonavir as Part of a Salvage Regimen in HIV Infected Patients With Multiple Treatment Failures (ANR [NCT00122577]Phase 250 participants Interventional2002-03-31Terminated
The Pharmacokinetics of Lopinavir/Ritonavir in Combination With Atazanavir in HIV-Infected Subjects [NCT00420355]Phase 419 participants (Actual)Interventional2007-04-30Terminated(stopped due to Unexpected adverse event)
Effect of Atazanavir on Endothelial Function in HIV-Infected Patients Compared to Standard Proteinase Inhibitors on Top of Potent Antiviral Combination Therapy [NCT00447070]Phase 450 participants Interventional2004-08-31Completed
Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism [NCT00135434]Phase 125 participants Interventional2004-09-30Completed
The De-Escalate Trial: Atazanavir or Atazanavir/Ritonavir Substitution for Ritonavir Boosted PI Therapy in HIV-Infected Individuals Experiencing Ongoing HIV Viremia and Hyperlipidemia: A Randomized Controlled Pilot Study [NCT00160329]Phase 360 participants (Actual)Interventional2004-01-31Completed
Switch to Unboosted Atazanavir With Tenofovir (SUAT) Study [NCT01351740]Phase 450 participants (Actual)Interventional2011-07-31Completed
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
A Pilot Open-Label Phase II Clinical Trial to Evaluate the Safety and Efficacy of a Compact Three Drug Antiretroviral Treatment Regimen for Subjects With Acute HIV-1 Infection or Recent HIV-1 Seroconversion [NCT00007202]Phase 255 participants (Actual)InterventionalCompleted
A Randomised, Controlled, Open-Label, 48-Week, Study To Asses Differences in Changes In Plasma Lipid Profile Between Patients On Saquinavir/Ritonavir Or Atazanavir/Ritonavir In Combination With Tenofovir Disoproxil Fumarate And Emtricitabine As A First-li [NCT00389402]Phase 4120 participants (Anticipated)Interventional2006-07-31Completed
[NCT00046345]0 participants Expanded Access2002-05-31No longer available
Randomized, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics of Atazanavir Administered Twice-Daily in Health Subjects [NCT00357721]Phase 118 participants Interventional2006-06-30Completed
Phase III, Randomized, Double-Blind Comparison of Three Protease Inhibitor-Sparing Regimens for the Initial Treatment of HIV Infection [NCT00013520]Phase 31,125 participants InterventionalCompleted
A Restrictively Randomized, Open-Label, Controlled, Pilot Study of the Effect of a Thymidine Analogue Substitution or Change to a Nucleoside-Sparing Regimen on Peripheral Fat Wasting [NCT00028314]150 participants Interventional2002-03-31Completed
Clinical Pilot Trial to Evaluate the Influence of Nevirapine in Exposure to Atazanavir in Steady State Equilibrium in HIV-infected Adult Patients. [NCT00355719]Phase 414 participants (Actual)Interventional2007-01-31Completed
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum [NCT04518228]325 participants (Anticipated)Observational2021-06-08Recruiting
Effect of Atazanavir-ritonavir on the Pharmacokinetics and Toxicity of Lumefantrine in People Living With HIV Attending Lagos University Teaching Hospital [NCT04531072]Phase 420 participants (Actual)Interventional2018-09-18Completed
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
Cross-sectional Study for the Characterisation of the Pharmacokinetic Parameters of Protease Inhibitors and Non-nucleoside Analog Reverse Transcriptase Inhibitors in the Spanish Population of HIV-infected Subjects [NCT00307502]Phase 1675 participants (Actual)Interventional2005-01-31Completed
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
An Open-Label Phase 3B Study in HIV-Infected Individuals With Viremia on or After Their First-Line Non-Nucleoside Reverse Transcriptase Inhibitor or Integrase Inhibitor-Based Regimen and Starting a Second-Line Regimen Consisting of ATV/RTV or DRV/RTV With [NCT01605084]Phase 30 participants (Actual)Interventional2012-06-30Withdrawn
Effects of Gastric pH on the Pharmacokinetics of Atazanavir in Healthy Volunteers [NCT01759875]Phase 18 participants (Actual)Interventional2013-01-31Completed
Pharmacokinetic Interactions Between Telaprevir and Un-boosted Atazanavir in HIV/HCV-co-infected Patients Under Treatment for Genotype 1 Chronic Hepatitis C. [NCT01818856]Phase 114 participants (Anticipated)Interventional2012-12-31Completed
Randomized, Double Blind, Crossover Taste Assessment Study of Two Atazanavir Powder Formulations As Compared to a Reference Atazanavir Powder Formulation in Healthy Subjects [NCT01404572]Phase 112 participants (Actual)Interventional2011-08-31Completed
The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception [NCT01667978]35 participants (Actual)Interventional2012-06-30Completed
Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of BMS-955176 (Double-Blinded) and BMS-955176 With Atazanavir +/- Ritonavir (Open-Labeled) in HIV-1 Infected Subjects [NCT01803074]Phase 2107 participants (Actual)Interventional2013-04-04Completed
A Study on ART Naïve Patients On Different Regimens to Treat Hiv (a Phase 4 Study) [NCT01445223]Phase 4242 participants (Actual)Interventional2004-04-30Completed
An Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, 3-Sequence, Crossover Design, Relative Bioavailability Study Comparing the Pharmacokinetics of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulation [NCT05236738]Phase 142 participants (Actual)Interventional2022-05-13Completed
A Randomized Study to Evaluate the Effect of Switching From Efavirenz to Atazanavir/ Ritonavir on Lipoatrophy and Mitochondrial Dysfunction in HIV-infected Subjects With Good Virologic Suppression [NCT01194856]Phase 41 participants (Actual)Interventional2010-10-31Terminated(stopped due to Closed due to low enrollment)
Antiviral for Adult Patients Hospitalized for SARS-CoV-2 Infection: a Randomized, Phase 2/3, Multicenter, Placebo Controlled, Adaptive, Multi-arm, Multi-stage Clinical Trial - Coalition Brazil COVID-19 IX: REVOLUTIOn [NCT04468087]Phase 2/Phase 3256 participants (Actual)Interventional2021-02-15Active, not recruiting
A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus [NCT01421355]Phase 115 participants (Actual)Interventional2012-05-31Completed
Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study: Endothelial Function in HIV-Infected Subjects Switched to an Atazanavir Regimen [NCT00225017]Phase 350 participants (Actual)Interventional2005-06-30Completed
A Phase III Study Comparing the Antiviral Efficacy and Safety of BMS-232632 With Efavirenz; Each in Combination With Fixed Dose Zidovudine-Lamivudine [NCT00013897]Phase 30 participants Interventional2001-02-28Completed
Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens With Other PI's/NNRTI's in HIV+ Children and Adolescents With Elevated Lipid Levels [NCT00940771]Phase 410 participants (Actual)Interventional2009-08-26Completed
A Multi-Center, Open-Label, Extension Study to Allow Continued Treatment of Patients Who Have Participated in Spectrum-Sponsored Clinical Studies With Belinostat [NCT04184869]Phase 18 participants (Actual)Interventional2019-08-05Completed
A Randomized, Single-center, Open-label, One-sequence, Two-period Crossover Study in 3 Parts to Investigate the Effects of Multiple Doses of Ketoconazole (Part 1), Rifampicin (Part 2), and Ritonavir-boosted Atazanavir (Part 3) on the PK of a Single Dose o [NCT01591850]Phase 151 participants (Actual)Interventional2011-09-30Completed
A Study to Evaluate the Potential Drug-Drug Interaction Between Danoprevir When Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir in Healthy Adult Volunteers [NCT01592305]Phase 140 participants (Actual)Interventional2012-05-31Completed
Safety and Efficacy of Switching a Stable Combined Antiretroviral Therapeutic Regimen to Atazanavir With Ritonavir Plus Lamivudine in Treatment Experienced HIV Positive Patients With Full and Stable Virological Suppression [NCT01599364]Phase 4266 participants (Actual)Interventional2014-04-30Completed
The Effect of the Co-administration of Atazanavir (ATV) and Ritonavir (RTV) on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects [NCT00357604]Phase 122 participants Interventional2006-07-31Completed
Comparison of 2 Alternative Antiretroviral Combinations in HIV Post-exposure Prophylaxis: AZT-3TC (Combivir®) + Lopinavir-ritonavir (Kaletra®) Versus AZT-3TC (Combivir®)+ Atazanavir (Reyataz®). Multicentre, Prospective, Randomized, Open Study [NCT00385645]Phase 4255 participants (Actual)Interventional2006-05-31Completed
A Phase 3, Two-Part Study to Evaluate the Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral [NCT01967940]Phase 355 participants (Actual)Interventional2013-10-25Completed
Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects [NCT00365339]Phase 140 participants Interventional2006-04-30Completed
Open-Label, Multiple Dose Study to Determine the Relative Bioavailability of Atazanavir (ATV) 400 mg Administered With Ritonavir (RTV) and Efavirenz (EFV) Compared to Atazanavir 300 mg Administered With Ritonavir Alone in Healthy Subjects [NCT00357188]Phase 122 participants Interventional2006-07-31Completed
Effect of Atazanavir Administered With and Without Ritonavir on the Pharmacokinetics of the Cytochrome P450 2C8 Substrate Rosiglitazone in Healthy Subjects [NCT00362726]Phase 114 participants Interventional2006-09-30Completed
Atazanavir and Endothelial Function in Older HIV Patients [NCT03019783]Phase 2/Phase 360 participants (Actual)Interventional2011-12-31Completed
Switching From Regimens Consisting of a RTV-Boosted Protease Inhibitor Plus TDF/FTC to a Combination of Raltegravir Plus Nevirapine and Lamivudine in HIV Patients With Suppressed Viremia and Impaired Renal Function (RANIA Study) (Pilot Study) Protocol MK- [NCT02116660]Phase 211 participants (Actual)Interventional2014-09-03Terminated(stopped due to This study was terminated early due to poor recruitment.)
Pharmacokinetics Study of Tenofovir in HIV-infected Thai Children Using Tenofovir-based Regimen [NCT02404259]32 participants (Actual)Interventional2010-06-30Completed
Population Pharmacokinetics of Antiretroviral in Children [NCT03194165]65 participants (Actual)Observational2017-06-16Completed
A Phase 2b Randomized, Active-Controlled, Staged, Open-Label Trial to Investigate Safety and Efficacy of BMS-955176/GSK3532795 in Combination With Dolutegravir and Atazanavir (With or Without Ritonavir) in Treatment-Experienced HIV-1 Infected Adults [NCT02386098]Phase 286 participants (Actual)Interventional2015-07-08Terminated(stopped due to GI Intolerability)
Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and Antiretroviral Therapy (ART) [NCT01903031]Phase 284 participants (Actual)Interventional2014-12-30Completed
Efficacy of Atazanavir / Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression. Randomized, Open Label Non Inferiority Trial. A Phase 3 Study. [NCT01511809]Phase 3117 participants (Actual)Interventional2010-09-30Completed
Evaluation of Pharmacokinetic Interaction Between Nitazoxanide and Atazanavir/Ritonavir in Healthy Volunteers [NCT05680792]17 participants (Actual)Interventional2020-09-10Completed
A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety, Efficacy and Dose-Response of BMS-663068 in Treatment-experienced HIV-1 Subjects, Followed by an Open-Label Period on the Recommended Dose [NCT01384734]Phase 2254 participants (Actual)Interventional2011-07-26Completed
A Phase IIIb, Open -Label, Randomized Multi-center Study Comparing the Antiviral Efficacy, Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, in Combination With Two Nucleoside or Nucleotide Reverse Transcriptase Inhibi [NCT00135395]Phase 3200 participants (Anticipated)Interventional2004-05-31Completed
A Randomized Open-label Study of the Antiviral Efficacy and Safety of Atazanavir Versus Lopinavir/Ritonavir(LPV/RTV), Each in Combination With Two Nucleosides in Subjects Who Have Experienced Virologic Failure With Prior Protease Inhibitor-Containing HAAR [NCT00028301]Phase 30 participants Interventional2001-02-28Completed
A Phase III Study Comparing the Antiviral Efficacy and Safety of Atazanavir With Nelfinavir: Each in Combination With Dual Nucleoside Therapy in HIV-Infected Subjects Who Have Failed a Regimen Not Containing a Protease Inhibitor [NCT00028067]Phase 3500 participants Interventional2001-08-31Terminated
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 Randomized, 5-Period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of Atazanavir When Co-Administered With Cobicistat as a Fixed Dose Combination Relative to the Single Agents Following a Light Meal, the Relative Bioavailability of A [NCT01837719]Phase 164 participants (Actual)Interventional2013-04-30Completed
HIV Reservoir Dynamics After Switching to Dolutegravir in Patients With Two NRTI and a Protease Inhibitor Based Regimen. A Phase IV Open Randomized Trial [NCT02513147]Phase 444 participants (Actual)Interventional2015-06-30Completed
A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety of Atazanavir (ATV) Capsule Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in HIV Infected, Antiretroviral Naive and Experienced Pediatr [NCT01691794]Phase 4108 participants (Actual)Interventional2012-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00035932 (38) [back to overview]Most Common AEs and AEs of Interest Through Week 48
NCT00035932 (38) [back to overview]Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)
NCT00035932 (38) [back to overview]Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)
NCT00035932 (38) [back to overview]PR Interval and Change From Baseline by Analysis Time Point
NCT00035932 (38) [back to overview]Change From Baseline in CD4 Cell Count at Week 24
NCT00035932 (38) [back to overview]Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48
NCT00035932 (38) [back to overview]Change From Baseline in CD4 Cell Count at Week 48
NCT00035932 (38) [back to overview]Change From Baseline in CD4 Cell Count at Week 96
NCT00035932 (38) [back to overview]Fasting Glucose Mean Change From Baseline at Week 24
NCT00035932 (38) [back to overview]HIV IC50 at Week 24
NCT00035932 (38) [back to overview]Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96
NCT00035932 (38) [back to overview]Inhibitory Quotient at Week 24
NCT00035932 (38) [back to overview]Fasting Glucose Mean Change From Baseline at Week 48
NCT00035932 (38) [back to overview]Lipid Mean Percent Change From Baseline at Week 24
NCT00035932 (38) [back to overview]Lipid Mean Percent Change From Baseline at Week 48
NCT00035932 (38) [back to overview]Lipid Mean Percent Change From Baseline at Week 96, Observed Values
NCT00035932 (38) [back to overview]Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values
NCT00035932 (38) [back to overview]Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)
NCT00035932 (38) [back to overview]Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)
NCT00035932 (38) [back to overview]HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24
NCT00035932 (38) [back to overview]Grade 3/4 Laboratory Abnormalities Through Week 48
NCT00035932 (38) [back to overview]Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point
NCT00035932 (38) [back to overview]Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48
NCT00035932 (38) [back to overview]Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24
NCT00035932 (38) [back to overview]Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24
NCT00035932 (38) [back to overview]Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire
NCT00035932 (38) [back to overview]Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96
NCT00035932 (38) [back to overview]Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48
NCT00035932 (38) [back to overview]Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24
NCT00035932 (38) [back to overview]Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96
NCT00035932 (38) [back to overview]Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48
NCT00035932 (38) [back to overview]Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24
NCT00035932 (38) [back to overview]Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96
NCT00035932 (38) [back to overview]Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24
NCT00035932 (38) [back to overview]Mean Change From Baseline in HIV RNA at Week 96
NCT00035932 (38) [back to overview]Mean Change From Baseline in HIV RNA at Week 48
NCT00035932 (38) [back to overview]Mean Change From Baseline in HIV RNA at Week 2
NCT00035932 (38) [back to overview]Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24
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 (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) 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: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs
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]Plasma Concentration for Contraceptives
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]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 Geometric Mean (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 Median (Range) 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: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs
NCT00074581 (2) [back to overview]Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
NCT00074581 (2) [back to overview]All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
NCT00084136 (18) [back to overview]Time to Loss of Virologic Response at Week 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 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(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 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)
NCT00084136 (18) [back to overview]Time to Treatment Failure (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Treatment Failure (PI Comparison)
NCT00084136 (18) [back to overview]Time to Immunologic Failure (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)
NCT00084136 (18) [back to overview]Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)
NCT00084136 (18) [back to overview]Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)
NCT00084136 (18) [back to overview]Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)
NCT00084136 (18) [back to overview]Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (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]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]Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI 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)
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing Regimen Failure
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing Treatment Modification
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing 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]Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL
NCT00118898 (22) [back to overview]The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
NCT00118898 (22) [back to overview]Time From Randomization to Virologic Failure
NCT00118898 (22) [back to overview]Time From Treatment Dispensation to a Grade 3/4 Safety Event
NCT00118898 (22) [back to overview]Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)
NCT00118898 (22) [back to overview]Time From Treatment Dispensation to Treatment Modification
NCT00118898 (22) [back to overview]Number of Participants With Regimen Failure
NCT00118898 (22) [back to overview]Amount of Study Follow-up
NCT00118898 (22) [back to overview]Number of Participants With a Grade 3/4 Safety Event
NCT00118898 (22) [back to overview]Number of Participants With Treatment Modification
NCT00118898 (22) [back to overview]Number of Participants With Virologic Failure
NCT00118898 (22) [back to overview]Number of Participants With Virologic Failure and Emergence of Major Resistance
NCT00118898 (22) [back to overview]Change in CD4 Count (Cells/mm3) From Baseline
NCT00118898 (22) [back to overview]Change in Fasting High-density Lipoprotein (HDL) 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 Total Cholesterol Level From Baseline
NCT00118898 (22) [back to overview]Change in Fasting Triglyceride Level From Baseline
NCT00135356 (18) [back to overview]Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96
NCT00135356 (18) [back to overview]Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96
NCT00135356 (18) [back to overview]Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48
NCT00135356 (18) [back to overview]Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline
NCT00135356 (18) [back to overview]Mean Change From Baseline in CD4 Count
NCT00135356 (18) [back to overview]Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96
NCT00135356 (18) [back to overview]Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.
NCT00135356 (18) [back to overview]Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
NCT00135356 (18) [back to overview]Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96
NCT00135356 (18) [back to overview]Mean Changes From Baseline in Body Weight at Week 48 and Week 96
NCT00135356 (18) [back to overview]Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
NCT00135356 (18) [back to overview]Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation
NCT00135356 (18) [back to overview]Percentage of Participants With Abnormal Liver Function Tests
NCT00135356 (18) [back to overview]Mean Percent Changes From Baseline in Fasting Lipids
NCT00135356 (18) [back to overview]Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans
NCT00135356 (18) [back to overview]Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans
NCT00135356 (18) [back to overview]Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96
NCT00135356 (18) [back to overview]Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96
NCT00207142 (17) [back to overview]Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase
NCT00207142 (17) [back to overview]Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
NCT00207142 (17) [back to overview]Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase
NCT00207142 (17) [back to overview]Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase
NCT00207142 (17) [back to overview]Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase
NCT00207142 (17) [back to overview]Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase
NCT00207142 (17) [back to overview]Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase
NCT00207142 (17) [back to overview]Summary of Adverse Events During Rescue Phase
NCT00207142 (17) [back to overview]Summary of Adverse Events During Maintenance Phase
NCT00207142 (17) [back to overview]Summary of Adverse Events During Induction Phase
NCT00207142 (17) [back to overview]Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase
NCT00207142 (17) [back to overview]Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
NCT00207142 (17) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase
NCT00207142 (17) [back to overview]Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase
NCT00207142 (17) [back to overview]Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase
NCT00207142 (17) [back to overview]Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase
NCT00207142 (17) [back to overview]Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase
NCT00225017 (3) [back to overview]Changes in LDL Particle Number From Baseline to Week 24
NCT00225017 (3) [back to overview]Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24
NCT00225017 (3) [back to overview]Change in Total Cholesterol Levels From Baseline to Week 24
NCT00242216 (2) [back to overview]Proportion of Patient With Viral Load Less Than 400 Copies/mL
NCT00242216 (2) [back to overview]CD4 Cell Count Change From Baseline During Treatment.
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 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]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 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]Mean Change From Baseline in Waist-to-hip-ratio at Week 96
NCT00272779 (88) [back to overview]Cmax of Tenofovir at Week 4
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 Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980
NCT00272779 (88) [back to overview]Mean Change From Baseline in VAT Associated With RETN_730
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]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 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]Cmin of RTV at Week 4
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 Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097
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 Triglycerides Associated With APOE_C130R
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 RETN_2265
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_734
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 Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679
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 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]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]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]Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980
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]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
NCT00326716 (27) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00326716 (27) [back to overview]Number of Participants With Grade 2 to Grade 4 AEs and SAEs
NCT00326716 (27) [back to overview]SAEs in Enrolled Infants
NCT00326716 (27) [back to overview]SAEs in Enrolled Mothers
NCT00326716 (27) [back to overview]Infant Gestational Age at Delivery
NCT00326716 (27) [back to overview]Mean ATV Area Under the Concentration Curve (AUC TAU)
NCT00326716 (27) [back to overview]Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval
NCT00326716 (27) [back to overview]Mean ATV Terminal Elimination Half Life (T 1/2)
NCT00326716 (27) [back to overview]Mean ATV Time of Maximum Observed Plasma Concentration (Tmax)
NCT00326716 (27) [back to overview]Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose
NCT00326716 (27) [back to overview]Mean CD4 Cell Count at Baseline
NCT00326716 (27) [back to overview]Mean HIV RNA Level at Baseline
NCT00326716 (27) [back to overview]Mean RTV Area Under the Concentration Curve (AUC TAU)
NCT00326716 (27) [back to overview]Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval
NCT00326716 (27) [back to overview]Mean RTV Terminal Elimination Half Life (T 1/2)
NCT00326716 (27) [back to overview]Mean RTV Time of Maximum Observed Plasma Concentration (Tmax)
NCT00326716 (27) [back to overview]Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose
NCT00326716 (27) [back to overview]Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count
NCT00326716 (27) [back to overview]Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level
NCT00326716 (27) [back to overview]Infant Gender
NCT00326716 (27) [back to overview]Infant HIV Status
NCT00326716 (27) [back to overview]Infant Race
NCT00326716 (27) [back to overview]Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery
NCT00326716 (27) [back to overview]Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration
NCT00326716 (27) [back to overview]Mean Atazanavir Plasma Protein Binding
NCT00326716 (27) [back to overview]Median Infant Total Bilirubin Level
NCT00326716 (27) [back to overview]Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
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.
NCT00337467 (13) [back to overview]Cumulative Proportion of Participants Without Treatment Failure Through Week 100
NCT00337467 (13) [back to overview]Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24
NCT00337467 (13) [back to overview]Mean Change From Baseline in CD4 Cell Count at Week 96
NCT00337467 (13) [back to overview]Mean Change From Baseline in CD4 Cell Count at Week 48
NCT00337467 (13) [back to overview]Percentage of Participants With Treatment Failure Through Week 48
NCT00337467 (13) [back to overview]Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
NCT00337467 (13) [back to overview]Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96
NCT00337467 (13) [back to overview]Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48
NCT00337467 (13) [back to overview]Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96
NCT00337467 (13) [back to overview]Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
NCT00337467 (13) [back to overview]Percentage of Participants With Treatment Failure Through Week 96
NCT00337467 (13) [back to overview]Percentage of Participants With Virological Rebound Through Week 48
NCT00337467 (13) [back to overview]Percentage of Participants With Virological Rebound Through Week 96
NCT00389207 (34) [back to overview]Change in Framingham Score From Baseline
NCT00389207 (34) [back to overview]Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144
NCT00389207 (34) [back to overview]Change in Physical Health Summary (PHS) Score From Baseline
NCT00389207 (34) [back to overview]Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144
NCT00389207 (34) [back to overview]Change of Cholesterol Values From Baseline to Week 48, 96, 144
NCT00389207 (34) [back to overview]Change of hsCRP From Baseline to Week 48, 96, 144
NCT00389207 (34) [back to overview]Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144
NCT00389207 (34) [back to overview]Change of Total Triglycerides From Baseline to Week 48, 96, 144
NCT00389207 (34) [back to overview]Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144
NCT00389207 (34) [back to overview]Genotypic Resistance Associated With Virologic Failure
NCT00389207 (34) [back to overview]Glycaemic Abnormalities
NCT00389207 (34) [back to overview]Lipodystrophy
NCT00389207 (34) [back to overview]Non-scheduled Physician Visits
NCT00389207 (34) [back to overview]Number of Patients Hospitalized
NCT00389207 (34) [back to overview]Change in CD4+ Count From Baseline
NCT00389207 (34) [back to overview]Proportion of Patients With Virologic Failure at Week 48, 96, 144
NCT00389207 (34) [back to overview]Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144
NCT00389207 (34) [back to overview]Proportion of Patients With VL < 400 Copies/ml
NCT00389207 (34) [back to overview]Proportion of Patients With VL < 50 Copies/ml
NCT00389207 (34) [back to overview]Serum Lipid Abnormalities
NCT00389207 (34) [back to overview]Treatment Response at Week 144
NCT00389207 (34) [back to overview]Treatment Response at Week 48
NCT00389207 (34) [back to overview]Treatment Response at Week 48 (TLOVR Algorithm)
NCT00389207 (34) [back to overview]Treatment Response at Week 96
NCT00389207 (34) [back to overview]Treatment-emergent AIDS-defining Illness
NCT00389207 (34) [back to overview]Treatment-emergent AIDS-defining Illness Leading to Death
NCT00389207 (34) [back to overview]Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities
NCT00389207 (34) [back to overview]Change in Mental Health Summary (MHS) Score From Baseline
NCT00389207 (34) [back to overview]Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity
NCT00389207 (34) [back to overview]Proportion of Patients Reporting Hepatic Events of Any Severity
NCT00389207 (34) [back to overview]Proportion of Patients Reporting Rash of Any Severity
NCT00389207 (34) [back to overview]Time to Loss of Virologic Response (Rebound)
NCT00389207 (34) [back to overview]Time to Treatment Failure
NCT00389207 (34) [back to overview]Time to Treatment Response (First Confirmed VL<50 Copies/mL)
NCT00413153 (9) [back to overview]Glucose Trafficking
NCT00413153 (9) [back to overview]Fasting Glucose
NCT00413153 (9) [back to overview]Body Composition - Visceral Adipose Tissue
NCT00413153 (9) [back to overview]Total Bilirubin
NCT00413153 (9) [back to overview]Liver Enzymes -- Aspartate Aminotransferase (AST)
NCT00413153 (9) [back to overview]Liver Enzymes -- Alanine Aminotransferase (ALT)
NCT00413153 (9) [back to overview]Lipid Metabolism - Serum Triglyceride
NCT00413153 (9) [back to overview]Insulin Sensitivity
NCT00413153 (9) [back to overview]Immune Parameters -- CD4 Count
NCT00440947 (26) [back to overview]Number of Participants Who Met the PDVF Criteria at Week 84
NCT00440947 (26) [back to overview]Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36
NCT00440947 (26) [back to overview]Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit
NCT00440947 (26) [back to overview]Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit
NCT00440947 (26) [back to overview]Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit
NCT00440947 (26) [back to overview]Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit
NCT00440947 (26) [back to overview]Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit
NCT00440947 (26) [back to overview]Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase
NCT00440947 (26) [back to overview]Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit
NCT00440947 (26) [back to overview]Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit
NCT00440947 (26) [back to overview]Mean Percent Compliance at Week 144
NCT00440947 (26) [back to overview]Mean Percent Compliance at Week 36
NCT00440947 (26) [back to overview]Mean Percent Compliance at Week 84
NCT00440947 (26) [back to overview]Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
NCT00440947 (26) [back to overview]Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
NCT00440947 (26) [back to overview]Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
NCT00440947 (26) [back to overview]Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36
NCT00440947 (26) [back to overview]Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84
NCT00440947 (26) [back to overview]Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144
NCT00440947 (26) [back to overview]Number of Participants Who Met the PDVF Criteria at Week 144
NCT00440947 (26) [back to overview]Change From Baseline in CD4+ Cell Count at Week 144
NCT00440947 (26) [back to overview]Change From Baseline in CD4+ Cell Count at Week 36
NCT00440947 (26) [back to overview]Change From Baseline in CD4+ Cell Count at Week 84
NCT00440947 (26) [back to overview]Change From Baseline in HIV-1 RNA at Week 144
NCT00440947 (26) [back to overview]Change From Baseline in HIV-1 RNA at Week 36
NCT00440947 (26) [back to overview]Change From Baseline in HIV-1 RNA at Week 84
NCT00552240 (46) [back to overview]Change in CD4+ Cell Count From Baseline to Week 48.
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 < 50 Copies/ml at Week 6 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
NCT00552240 (46) [back to overview]Number of Participants With Virologic Response (VR)
NCT00552240 (46) [back to overview]Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
NCT00552240 (46) [back to overview]Number of Participants With Virologic Success (FDA Definition)
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
NCT00552240 (46) [back to overview]Number of Patients With Virologic Rebound to >400 Copies/ml
NCT00552240 (46) [back to overview]Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities
NCT00552240 (46) [back to overview]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]Change in CD4+ Cell Count From Baseline to Week 6.
NCT00552240 (46) [back to overview]Change in CD4+ Cell Count From Baseline to Week 8.
NCT00552240 (46) [back to overview]Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level
NCT00552240 (46) [back to overview]Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level
NCT00552240 (46) [back to overview]Change in Fasting Plasma Total Cholesterol Level
NCT00552240 (46) [back to overview]Change in Fasting Plasma Triglycerides Level
NCT00552240 (46) [back to overview]Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio
NCT00552240 (46) [back to overview]Change in Framingham Score
NCT00552240 (46) [back to overview]Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48
NCT00552240 (46) [back to overview]Percentage Adherence by Pill Count
NCT00552240 (46) [back to overview]Proportion of Patients Reporting CNS Side Effects 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 Rash of Any Severity
NCT00552240 (46) [back to overview]Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
NCT00552240 (46) [back to overview]Incidence of Patients With AIDS Progression at Each Visit
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]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 24 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
NCT00552240 (46) [back to overview]Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
NCT00552240 (46) [back to overview]AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death
NCT00552240 (46) [back to overview]Change in CD4+ Cell Count From Baseline to Week 12.
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 24.
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 4.
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
NCT00646776 (26) [back to overview]Tmax of RTV
NCT00646776 (26) [back to overview]Total Area Under the Plasma Concentration-time Curve (AUCtot)
NCT00646776 (26) [back to overview]Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Platelet Count and Leukocytes
NCT00646776 (26) [back to overview]Number of Participants With MAs in Hematology: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
NCT00646776 (26) [back to overview]Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP),Aspartate Aminotransferase (AST),Alanine Aminotransferase (ALT),Bilirubin (Total),Bilirubin (Direct),Blood Urea Nitrogen (BUN),Creatinine,Sodium (Serum),Potassium (Serum)
NCT00646776 (26) [back to overview]Number of Participants With MAs in Serum Chemistry: Chloride (Serum), Calcium (Total), Protein (Total), Bicarbonate, Phosphorous (Inorganic)
NCT00646776 (26) [back to overview]Number of Participants With MAs in Serum Chemistry: Glucose (Fasting Serum), Albumin, Creatine Kinase, Uric Acid, Lactate Dehydrogenase (LDH)
NCT00646776 (26) [back to overview]Number of Participants With MAs in Urinalysis
NCT00646776 (26) [back to overview]Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation.
NCT00646776 (26) [back to overview]AUC(TAU) for ATV
NCT00646776 (26) [back to overview]AUC(TAU) for RTV
NCT00646776 (26) [back to overview]AUC24avg for 25-O-Desacetyl-RIB
NCT00646776 (26) [back to overview]Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB)
NCT00646776 (26) [back to overview]Cmax of 25-O-Desacetylrifabutin (25-O-Desacetyl-RIB)
NCT00646776 (26) [back to overview]Cmax of ATV
NCT00646776 (26) [back to overview]Cmax of RTV
NCT00646776 (26) [back to overview]Cmin of 25-O-Desacetyl-RIB
NCT00646776 (26) [back to overview]Cmin of ATV
NCT00646776 (26) [back to overview]Cmin of RTV
NCT00646776 (26) [back to overview]Maximum Plasma Concentration (Cmax) of RIB
NCT00646776 (26) [back to overview]Minimum Plasma Concentration (Cmin) of RIB
NCT00646776 (26) [back to overview]Number of Participants With Clinically Significant Vital Signs or Physical Examination Findings
NCT00646776 (26) [back to overview]Number of Participants With Identified Electrocardiogram (ECG) Abnormalities
NCT00646776 (26) [back to overview]T-half of RTV
NCT00646776 (26) [back to overview]Terminal Elimination Half-life (T-half) of ATV
NCT00646776 (26) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV
NCT00756730 (8) [back to overview]HDL Cholesterol at Week 24
NCT00756730 (8) [back to overview]At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL
NCT00756730 (8) [back to overview]Difference in CD4 From Baseline to Week 24
NCT00756730 (8) [back to overview]LDL Cholesterol at Week 24
NCT00756730 (8) [back to overview]Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.
NCT00756730 (8) [back to overview]The Change in Fasting Triglyceride Level From Baseline to Week 24
NCT00756730 (8) [back to overview]Total Cholesterol in the Two Study Groups at 24 Weeks
NCT00756730 (8) [back to overview]Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24
NCT00757783 (16) [back to overview]Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.
NCT00757783 (16) [back to overview]Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.
NCT00757783 (16) [back to overview]Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.
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 Insulin 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 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 Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12
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]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]Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)
NCT00757783 (16) [back to overview]Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).
NCT00762892 (5) [back to overview]Change From Baseline in Lipids at 48 Weeks
NCT00762892 (5) [back to overview]Change From Baseline in CD4 Count 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 Log HIV Viral Load at 48 Weeks
NCT00768989 (28) [back to overview]Atazanavir Individual Inhibitory Quotient (IQ)
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]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]Atazanavir Terminal Elimination Half Life
NCT00768989 (28) [back to overview]Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval
NCT00768989 (28) [back to overview]Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24
NCT00768989 (28) [back to overview]Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24
NCT00768989 (28) [back to overview]Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants
NCT00768989 (28) [back to overview]Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4
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 Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4
NCT00768989 (28) [back to overview]Mean Change From Baseline in Electrocardiogram Findings
NCT00768989 (28) [back to overview]Mean Change From Baseline in Total Bilirubin Level
NCT00768989 (28) [back to overview]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]Raltegravir Cmin Prior to the Morning Dose
NCT00768989 (28) [back to overview]Raltegravir Cmin 12 Hours Postdose
NCT00768989 (28) [back to overview]Raltegravir Cmax in 1 Dosing Interval
NCT00768989 (28) [back to overview]Raltegravir AUC (0-12h) in 1 Dosing Interval
NCT00768989 (28) [back to overview]Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96
NCT00768989 (28) [back to overview]Number of Nonresponders at Week 8
NCT00768989 (28) [back to overview]Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose
NCT00768989 (28) [back to overview]Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)
NCT00768989 (28) [back to overview]Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48
NCT00768989 (28) [back to overview]Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval
NCT00811954 (19) [back to overview]Self-reported Adherence
NCT00811954 (19) [back to overview]Change in Waist:Height Ratio From Baseline
NCT00811954 (19) [back to overview]Presence of Mutations Associated With NRTI Resistance
NCT00811954 (19) [back to overview]Cumulative Probability of First Virologic Failure by Week 96
NCT00811954 (19) [back to overview]Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96
NCT00811954 (19) [back to overview]Incidence of Death or AIDS Defining Events (CDC Category C)
NCT00811954 (19) [back to overview]Incidence of Targeted Serious Non-AIDS Defining Events (Renal Failure, Liver Disease, Serious Metabolic Disorder, and CVD)
NCT00811954 (19) [back to overview]Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance
NCT00811954 (19) [back to overview]Presence of Mutations Associated With INI Resistance
NCT00811954 (19) [back to overview]CD4+ T-cell Count
NCT00811954 (19) [back to overview]CD4+ T-cell Count Changes From Baseline
NCT00811954 (19) [back to overview]Change in Fasting HDL Cholesterol Level From Baseline
NCT00811954 (19) [back to overview]Change in Fasting Plasma Glucose Level From Baseline
NCT00811954 (19) [back to overview]Change in Fasting 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]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
NCT00814879 (6) [back to overview]Cholesterol
NCT00814879 (6) [back to overview]Number of Patients With < 400 Copies HIV RNA/mL at Week 48
NCT00814879 (6) [back to overview]Number of Patients Reaching Virologic Failure at Week 48.
NCT00814879 (6) [back to overview]Mean Change in Total Bilirubin (mg/dL) From Baseline
NCT00814879 (6) [back to overview]CD4+ Cell Count
NCT00814879 (6) [back to overview]CD4+ Cell Count
NCT00827112 (16) [back to overview]Number of Participants With Phenotypic Resistance
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]Time to Loss of Virological Response (TLOVR)
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]Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
NCT00827112 (16) [back to overview]Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
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]Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
NCT00827112 (16) [back to overview]Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
NCT00827112 (16) [back to overview]Time-Averaged Difference (TAD) in log10 Viral Load
NCT00827112 (16) [back to overview]Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay
NCT00827112 (16) [back to overview]Average Observed Plasma Concentration (Cavg) of Maraviroc
NCT00827112 (16) [back to overview]HIV-1 RNA Levels at Baseline
NCT00827112 (16) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Maraviroc
NCT00827112 (16) [back to overview]Minimum Observed Plasma Concentration (Cmin) of Maraviroc
NCT00827112 (16) [back to overview]Number of Participants With Genotypic Resistance
NCT00833482 (14) [back to overview]AUC(TAU) of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants
NCT00833482 (14) [back to overview]Number of Participants With Marked Abnormalities in Hematology Laboratory Test and Urinalysis Results
NCT00833482 (14) [back to overview]Tmax of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants
NCT00833482 (14) [back to overview]Cmax and Cmin of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants
NCT00833482 (14) [back to overview]Number of Participants With Investigator-identified Abnormalities in Electrocardiogram Results Not Present Prior to Administration of Study Drug and Considered Not Relevant and Not AEs by Investigator
NCT00833482 (14) [back to overview]Number of Participants With Marked Abnormalities in Serum Chemistry Test Results
NCT00833482 (14) [back to overview]Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Any AE
NCT00833482 (14) [back to overview]Area Under the Plasma Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] of Atazanavir Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants
NCT00833482 (14) [back to overview]AUC(TAU)of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants
NCT00833482 (14) [back to overview]Time to Maximum Concentration (Tmax) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants
NCT00833482 (14) [back to overview]Tmax of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants
NCT00833482 (14) [back to overview]Cmax and Cmin of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants
NCT00833482 (14) [back to overview]Number of Participants With Abnormalities in Vital Signs
NCT00833482 (14) [back to overview]Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in Participants Who Are Extensive Metabolizers (EM)
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]Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96
NCT00851799 (27) [back to overview]Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96
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 CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144
NCT00851799 (27) [back to overview]CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144
NCT00851799 (27) [back to overview]Percent Change in Visceral Abdominal Fat (VAT) 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]Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96
NCT00851799 (27) [back to overview]Percent Change in Total Limb Fat From Study Entry to Week 96
NCT00851799 (27) [back to overview]Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96
NCT00851799 (27) [back to overview]Percent Change in Lean Mass From Study Entry to Week 96
NCT00851799 (27) [back to overview]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 Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96
NCT00851799 (27) [back to overview]Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24
NCT00851799 (27) [back to overview]Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT)
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]Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 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]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 Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 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]Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48
NCT00851799 (27) [back to overview]Fold Change in D-dimer From Study Entry to Weeks 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]Change in Fasting Total Cholesterol (TC) 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
NCT00869960 (8) [back to overview]Atazanavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
NCT00869960 (8) [back to overview]Atazanavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
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 Luteal Phase (Days 20-25 After Menses)
NCT00869960 (8) [back to overview]Tenofovir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
NCT00869960 (8) [back to overview]Emtricitabine Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
NCT00869960 (8) [back to overview]Ritonavir 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)
NCT00884793 (4) [back to overview]Number of Subjects Who Had a Decrease in HIV RNA Per Million CD4+ T Cells in the Ileum
NCT00884793 (4) [back to overview]Number of Subjects Who Experienced an Increase in CD4+ T Cells (as a % of All Cells) in the Ileum.
NCT00884793 (4) [back to overview]Number of Subjects Who Experienced an Increase in CD4% in the Ileum.
NCT00884793 (4) [back to overview]"Average Change in Activated (CD38+HLADR+) CD8+ T Cells in the Ileum"
NCT00885482 (1) [back to overview]Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis
NCT00892437 (6) [back to overview]Change From Baseline in CD4 Cell Count at Week 24
NCT00892437 (6) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
NCT00892437 (6) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
NCT00892437 (6) [back to overview]Change From Baseline in HIV-1 RNA at Week 48
NCT00892437 (6) [back to overview]Change From Baseline in HIV-1 RNA at Week 24
NCT00892437 (6) [back to overview]Change From Baseline in CD4 Cell Count at Week 48
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for AUC24hr)
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Etravirine (ETR) (Results for AUC12hr)
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for AUC24hr)
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for AUC24hr)
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax)
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Etravirine (ETR) (Results for C0h, Cmin, and Cmax)
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for C0h, Cmin, and Cmax)
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for C0h, Cmin, and Cmax)
NCT00896051 (18) [back to overview]The Percentage of Participants With a Virologic Response (Plasma Viral Load < 50 Copies/mL) at Week 48 Using the Snapshot Analysis Method
NCT00896051 (18) [back to overview]The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method
NCT00896051 (18) [back to overview]The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method
NCT00896051 (18) [back to overview]Time to Confirmed Virologic Response
NCT00896051 (18) [back to overview]Time to Virologic Failure
NCT00896051 (18) [back to overview]Change From Pre-Baseline in Log10 Viral Load Over Time
NCT00896051 (18) [back to overview]Change From Prebaseline in CD4+ Cell Count Over Time
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for C0h, Cmin, and Cmax)
NCT00896051 (18) [back to overview]Percentage of Participants With Undetectable Plasma Viral Load (VL) Values (<50 Copies/mL) at Week 48
NCT00896051 (18) [back to overview]Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for AUC24hr)
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 Change in Adherence to Study Treatment Arm From Baseline to Week 48
NCT00931801 (4) [back to overview]The Difference in CD4 From Baseline to Week 48
NCT00940771 (4) [back to overview]Viral Load
NCT00940771 (4) [back to overview]CD4 Count
NCT00940771 (4) [back to overview]Non-fasting Cholesterol
NCT00940771 (4) [back to overview]Non-fasting Triglycerides
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
NCT01099579 (18) [back to overview]Area Under the Concentration Curve (in 1 Dosing Interval From Time 0 to 24 Hours Post Observed Dose) (AUC[TAU])of Atazanavir and Ritonavir
NCT01099579 (18) [back to overview]Apparent Total Body Clearance Per Body Weight (CLT/F) Per Kilogram of Atazanavir and Ritonavir
NCT01099579 (18) [back to overview]Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4
NCT01099579 (18) [back to overview]Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48
NCT01099579 (18) [back to overview]Mean CD4 Percent Changes From Baseline at Week 48 by Antiretroviral (ARV) Treatment Status
NCT01099579 (18) [back to overview]Mean CD4 Percent Changes From Baseline at Week 48 by Treatment/Weight
NCT01099579 (18) [back to overview]Mean Change From Baseline in HIV RNA Levels at Week 48 by Prior Antiretroviral (ARV) Treatment Status
NCT01099579 (18) [back to overview]Mean Change From Baseline in HIV RNA Levels at Week 48 by Treatment/Weight
NCT01099579 (18) [back to overview]Apparent Total Body Clearance (CLT/F) of Atazanavir and Ritonavir
NCT01099579 (18) [back to overview]Number of Participants With Centers for Disease Control (CDC) Class C AIDS Events
NCT01099579 (18) [back to overview]Number of Participants Who Acquired Phenotypic Resistance to Atazanavir or Atazanovir/Ritonavir
NCT01099579 (18) [back to overview]Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation
NCT01099579 (18) [back to overview]Time to Maximum Observed Concentration (Tmax) of Atazanavir and Ritonavir
NCT01099579 (18) [back to overview]Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight
NCT01099579 (18) [back to overview]Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Prior Antiretroviral (ARV) Treatment Status
NCT01099579 (18) [back to overview]Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir
NCT01099579 (18) [back to overview]CD4 Cell Count Changes From Baseline at Week 48 by Treatment/Weight
NCT01099579 (18) [back to overview]CD4 Cell Count Changes From Baseline at Week 48 by Prior Antiretroviral (ARV) Treatment Status
NCT01102972 (24) [back to overview]Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses
NCT01102972 (24) [back to overview]Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses
NCT01102972 (24) [back to overview]Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses
NCT01102972 (24) [back to overview]Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses
NCT01102972 (24) [back to overview]Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
NCT01102972 (24) [back to overview]Change From Baseline in Cholesterol/HDL Ratio at Week 48
NCT01102972 (24) [back to overview]Change From Baseline in Cholesterol/HDL Ratio at Week 24
NCT01102972 (24) [back to overview]Change From Baseline in CD4+ Cell Count at Week 48
NCT01102972 (24) [back to overview]Change From Baseline in CD4+ Cell Count at Week 24
NCT01102972 (24) [back to overview]Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48
NCT01102972 (24) [back to overview]Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis
NCT01102972 (24) [back to overview]Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis
NCT01102972 (24) [back to overview]Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis
NCT01102972 (24) [back to overview]Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24
NCT01102972 (24) [back to overview]Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48
NCT01102972 (24) [back to overview]Change From Baseline in HIV-1 RNA at Week 48
NCT01102972 (24) [back to overview]Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24
NCT01102972 (24) [back to overview]Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48
NCT01102972 (24) [back to overview]Number of Participants Who Experienced Death and/or Disease Progression
NCT01102972 (24) [back to overview]Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24
NCT01102972 (24) [back to overview]Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
NCT01102972 (24) [back to overview]Change From Baseline in HIV-1 RNA at Week 24
NCT01102972 (24) [back to overview]Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
NCT01102972 (24) [back to overview]Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
NCT01108510 (8) [back to overview]Change From Baseline in CD4 Cell Count at Week 48
NCT01108510 (8) [back to overview]Change From Baseline in CD4 Cell Count at Week 192
NCT01108510 (8) [back to overview]Change From Baseline in CD4 Cell Count at Week 144
NCT01108510 (8) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
NCT01108510 (8) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
NCT01108510 (8) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
NCT01108510 (8) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
NCT01108510 (8) [back to overview]Change From Baseline in CD4 Cell Count at Week 96
NCT01232127 (7) [back to overview]Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir
NCT01232127 (7) [back to overview]Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir
NCT01232127 (7) [back to overview]Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir
NCT01232127 (7) [back to overview]Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest
NCT01232127 (7) [back to overview]Number of Participants With Abnormalities in Vital Signs
NCT01232127 (7) [back to overview]Number of Participants With Abnormalities in Laboratory Test Results
NCT01232127 (7) [back to overview]Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings
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
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
NCT01335698 (14) [back to overview]CD4 Cell Count Changes From Baseline on ATV Powder
NCT01335698 (14) [back to overview]CD4 Cell Count Changes From Baseline on ATV Powder
NCT01335698 (14) [back to overview]Mean Change From Baseline in CD4 Percent on ATV Powder
NCT01335698 (14) [back to overview]Mean Change From Baseline in HIV RNA on ATV Powder
NCT01335698 (14) [back to overview]Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder
NCT01335698 (14) [back to overview]Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48
NCT01335698 (14) [back to overview]Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort
NCT01335698 (14) [back to overview]Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
NCT01335698 (14) [back to overview]Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder
NCT01335698 (14) [back to overview]Mean Change From Baseline in CD4 Percent on ATV Powder
NCT01335698 (14) [back to overview]Area Under the Concentration-Time Curve [AUC(TAU)]
NCT01335698 (14) [back to overview]Maximum Observed Plasma Concentration (Cmax)
NCT01335698 (14) [back to overview]Minimum Plasma Concentration (Cmin)
NCT01335698 (14) [back to overview]Number of Participants Who Experienced a SAE on ATV Powder
NCT01351740 (2) [back to overview]Proportions of Subjects Experiencing Virologic Failure by Randomized Treatment Arm
NCT01351740 (2) [back to overview]Proportions of Subjects in Each Randomized Treatment Arm With Atazanavir Trough Levels Below 150ng/mL
NCT01384734 (17) [back to overview]Number of Participants With Newly-emergent Genotypic Substitutions at Week 24
NCT01384734 (17) [back to overview]Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA
NCT01384734 (17) [back to overview]Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24
NCT01384734 (17) [back to overview]Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24
NCT01384734 (17) [back to overview]Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96
NCT01384734 (17) [back to overview]Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48
NCT01384734 (17) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period
NCT01384734 (17) [back to overview]Change From Baseline in CD4+ T-cell Count
NCT01384734 (17) [back to overview]Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy
NCT01384734 (17) [back to overview]Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy
NCT01384734 (17) [back to overview]Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period
NCT01384734 (17) [back to overview]Number of Participants With Newly-emergent Genotypic Substitutions at Week 48
NCT01384734 (17) [back to overview]Number of Participants With Newly-emergent Genotypic Substitutions at Week 96
NCT01384734 (17) [back to overview]Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period
NCT01384734 (17) [back to overview]Number of Participants With SAE and Discontinuation Due to AEs During Primary Study
NCT01384734 (17) [back to overview]Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24
NCT01384734 (17) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study
NCT01388543 (1) [back to overview]Day 7 Atazanavir Oral Clearance
NCT01404572 (5) [back to overview]Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01404572 (5) [back to overview]Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
NCT01404572 (5) [back to overview]Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
NCT01404572 (5) [back to overview]Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir
NCT01404572 (5) [back to overview]Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
NCT01421355 (1) [back to overview]Change in Brachial Artery Diameter
NCT01511809 (1) [back to overview]Proportion of Patients With Treatment Failure (TF)
NCT01667978 (1) [back to overview]AUC Norethindrone
NCT01691794 (3) [back to overview]Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4
NCT01691794 (3) [back to overview]Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued)
NCT01691794 (3) [back to overview]Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, and Centers for Disease Control (CDC) Class C AIDS Events
NCT01803074 (28) [back to overview]Time to Maximum Decline in Log 10 HIV-1 RNA - Part B
NCT01803074 (28) [back to overview]Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C
NCT01803074 (28) [back to overview]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]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]Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline
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]Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C
NCT01803074 (28) [back to overview]Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B
NCT01803074 (28) [back to overview]Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C
NCT01803074 (28) [back to overview]Plasma Concentration 24 Hours Post-Dose (C24) - Part B
NCT01803074 (28) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C
NCT01803074 (28) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) - 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]Accumulation Index (AI): Part A and C
NCT01837719 (12) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Cobicistat
NCT01837719 (12) [back to overview]Apparent Terminal Half-life (T-HALF) of Atazanavir
NCT01837719 (12) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Atazanavir
NCT01837719 (12) [back to overview]Observed Concentration at 24 Hours (C24) of Atazanavir
NCT01837719 (12) [back to overview]T-HALF of Cobicistat
NCT01837719 (12) [back to overview]Time of Maximum Observed Concentration (Tmax) of Atazanavir
NCT01837719 (12) [back to overview]Time of Maximum Observed Concentration (Tmax) of Cobicistat
NCT01837719 (12) [back to overview]Area Under the Concentration Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and Area Under the Concentration Curve From Time 0 to Infinity (AUC[INF]) of Cobicistat
NCT01837719 (12) [back to overview]Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and From Time 0 to Infinity (AUC[INF]) for Atazanavir
NCT01837719 (12) [back to overview]Number of Participants Who Died and With Serious Adverse Events (SAEs)
NCT01837719 (12) [back to overview]Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests
NCT01837719 (12) [back to overview]Number of Participants With Out-of-range Intervals on Electrocardiogram (ECG) Findings
NCT01903031 (21) [back to overview]ATV PK Parameter Cmax Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]Ethinyl Estradiol Concentrations Obtained on Study Days 7 and 14.
NCT01903031 (21) [back to overview]Etonogestrel Concentrations Obtained on Study Days 7 and 14
NCT01903031 (21) [back to overview]Proportion of Participants With Plasma HIV-1 RNA Levels <40 Copies/mL
NCT01903031 (21) [back to overview]RTV PK Parameter Cmin Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]Ritonavir (RTV) PK Parameter AUC(0-24h) Calculated Based on Intensive RTV PK Samples Obtained From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]RTV PK Parameter CLss/F Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]RTV PK Parameter Tmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]ATV PK Parameter CLss/F Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]ATV PK Parameter Cmin Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]ATV PK Parameter AUC(0-24h) Calculated Based on Intensive Atazanavir (ATV) PK Samples Obtained From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]Percentage of Participants With Signs and Symptoms of Grade 2 or Higher Deemed Possibly, Probably or Definitely Related to Study Treatment
NCT01903031 (21) [back to overview]Etonogestrel Concentrations at Study Day 21
NCT01903031 (21) [back to overview]Ethinyl Estradiol Concentrations at Study Day 21
NCT01903031 (21) [back to overview]EFV PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
NCT01903031 (21) [back to overview]ATV PK Parameter Time to Cmax (Tmax) Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]EFV PK Parameter Area Under the Concentration-Time Curve (AUC0-24hours) Calculated Based on Intensive EFV PK Samples Obtained From Individual Participants Enrolled in Arm B
NCT01903031 (21) [back to overview]EFV PK Parameter Clearance (CLss/F) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
NCT01903031 (21) [back to overview]EFV PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
NCT01903031 (21) [back to overview]RTV PK Parameter Cmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]Proportion of Participants With Progesterone Levels Greater Than 5 ng/mL.
NCT01910402 (48) [back to overview]Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase
NCT01910402 (48) [back to overview]Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase
NCT01910402 (48) [back to overview]Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
NCT01910402 (48) [back to overview]Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase
NCT01910402 (48) [back to overview]Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline
NCT01910402 (48) [back to overview]Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS
NCT01910402 (48) [back to overview]Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase 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 Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints
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 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 CD4+ Cell Count at Indicated Timepoints-Continuation Phase
NCT01910402 (48) [back to overview]Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase
NCT01910402 (48) [back to overview]Change From Baseline in Creatinine Clearance at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Hematocrit Count at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
NCT01910402 (48) [back to overview]Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase
NCT01910402 (48) [back to overview]Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48
NCT01910402 (48) [back to overview]HIVTSQs Total Score at Indicated Timepoints
NCT01910402 (48) [back to overview]Number of Participants With AEs by Maximum Toxicity-Continuation 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 Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With Any AEs, and SAEs in Continuation Phase
NCT01910402 (48) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase
NCT01910402 (48) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase
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 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 Post-Baseline HIV-1 Disease Progression-Randomized 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 Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + 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]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 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 Erythrocytes at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in TC/HDL Ratio at Week 48
NCT01910402 (48) [back to overview]Change From Baseline in Lipase at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in Triglycerides at Week 48
NCT01910402 (48) [back to overview]Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase
NCT01910402 (48) [back to overview]Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase
NCT01910402 (48) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48
NCT01967940 (16) [back to overview]Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 48
NCT01967940 (16) [back to overview]Part 1: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Day 10
NCT01967940 (16) [back to overview]Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10
NCT01967940 (16) [back to overview]Part 2: Change From Baseline in CD4+ Cell Count at Week 24
NCT01967940 (16) [back to overview]Part 2: Change From Baseline in CD4+ Cell Count at Week 48
NCT01967940 (16) [back to overview]Part 2: Change From Baseline in CD4+ Percentage at Week 24
NCT01967940 (16) [back to overview]Part 2: Change From Baseline in CD4+ Percentage at Week 48
NCT01967940 (16) [back to overview]Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 24
NCT01967940 (16) [back to overview]Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24
NCT01967940 (16) [back to overview]Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48
NCT01967940 (16) [back to overview]Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24
NCT01967940 (16) [back to overview]Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48
NCT01967940 (16) [back to overview]Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 24
NCT01967940 (16) [back to overview]Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 48
NCT01967940 (16) [back to overview]Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 24
NCT01967940 (16) [back to overview]Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 48
NCT02116660 (1) [back to overview]Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
NCT02155101 (3) [back to overview]HIV-1 RNA Viral Load
NCT02155101 (3) [back to overview]HIV-1 RNA Viral Load
NCT02155101 (3) [back to overview]HIV-1 RNA Viral Load
NCT02386098 (8) [back to overview]Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1
NCT02386098 (8) [back to overview]Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1
NCT02386098 (8) [back to overview]Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1
NCT02386098 (8) [back to overview]Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1
NCT02386098 (8) [back to overview]Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24-Stage 1
NCT02386098 (8) [back to overview]Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1
NCT02386098 (8) [back to overview]Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1
NCT02386098 (8) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1
NCT03019783 (2) [back to overview]Change in Flow-mediated, Endothelium-dependent Vasodilation
NCT03019783 (2) [back to overview]Change in Plasma Total Antioxidant Capacity

Most Common AEs and AEs of Interest Through Week 48

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

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

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

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

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

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

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

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

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PR Interval and Change From Baseline by Analysis Time Point

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

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

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Change From Baseline in CD4 Cell Count at Week 24

(NCT00035932)
Timeframe: Baseline, Week 24

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

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

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

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

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Change From Baseline in CD4 Cell Count at Week 48

(NCT00035932)
Timeframe: Baseline, Week 48

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

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Change From Baseline in CD4 Cell Count at Week 96

(NCT00035932)
Timeframe: Baseline, Week 96

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

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Fasting Glucose Mean Change From Baseline at Week 24

(NCT00035932)
Timeframe: Baseline, Week 24

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

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HIV IC50 at Week 24

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

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

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

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

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

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Inhibitory Quotient at Week 24

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

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

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Fasting Glucose Mean Change From Baseline at Week 48

(NCT00035932)
Timeframe: Week 48

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

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Lipid Mean Percent Change From Baseline at Week 24

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

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

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Lipid Mean Percent Change From Baseline at Week 48

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Grade 3/4 Laboratory Abnormalities Through Week 48

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(NCT00035932)
Timeframe: Week 96

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

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

(NCT00035932)
Timeframe: Week 48

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

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

(NCT00035932)
Timeframe: Week 24

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Mean Change From Baseline in HIV RNA at Week 96

(NCT00035932)
Timeframe: Baseline, Week 96

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

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Mean Change From Baseline in HIV RNA at Week 48

(NCT00035932)
Timeframe: Baseline, Week 48

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

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Mean Change From Baseline in HIV RNA at Week 2

(NCT00035932)
Timeframe: Baseline, Week 2

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

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

(NCT00035932)
Timeframe: Baseline, Week 24

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

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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 (Range) for ARVs and TB Drugs

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

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

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

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

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

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PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With 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: 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: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Time to Treatment Failure (NRTI Comparison)

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

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

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Time to Treatment Failure (PI Comparison)

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

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

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

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

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

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

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

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

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Time to 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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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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Cumulative Probability of Not Experiencing Regimen Failure

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

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

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Cumulative Probability of Not Experiencing Treatment Modification

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

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

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Cumulative Probability of Not Experiencing 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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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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The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL

(NCT00118898)
Timeframe: At Weeks 48 and 96

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

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Time From Randomization to Virologic Failure

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

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

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

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

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

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

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

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

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Time From Treatment Dispensation to Treatment Modification

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

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

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Number of Participants With 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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Number of Participants With a Grade 3/4 Safety Event

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

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

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Number of Participants With 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 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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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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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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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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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 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 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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Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96

(NCT00135356)
Timeframe: Baseline, Week 48, Week 96

,
Interventionmg/dL (Mean)
Week 48 (n=124; n=63)Week 96 (n=124; n=64)
ATV/RTV Switch Arm3.61.2
PI/RTV Control Arm-3.33.0

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Change From Baseline in Trunk-to-limb Fat Ratio as Measured by 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.(Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.) (NCT00135356)
Timeframe: Baseline, Week 96

,
Interventionratio (Mean)
LOCF Population (n=112; n=54)OC Population (n=94; n=45)
ATV/RTV Switch Arm0.040.04
PI/RTV Control Arm0.020.05

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Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (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 is associated with a decrease in values. (Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.) (NCT00135356)
Timeframe: Baseline, Week 48

,
Interventionratio (Mean)
LOCF Population (n=112; n=54)OCPopulation (n=105; n=51)
ATV/RTV Switch Arm0.020.02
PI/RTV Control Arm-0.02-0.01

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Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline

Virologic rebound was measured from the first dose of study therapy to the first of the 2 consecutive measurements ≥400 c/mL. Time to virologic rebound was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative proportion of participants without virologic rebound up to the end of the respective interval. (NCT00135356)
Timeframe: Weeks 8-12, Weeks 20-24, Weeks 32-36, Weeks 44-48, Weeks 56-60, Weeks 68-72, Weeks 80-84, Weeks 92-96

,
InterventionProportion of participants (Number)
By Weeks 8-12By Weeks 20-24By Weeks 32-36By Weeks 44-48By Weeks 56-60By Weeks 68-72By Weeks 80-84By Weeks 92-96
ATV/RTV Switch Arm0.98370.98370.97530.96690.95850.95850.95850.9585
PI/RTV Control Arm1.0001.0000.98410.98410.98410.98410.96740.9309

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Mean Change From Baseline in CD4 Count

Mean change from baseline in CD4 count among treated subjects (NCT00135356)
Timeframe: Baseline, Week 48, Week 96

,
Interventioncells/mm3 (Mean)
Week 48 (n=114; n=56)Week 96 (n=96; n=54)
ATV/RTV Switch Arm143
PI/RTV Control Arm4482

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Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96

(NCT00135356)
Timeframe: Baseline, Week 48, Week 96

,
Interventionmicrounits per milliliter (Mean)
Baseline (n=124; n=62)Week 48 (n=124; n=59)Week 96 (n=124; n=59)
ATV/RTV Switch Arm14.11.30.0
PI/RTV Control Arm21.8-4.10.3

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Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.

The mean percent change from baseline in physical signs of lipohypertrophy, as assessed objectively by changes in visceral adipose tissue (VAT) area (cm2) by computed tomography (CT) scans and by changes in trunk fat (kg) by DEXA. Clinical improvement is associated with a decrease in values. (Baseline values can be found in the Baseline Characteristics section.) (NCT00135356)
Timeframe: Baseline, Week 48, Week 96

,
InterventionPercent change (Mean)
Week 48 VAT (n=98; n=53)Week 96 VAT (n=101; n=53)Week 48 Trunk Fat (n=112; n=57)Week 96 Trunk Fat (n=112; n=57)
ATV/RTV Switch Arm6.54.32.61.6
PI/RTV Control Arm-0.42.1-1.8-3.6

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Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

HOMA-IR is an index used in evaluation of obese patients at risk for type 2 diabetes which requires fasting glucose and insulin concentrations. It is a mathematical model based on the theory of a negative feedback loop between the liver and β-cells that regulates both fasting glucose and insulin concentrations and can be used to estimate pancreatic β-cell function and degree of insulin resistance. HOMA-IR normal values are between 2 and 2.5. HOMA-IR ≥ 2.5 indicates insulin-resistance. (NCT00135356)
Timeframe: Baseline, Week 48, Week 96

,
Interventionmg/dL x uU/mL (Mean)
Baseline (n=115; n=59)Week 48 (n=115; n=57)Week 96 (n=115; n=57)
ATV/RTV Switch Arm3.420.740.28
PI/RTV Control Arm5.43-1.731.00

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Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96

(NCT00135356)
Timeframe: Baseline, Week 48, Week 96

,
Interventionkg/m2 (Mean)
Week 48 (n=130; n=67)Week 96 (n=130; n=67)
ATV/RTV Switch Arm0.30.2
PI/RTV Control Arm-0.2-0.5

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Mean Changes From Baseline in Body Weight at Week 48 and Week 96

(NCT00135356)
Timeframe: Baseline, Week 48, Week 96

,
Interventionkg (Mean)
Week 48 (n=130; n=68)Week 96 (n=130; n=68)
ATV/RTV Switch Arm10
PI/RTV Control Arm-1-1

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Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation

Percentage of Participants with AEs, Serious AEs (SAEs), Deaths, and AEs leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. (NCT00135356)
Timeframe: Through Week 96 of study therapy

,
InterventionPercentage of Participants (Number)
DeathSAEAE Leading to DiscontinuationAny AEs (all grades) through Week 96
ATV/RTV Switch Arm08590
PI/RTV Control Arm07383

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Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation

Percentage of Participants with AEs leading to discontinuation of study therapy. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. All events listed in this table were SAEs, except for renal impairment and hypertriglycerideamia, which were an AEs (and did not meet the 5 percent threshold reported in Adverse Event module of this record). (NCT00135356)
Timeframe: Through Week 96

,
InterventionPercent of Participants (Number)
Any adverse experience leading to discontinuationHyperbilirubinemiaJaundiceDrug abuseRenal impairmentStevens-Johnson syndromeHypertriglyceridemiaSquamous cell carcinoma
ATV/RTV Switch Arm52111100
PI/RTV Control Arm30000011

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Percentage of Participants With Abnormal Liver Function Tests

Percentage of participants with Abnormal Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin (TBILI) measurements. Values for liver tests are graded using the modified World Health Organization (WHO) criteria. Grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life threatening or disabling. (NCT00135356)
Timeframe: Week 48, Week 96

,
InterventionPercentage of Participants (Number)
Wk 48 ALT Grades 1-4Wk 48 ALT Grades 3-4Wk 48 ALT Grade 4Wk 96 ALT Grades 1-4Wk 96 ALT Grades 3-4Wk 96 ALT Grade 4Wk 48 AST Grade 1-4Wk 48 AST Grades 3-4Wk 48 AST Grade 4Wk 96 AST Grades 1-4Wk 96 AST Grades 3-4Wk 96 AST Grade 4Wk 48 TBILI Grades 1-4Wk 48 TBILI Grades 3-4Wk 48 TBILI Grade 4Wk 96 TBILI Grades 1-4Wk 96 TBILI Grades 3-4Wk 96 TBILI Grade 4
ATV/RTV Switch Arm3410372019102410945313956017
PI/RTV Control Arm230032001500190019002100

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Mean Percent Changes From Baseline in Fasting Lipids

Mean percent changes from baseline in fasting total, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and non-HDL cholesterol, triglycerides, and apolipoprotein B (NCT00135356)
Timeframe: Baseline, Week 48, Week 96

,
InterventionPercent change (Number)
Week 48 - Total CholesterolWeek 48 - HDL CholesterolWeek 48 - Non-HDL CholesterolWeek 48 - LDL CholesterolWeek 48 - TriglyceridesWeek 48 - Apolipoprotein BWeek 96 - Total CholesterolWeek 96 - HDL CholesterolWeek 96 - Non-HDL CholesterolWeek 96 - LDL CholesterolWeek 96 - TriglyceridesWeek 96 - Apolipoprotein B
ATV/RTV Switch Arm-13.0-6.2-14.8-10.4-23.8-7.6-12.5-6.8-14.0-8.4-25.0-8.3
PI/RTV Control Arm-1.0-2.6-0.62.6-11.71.1-0.1-4.61.23.6-12.28.3

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Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans

The mean percent change from baseline in total body fat by DEXA and in total adipose tissue (TAT) area by CT scans. Total body fat and TAT are both associated many factors (trunk fat + limb fat + other [weight, etc]), and thus clinical improvement cannot be predicted based solely an increase or decrease of these values. (Baseline values can be found in the Baseline Characteristics section.) (NCT00135356)
Timeframe: Baseline, Week 48, Week 96

,
Interventionpercent change (Mean)
Week 48 TAT (n=108; n= 59)Week 96 TAT (n=111; n=59)Week 48 Total Body Fat (n=105; n=51)Week 96 Total Body Fat (n=94; n=45)
ATV/RTV Switch Arm0.0-0.91.90.5
PI/RTV Control Arm-3.5-5.0-3.7-7.4

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Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans

The mean percent change from baseline in physical signs of lipoatrophy, as assessed objectively by changes in peripheral adipose tissue (ie, limb fat (kg) by DEXA and in subcutaneous adipose tissue (SAT) area by CT scans. Clinical improvement is associated with stable values, or an increase in values. (Baseline values can be found in the Baseline Characteristics section.) (NCT00135356)
Timeframe: Baseline, Week 48, Week 96

,
Interventionpercent change (Mean)
Week 48 SAT (n=108; n=59)Week 96 SAT (n=111; n=59)Week 48 Limb Fat (n=112; 54)Week 48 Limb Fat (n=112; n=54)
ATV/RTV Switch Arm-2.2-3.50.9-0.8
PI/RTV Control Arm-5.9-9.7-3.6-6.1

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Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96

Mean changes from baseline in proportion of waist to hip measurements. (NCT00135356)
Timeframe: Baseline, Week 48, Week 96

,
Interventionratio (Mean)
Week 48 (n=123; n=65)Week 96 (n=124; n=65)
ATV/RTV Switch Arm-0.01-0.01
PI/RTV Control Arm-0.01-0.01

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Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96

(NCT00135356)
Timeframe: Baseline, Week 48, Week 96

,
Interventioncm (Mean)
Week 48 (n=123; n=66)Week 96 (n=124; n=66)
ATV/RTV Switch Arm-1-1
PI/RTV Control Arm-1-1

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Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase

Change From Baseline in CD4 Count at Week 48 of Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies worsening. (NCT00207142)
Timeframe: Baseline, Week 48 of Rescue Phase

Interventioncells/mm3 (Mean)
Rescue Treatment313

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Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase

Treatment failure based on HIV-1 RNA ≥ 50 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason. Time to treatment failure was analyzed using life tables. Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval. (NCT00207142)
Timeframe: Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48

,
InterventionProportion of participants (Number)
Proportion by Week 6-8Proportion by Week 14-16Proportion by Week 22-24Proportion by Week 30-32Proportion by Week 38-40Proportion by Week 46-48
Continuation Regimen0.94120.91760.90590.88240.83430.8176
Switch Regimen0.96550.96550.95400.93100.85060.8273

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Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase

Change From Baseline in CD4 Count at Week 24 of Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies worsening. (NCT00207142)
Timeframe: Baseline, Week 24 of Induction Phase

Interventioncells/mm3 (Mean)
Randomized Subjects170
Nonrandomized Subjects201
Total177

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Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase

Treatment outcome is based on the first reason of failure. These analyses were performed using HIV-1 RNA of 50 c/mL to define suppression and virologic rebound. (NCT00207142)
Timeframe: Through Week 48 of Rescue Phase. Measurements were included from the end of Induction Phase through the last dose of Rescue Phase study therapy plus 4 days.

InterventionParticipants (Number)
Suppression Maintained Through Week 48Suppression, then Virologic Rebound at/before Wk48Discontinuation Before Week 48Viral Suppression Never Achieved
Rescue Treatment29786

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Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase

Treatment outcome is based on the first reason of failure. These analyses were performed using HIV-1 RNA of 400 c/mL to define suppression and virologic rebound. (NCT00207142)
Timeframe: Baseline, Week 48 of Rescue Phase

InterventionParticipants (Number)
Suppression Maintained Through Week 48Suppression, then Virologic Rebound at/before Wk48Discontinuation Before Week 48Viral Suppression Never Achieved
Rescue Treatment39290

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Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase

Description: Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements < 50 c/mL. Time to suppression was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval. (NCT00207142)
Timeframe: Week 16-18, Week 24-26, Week 38-40, Week 64-66

,
InterventionParticipants (Number)
Number of Participants Suppressed by Wk 16-18Number of Participants Suppressed by Wk 24-26Number of Participants Suppressed by Wk 38-40Number of Participants Suppressed by Wk 64-66
Nonrandomized Subjects353142
Randomized Subjects131171172172

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Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase

Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements <400 c/mL. Time to suppression was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval. (NCT00207142)
Timeframe: Week 16-18, Week 24-26, Week 30-32

,
InterventionParticipants (Number)
Number of Participants Suppressed by Week 16-18Number of Participants Suppressed by Wk 24-26Number of Participants Suppressed by Wk 30-32
Nonrandomized Subjects395455
Randomized Subjects168171172

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Summary of Adverse Events During Rescue Phase

Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. (NCT00207142)
Timeframe: Measurements are included from the end of Induction Phase (26 to 30 weeks after the first dose therapy) through the last dose of Rescue Phase study therapy plus 30 days.

InterventionParticipants (Number)
DeathsSAEsSAEs related to study therapyAEs leading to discontinuation
Rescue Treatment1201

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Summary of Adverse Events During Maintenance Phase

Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. (NCT00207142)
Timeframe: Measurements are included from the end of Induction Phase (26 to 30 weeks after first dose) through the last dose of Maintenance Phase study therapy plus 30 days.

,
InterventionParticipants (Number)
DeathsSerious Adverse Events (SAEs)SAEs related to study therapyAEs leading to discontinuation
Continuation Regimen0304
Switch Regimen0401

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Summary of Adverse Events During Induction Phase

Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. (NCT00207142)
Timeframe: Measurements are included through the earlier of the last dose of Induction Phase study therapy plus 30 days or the first dose of Maintenance/Rescue Phase therapy (ie, up until 26 to 31 weeks + 30 days).

,,
InterventionParticipants (Number)
DeathsSAEsSAEs related to study therapyAEs leading to discontinuation
Nonrandomized Subjects3929
Randomized Subjects0700
Total31629

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Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase

Percent change in fasting lipids from end of Induction Phase to Week 48 of Maintenance Phase.Percent changes were calculated on the log scale and then back transformed to the original scale.Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening for HDL cholesterol and improvement for all other lipds. (NCT00207142)
Timeframe: Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase.

,
Interventionpercent change (Mean)
Total CholesterolHDL CholesterolLDL CholesterolTriglyceridesNon-HDL Cholesterol
Continuation Regimen1.40.8-2.19.81.1
Switch Regimen-4.73.7-0.7-27.0-7.4

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Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase

Treatment failure based on HIV-1 RNA ≥ 400 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason. Time to treatment failure was analyzed using life tables. Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval. (NCT00207142)
Timeframe: Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48

,
InterventionProportion of participants (Number)
Proportion by Week 6-8Proportion by Week 14-16Proportion by Week 22-24Proportion by Week 30-32Proportion by Week 38-40Proportion by Week 46-48
Continuation Regimen0.98850.98850.97700.95400.89660.8823
Switch Regimen0.94120.91760.90590.88240.85850.8585

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Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase

Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 50 c/mL, or last HIV-1 RNA ≥ 50 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants. (NCT00207142)
Timeframe: From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase

InterventionPercentage of participants (Number)
Switch Regimen78
Continuation Regimen75

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Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase

Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 400 c/mL, or last HIV-1 RNA ≥ 400 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants. (NCT00207142)
Timeframe: From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase

InterventionPercentage of participants (Number)
Switch Regimen86
Continuation Regimen81

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Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase

Change in CD4 Cell Count From End of Induction Phase at Week 48 of Maintenance Phase. Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening. (NCT00207142)
Timeframe: End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase

Interventioncells/mm3 (Mean)
Switch Regimen100
Continuation Regimen92

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Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase

Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies improvement. (NCT00207142)
Timeframe: Baseline, Week 48 of Rescue Phase

Interventionlog10 c/mL (Mean)
Rescue Treatment-3.71

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Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase

Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies improvement. (NCT00207142)
Timeframe: Baseline, Week 24 of Induction Phase

Interventionlog10 c/mL (Mean)
Randomized Subjects-3.16
Nonrandomized Subjects-3.35
Total-3.21

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Changes in LDL Particle Number From Baseline to Week 24

Change in LDL particle number (NCT00225017)
Timeframe: Baseline to 24 weeks

Interventionnmol/l (Median)
Atazanavir Switch-194
Control (Continue Protease Inhibitor)-116

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Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24

Brachial artery reactivity assessed by noninvasively measuring brachial artery diameter and flow velocities in response to overinflated blood pressure cuff (Flow mediated dilation (FMD))in subjects switching to atazanavir and in subjects continuing on a stable antiretroviral regimen (NCT00225017)
Timeframe: Baseline to week 24

Interventionpercentage change (Median)
Atazanavir Switch-1.14
Control (Continue Protease Inhibitor)0.25

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Change in Total Cholesterol Levels From Baseline to Week 24

Total cholesterol level changes within and between arms (NCT00225017)
Timeframe: Baseline to 24 weeks

Interventionmg/dL (Median)
Atazanavir Switch-25
Control (Continue Protease Inhibitor)2

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Proportion of Patient With Viral Load Less Than 400 Copies/mL

(NCT00242216)
Timeframe: 24 weeks

Interventionpercentage (Number)
Atazanavir89
Fosamprenavir73

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CD4 Cell Count Change From Baseline During Treatment.

(NCT00242216)
Timeframe: 24 weeks.

Interventioncell/mm3 (Mean)
Atazanavir139
Fosamprenavir117

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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 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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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 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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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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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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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 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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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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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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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 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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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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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 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 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 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 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 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_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_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 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 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 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 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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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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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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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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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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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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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. 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 development of drug dependency or drug abuse, is an important medical event. (NCT00326716)
Timeframe: During study period and 30 days post-study.

,
InterventionParticipants (Number)
Death (n=41, n=40)Serious Adverse Event (n=41, n=40)Total AEs Leading to Discontinuation (n=41, n=40)Anemia Leading to Discontinuation (n=41, n=40)Transaminitis Discontinuation (n=41, n=40)Prematurity Causing Discontinuation (n=41, n=40)All AEs (n=41, n=40)Anemia (n=41, n=40)Diarrhea (n=41, n=40)Nausea (n=41, n=40)Vomiting (n=41, n=40)Jaundice (n=41, n=40)Hyperbilirubinemia (n=41, n=40)Ocular Icterus (n=41, n=40)Skin / subcutaneous tissue disorders (n=41, n=40)
All Infants0142201403405201020
All Treated Mothers016211NA406467101310

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Number of Participants With Grade 2 to Grade 4 AEs and SAEs

AEs and SAEs considered possibly, probably, or certainly related to study treatment, were graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). Hyperbilirubinemia (Grade 1=1.1 to 1.5 upper limit of normal [ULN] [mild], Grade 2=1.6 to 2.5 ULN [moderate], Grade 3=2.6 to 5.0 ULN [severe], Grade 4= > 5.0 ULN [potentially life threatening]). (NCT00326716)
Timeframe: During Study Period and 30 Days Post-Study.

,
InterventionParticipants (Number)
Grade 2 to Grade 4 (n=41, n=40)Related Grade 2 to Grade 4 (n=41, n=40)Grade 3 to Grade 4 (n=41, n=40)Grade 3 to Grade 4 Total Bilirubin (n=41, n=40)
All Infants19087
All Treated Mothers32101219

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SAEs in Enrolled Infants

SAEs were evaluated for all treated and untreated participants. An SAE was defined as an untoward medical occurrence that results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event); might have caused death if it were more severe, required inpatient hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, an important medical event that required intervention to prevent serious outcomes. (NCT00326716)
Timeframe: Birth Through Week 16 of Life

,
InterventionParticipants (Number)
Any Adverse ExperienceBlood and Lymphatic System DisordersAnemiaCardiac DisordersCardio-Respiratory ArrestRestrictive CardiomyopathyCongenital, Familial, and Genetic DisordersAtrial Septal DefectGastrointestinal DisordersConstipationVomitingHepatobiliary DisordersHyperbilirubinemiaJaundiceInfections and InfestationsBronchiolitisGastroenteritisMeningitisPneumoniaSepsisSyphilisInjury, Poisoning, and Procedural ComplicationsOverdoseMetabolism and Nutrition DisordersHyperkalemiaHypoglycemiaNervous System DisordersCerebral IschemiaConvulsionPregnancy, Puerperium, and Perinatal ConditionsPremature BabyRespiratory, Thoracic, and Mediastinal DisordersNeonatal Respiratory Distress SyndromeRespiratory Distress
Infant ATV 300 mg / RTV 100 mg10111110011110140110111111011111211
Infant ATV 400 mg / RTV 100 mg4110001100011022001000010100011000

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SAEs in Enrolled Mothers

SAEs were evaluated for all treated and untreated participants. An SAE was defined as an untoward medical occurrence that results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event); might have caused death if it were more severe, required inpatient hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, an important medical event that required intervention to prevent serious outcomes. (NCT00326716)
Timeframe: During Study Period and 30 Days Post-Study.

,
InterventionParticipants (Number)
Any Adverse ExperienceBlood and Lymphatic System DisordersAnemiaCardiac DisordersCardiomyopathySinus ArrhythmiaGastrointestinal DisordersAbdominal HerniaHepatobiliary DisordersHyperbilirubinemiaInfections and InfestationsEndometrial DecidualPneumoniaSepsisInvestigationsTransaminases IncreasedPregnancy, Puerperium, and Perinatal ConditionsAmenorrheaPre-eclampsiaPregnancy Induced HypertensionPremature Rupture of MembranesVascular DisordersHypertensionHemorrhage
Mother ATV 300 mg / RTV 100 mg711110000022000020101101
Mother ATV 400 mg / RTV 100 mg822101111120111121100110

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Infant Gestational Age at Delivery

(NCT00326716)
Timeframe: At the time of delivery

InterventionWeeks (Mean)
Mothers ATV 300 mg / 100 mg Third Trimester38
Mothers ATV 400 mg / 100 mg Third Trimester38

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Mean ATV Area Under the Concentration Curve (AUC TAU)

AUC = area under the concentration curve (AUC [TAU]) of atazanavir in one dosing interval from time zero to 24 hours. (NCT00326716)
Timeframe: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

Interventionng•h / mL (Geometric Mean)
Mothers ATV 300 mg / RTV 100 mg Second Trimester34,399.13
Mothers ATV 300 mg / RTV 100 mg Third Trimester34,251.50
Mothers ATV 400 mg / RTV 100 mg Third Trimester46,602.45

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Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval

Cmax = maximum observed plasma concentration of atazanavir at specified time points. (NCT00326716)
Timeframe: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

Interventionng / mL (Geometric Mean)
Mothers ATV 300 mg / RTV 100 mg Second Trimester3,729.09
Mothers ATV 300 mg / RTV 100 mg Third Trimester3,291.46
Mothers ATV 400 mg / RTV 100 mg Third Trimester4,210.76

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Mean ATV Terminal Elimination Half Life (T 1/2)

T 1/2 = terminal elimination half life of atazanavir at specified time points. (NCT00326716)
Timeframe: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

InterventionHours (Geometric Mean)
Mothers ATV 300 mg / 100 mg Second Trimester10.42
Mothers ATV 300 mg / 100 mg Third Trimester12.10
Mothers ATV 400 mg / 100 mg Third Trimester12.17

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Mean ATV Time of Maximum Observed Plasma Concentration (Tmax)

Tmax = time to reach maximum observed plasma concentration of atazanavir at specified time points. (NCT00326716)
Timeframe: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

InterventionHours (Geometric Mean)
Mothers ATV 300 mg / 100 mg Second Trimester3.68
Mothers ATV 300 mg / 100 mg Third Trimester2.94
Mothers ATV 400 mg / 100 mg Third Trimester3.30

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Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose

Cmin = plasma concentration 24 hours post dose of atazanavir at specified time points. (NCT00326716)
Timeframe: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.

Interventionng•h / mL (Geometric Mean)
Mothers ATV 300 mg / RTV 100 mg Second Trimester663.78
Mothers ATV 300 mg / RTV 100 mg Third Trimester668.48
Mothers ATV 400 mg / RTV 100 mg Third Trimester916.63

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Mean CD4 Cell Count at Baseline

(NCT00326716)
Timeframe: Baseline

Interventioncells / mm^3 (Mean)
Mothers ATV 300 mg / RTV 100 mg Third Trimester435.0
Mothers ATV 400 mg / RTV 100 mg Third Trimester390.0

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Mean HIV RNA Level at Baseline

(NCT00326716)
Timeframe: Baseline

Interventionlog10 cm / mL (Mean)
Mothers ATV 300 mg / RTV 100 mg Third Trimester3.520
Mothers ATV 400 mg / RTV 100 mg Third Trimester4.020

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Mean RTV Area Under the Concentration Curve (AUC TAU)

AUC = area under the concentration curve (AUC [TAU]) of ritonavir in one dosing interval. (NCT00326716)
Timeframe: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

Interventionng•h / mL (Geometric Mean)
Mothers ATV 300 mg / RTV 100 mg Second Trimester4,500.03
Mothers ATV 300 mg / RTV 100 mg Third Trimester4,664.93
Mothers ATV 400 mg / RTV 100 mg Third Trimester4,383.30

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Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval

Cmax = maximum observed plasma concentration of ritonavir at specified time points. (NCT00326716)
Timeframe: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

Interventionng / mL (Geometric Mean)
Mothers ATV 300 mg / RTV 100 mg Second Trimester530.81
Mothers ATV 300 mg / RTV 100 mg Third Trimester587.36
Mothers ATV 400 mg / RTV 100 mg Third Trimester524.48

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Mean RTV Terminal Elimination Half Life (T 1/2)

T 1/2 = terminal elimination half life of ritonavir at specified time points. (NCT00326716)
Timeframe: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

InterventionHours (Geometric Mean)
Mothers ATV 300 mg / 100 mg Second Trimester5.03
Mothers ATV 300 mg / 100 mg Third Trimester5.28
Mothers ATV 400 mg / 100 mg Third Trimester5.10

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Mean RTV Time of Maximum Observed Plasma Concentration (Tmax)

Tmax = time to reach the maximum observed plasma concentration of ritonavir at specified time points. (NCT00326716)
Timeframe: Pregnancy Weeks 12 to 28, Weeks 28 to 36, and 4-6 Weeks Postpartum

InterventionHours (Geometric Mean)
Mothers ATV 300 mg / 100 mg Second Trimester6.11
Mothers ATV 300 mg / 100 mg Third Trimester4.15
Mothers ATV 400 mg / 100 mg Third Trimester4.63

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Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose

Cmin = plasma concentration 24 hours post dose of ritonavir at specified time points. (NCT00326716)
Timeframe: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.

Interventionng•h / mL (Geometric Mean)
Mothers ATV 300 mg / RTV 100 mg Second Trimester50.10
Mothers ATV 300 mg / RTV 100 mg Third Trimester41.12
Mothers ATV 400 mg / RTV 100 mg Third Trimester38.05

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Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count

The median CD4 cell count change from baseline was calculated for all treated mothers at the time of delivery ± 2 days. Maternal CD4 cell counts were assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5. (NCT00326716)
Timeframe: Baseline, Day of Delivery ± 2 Days

Interventioncells / mm^3 (Median)
Mother ATV 300 mg / RTV 100 mg89
Mother ATV 400 mg / RTV 100 mg174

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Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level

The maternal HIV RNA level was determined at baseline and the day of delivery ± 2 days using VR-OC. The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5. (NCT00326716)
Timeframe: Baseline, Day of Delivery ± 2 Days

Interventionlog10 c / mL (Median)
Mother ATV 300 mg / RTV 100 mg-1.8
Mother ATV 400 mg / RTV 100 mg-2.37

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Infant Gender

(NCT00326716)
Timeframe: At the time of delivery

,
InterventionParticipants (Number)
MaleFemale
Mothers ATV 300 mg / 100 mg Third Trimester128
Mothers ATV 400 mg / 100 mg Third Trimester911

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Infant HIV Status

The neonatal HIV-1 status are assessed by the Roche Amplicor HIV-1 DNA Assay Version 1.5 (Roche Molecular Systems). (NCT00326716)
Timeframe: Birth Through 6 Months on Study

,
InterventionParticipants (Number)
HIV PositiveHIV Negative
Infant ATV 300 mg / RTV 100 mg020
Infant ATV 400 mg / RTV 100 mg020

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Infant Race

(NCT00326716)
Timeframe: At the time of delivery

,
InterventionParticipants (Number)
BlackWhiteMixed Race
Mothers ATV 300 mg / 100 mg Third Trimester1550
Mothers ATV 400 mg / 100 mg Third Trimester1811

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Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery

The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5. (NCT00326716)
Timeframe: Day of Delivery ± 2 Days

,
InterventionParticipants (Number)
HIV RNA < 400 copies/mLHIV RNA < 50 copies/mL
Mothers ATV 300 mg / RTV 100 mg1919
Mothers ATV 400 mg / RTV 100 mg2019

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Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration

Mean atazanavir maternal plasma concentration and neonatal cord blood concentration as measured at the time of delivery. (NCT00326716)
Timeframe: At Time of Delivery

,
Interventionng / mL (Mean)
Maternal Serum ConcentrationCord Blood Concentration
Mothers ATV 300 mg / RTV 100 mg1,412.05273.20
Mothers ATV 400 mg / RTV 100 mg1,568.06231.49

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Mean Atazanavir Plasma Protein Binding

Atazanavir Plasma Protein Binding Percentage measured at specified time points. (NCT00326716)
Timeframe: Pregnancy Weeks 28 to Delivery at 3 Hours Postdose and 24 Hours Postdose, and Time of Delivery

,
InterventionPercentage Bound (Mean)
Third Trimester 3 Hours Post Dose (n = 20, 20)Third Trimester 24 Hours Post Dose (n = 19, 20)Time of Delivery (n = 15, 12)
Mother ATV 300 mg / RTV 100 mg91.3490.3777.05
Mother ATV 400 mg / RTV 100 mg87.7088.8975.62

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Median Infant Total Bilirubin Level

Median infant total bilirubin level as measured at specified time points. (NCT00326716)
Timeframe: Birth (Day 1), Day 3, Day 5, and Day 7 of Life

,
Interventionmg / dL (Median)
Day 1 (Birth)Day 3Day 5Day 7
Infant ATV 300 mg / RTV 100 mg3.208.407.105.10
Infant ATV 400 mg / RTV 100 mg3.259.209.257.30

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Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose

The MACS was administered to evaluate participant adherence to each drug and the adherence to the regimen. The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance. (NCT00326716)
Timeframe: Study Week 2, Pregnancy Weeks 20 to Weeks 28, Pregnancy Weeks 28 to Delivery, Week 2 Postpartum, Week 4 Postpartum

,
InterventionParticipants (Number)
Study Week 2 Regimen (n = 20,18)Study Week 2 ATV (n = 20,18)Study Week 2 RTV (n = 20,18)Study Week 2 ZDV/3TC (n = 20,18)Visit 1 Pregnancy Week 20 to 28 Regimen (n=12, 9)Visit 1 Pregnancy Week 20 to 28 ATV (n=12, 9)Visit 1 Pregnancy Week 20 to 28 RTV (n=12, 9)Visit 1 Pregnancy Week 20 to 28 ZDV/3TC (n=12, 9)Visit 2 Pregnancy Week 20 to 28 Regimen (n=8, 5)Visit 2 Pregnancy Week 20 to 28 ATV (n=8, 5)Visit 2 Pregnancy Week 20 to 28 RTV (n=8, 5)Visit 2 Pregnancy Week 20 to 28 ZDV/3TC (n=8, 5)Visit 3 Pregnancy Week 20 to 28 Regimen (n=6, 2)Visit 3 Pregnancy Week 20 to 28 ATV (n=6, 2)Visit 3 Pregnancy Week 20 to 28 RTV (n=6, 2)Visit 3 Pregnancy Week 20 to 28 ADV/3TC (n=6, 2)Visit 4 Pregnancy Wk 20 to 28 Regimen (n=0, 13)Visit 4 Pregnancy Week 20 to 28 ATV (n=0, 13)Visit 4 Pregnancy Week 20 to 28 RTV (n=0, 13)Visit 4 Pregnancy Wk 20 to 28 ZDV/3TC (n=0, 13)Visit 1 Pregnancy Wk 20 to Birth Regimen (n=20,20)Visit 1 Pregnancy Week 20 to Birth ATV (n=20,20)Visit 1 Pregnancy Week 20 to Birth RTV (n=20,20)Visit 1 Pregnancy Wk 20 to Birth ZDV/3TC (n=20,20)Visit 2 Pregnancy Wk 20 to Birth Regimen (n=19,19)Visit 2 Pregnancy Week 20 to Birth ATV (n=19,19)Visit 2 Pregnancy Week 20 to Birth RTV (n=19,19)Visit 2 Pregnancy Wk 20 to Birth ZDV/3TC (n=19,19)Visit 3 Pregnancy Wk 20 to Birth Regimen (n=15,19)Visit 3 Pregnancy Week 20 to Birth ATV (n=15,19)Visit 3 Pregnancy Week 20 to Birth RTV (n=15,19)Visit 3 Pregnancy Wk 20 to Birth ZDV/3TC (n=15,19)Visit 4 Pregnancy Wk 28 to Birth Regimen (n=5,15)Visit 4 Pregnancy Week 28 to Birth ATV (n=5,15)Visit 4 Pregnancy Week 28 to Birth RTV (n=5,15)Visit 4 Pregnancy Wk 28 to Birth ZDV/3TC (n=5,15)Visit 5 Pregnancy Wk 28 to Birth Regimen (n=1, 2)Visit 5 Pregnancy Week 28 to Birth ATV (n=1, 2)Visit 5 Pregnancy Week 28 to Birth RTV (n=1, 2)Visit 5 Pregnancy Wk 28 to Birth ZDV/3TC (n=1, 2)Visit 6 Pregnancy Wk 28 to Birth Regimen (n=0, 1)Visit 6 Pregnancy Week 28 to Birth ATV (n=0, 1)Visit 6 Pregnancy Week 28 to Birth RTV (n=0, 1)Visit 6 Pregnancy Wk 28 to Birth ZDV/3TC (n=0, 1)Postpartum Week 2 Regimen (n=19, 19)Postpartum Week 2 ATV (n=18, 19)Postpartum Week 2 RTV (n=18, 19)Postpartum Week 2 ZDV/3TC (n =19, 19)Postpartum Week 4 Regimen (n=17, 19)Postpartum Week 4 ATV (n=17, 19)Postpartum Week 4 RTV (n=17, 19)Postpartum Week 4 ZDV/3TC (n=17, 19)
Mother ATV 300 mg / RTV 100 mg202020201112121138744554NANANANA19202019181919181213131255551111NANANANA1416161416171617
Mother ATV 400 mg / RTV 100 mg171717178899354422221313131320202020181919181819191815151515222211111818181818191918

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Time Weighted Mean Change From Baseline Plasma HIV-RNA

(NCT00335322)
Timeframe: 144 weeks

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

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

(NCT00335322)
Timeframe: 48 weeks

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

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Cumulative Proportion of Participants Without Treatment Failure Through Week 100

This Kaplan-Meier life table reports the cumulative proportion of participants without treatment failure up to the end of the respective time interval. Failure time is measured from the start of study therapy, and is based on the earliest event defining failure (virologic rebound at or before Week 96, or discontinuation prior to Week 96). (NCT00337467)
Timeframe: Through Week 100

Interventionproportion of participants (Number)
Interval Week 4 - 8 (n=61)Interval Week 8 - 12 (n=60)Interval Week 12 - 16 (n=58)Interval Week 16 - 20 (n=55)Interval Week 20 - 24 (n=54)Interval Week 24 - 28 (n=53)Interval Week 32 - 36 (n=52)Interval Week 36 - 40 (n=50)Interval Week 48 - 52 (n=48)Interval Week 56 - 60 (n=46)Interval Week 64 - 68 (n=45)Interval Week 68 - 72 (n=43)Interval Week 72 - 76 (n=42)Interval Week 84 - 88 (n=41)Interval Week 92 - 96 (n=40)Interval Week 96 - 100 (n=31)
Proportion of Participants0.98360.95080.90160.88520.86890.85250.81970.78690.75410.73770.70490.68850.67210.65570.65570.6557

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

(NCT00337467)
Timeframe: Baseline, Week 24

Interventioncells /mm3 (Mean)
Baseline Value (n=61)Change at Week 24 (n=51)
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.55961

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Mean Change From Baseline in CD4 Cell Count at Week 96

(NCT00337467)
Timeframe: Baseline, Week 96

Interventioncells /mm3 (Mean)
Baseline Value (n=61)Change at Week 96 (n=40)
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.55963

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Mean Change From Baseline in CD4 Cell Count at Week 48

(NCT00337467)
Timeframe: Baseline, Week 48

Interventioncells /mm3 (Mean)
Baseline Value (n=61)Change at Week 48 (n=46)
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.55953

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Percentage of Participants With Treatment Failure Through Week 48

Treatment Failure through Week 48 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. (NCT00337467)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy21.3

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Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48

Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics. (NCT00337467)
Timeframe: Baseline, Week 48

Interventionpercent change (Mean)
Total Cholesterol (n=36)HDL Cholesterol (n=35)Non-HDL Cholesterol (n=35)LDL Cholesterol (n=33)Triglycerides (n=36)
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.92122017

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Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96

Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics. (NCT00337467)
Timeframe: Baseline, Week 96

Interventionpercent change (Mean)
Total Cholesterol (n=29)HDL Cholesterol (n=29)Non-HDL Cholesterol (n=29)LDL Cholesterol (n=28)Triglycerides (n=29)
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.142192916

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Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48

International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V. (NCT00337467)
Timeframe: Week 48

Interventionparticipants (Number)
IAS-USA-defined major PI substitutionsRT substitutions
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.10

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Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96

International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V. (NCT00337467)
Timeframe: Week 96

Interventionparticipants (Number)
IAS-USA-defined major PI substitutionsRT substitutions
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy20

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Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition that does not necessarily have a causal relationship to treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. AE grades are: mild (1), moderate (2), severe (3), life-threatening (4), and death (5). (NCT00337467)
Timeframe: From Baseline through Week 96

Interventionpercentage of participants (Number)
All Grades AEsAll Grades AEs Related to Study TherapyGrade 3 to Grade 4 AEsGrade 3 to Grade 4 AEs Related to Study TherapyDeathsSAEsSAEs Related to Study TherapyAEs Leading to DiscontinuationLipodystrophy-Related AEs
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.75.413.1183.33.319.704.91.6

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Percentage of Participants With Treatment Failure Through Week 96

Treatment Failure through Week 96 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 96 or study discontinuation before Week 96. In addition, treatment failure defined based on HIV RNA >= 50 c/mL, latter analysis performed on treated subjects with baseline HIV RNA < 50 c/mL. (NCT00337467)
Timeframe: Week 96

Interventionpercentage of participants (Number)
HIV RNA >= 400 c/mL(n=61)HIV RNA>=50 c/mL w/Baseline HIV RNA<50 c/mL (n=60)
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy34.443.3

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Percentage of Participants With Virological Rebound Through Week 48

Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL. (NCT00337467)
Timeframe: Week 48

Interventionpercentage of participants (Number)
HIV RNA >= 400 c/mL (n=61)HIV RNA>=50 c/mL w/Baseline HIV RNA<50 c/mL (n=60)
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy1226.7

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Percentage of Participants With Virological Rebound Through Week 96

Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL. (NCT00337467)
Timeframe: Week 96

Interventionpercentage of participants (Number)
HIV RNA >= 400 c/mL (n=61)HIV RNA>=50 c/mL w/Baseline HIV RNA<50 c/mL (n=60)
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy14.833.3

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Change in Framingham Score From Baseline

Change in the estimated risk of cardiovascular disease using the Framingham algorithm from baseline to after 48, 96 and 144 weeks, last observation carried forward (LOCF). The score is based on age, gender, systolic blood pressure, total cholesterol, high density lipoprotein cholesterol and smoking status. Scores range from 0 to 21 with higher scores indicating a greater risk. (NCT00389207)
Timeframe: From baseline to Weeks 48, 96 and 144/EOT

,
InterventionUnits on a scale (Mean)
Change in Framingham score to Week 48Change in Framingham score to Week 96Change in Framingham score to Week 144/EOT
Atazanvir/Ritonavir0.661.190.82
Nevirapine QD+BID0.500.931.14

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Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144

The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL) (NCT00389207)
Timeframe: at Week 24, 48, 96, 144

,,,
Interventionparticipants (Number)
virologic rebound after CVR at Week 24virologic rebound after CVR at Week 48virologic rebound after CVR at Week 96virologic rebound after CVR at Week 144
Atazanvir/Ritonavir5121015
Nevirapine BID2569
Nevirapine QD3448
Nevirapine QD+BID591017

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Change in Physical Health Summary (PHS) Score From Baseline

QoL assessment by change in PHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the MOS-HIV, a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The PHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL. (NCT00389207)
Timeframe: From baseline to Weeks 48, 96 and 144/EOT

,
InterventionUnits on a scale (Mean)
Change in PHS score to Week 48Change in PHS score to Week 96Change in PHS score to Week 144/EOT
Atazanvir/Ritonavir3.353.003.35
Nevirapine QD+BID3.343.192.22

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Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144

Calculations based on the MDRD algorithm. (NCT00389207)
Timeframe: From baseline to Week 48, 96, 144

,,,
InterventionmL/min/1.73 m^2 (Mean)
change baseline to week 48 (N=143, 128, 271, 173)change baseline to week 96 (N=130, 122, 252, 157)change baseline to week 144 (N=163, 168, 331, 174)
Atazanvir/Ritonavir-7.18-11.53-9.56
Nevirapine BID-5.92-10.02-6.33
Nevirapine QD-3.91-6.93-3.27
Nevirapine QD+BID-4.86-8.42-4.82

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Change of Cholesterol Values From Baseline to Week 48, 96, 144

Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL (NCT00389207)
Timeframe: baseline to week 48, 96, 144

,,
Interventionmg/dL (Mean)
total cholesterol, week 48 (N=138,122,164)total cholesterol, week 96 (N=124,114,147)total cholesterol, week 144 (N=154,155,160)LDL-c, week 48 (N=136,117,159)LDL-c, week 96 (N=119,110,145)LDL-c, week 144 (N=151,150,157)HDL, week 48(N=138,122,164)HDL, week 96 (N=124,114,147)HDL, week 144(N=154,155,160)
Atazanvir/Ritonavir20.8429.9928.1310.5819.1917.613.494.745.73
Nevirapine BID29.5436.8730.6617.7021.6617.9511.5913.3310.47
Nevirapine QD29.2839.1733.1216.5421.9321.4212.0613.8612.61

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Change of hsCRP From Baseline to Week 48, 96, 144

Change of hsCRP from baseline to week 48, 96, 144 (NCT00389207)
Timeframe: baseline to week 48, 96, 144

,,
Interventionmg/L (Mean)
hsCRP, week 48 (N=142,126,173)hsCRP, week 96 (N=128,120,157)hsCRP, week 144 (N=160,164,174)
Atazanvir/Ritonavir-0.700.350.04
Nevirapine BID-0.67-0.79-0.02
Nevirapine QD-1.01-1.54-0.09

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Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144

Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144 (NCT00389207)
Timeframe: baseline to week 48, 96, 144

,,
Interventionratio (Mean)
total triglycerides, week 48 (N=138,122,164)total triglycerides, week 96 (N=124,114,147)total triglycerides, week 144 (N=154,155,160)
Atazanvir/Ritonavir0.200.280.17
Nevirapine BID-0.33-0.25-0.07
Nevirapine QD-0.37-0.22-0.24

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Change of Total Triglycerides From Baseline to Week 48, 96, 144

Change of total triglycerides from baseline to week 48, 96, 144 (NCT00389207)
Timeframe: baseline to week 48, 96, 144

,,
Interventionmg/dL (Mean)
total triglycerides, week 48 (N=138,120,164)total triglycerides, week 96 (N=124,113,147)total triglycerides, week 144 (N=153,153,159)
Atazanvir/Ritonavir36.2830.4527.11
Nevirapine BID1.675.356.11
Nevirapine QD0.089.34-3.46

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Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144

Changes frombaseline apolipoprotein A1 & B (NCT00389207)
Timeframe: baseline to week 48, 96, 144

,,
Interventiong/L (Mean)
apolipoprotein A1, week 48 (N=134,121,156)apolipoprotein A1, week 96 (N=115,106,141)apolipoprotein A1, week 144 (N=144,140,148)apolipoprotein B, week 48 (N=134,120,156)apolipoprotein B, week 96 (N=115,106,141)apolipoprotein B, week 144 (N=144,139,148)
Atazanvir/Ritonavir0.080.070.060.030.030.03
Nevirapine BID0.230.230.140.03-0.000.05
Nevirapine QD0.230.230.160.000.000.01

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Genotypic Resistance Associated With Virologic Failure

Number of treatment-emergent drug-associated substitutions in patients with virological failure up to Week 48. The total number of genotypic mutations in those patients who were virologic failures is given, not the number of patients with mutations. (NCT00389207)
Timeframe: From baseline to Week 48

,
InterventionNumber of substitutions (Number)
Emtricitabine-associated substitutions at Week 48Tenofovir-associated substitutions at Week 48Nevirapine-associated substitutions at Week 48
Atazanvir/Ritonavir000
Nevirapine QD+BID211134

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Glycaemic Abnormalities

Number of patients with AE elevated serum glucose (NCT00389207)
Timeframe: From baseline to Week 144

,
InterventionPatients (Number)
Number with glycaemic abnormalitiesNumber without glycaemic abnormalities
Atazanvir/Ritonavir3190
Nevirapine QD+BID0376

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Lipodystrophy

Number of patients with AE lipodystrophy (NCT00389207)
Timeframe: From baseline to Week 144

,
InterventionPatients (Number)
Number with lipodystrophyNumber without lipodystrophy
Atazanvir/Ritonavir1192
Nevirapine QD+BID1375

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Non-scheduled Physician Visits

Cost effectiveness assessment by number of patients with non-scheduled physician visits (NCT00389207)
Timeframe: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT

,
Interventionpatients (Number)
Number between baseline and Week 24Number between Week 24 and Week 48Number between Week 48 and Week 96Number between Week 96 and Wk 144/EOT
Atazanvir/Ritonavir35352835
Nevirapine QD+BID74455858

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Number of Patients Hospitalized

Cost effectiveness assessment by number of patients hospitalized (NCT00389207)
Timeframe: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT

,
InterventionPatients (Number)
Number hospitalized between baseline and Week 24Number hospitalized between Week 24 and Week 48Number hospitalized between Week 48 and Week 96Number hospitalized between Week 96 and Wk 144/EOT
Atazanvir/Ritonavir2551
Nevirapine QD+BID8659

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Change in CD4+ Count From Baseline

Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT (NCT00389207)
Timeframe: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT

,
Interventioncells/mm^3 (Mean)
Change in CD4+ count to Week 4Change in CD4+ count to Week 8Change in CD4+ count to Week 12Change in CD4+ count to Week 24Change in CD4+ count to Week 36Change in CD4+ count to Week 48Change in CD4+ count to Week 60Change in CD4+ count to Week 72Change in CD4+ count to Week 84Change in CD4+ count to Week 96Change in CD4+ count to Week 108Change in CD4+ count to Week 120Change in CD4+ count to Week 132Change in CD4+ count to Week 144/EOT
Atazanvir/Ritonavir86.198.0110.9133.8163.4183.6208.2231.9246.4251.6267.2269.2281.3285.8
Nevirapine QD+BID77.2105.6120.3134.4160.1168.2184.8213.7223.0217.7231.2231.3243.4251.0

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Proportion of Patients With Virologic Failure at Week 48, 96, 144

(NCT00389207)
Timeframe: at Week 48, 96, 144

,,,
Interventionparticipants (Number)
virologic failure at Week 48virologic failure at Week 96virologic failure at Week 144
Atazanvir/Ritonavir251317
Nevirapine BID252528
Nevirapine QD201519
Nevirapine QD+BID454047

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Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144

The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL) (NCT00389207)
Timeframe: at Week 24, 48, 96, 144

,,,
Interventionparticipants (Number)
virologic rebound after CVR at Week 24virologic rebound after CVR at Week 48virologic rebound after CVR at Week 96virologic rebound after CVR at Week 144
Atazanvir/Ritonavir2225
Nevirapine BID2366
Nevirapine QD2334
Nevirapine QD+BID46910

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Proportion of Patients With VL < 400 Copies/ml

VL <400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT) (NCT00389207)
Timeframe: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT

,
InterventionProportion of patients (Number)
Proportion with VL<400 copies /mL at Week 4Proportion with VL<400 copies /mL at Week 8Proportion with VL<400 copies /mL at Week 12Proportion with VL<400 copies /mL at Week 24Proportion with VL<400 copies /mL at Week 36Proportion with VL<400 copies /mL at Week 48Proportion with VL<400 copies /mL at Week 60Proportion with VL<400 copies /mL at Week 72Proportion with VL<400 copies /mL at Week 84Proportion with VL<400 copies /mL at Week 96Proportion with VL<400 copies /mL at Week 108Proportion with VL<400 copies /mL at Week 120Proportion with VL<400 copies /mL at Week 132Proportion with VL<400 copies /mL at Week 144/EOT
Atazanvir/Ritonavir0.2870.6790.8340.9560.9660.9770.9880.9880.9940.9871.0000.9940.9930.986
Nevirapine QD+BID0.3650.7140.8560.9240.9680.9850.9930.9960.9881.0000.9961.0000.9960.991

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Proportion of Patients With VL < 50 Copies/ml

VL <50 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT) for the patient (NCT00389207)
Timeframe: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT

,
InterventionProportion of patients (Number)
Proportion with VL<50 copies /mL at Week 4Proportion with VL<50 copies /mL at Week 8Proportion with VL<50 copies /mL at Week 12Proportion with VL<50 copies /mL at Week 24Proportion with VL<50 copies /mL at Week 36Proportion with VL<50 copies /mL at Week 48Proportion with VL<50 copies /mL at Week 60Proportion with VL<50 copies /mL at Week 72Proportion with VL<50 copies /mL at Week 84Proportion with VL<50 copies /mL at Week 96Proportion with VL<50 copies /mL at Week 108Proportion with VL<50 copies /mL at Week 120Proportion with VL<50 copies /mL at Week 132Proportion with VL<50 copies /mL at Week 144/EOT
Atazanvir/Ritonavir0.090.250.4120.7790.830.8860.9010.9150.8960.9240.9680.9550.9470.929
Nevirapine QD+BID0.1070.3040.5150.8420.9070.9310.9590.9650.9720.980.9640.9760.9710.952

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Serum Lipid Abnormalities

Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia) (NCT00389207)
Timeframe: From baseline to Week 144

,
Interventionpatients (Number)
Number with serum lipid abnormalitiesNumber without serum lipid abnormalities
Atazanvir/Ritonavir4189
Nevirapine QD+BID9367

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Treatment Response at Week 144

Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 144 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 144. (NCT00389207)
Timeframe: From baseline to Week 144

,,,
Interventionparticipants (Number)
Number of respondersNumber of non-responders
Atazanvir/Ritonavir14350
Nevirapine BID11375
Nevirapine QD12167
Nevirapine QD+BID234142

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Treatment Response at Week 48

Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 48 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 48. (NCT00389207)
Timeframe: From baseline to Week 48

,,,
InterventionPatients (Number)
Number of respondersNumber of non-responders
Atazanvir/Ritonavir12667
Nevirapine BID12464
Nevirapine QD12662
Nevirapine QD+BID250126

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Treatment Response at Week 48 (TLOVR Algorithm)

Treatment response is defined as a VL <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, based on time to loss of virologic response (TLOVR) algorithm, as a sensitivity analysis for the primary analysis. (NCT00389207)
Timeframe: From baseline to Week 48

,
InterventionPatients (Number)
Number of respondersNumber of non-responders
Atazanvir/Ritonavir14251
Nevirapine QD+BID261115

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Treatment Response at Week 96

Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 96 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 96. (NCT00389207)
Timeframe: From baseline to Week 96

,,,
Interventionparticipants (Number)
Number of respondersNumber of non-responders
Atazanvir/Ritonavir14944
Nevirapine BID12266
Nevirapine QD13157
Nevirapine QD+BID253123

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Treatment-emergent AIDS-defining Illness

Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment (NCT00389207)
Timeframe: From baseline to Week 144

,
InterventionPatients (Number)
Number with tr.-emerg. AIDS-def.illnessNumber without tr.-emerg. AIDS-def.illness
Atazanvir/Ritonavir7186
Nevirapine QD+BID26350

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Treatment-emergent AIDS-defining Illness Leading to Death

Patients with an AIDS-defining illness leading to death broken out by treatment. Statistical analysis shows time to death from AIDS-defining illness. (NCT00389207)
Timeframe: From baseline to Week 144

,
InterventionPatients (Number)
Number with AIDS-def. illness leading to deathNumber without AIDS-def. illness leading to death
Atazanvir/Ritonavir0193
Nevirapine QD+BID3373

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Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities

(NCT00389207)
Timeframe: week 148

,,
Interventionparticipants (Number)
DAIDS 2 moderateDAIDS 3 severeDAIDS 4 potential lifethreatening
Atazanvir/Ritonavir72399
Nevirapine BID842815
Nevirapine QD74309

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Change in Mental Health Summary (MHS) Score From Baseline

Quality of life (QoL) assessment by change in MHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the Medical Outcomes Study HIV Health Survey (MOS-HIV), a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The MHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL. (NCT00389207)
Timeframe: From baseline to Weeks 48, 96 and 144/EOT

,
InterventionUnits on a scale (Mean)
Change in MHS score to Week 48Change in MHS score to Week 96Change in MHS score to Week 144/EOT
Atazanvir/Ritonavir4.524.894.70
Nevirapine QD+BID6.096.104.76

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Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity

Proportion of Patients reporting CNS (central nervous system) side effects of any severity (NCT00389207)
Timeframe: week 148

Interventionparticipants (Number)
Nevirapine QD41
Nevirapine BID41
Atazanvir/Ritonavir37

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Proportion of Patients Reporting Hepatic Events of Any Severity

Proportion of Patients reporting hepatic events of any severity (NCT00389207)
Timeframe: week 148

Interventionparticipants (Number)
Nevirapine QD26
Nevirapine BID24
Atazanvir/Ritonavir92

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Proportion of Patients Reporting Rash of Any Severity

Proportion of Patients reporting rash of any severity (NCT00389207)
Timeframe: week 148

Interventionparticipants (Number)
Nevirapine QD75
Nevirapine BID64
Atazanvir/Ritonavir74

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Time to Loss of Virologic Response (Rebound)

Time to loss of virologic response (TLOVR) was defined as the time from start of treatment to the first measurement showing VL ≥ 50 copies/mL in the first virologic rebound, after having a confirmed virological response. (NCT00389207)
Timeframe: Baseline to week 144

Interventionweeks (Median)
Nevirapine QD143.86
Nevirapine BID143.21
Nevirapine QD+BID143.71
Atazanvir/Ritonavir143.00

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Time to Treatment Failure

Treatment failure is defined as the occurrence of the first of at least one of the following events: early discontinuation of trial drug, change in ARV therapy, failure to achieve an HIV RNA count < 50 copies/mL up to Visit 10 (week 48) or loss of virologic response (NCT00389207)
Timeframe: baseline to week 144

Interventionweeks (Median)
Nevirapine QD143.86
Nevirapine BID143.21
Nevirapine QD+BID143.71
Atazanvir/Ritonavir143.00

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Time to Treatment Response (First Confirmed VL<50 Copies/mL)

Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response (NCT00389207)
Timeframe: baseline to week 144

Interventionweeks (Median)
Nevirapine QD12.00
Nevirapine BID12.14
Nevirapine QD+BID12.00
Atazanvir/Ritonavir23.71

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Glucose Trafficking

"6 month mean and standard deviation for glucose uptake into anterior thigh muscle as measured by FDG/PET scanning during euglycemic hyperinsulinemic clamp. During the hyperinsulinemic conditions of the clamp, glucose and 18-FDG [labeled glucose] are taken up by muscle. The quantity of 18-FDG taken up is measured by the PET scan. Although there are no well-accepted norms for this measurement, a higher value indicates that more glucose is being taken up by (or trafficked to) muscle. Increased uptake of glucose indicates increased muscle insulin sensitivity." (NCT00413153)
Timeframe: 6 months

Interventionumol/kg/min (Mean)
Boosted Reyataz (ATV/r)26.7
Continue Kaletra (LPV/r)24.4

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Fasting Glucose

6 month mean and standard deviation for fasting glucose. (NCT00413153)
Timeframe: 6 months

Interventionmg/dL (Mean)
Boosted Reyataz (ATV/r)84
Continue Kaletra (LPV/r)90

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Body Composition - Visceral Adipose Tissue

6 month mean and standard deviation for visceral adipose tissue (VAT) as measured by single slice computed tomography (CT) scan at the L4 pedicle (pedicle of 4th lumbar vertebra). (NCT00413153)
Timeframe: 6 months

Interventionsquare centimeters (Mean)
Boosted Reyataz (ATV/r)91
Continue Kaletra (LPV/r)167

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Total Bilirubin

6 month mean and standard deviation for total bilirubin. (NCT00413153)
Timeframe: 6 months

Interventionmg/dL (Mean)
Boosted Reyataz (ATV/r)2.8
Continue Kaletra (LPV/r)0.6

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Liver Enzymes -- Aspartate Aminotransferase (AST)

6 month mean and standard deviation for AST. (NCT00413153)
Timeframe: 6 months

InterventionU/L (Mean)
Boosted Reyataz (ATV/r)39
Continue Kaletra (LPV/r)42

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Liver Enzymes -- Alanine Aminotransferase (ALT)

6 month mean and standard deviation for ALT. (NCT00413153)
Timeframe: 6 months

InterventionU/L (Mean)
Boosted Reyataz (ATV/r)61
Continue Kaletra (LPV/r)65

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Lipid Metabolism - Serum Triglyceride

6 month mean and standard deviation for serum triglyceride. (NCT00413153)
Timeframe: 6 months

Interventionmg/dL (Mean)
Boosted Reyataz (ATV/r)147
Continue Kaletra (LPV/r)209

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Insulin Sensitivity

6 month mean and standard deviation for insulin-stimulated glucose uptake (M) per unit insulin at 120 minutes as measured by euglycemic hyperinsulinemic clamp. (NCT00413153)
Timeframe: 6 months

Interventionumol/kg/min per uU/mL insulin (Mean)
Boosted Reyataz (ATV/r)39.0
Continue Kaletra (LPV/r)49.2

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Immune Parameters -- CD4 Count

6 month mean and standard deviation for CD4+ count. (NCT00413153)
Timeframe: 6 months

Interventioncells/microL (Mean)
Boosted Reyataz (ATV/r)432
Continue Kaletra (LPV/r)688

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Number of Participants Who Met the PDVF Criteria at Week 84

The number of participants that failed to respond to therapy from the time of treatment randomization through Week 84, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml. (NCT00440947)
Timeframe: Week 84

,
Interventionparticipants (Number)
Protocol-defined virologic failureConfirmed rebound after achieving <400 c/ml
ABC/3TC + ATV: Randomized Phase11
ABC/3TC + ATV/r: Randomized Phase77

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Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36

The number of participants that failed to respond to therapy through 36 weeks on treatment, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml. (NCT00440947)
Timeframe: Week 36

Interventionparticipants (Number)
Protocol-defined virologic failureFailure to achieve <400 c/ml by Week 30Confirmed rebound after achieving <400 c/ml
ABC/3TC + ATV/r: Induction Phase15510

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Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit

Percentage of PAR with HIV-1 RNA <400 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures. (NCT00440947)
Timeframe: Week 144

,
Interventionpercentage of participants (Number)
TLOVRObsM/D=F
ABC/3TC + ATV: Extension Phase849984
ABC/3TC + ATV/r: Extension Phase809782

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Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit

Percentage of PAR with HIV-1 RNA <400 c/ml at Week 84 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures. (NCT00440947)
Timeframe: Week 84

,
Interventionpercentage of participants (Number)
TLOVRObsM/D=F
ABC/3TC + ATV: Randomized Phase929992
ABC/3TC + ATV/r: Randomized Phase869887

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Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit

The percentage of PAR with HIV-1 RNA virus <400 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <400 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med; any reason), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study Med DC were failures. (NCT00440947)
Timeframe: Week 36

Interventionpercentage of participants (Number)
TLOVRObsM/D=F
ABC/3TC + ATV/r: Induction Phase829884

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Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit

The percentage of PAR with HIV-1 RNA virus <50 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (any reason), had confirmed rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study medication DC were failures. (NCT00440947)
Timeframe: Week 36

Interventionpercentage of participants (Number)
TLOVRObsM/D=F
ABC/3TC + ATV/r: Induction Phase808877

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Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit

A blood sample was drawn to determine the amount of HIV-1 RNA virus in c/ml at Week 84. The percentage of participants with HIV-1 RNA <50 c/ml at Week 84 was tabulated. The secondary analysis methods were: Observed (Obs; uses all visits with data in the analysis period), and missing/discontinuation=failure (M/D=F) analyses. M/D=F: participants with missing data or data collected after study medication DC were considered failures. (NCT00440947)
Timeframe: Week 84

,
Interventionpercentage of participants (Number)
ObsM/D=F
ABC/3TC + ATV: Randomized Phase9285
ABC/3TC + ATV/r: Randomized Phase9282

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Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase

The mean age of participants randomized to treatment in the Randomized Phase was calculated at Baseline. (NCT00440947)
Timeframe: Baseline of Randomized Phase

Interventionyears (Mean)
ABC/3TC + ATV: Randomized Phase37.5
ABC/3TC + ATV/r: Randomized Phase39.7

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Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit

Percentage of PAR with HIV-1 RNA <50 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <50 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures. (NCT00440947)
Timeframe: Week 144

,
Interventionpercentage of participants (Number)
TLOVRObsM/D=F
ABC/3TC + ATV: Extension Phase779580
ABC/3TC + ATV/r: Extension Phase739278

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Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit

The percentage of PAR with HIV-1 RNA virus <50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 c/ml and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/ml, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/ml, or had an unconfirmed HIV RNA of at least 50 c/ml at last visit. (NCT00440947)
Timeframe: Week 84

Interventionpercentage of participants (Number)
ABC/3TC + ATV: Randomized Phase86
ABC/3TC + ATV/r: Randomized Phase81

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Mean Percent Compliance at Week 144

Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen. (NCT00440947)
Timeframe: Week 144

,
Interventionpercent compliance (Mean)
Abacavir/LamivudineRitonavirAtazanavir
ABC/3TC + ATV: Extension Phase92.093.399.1
ABC/3TC + ATV/r: Extension Phase90.190.191.4

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Mean Percent Compliance at Week 36

Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen. (NCT00440947)
Timeframe: Week 36

Interventionpercent compliance (Mean)
Abacavir/LamivudineRitonavirAtazanavir
ABC/3TC + ATV/r: Induction Phase92.292.392.7

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Mean Percent Compliance at Week 84

Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen. (NCT00440947)
Timeframe: Week 84

,
Interventionpercent compliance (Mean)
Abacavir/LamivudineRitonavirAtazanavir
ABC/3TC + ATV: Randomized Phase92.092.998.9
ABC/3TC + ATV/r: Randomized Phase91.291.592.4

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Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir

A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant. (NCT00440947)
Timeframe: Baseline through Week 36

Interventionparticipants (Number)
PAR with reduced abacavir susceptibilityPAR with reduced lamivudine susceptibilityPAR with reduced atazanavir susceptibilityPAR with reduced ritonavir susceptibility
ABC/3TC + ATV/r: Induction Phase0100

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Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir

A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant. (NCT00440947)
Timeframe: Randomization at Week 36 through Week 84

,
Interventionparticipants (Number)
PAR with reduced abacavir susceptibilityPAR with reduced lamivudine susceptibilityPAR with reduced atazanavir susceptibilityPAR with reduced ritonavir susceptibility
ABC/3TC + ATV: Randomized Phase0100
ABC/3TC + ATV/r: Randomized Phase0000

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Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir

A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant. (NCT00440947)
Timeframe: Week 84 through Week 144

,
Interventionparticipants (Number)
PAR with reduced abacavir susceptibilityPAR with reduced lamivudine susceptibilityPAR with reduced atazanavir susceptibilityPAR with reduced ritonavir susceptibility
ABC/3TC + ATV: Extension Phase0100
ABC/3TC + ATV/r: Extension Phase1111

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Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36

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 resistance-associated mutations (defined by the International AIDS Society-USA guidelines) that developed at the time of failure were tabulated by drug class. PAR, participants; VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. (NCT00440947)
Timeframe: Baseline through Week 36

Interventionparticipants (Number)
PAR with paired genotypes at baseline and VFPAR with treatment-emergent mutationsPAR with NRTI mutationsPAR with NNRTI mutationsPAR with major PI mutationsPAR with minor PI mutations
ABC/3TC + ATV/r: Induction Phase1564102

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Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84

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 International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. (NCT00440947)
Timeframe: Randomization at Week 36 through Week 84

,
Interventionparticipants (Number)
PAR with paired genotypes at baseline and VFPAR with treatment-emergent mutationsPAR with NRTI mutationsPAR with NNRTI mutationsPAR with major PI mutationsPAR with minor PI mutations
ABC/3TC + ATV: Randomized Phase111000
ABC/3TC + ATV/r: Randomized Phase720002

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Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144

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 International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. (NCT00440947)
Timeframe: Week 84 through Week 144

,
Interventionparticipants (Number)
PAR with paired genotypes at baseline and VFPAR with treatment-emergent mutationsPAR with NRTI mutationsPAR with NNRTI mutationsPAR with major PI mutationsPAR with minor PI mutations
ABC/3TC + ATV: Extension Phase520002
ABC/3TC + ATV/r: Extension Phase511011

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Number of Participants Who Met the PDVF Criteria at Week 144

The number of participants enrolled in the extension phase that failed to respond to therapy from Week 84 through Week 144, based on the protocol definition of virologic failure (PDVF) was tabulated,. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml. (NCT00440947)
Timeframe: Week 144

,
Interventionparticipants (Number)
Protocol-defined virologic failureConfirmed rebound after achieving <400 c/ml
ABC/3TC + ATV: Extension Phase55
ABC/3TC + ATV/r: Extension Phase66

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Change From Baseline in CD4+ Cell Count at Week 144

A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count. (NCT00440947)
Timeframe: Baseline and Week 144

Interventioncells/millimeters cubed (mm^3) (Mean)
ABC/3TC + ATV: Extension Phase317.7
ABC/3TC + ATV/r: Extension Phase325.1

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Change From Baseline in CD4+ Cell Count at Week 36

Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 36 value minus the baseline value. (NCT00440947)
Timeframe: Baseline and Week 36

Interventioncells/millimeters cubed (mm^3) (Mean)
ABC/3TC + ATV/r: Induction Phase185.4

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Change From Baseline in CD4+ Cell Count at Week 84

A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count. (NCT00440947)
Timeframe: Baseline and Week 84

Interventioncells/millimeters cubed (mm^3) (Mean)
ABC/3TC + ATV: Randomized Phase265.7
ABC/3TC + ATV/r: Randomized Phase282.9

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Change From Baseline in HIV-1 RNA at Week 144

Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load. (NCT00440947)
Timeframe: Baseline and Week 144

Interventionlog10 c/ml (Mean)
ABC/3TC + ATV: Extension Phase-3.291
ABC/3TC + ATV/r: Extension Phase-3.239

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Change From Baseline in HIV-1 RNA at Week 36

Change from baseline was calculated as the Week 36 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load. (NCT00440947)
Timeframe: Baseline and Week 36

Interventionlog10 c/ml (Mean)
ABC/3TC + ATV/r: Induction Phase-3.241

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Change From Baseline in HIV-1 RNA at Week 84

Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load. (NCT00440947)
Timeframe: Baseline and Week 84

Interventionlog10 c/ml (Mean)
ABC/3TC + ATV: Randomized Phase-3.261
ABC/3TC + ATV/r: Randomized Phase-3.270

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Change in CD4+ Cell Count From Baseline to Week 48.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 48

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada155.1
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada160.4

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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

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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 2

,
InterventionParticipants (Number)
HIV viral load < 50 copies/mlHIV viral load ≥ 50 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada5639
Nevirapine (NVP) Plus Truvada6627

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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 12

,
InterventionParticipants (Number)
HIV viral load < 50 copies/mlHIV viral load ≥ 50 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada43277
Nevirapine (NVP) Plus Truvada422013

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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 6

,
InterventionParticipants (Number)
HIV viral load < 50 copies/mlHIV viral load ≥ 50 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada145310
Nevirapine (NVP) Plus Truvada233814

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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 8

,
InterventionParticipants (Number)
HIV viral load < 50 copies/mlHIV viral load ≥ 50 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada23504
Nevirapine (NVP) Plus Truvada342516

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Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response

HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml) (NCT00552240)
Timeframe: baseline to week 24 and week 48

,
InterventionParticipants (Number)
At week 24At week 48
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada49
Nevirapine (NVP) Plus Truvada12

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Number of Participants With Virologic Response (VR)

VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48. (NCT00552240)
Timeframe: baseline to week 48

,
Interventionparticipants (Number)
RespondersNonresponders
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada5027
Nevirapine (NVP) Plus Truvada4629

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Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm

HIV viral load <50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48. (NCT00552240)
Timeframe: baseline to week 48

,
InterventionParticipants (Number)
RespondersNonresponders
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada5126
Nevirapine (NVP) Plus Truvada4827

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Number of Participants With Virologic Success (FDA Definition)

HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS). (NCT00552240)
Timeframe: baseline to week 48

,
InterventionParticipants (Number)
RespondersNonresponders
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada4829
Nevirapine (NVP) Plus Truvada4233

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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 48

,
InterventionParticipants (Number)
HIV viral load < 50 copies/mlHIV viral load ≥ 50 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada48821
Nevirapine (NVP) Plus Truvada42231

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Number of Patients With Virologic Rebound to >400 Copies/ml

HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml) (NCT00552240)
Timeframe: baseline to week 48

,
InterventionParticipants (Number)
Rebound following responseNo rebound following response
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada663
Nevirapine (NVP) Plus Truvada255

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Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities

(NCT00552240)
Timeframe: baseline to week 52

,
Interventionparticipants (Number)
Grade 2 moderateGrade 3 severeGrade 4 potential lifethreatening
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada3173
Nevirapine (NVP) Plus Truvada2587

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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 4

,
InterventionParticipants (Number)
HIV viral load < 50 copies/mlHIV viral load ≥ 50 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada10625
Nevirapine (NVP) Plus Truvada125310

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Number of Participants With HIV Viral Load < 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

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Change in CD4+ Cell Count From Baseline to Week 6.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 6

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada87.2
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada78.4

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Change in CD4+ Cell Count From Baseline to Week 8.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 8

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada111.9
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada90.5

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Change in 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 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 Plasma Total Cholesterol Level

(NCT00552240)
Timeframe: baseline to week 48

Interventionmg/dl (Mean)
Nevirapine (NVP) Plus Truvada18.2
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada13.8

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Change in Fasting Plasma Triglycerides Level

(NCT00552240)
Timeframe: baseline to week 48

Interventionmg/dl (Mean)
Nevirapine (NVP) Plus Truvada-4.7
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada8.4

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Change in Fasting 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 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 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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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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Proportion of Patients Reporting CNS Side Effects of Any Severity

(NCT00552240)
Timeframe: baseline to week 52

Interventionparticipants (Number)
Nevirapine (NVP) Plus Truvada25
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada23

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Proportion of Patients Reporting Hepatic Events of Any Severity

(NCT00552240)
Timeframe: baseline to week 52

Interventionparticipants (Number)
Nevirapine (NVP) Plus Truvada5
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada24

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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

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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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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48

HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment. (NCT00552240)
Timeframe: baseline to week 48

,
InterventionParticipants (Number)
RespondersNonresponders
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada488
Nevirapine (NVP) Plus Truvada422

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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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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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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 24 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 24

,
InterventionParticipants (Number)
HIV viral load < 400 copies/mlHIV viral load ≥ 400 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada63311
Nevirapine (NVP) Plus Truvada51618

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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 36

,
InterventionParticipants (Number)
HIV viral load < 400 copies/mlHIV viral load ≥ 400 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada59117
Nevirapine (NVP) Plus Truvada54318

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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 4

,
InterventionParticipants (Number)
HIV viral load < 400 copies/mlHIV viral load ≥ 400 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada31415
Nevirapine (NVP) Plus Truvada382710

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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 48

,
InterventionParticipants (Number)
HIV viral load < 400 copies/mlHIV viral load ≥ 400 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada54221
Nevirapine (NVP) Plus Truvada43131

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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 6

,
InterventionParticipants (Number)
HIV viral load < 400 copies/mlHIV viral load ≥ 400 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada442310
Nevirapine (NVP) Plus Truvada402114

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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment

Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 8

,
InterventionParticipants (Number)
HIV viral load < 400 copies/mlHIV viral load ≥ 400 copies/mlMissing data
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada58154
Nevirapine (NVP) Plus Truvada481116

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AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death

"AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi's sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting.~Number of cases (no time-to analysis was performed due to small numbers)." (NCT00552240)
Timeframe: baseline to week 48

InterventionParticipants (Number)
Nevirapine (NVP) Plus Truvada1
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada3

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Change in 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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Change in CD4+ Cell Count From Baseline to Week 2.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 2

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada62.6
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada61.0

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Change in CD4+ Cell Count From Baseline to Week 24.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 24

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada131.8
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada132.5

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Change in CD4+ Cell Count From Baseline to Week 36.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 36

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada147.6
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada120.5

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Change in CD4+ Cell Count From Baseline to Week 4.

Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 4

Interventioncells/mm^3 (Mean)
Nevirapine (NVP) Plus Truvada76.4
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada63.0

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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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Tmax of RTV

Tmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

InterventionHour (Median)
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly4.00

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Total Area Under the Plasma Concentration-time Curve (AUCtot)

AUCtot represents the total free RIB plus 25-O-Desacetyl-RIB output. It is calculated as: AUCtot (micromolar[µM]*h) = AUC24avg(RIB)(ng*h/mL)/847.016 (g/mole) + AUC24avg(25-O-Desacetyl-RIB)(ng*h/mL)/804.979(g/mole). The 300 mg RIB arm represents an extrapolation from the 150 mg RIB group. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

InterventionµM*h (Geometric Mean)
RIB 150 mg Once Daily (QD)2.00
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly4.38

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Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Platelet Count and Leukocytes

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin/hematocrit: <0.85 x pre-treatment (pre-Rx) value. Platelet count: <0.85 x lower limit of normal (LLN) (or, if pre-Rx value 1.5 x upper limit of normal (ULN). Leukocytes: <0.9 x LLN or >1.2 x ULN (or, if pre-Rx value ULN. If pre-Rx value >ULN, then >1.15 x pre-Rx or NCT00646776)
Timeframe: Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.

,
InterventionParticipants (Number)
HemoglobinHematocritPlatelet countLeukocytes
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly1107
RIB 150 mg Once Daily (QD)0001

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Number of Participants With MAs in Hematology: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils+bands (absolute): <=1.50 x 10^3 cells/microliter (uL). Lymphocytes (absolute): <0.75 x 10^3 cells/uL or >7.50 x 10^3 cells/uL. Monocytes (absolute): >2.00 x 10^3 cells/uL. Basophils (absolute): >0.40 x 10^3 cells/uL. Eosinophils (absolute): >0.75 x 10^3 cells/uL. (NCT00646776)
Timeframe: Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.

,
InterventionParticipants (Number)
Neutrophils+bands (absolute)Lymphocytes (absolute)Monocytes (absolute)Basophils (absolute)Eosinophils (absolute)
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly105000
RIB 150 mg Once Daily (QD)11000

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Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP),Aspartate Aminotransferase (AST),Alanine Aminotransferase (ALT),Bilirubin (Total),Bilirubin (Direct),Blood Urea Nitrogen (BUN),Creatinine,Sodium (Serum),Potassium (Serum)

MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, AST, ALT:>1.25xULN (if pre-Rx >ULN, then >1.25xpre-Rx). Bilirubin (total), bilirubin (direct), BUN:>1.1xULN (if pre-Rx >ULN, then >1.25xpre-Rx). Creatinine:>1.33xpre-Rx. Sodium (serum):<0.95xLLN or >1.05xULN (if pre-Rx ULN. If pre-Rx >ULN, then >1.05xpre-Rx or 1.1xULN (if pre-Rx ULN. If pre-Rx >ULN, then >1.1xpre-Rx or NCT00646776)
Timeframe: Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.

,
InterventionParticipants (Number)
ALPASTALTBilirubin (total)Bilirubin (direct)BUNCreatinineSodium (serum)Potassium (serum)
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly00017160100
RIB 150 mg Once Daily (QD)000000000

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Number of Participants With MAs in Serum Chemistry: Chloride (Serum), Calcium (Total), Protein (Total), Bicarbonate, Phosphorous (Inorganic)

MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Chloride (serum), calcium (total), protein (total):<0.9xLLN or >1.1xULN (if pre-Rx ULN. If pre-Rx >ULN, then >1.1xpre-Rx or 1.2xULN (if pre-Rx value ULN. If pre-Rx >ULN, then >1.2xpre-Rx value or 1.25xULN (if pre-Rx ULN, then >1.25x re-Rx or NCT00646776)
Timeframe: Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.

,
InterventionParticipants (Number)
Chloride (serum)Calcium (total)Protein (total)BicarbonatePhosphorous (inorganic)
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly00000
RIB 150 mg Once Daily (QD)00000

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Number of Participants With MAs in Serum Chemistry: Glucose (Fasting Serum), Albumin, Creatine Kinase, Uric Acid, Lactate Dehydrogenase (LDH)

MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): <0.8 x LLN or >1.5 ULN (if pre-Rx ULN. If pre-Rx >ULN, then >2.0 x pre-Rx or 1.5 x ULN (if pre-Rx >ULN, then >1.5 x pre-Rx). Uric acid: >1.2 x ULN (if pre-Rx >ULN, then >1.25 x pre-Rx). LDH: >1.25 x ULN (if pre-Rx >ULN, then >1.5 x pre-Rx). (NCT00646776)
Timeframe: Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.

,
InterventionParticipants (Number)
Glucose (Fasting Serum)AlbuminCreatine KinaseUric AcidLDH
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly00000
RIB 150 mg Once Daily (QD)00000

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Number of Participants With MAs in Urinalysis

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs. Protein, glucose and blood: >=2+ (or, if pre-treatment value >=1+, then >= 2 x pre-treatment value). (NCT00646776)
Timeframe: Pre-dose on Day -1, Day 7 and discharge.

,
InterventionParticipants (Number)
ProteinGlucoseBlood
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly101
RIB 150 mg Once Daily (QD)000

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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.

AEs were defined as new, untoward medical occurrences/worsening of pre-existing medical condition, whether drug-related or not. SAEs were defined as 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 a cancer; or was an overdose. Discontinuation from the study was due either to an AE or was conducted at the investigator's discretion. (NCT00646776)
Timeframe: From Day 1 to 30 days after the last dose of study drug.

,
InterventionParticipants (Number)
DeathsOther SAEsAEsAE leading to discontinuationDiscontinuation due to investigator discretion
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly021394
RIB 150 mg Once Daily (QD)00510

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AUC(TAU) for ATV

AUC(TAU) was derived from the plasma concentration versus time for ATV, and was calculated by linear and log-linear trapezoidal summations using a mixed log-linear algorithm. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

Interventionng*h/mL (Geometric Mean)
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly51795

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AUC(TAU) for RTV

AUC(TAU) was derived from the plasma concentration versus time for RTV, and was calculated by linear and log-linear trapezoidal summations using a mixed log-linear algorithm. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

Interventionng*h/mL (Geometric Mean)
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly8699

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AUC24avg for 25-O-Desacetyl-RIB

AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150 mg QD; AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC[TAU]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7 (NCT00646776)
Timeframe: Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

Interventionng*h/mL (Geometric Mean)
RIB 150 mg Once Daily (QD)117.7
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly1283

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Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB)

AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150mg once daily (QD); AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC[TAU]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7. (NCT00646776)
Timeframe: Pre-dose (0 hours [h]) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

Interventionnanograms*hour /milliliters (ng*h/mL) (Geometric Mean)
RIB 150 mg Once Daily (QD)1565
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly2311

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Cmax of 25-O-Desacetylrifabutin (25-O-Desacetyl-RIB)

Cmax was derived from the plasma concentration versus time for 25-O-Desacetyl-RIB (a metabolite of RIB) and was recorded directly from experimental observations for each treatment period. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

Interventionng/mL (Geometric Mean)
RIB 150 mg Once Daily (QD)13.44
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly104.36

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Cmax of ATV

Cmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

Interventionng/mL (Geometric Mean)
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly5633

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Cmax of RTV

Cmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

Interventionng/mL (Geometric Mean)
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly1466

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Cmin of 25-O-Desacetyl-RIB

Cmin was derived from plasma concentration versus time for 25-O-Desacetyl-RIB. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

Interventionng/mL (Geometric Mean)
RIB 150 mg Once Daily (QD)2.79
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly31.97

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Cmin of ATV

Cmin was derived from the plasma concentration versus time for ATV. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

Interventionng/mL (Geometric Mean)
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly920.69

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Cmin of RTV

Cmin was derived from the plasma concentration versus time for RTV. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

Interventionng/mL (Geometric Mean)
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly40.54

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Maximum Plasma Concentration (Cmax) of RIB

Cmax was derived from plasma concentration versus time for RIB and was recorded directly from experimental observations for each treatment period. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

Interventionng/mL (Geometric Mean)
RIB 150 mg Once Daily (QD)159.0
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly395.6

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Minimum Plasma Concentration (Cmin) of RIB

Cmin was derived from plasma concentration versus time for RIB. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

Interventionng/mL (Geometric Mean)
RIB 150 mg Once Daily (QD)28.89
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly40.49

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Number of Participants With Clinically Significant Vital Signs or Physical Examination Findings

Vital signs assessments and physical examination were conducted throughout the study. Vital signs assessments included body temperature, respiratory rate, blood pressure (systolic and diastolic), and heart rate. Physical examination included a neurological examination (if ocular signs or symptoms occurred, a reflex to slit lamp exam was performed by an ophthalmologist). The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs or physical examination were clinically meaningful. (NCT00646776)
Timeframe: Vital signs:screening, prior to dosing on Day 1, Day 7, study discharge. Physical examination:screening, Day -1, Day 7, study discharge

InterventionParticipants (Number)
RIB 150 mg Once Daily (QD)0
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly0

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Number of Participants With Identified Electrocardiogram (ECG) Abnormalities

ECG abnormalities were defined as findings that are clinically meaningful as judged by the investigator. A 12-lead ECG was recorded at least 5 minutes after the participant had been lying down and all ECG recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed. (NCT00646776)
Timeframe: Pre-dose on Day -1 and study discharge.

InterventionParticipants (Number)
RIB 150 mg Once Daily (QD)0
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly3

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T-half of RTV

T-half was obtained directly from the concentration-time data. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

InterventionHour (Mean)
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly4.45

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Terminal Elimination Half-life (T-half) of ATV

T-half was obtained directly from the concentration-time data. T-half following doses administered for treatment ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

InterventionHour (Mean)
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly11.89

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Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV

Tmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period. (NCT00646776)
Timeframe: Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.

InterventionHour (Median)
ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly2.00

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HDL Cholesterol at Week 24

(NCT00756730)
Timeframe: 24 weeks

Interventionmg/dL (Mean)
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD38
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD40

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At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL

(NCT00756730)
Timeframe: 24 weeks

Interventionpercentage of participants (Number)
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD48
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD55

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Difference in CD4 From Baseline to Week 24

(NCT00756730)
Timeframe: baseline to Week 24

Interventioncells/mm^3 (Mean)
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD10.75
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD14.28

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LDL Cholesterol at Week 24

(NCT00756730)
Timeframe: week 24

Interventionmg/dL (Mean)
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD116
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD111

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Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.

A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm. (NCT00756730)
Timeframe: baseline, 24 weeks

Interventionpercentage of patients (Number)
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD80
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD73

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The Change in Fasting Triglyceride Level From Baseline to Week 24

(NCT00756730)
Timeframe: Baseline to week 24

Interventionmg/dL (Mean)
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD-126
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD-88

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Total Cholesterol in the Two Study Groups at 24 Weeks

(NCT00756730)
Timeframe: Week 24

Interventionmg/dL (Mean)
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD195
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD195

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Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24

(NCT00756730)
Timeframe: Week 4, 12 & 24

,
Interventionpercentage of participants (Number)
Week 4Week 12Week 24
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD100100100
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD100100100

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Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.

Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed. (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
Interventioncells/micro L (Mean)
Baseline (n=34,31)Change at Week 12 (n=32,29)Change at Week 48 (n=29,25)
Atazanavir326.768.3205.3
Darunavir268.3111.1217.4

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Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.

Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48

,
Interventiong/L (Mean)
Baseline (n=28,27)Change at Week 12 (n=27,27)Change at Week 48 (n=26,22)
Atazanavir0.8-0.050.0
Darunavir0.7-0.0040.0

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Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.

Number of Participants with antiviral activity, human immunodeficiency virus Type 1 (HIV-1) RNA less than (<) 50 copies per milliliters (copies/mL) or < 400 copies/mL. (NCT00757783)
Timeframe: Week 12 and 48

,
Interventionnumber of participants (Number)
Week12: HIV-1 RNA Less Than (<) 50 copies/mLWeek 12: HIV-1 RNA < 400 copies/mLWeek 48: HIV-1 RNA < 50 copies/mLWeek 48: HIV-1 RNA < 400 copies/mL
Atazanavir19292224
Darunavir13282528

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Change From Baseline in 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 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 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 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 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 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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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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Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)

Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed. (NCT00757783)
Timeframe: Week 12 and 48

,
Interventionnumber of participants (Number)
Week 12: HIV-1 RNA Less Than (<) 50 copies/mLWeek 12: HIV-1 RNA < 400 copies/mLWeek 48: HIV-1 RNA < 50 copies/mLWeek 48: HIV-1 RNA < 400 copies/mL
Atazanavir19282224
Darunavir13282528

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Change From Baseline in Cluster of Differentiation (CD) 4 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 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 CD4 Count at 48 Weeks

(NCT00762892)
Timeframe: Baseline and 48 weeks

Interventioncells/uL (Mean)
Raltegravir192
Atazanavir205

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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 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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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 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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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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Atazanavir Terminal Elimination Half Life

(NCT00768989)
Timeframe: At Week 2 from Baseline

InterventionHours (Mean)
Atazanavir + Raltegravir5.0

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Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval

Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng/mL (Geometric Mean)
Atazanavir + Raltegravir3506.5

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Number of Participants With 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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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 Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants

ULN=upper limit of normal. Hematocrit(%) Grade (Gr) 1: ≥28.5-<31; Gr 2: ≥24-<28.5; Gr 3: ≥19.5-<24; Gr 4: <19.5. Hemoglobin (g/dL) Gr 1: 9.5-11; Gr 2: 8-9.4; Gr 3: 6.5-7.9; Gr 4: <6.5. Platelets (/mm^3) Gr 1: 75,000-99,000; Gr 2: 50,000-74,999; Gr 3: 20,000-49,999; Gr 4: <20,000. White Blood Cells (/mm^3) Gr 1: >2500-4000; Gr 2: >1000-<2500; Gr 3: >800-<1000; Gr 4: <800. . Prothrombin time (seconds) Gr 1: 1.01-1.25*ULN; Gr 2: 1.26-1.5*ULN; Gr 3: 1.51-3*ULN; Gr 4: >3*ULN. (NCT00768989)
Timeframe: While on treatment from Baseline through Week 96

,
InterventionParticipants (Number)
HematocritHemoglobinPlateletsProthrombin TimeWhite Blood Cells
Atazanavir + Raltegravir1211222
Atazanavir + Ritonavir + Tenofovir/Emtricitabine001714

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Number of Participants With 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 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 Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4

Blood urea nitrogen Gr 1:1.25-2.5*ULN;Gr 2:2.6-5.0*ULN; Gr 3:5.1-10*ULN; Gr 4:>10*ULN. Creatinine (mg/dL) Gr 1: 1.1-1.5 *ULN; Gr 2: 1.6-3*ULN: Gr 3: 3.1-6*ULN; Gr 4: >6*ULN. Hypercarbia (meq/L)Gr 1: 33-36; Gr 2:37-40; Gr 3: 41-45; Gr 4:>45. Hypocarbia (meq/L)Gr 1:19-21; Gr 2: 15-18; Gr 3: 10-14; Gr 4:<10. Hypercalcemia (mg/dL)Gr 1:10.6-11.5;Gr 2:11.6-12.5; Gr 3:12.6-13.5;Gr 4: >13.5. Hypocalcemia (mg/dL)Gr 1: 8.4-7.8;Gr 2:7.7-7; Gr 3:6.9-6.1; Gr 4: <6.1.Hyperchloremia(meq/L)Gr 1:113-116; Gr 2:117-120; Gr 3:121-125; Gr 4: >125.Hypochloremia(meq/L)Gr 1: 90-93; Gr 2: 85-89; Gr 3:80-84; Gr 4:<80. (NCT00768989)
Timeframe: While on treatment from Baseline through Week 96

,
InterventionParticipants (Number)
Blood urea nitrogenCreatinineHypercarbiaHypocarbiaHypercalcemiaHypocalcemiaHyperchloremiaHypochloremiaHyperkalemiaHypokalemiaHypernatremiaHyponatremiaHyperclycemiaHypoglycemia
Atazanavir + Raltegravir031152101260386
Atazanavir + Ritonavir + Tenofovir/Emtricitabine12171101050154

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Mean Change From Baseline in Electrocardiogram Findings

The incidence of QRS wave widening and QT and PR prolongation on participant electrocardiogram findings were evaluated at study Week 24. (NCT00768989)
Timeframe: From Baseline to Week 24

,
Interventionmsec (Mean)
QRS IntervalQTc Friderica IntervalPR Interval
Atazanavir + Raltegravir8.9-2.717.6
Atazanavir + Ritonavir + Tenofovir/Emtricitabine3.66.04.9

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Mean Change From Baseline in Total Bilirubin Level

(NCT00768989)
Timeframe: From Baseline to Week 24 and Week 48

,
Interventionmg/dL (Mean)
Mean change from Baseline at Week 24Mean change from Baseline at Week 48
Atazanavir + Raltegravir2.152.08
Atazanavir + Ritonavir + Tenofovir/Emtricitabine1.711.52

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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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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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Raltegravir Cmax in 1 Dosing Interval

Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng/mL (Geometric Mean)
Atazanavir + Raltegravir1577.0

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Raltegravir AUC (0-12h) in 1 Dosing Interval

(NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng•h/mL (Geometric Mean)
Atazanavir + Raltegravir6446.4

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Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96

Participant HIV RNA level was determined at Weeks 48 and 96 using the Roche Amplicor® Ultrasensitive Assay Version 1. VR-OC=Virologic response-observed cases. (NCT00768989)
Timeframe: At Weeks 48 and 96 from Baseline

InterventionParticipants (Number)
Atazanavir + Raltegravir37
Atazanavir + Ritonavir + Tenofovir/Emtricitabine19

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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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Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose

(NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng•h/mL (Geometric Mean)
Atazanavir + Raltegravir687.1

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Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)

Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline

InterventionHours (Geometric Mean)
Atazanavir + Raltegravir3.0

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Number of Participants With 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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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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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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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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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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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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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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Incidence of Death or AIDS Defining Events (CDC Category C)

The incidence of death or AIDS defining events (CDC category C) was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence. (NCT00811954)
Timeframe: Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable

Interventionevents per 100 person-years (Number)
Arm A: ATV/RTV + FTC/TDF1.55
Arm B: RAL + FTC/TDF1.64
Arm C: DRV/RTV + FTC/TDF2.14

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Incidence of Targeted Serious Non-AIDS Defining Events (Renal Failure, Liver Disease, Serious Metabolic Disorder, and CVD)

The incidence of targeted serious non-AIDS defining events was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence. (NCT00811954)
Timeframe: Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable

Interventionevents per 100 person-years (Number)
Arm A: ATV/RTV + FTC/TDF2.38
Arm B: RAL + FTC/TDF2.24
Arm C: DRV/RTV + FTC/TDF2.69

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Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance

The number of participants with ATV/RTV or DRV/RTV resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. (NCT00811954)
Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)

Interventionparticipants (Number)
Arm A: ATV/RTV + FTC/TDF0
Arm B: RAL + FTC/TDF0
Arm C: DRV/RTV + FTC/TDF0

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Presence of Mutations Associated With INI Resistance

The number of participants with INI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. (NCT00811954)
Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)

Interventionparticipants (Number)
Arm A: ATV/RTV + FTC/TDF1
Arm B: RAL + FTC/TDF1
Arm C: DRV/RTV + FTC/TDF1

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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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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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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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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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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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Cholesterol

Total cholersterol (mg/dL) (NCT00814879)
Timeframe: baseline, week 24, week 48

,
Interventionmg/dL (Mean)
BaselineWeek 24Week 48
N(t)RTI(s) + PI/r166.25168.07167.41
RAL + ATV178.83169.65174.48

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Number of Patients With < 400 Copies HIV RNA/mL at Week 48

(NCT00814879)
Timeframe: 48 weeks

Interventionparticipants (Number)
N(t)RTI(s) + PI/r22
RAL + ATV21

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Number of Patients Reaching Virologic Failure at Week 48.

Virologic failure was defined by protocol as a plasma HIV RNA >50 c/mL on 2 consecutive occasions >7 days apart or > 10 000 c/mL on one occasion (in the absence of an intercurrent infection or recent immunization). (NCT00814879)
Timeframe: 48 Weeks

Interventionparticipants (Number)
N(t)RTI(s) + PI/r2
RAL + ATV3

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Mean Change in Total Bilirubin (mg/dL) From Baseline

mean change in total bilirubin from baseline (NCT00814879)
Timeframe: baseline and 48 weeks

Interventionmg/dL (Mean)
N(t)RTI(s) + PI/r-0.15
RAL + ATV0.37

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CD4+ Cell Count

(NCT00814879)
Timeframe: Weeks 24

Interventioncells/mm^3 (Mean)
N(t)NRTI + Plr599.4
RAL + ATV710.0

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CD4+ Cell Count

(NCT00814879)
Timeframe: Week 48

Interventioncells/mm^3 (Mean)
N(t)RTI(s) + PI/r596.6
RAL + ATV665.9

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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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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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Time to Loss of Virological Response (TLOVR)

TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm. (NCT00827112)
Timeframe: Baseline through Week 96

InterventionDays (Mean)
Maraviroc+ Atazanavir / Ritonavir436.2
Atazanavir / Ritonavir + Emtricitabine / Tenofovir463.8

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Change From Baseline in 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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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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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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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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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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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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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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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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Average Observed Plasma Concentration (Cavg) of Maraviroc

Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24). (NCT00827112)
Timeframe: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)

Interventionng/mL (Mean)
Maraviroc+ Atazanavir / Ritonavir185.10

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HIV-1 RNA Levels at Baseline

(NCT00827112)
Timeframe: Baseline

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

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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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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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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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AUC(TAU) of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants

AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles. (NCT00833482)
Timeframe: Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle

Interventionng.h/mL (Geometric Mean)
Atazanavir/Ritonavir, 300/100 QD (EM)9572
Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)8280

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Number of Participants With Marked Abnormalities in Hematology Laboratory Test and Urinalysis Results

LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: Neutrophils + bands: If <.85*LLN or >1.15*ULN or ULN or if preRXULN; if preRX>ULN, use >1.15*preRX or 1.15*ULN, or if preRX ULN; if preRX >ULN, use >1.15*preRX or = 2+, or if preRX >=1+, use >=2*preRX. White blood cells, urine: If >=2+, or if preRX >=2+, use >=4+. Red blood cells, urine: If >=2+ or if preRX >=2+, use >=4+. Not all categories were evaluated for each arm. (NCT00833482)
Timeframe: Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)

,,,,,
InterventionParticipants (Number)
Neutrophils + bands(absolute)(*10^3 cells/uL): LowLymphocytes, relative (*10*3 cells/uL): LowLymphocytes, relative (*10*3 cells/uL): HighBlood, urine: HighWhite blood cells (WBC), urine: HighRed blood cells (RBC), urine: High
Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)0NANA0NANA
Atazanavir/Ritonavir, 300/100 QD (EM)011100
Atazanavir/Ritonavir, 300/100 QD (PM)0NANA0NANA
Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)1112NANA
Voriconazole, 200 BID (EM)115111
Voriconazole, 50 mg BID (PM)0NANA0NANA

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Tmax of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants

Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles. (NCT00833482)
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle

InterventionHours (Median)
Voriconazole, 200 BID (EM)1.50
Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)1.25

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Cmax and Cmin of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants

Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles. (NCT00833482)
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle

,
Interventionng/mL (Geometric Mean)
Voriconazole CmaxVoriconazole Cmin
Atazanavir/Ritonavir, 300/100mg QD + Voriconazole, 200 mg BID3014439
Voriconazole, 200 BID3416776

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Number of Participants With Investigator-identified Abnormalities in Electrocardiogram Results Not Present Prior to Administration of Study Drug and Considered Not Relevant and Not AEs by Investigator

volt=voltage; LVH=left ventricular hypertrophy (NCT00833482)
Timeframe: Within 21 days of Day 1 and on Days -1, 21, and 31 (at discharge)

,,,,,
InterventionParticipants (Number)
Sinus bradycardiaST elevation and fusion complexesT-wave abnormality + minimum volt criteria for LVHNonspecific T-wave abnormality
Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)2111
Atazanavir/Ritonavir, 300/100 QD (EM)0000
Atazanavir/Ritonavir, 300/100 QD (PM)0000
Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)0000
Voriconazole, 200 BID (EM)0000
Voriconazole, 50 mg BID (PM)0000

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Number of Participants With Marked Abnormalities in Serum Chemistry Test Results

LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: AST and ALT: If >1.25*ULN, or if preRX>ULN, use >1.25*preRX. Total and direct bilirubin: If >1.1*ULN or if preRX>ULN, use >1.25*preRX. Creatinine: If >1.33*preRX. Serum glucose, fasting: If preRXULN; if preRX>ULN, use >2*preRX or 1.5*ULN or preRX>ULN, use >1.5*or preRX. Lactose dehydrogenase: If >1.25*ULN or preRX>ULN, use >1.5*preRX. (NCT00833482)
Timeframe: Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)

,,,,,
InterventionParticipants (Number)
Aspartate aminotransferase (AST) (U/L): HighAlanine aminotransferase (ALT) (U/L): HighTotal bilirubin (mg/dL): HighDirect bilirubin (mg/dL): HighCreatinine (mg/dL): HighSerum glucose, fasting (mg/dL): LowCreatine kinase (U/L): HighLactase dehydrogenase (U/L): High
Atazanavir/Ritonavir, 300/100 QD (EM)012200011
Atazanavir/Ritonavir, 300/100 QD (PM)01721000
Atazanavir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)01820000
Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)112100030
Voriconazole, 200 BID (EM)00400101
Voriconazole, 50 mg BID (PM)00000000

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Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Any AE

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT00833482)
Timeframe: Days 1 to 31 (discharge), continuously

,,,,,
InterventionParticipants (Number)
DeathsSAEsAEs leading to discontinuationAny AE
Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)0003
Atazanavir/Ritonavir, 300/100 QD (EM)00224
Atazanavir/Ritonavir, 300/100 QD (PM)0002
Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)00121
Voriconazole, 200 BID (EM)00022
Voriconazole, 50 mg BID (PM)0000

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Area Under the Plasma Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] of Atazanavir Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants

EM=extensive metabolizers, or participants with functional CYP2C19 alleles. (NCT00833482)
Timeframe: Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle

Interventionng*h/mL (Geometric Mean)
Atazanavir/Ritonavir, 300/100 QD (EM)44634
Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)38276

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AUC(TAU)of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants

AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles. (NCT00833482)
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle

Interventionng.h/mL (Geometric Mean)
Voriconazole, 200 BID (EM)20284
Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)12944

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Time to Maximum Concentration (Tmax) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants

EM=extensive metabolizers, or participants with functional CYP2C19 alleles. (NCT00833482)
Timeframe: Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle

InterventionHours (Median)
Atazanavir/Ritonavir, 300/100 QD (EM)3.0
Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)2.07

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Tmax of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants

Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles. (NCT00833482)
Timeframe: Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle

InterventionHours (Median)
Atazanavir/Ritonavir, 300/100 QD (EM)4.0
Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)4.0

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Cmax and Cmin of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants

Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles. (NCT00833482)
Timeframe: Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle

,
Interventionng/mL (Geometric Mean)
Ritonavir CmaxRitonavir Cmin
Atazanavir/Ritonavir, 300/100 QD (EM)159737.1
Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)142928.3

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Number of Participants With Abnormalities in Vital Signs

(NCT00833482)
Timeframe: Within 21 days of Day 1 and on Days -1, 1, 3, 11, 21, and 31 (at discharge)

,,,,,
InterventionParticipants (Number)
Diastolic blood pressureSystolic blood pressureHeart rateRespiratory rateTemperature
Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)00000
Atazanavir/Ritonavir, 300/100 QD (EM)00000
Atazanavir/Ritonavir, 300/100 QD (PM)00000
Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)00000
Voriconazole, 200 BID (EM)00000
Voriconazole, 50 mg BID (PM)00000

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Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in Participants Who Are Extensive Metabolizers (EM)

EM participants are those with functional CYP2C19 alleles. (NCT00833482)
Timeframe: Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle

,
Interventionng/mL (Geometric Mean)
Atazanavir CminAtazanavir Cmax
Atazanavir/Ritonavir, 300/100 QD (EM)6744715
Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)5254076

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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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Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96

hsCRP was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96

,,
InterventionFold change (Median)
Fold change from study entry to week 48Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0.750.85
Cohort B: RAL + FTC/TDF0.880.78
Cohort C: DRV/RTV + FTC/TDF0.781.31

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Change in Fasting 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 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 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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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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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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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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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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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 Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96

Subcutaneous abdominal fat (SAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF10.3
Cohort B: RAL + FTC/TDF11.8
Cohort C: DRV/RTV + FTC/TDF11.4

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Percent Change in Lean Mass From Study Entry to Week 96

Lean mass was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF1.8
Cohort B: RAL + FTC/TDF1.7
Cohort C: DRV/RTV + FTC/TDF0.1

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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 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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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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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 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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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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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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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 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 Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96

IL-6 was measured at study entry and weeks 48 and 96 (unit of measure pg/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96

,,
InterventionFold change (Median)
Fold change from study entry to week 48Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0.620.89
Cohort B: RAL + FTC/TDF0.710.82
Cohort C: DRV/RTV + FTC/TDF0.750.89

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Change in 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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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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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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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 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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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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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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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 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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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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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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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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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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Number of Subjects Who Had a Decrease in HIV RNA Per Million CD4+ T Cells in the Ileum

Number of subjects who had a decrease from week 0 to week 12 in unspliced cell-associated HIV RNA per million CD4+ T cells in the ileum (NCT00884793)
Timeframe: 12 weeks

Interventionparticipants (Number)
Intensification Arm5

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Number of Subjects Who Experienced an Increase in CD4+ T Cells (as a % of All Cells) in the Ileum.

Number of subjects who experienced an increase in CD4+ T cells (as a % of all cells) in the ileum (by flow cytometry) from week 0 to week 12. (NCT00884793)
Timeframe: 12 weeks

Interventionparticipants (Number)
Intensification Arm6

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Number of Subjects Who Experienced an Increase in CD4% in the Ileum.

Number of subjects who experienced an increase from week 0 to week 12 in CD4+ T cells (as a % of T cells, by flow cytometry) in the ileum (NCT00884793)
Timeframe: 12 weeks

Interventionparticipants (Number)
Intensification Arm5

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"Average Change in Activated (CD38+HLADR+) CD8+ T Cells in the Ileum"

Average of changes(week 0-week 12) in the % of CD8+ T cells that are CD38+HLA-DR+, by flow cytometry (NCT00884793)
Timeframe: 12 weeks

Interventionpercentage change (Mean)
Intensification Arm-5.4

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Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis

(NCT00885482)
Timeframe: 48 weeks

Interventionpatients (Number)
Single Arm1

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Change From Baseline in CD4 Cell Count at Week 24

The change from baseline in CD4 cell count at Week 24 was analyzed. (NCT00892437)
Timeframe: Baseline to Week 24

Interventioncells/μL (Mean)
ATV+COBI+FTC/TDF200
ATV+RTV+FTC/TDF202

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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 analyzed using the missing = failure method. (NCT00892437)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ATV+COBI+FTC/TDF82.0
ATV+RTV+FTC/TDF89.7

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the missing = failure method, where participants with missing data were considered to have failed to achieve the endpoint. (NCT00892437)
Timeframe: Week 24

Interventionpercentage of participants (Number)
ATV+COBI+FTC/TDF84.0
ATV+RTV+FTC/TDF89.7

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Change From Baseline in HIV-1 RNA at Week 48

The change from baseline in log_10 HIV-1 RNA at Week 48 was analyzed. (NCT00892437)
Timeframe: Baseline to Week 48

Interventionlog_10 copies/mL (Mean)
ATV+COBI+FTC/TDF-2.79
ATV+RTV+FTC/TDF-2.96

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Change From Baseline in HIV-1 RNA at Week 24

The change from baseline in log_10 HIV-1 RNA at Week 24 was analyzed. (NCT00892437)
Timeframe: Baseline to Week 24

Interventionlog_10 copies/mL (Mean)
ATV+COBI+FTC/TDF-2.80
ATV+RTV+FTC/TDF-2.97

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Change From Baseline in CD4 Cell Count at Week 48

The change from baseline in CD4 cell count at Week 48 was analyzed. (NCT00892437)
Timeframe: Baseline to Week 48

Interventioncells/μL (Mean)
ATV+COBI+FTC/TDF243
ATV+RTV+FTC/TDF213

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Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for AUC24hr)

The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)

Interventionng.h/mL (Mean)
ATV/Rtv 300/100 mg (Reference)74210
ATV/Rtv 300/100 mg (Test)72220

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Pharmacokinetic Results of Etravirine (ETR) (Results for AUC12hr)

The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the area under the plasma concentration-time curve from time of intake to 12 hours after dosing (AUC12hr). (NCT00896051)
Timeframe: Week 2

Interventionng.h/mL (Mean)
ATV/Rtv 300/100 mg (Treatment A)7629
ATV/Rtv 400/100 mg (Treatment B)5171

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Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for AUC24hr)

The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)

Interventionng.h/ml (Mean)
ATV/Rtv 300/100 mg (Reference)12560
ATV/Rtv 300/100 mg (Test)11120

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Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for AUC24hr)

The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)

Interventionng.h/ml (Mean)
ATV/Rtv 300/100 mg (Reference)13880
ATV/Rtv 300/100 mg (Test)13660

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Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax)

The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax). (NCT00896051)
Timeframe: Day -1 (Pretreatment); Week 2 (Test)

,
Interventionng/ml (Mean)
C0h, ng/ml (Reference, n=21; Test, n=19)Cmin, ng/ml (Reference, n=20; Test, n=18)Cmax, ng/ml (Reference, n=20; Test, n=19)
ATV/Rtv 300/100 mg (Reference)133911045652
ATV/Rtv 300/100 mg (Test)845.7758.65232

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Pharmacokinetic Results of Etravirine (ETR) (Results for C0h, Cmin, and Cmax)

The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin) and maximum plasma concentration (Cmax). (NCT00896051)
Timeframe: Week 2

,
Interventionng/ml (Mean)
C0h (Treatment B, n=19)Cmin (Treatment A, n=16; Treatment B, n=18)Cmax (Treatment A, n=18; Treatment B, n=18)
ATV/Rtv 300/100 mg (Treatment A)422.2425.1773.0
ATV/Rtv 400/100 mg (Treatment B)316.6286.5628.7

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Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for C0h, Cmin, and Cmax)

The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)

,
Interventionng/ml (Mean)
C0h, ng/ml (Reference, n=21; Test, n=19)Cmin, ng/ml (Reference, n=20; Test, n=18)Cmax, ng/ml (Reference, n=20; Test, n=19)
ATV/Rtv 300/100 mg (Reference)143.460.421834
ATV/Rtv 300/100 mg (Test)102.543.971740

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Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for C0h, Cmin, and Cmax)

The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)

,
Interventionng/ml (Mean)
C0h, ng/ml (Reference, n=22; Test, n=20)Cmin, ng/mlCmax, ng/ml (Reference, n=22)
ATV/Rtv 300/100 mg (Reference)109.264.701882
ATV/Rtv 400/100 mg (Test)163.475.681847

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The Percentage of Participants With a Virologic Response (Plasma Viral Load < 50 Copies/mL) at Week 48 Using the Snapshot Analysis Method

The table below provides the results from the snapshot analysis method that includes the percentage of participants with virologic response (<50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available at Week 48. (NCT00896051)
Timeframe: Week 48

,
InterventionPercentage of Participants (Number)
Virologic ResponseVirologic FailureNo VL Data Available
ATV/Rtv 300/100 mg (Treatment A)50.031.818.2
ATV/Rtv 400/100 mg (Treatment B)45.536.418.2

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The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method

The table below shows the percentage of participants per time point with a virologic response defined as having a plasma viral load (VL) <50 copies/mL, and with plasma VL <400 copies/mL using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their Baseline value, thus resulting in a 0 change). (NCT00896051)
Timeframe: Baseline, Weeks 4, 12, 24, 48

,
InterventionPercentage of Participants (Number)
<50 copies/mL, Baseline<50 copies/mL, Week 4<50 copies/mL, Week 12<50 copies/mL, Week 24<50 copies/mL, Week 48<400 copies/mL, Baseline<400 copies/mL, Week 4<400 copies/mL, Week 12<400 copies/mL, Week 24<400 copies/mL, Week 48
ATV/Rtv 300/100 mg (Treatment A)9.131.859.163.650.040.977.368.272.750.0
ATV/Rtv 400/100 mg (Treatment B)9.136.459.163.645.540.977.381.872.759.1

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The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method

The table below shows the percentage of participants with a virologic response defined as a viral load <50 Copies/mL and <400 Copies/mL per time point calculated using the time to loss of virologic response (TLOVR) imputation method. (NCT00896051)
Timeframe: Baseline, Weeks 4, 12, 24, 48

,
InterventionPercentage of Particpants (Number)
<50 copies/mL, Baseline<50 copies/mL, Week 4<50 copies/mL, Week 12<50 copies/mL, Week 24<50 copies/mL, Week 48<400 copies/mL, Baseline<400 copies/mL, Week 4<400 copies/mL, Week 12<400 copies/mL, Week 24<400 copies/mL, Week 48
ATV/Rtv 300/100 mg (Treatment A)9.131.859.163.645.536.477.368.268.259.1
ATV/Rtv 400/100 mg (Treatment A)4.536.454.559.150.040.977.386.468.254.5

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Time to Confirmed Virologic Response

The table below provides the time in days it took participants to reach a confirmed virologic response defined as a plasma viral load (VL) <50 copies/mL, and plasma VL <400 copies/mL analyzed according to the Time to Loss of Virologic Response (TLOVR) imputation method. (NCT00896051)
Timeframe: Prebaseline to Week 48

,
InterventionDays (Median)
Plasma VL < 50 copies/mLPlasma VL < 400 copies/mL
ATV/Rtv 300/100 mg (Treatment A)71.028.0
ATV/Rtv 400/100 mg (Treatment B)76.028.0

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Time to Virologic Failure

The table below shows the number of days to virologic failure defined as a plasma viral load (VL) > 50 copies/mL for participants who had been virologic responders (ie, having a plasma VL <50, and <400 copies/mL according to the time to loss of virologic response [TLOVR] imputation method). Time to virologic failure was the time to subsequent loss of virologic response, and the time was calculated from Prebaseline (Week -2). Participants who never achieved a virologic response were defined as nonresponders and counted as virologic failures on Day 1. (NCT00896051)
Timeframe: Prebaseline to Week 48

,
InterventionDays (Median)
Virologic Responders (Plasma VL < 50 copies/mL)Virologic Responders (Plasma VL < 400 copies/mL)
ATV/Rtv 300/100 mg (Treatment A)318.0NA
ATV/Rtv 400/100 mg (Treatment B)NANA

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Change From Pre-Baseline in Log10 Viral Load Over Time

The table below shows the mean change from prebaseline over time in log10 (Copies/mL) plasma viral load using the Non-Completing = Failure (NC=F) imputation method. (NCT00896051)
Timeframe: Pre-Baseline, Baseline, Weeks 4, 12, 24, 48

,
Interventionlog10 (Copies/mL) (Mean)
BaselineWeek 4Week 12Week 24Week 48
ATV/Rtv 300/100 mg (Treatment A)-1.4-1.9-1.7-1.8-1.4
ATV/Rtv 400/100 mg (Treatment B)-1.4-1.8-2.0-1.8-1.4

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Change From Prebaseline in CD4+ Cell Count Over Time

The table below shows the mean change from prebaseline over time in CD4+ cell count using the Non-Completing = Failure (NC=F) imputation method. (NCT00896051)
Timeframe: Prebaseline, Baseline, Weeks 4, 12, 24, 48

,
InterventionCD4+ cell count (Mean)
BaselineWeek 4Week 12Week 24Week 48
ATV/Rtv 300/100 mg (Treatment A)16553154105
ATV/Rtv 400/100 mg (Treatment B)8467283132

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Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for C0h, Cmin, and Cmax)

The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)

,
Interventionng/ml (Mean)
C0h, ng/ml (Reference, n=22; Test, n=20)Cmin, ng/ml (Reference, n=21;Test, n=18)Cmax, ng/ml (Reference, n=22; Test, n=20)
ATV/Rtv 300/100 mg (Reference)189816716419
ATV/Rtv 400/100 mg (Test)154511076950

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Percentage of Participants With Undetectable Plasma Viral Load (VL) Values (<50 Copies/mL) at Week 48

The table below shows the percentage of participants wih undetectable plasma viral load (VL) values (<50 copies/mL) at Week 48 using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their baseline value, thus resulting in a 0 change). (NCT00896051)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
ATV/Rtv 300/100 mg (Treatment A)50.0
ATV/Rtv 400/100 mg (Treatment B)45.5

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Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for AUC24hr)

The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Pretreatment); Week 2 (Test)

Interventionng.h/mL (Mean)
ATV/Rtv 300/100 mg (Reference)60030
ATV/Rtv 300/100 mg (Test)55070

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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 Change in Adherence to Study Treatment Arm From Baseline to Week 48

Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits. (NCT00931801)
Timeframe: Baseline and Week 48

,,,
Interventionpercentage of prescribed doses (Mean)
3 Day Adherence Recall at Baseline3 Day Adherence Recall at Week 48Change in 3 Day Adherence Recall
Control Arm1001000
Intervention Arm No.197.597.50
Intervention Arm No.296.795.0-1.7
Total98.197.6-0.5

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The Difference in CD4 From Baseline to Week 48

Change in mean CD4 from Baseline to Week 48. (NCT00931801)
Timeframe: Baseline and Week 48

,,,
Interventioncells/mm3 (Mean)
CD4 at BaselineCD4 at Week 48CD4 Change
Control Arm535.8611.275.4
Intervention Arm No.1514.1526.312.1
Intervention Arm No.2539.1507.2-31.9
Total528.3549.321.0

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Viral Load

Number of participants with undetectable viral load (NCT00940771)
Timeframe: 4 weeks, 12 weeks, 24 weeks

InterventionParticipants (Count of Participants)
Week 4Week 12Week 24
Boosted Atazanavir1099

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CD4 Count

(NCT00940771)
Timeframe: 4 Weeks, 12 weeks, 24 weeks

Interventioncells/uL (Mean)
Week 4Week 12Week 24
Boosted Atazanavir1214.31151.91120.0

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Non-fasting Cholesterol

(NCT00940771)
Timeframe: 4 Weeks, 12 weeks, 24 weeks

Interventionmg/dL (Mean)
Week 4Week 12Week 24
Boosted Atazanavir187.2178.5181.5

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Non-fasting Triglycerides

(NCT00940771)
Timeframe: 4 weeks, 12 weeks, 24 weeks

Interventionmg/dL (Mean)
Week 4Week 12Week 24
Boosted Atazanavir240.5195.5193.3

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Area Under the Concentration Curve (in 1 Dosing Interval From Time 0 to 24 Hours Post Observed Dose) (AUC[TAU])of Atazanavir and Ritonavir

(NCT01099579)
Timeframe: At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose

,,
Interventionng*h/mL (Geometric Mean)
AUC(TAU) AtazanavirAUC(TAU) Ritonavir (n=19, 18, 15)
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg3250317439
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg5030520510
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg6148513640

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Apparent Total Body Clearance Per Body Weight (CLT/F) Per Kilogram of Atazanavir and Ritonavir

Calculated as CLT/F divided by body weight (NCT01099579)
Timeframe: At Week 2

,,
InterventionL/h per kilogram (Geometric Mean)
CLT/F per kilogram AtazanavirCLT/F per kilogram Ritonavir (n=19, 18, 15)
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg0.650.65
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg0.320.32
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg0.240.35

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Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4

ALT=alanine aminotransferase; SGPT=serum glutamic-pyruvic transaminase; AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal. Grading by the National Institute of Health Division of AIDs and World Health Organization criteria. Hemoglobin (g/dL): Grade (Gr)1=9.5-11.0; Gr 2=8.0-9.4; Gr 3=6.5-7.9; Gr 4=<6.5. Neutrophils, absolute (/mm^3): Gr 1=>=1000-<1500; Gr 2= >=750-<1000; Gr 3=>=500-<750; Gr 4=<500. ALT/SGPT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=>10. AST/SGOT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=>10. Alkaline phosphatase(*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5: Gr 3=5.1-10; Gr 4=>10. Total bilirubin (*ULN): Gr 1=1.1-1; Gr 2=1.6-2.5; Gr 3=2.6-5; Gr 4=>5. Amylase (*ULN): Gr 1=1.10-39; Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Lipase (*ULN): Gr 1=1.10-1.39: Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12.0; Gr 3=12.1-15.0; Gr 4=>15. (NCT01099579)
Timeframe: After Day 1 to Week 48

,,
InterventionParticipants (Number)
Hemoglobin (n=20, 17, 15)Neutrophils, absolute (n=20, 17, 15)ALT/SGPT (n=20, 18, 15)AST/SGOT (n=20, 18, 15)Alkaline phosphatase (n=20, 18, 15)Total bilirubin (n=20, 18, 15)Amylase (n=20, 18, 15)Lipase (n=20, 18, 15)Uric acid n=20, 18, 15)
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg235102800
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg320010510
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg001003111

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Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48

Electrocardiogram parameters were measured at baseline for QTC Bazett, QTC Fridericia, and PR interval. The mean change from baseline at week 48 is reported by arm in milliseconds. (NCT01099579)
Timeframe: From Baseline to Week 48

,,
InterventionMilliseconds (Mean)
PR IntervalQTC BazettQTC Fridericia
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg4.91.77.9
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg12.0-3.213.2
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg6.2-4.24.8

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Mean CD4 Percent Changes From Baseline at Week 48 by Antiretroviral (ARV) Treatment Status

(NCT01099579)
Timeframe: From Baseline to Week 48

InterventionPercentage of lymphocytes (Mean)
ARV-experienced4.3
ARV-naive9.8

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Mean CD4 Percent Changes From Baseline at Week 48 by Treatment/Weight

(NCT01099579)
Timeframe: From Baseline to Week 48

InterventionPercentage of lymphocytes (Mean)
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg6.1
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg7.3
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg8.8

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Mean Change From Baseline in HIV RNA Levels at Week 48 by Prior Antiretroviral (ARV) Treatment Status

(NCT01099579)
Timeframe: From Baseline to Week 48

InterventionLog10 c/mL (Mean)
ARV-experienced-2.53
ARV-naive-2.81

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Mean Change From Baseline in HIV RNA Levels at Week 48 by Treatment/Weight

Participants who received at least 1 dose of atazanavir (ATV) and had an HIV RNA measurement on ATV powder at did not switch to the capsule formulation before Week 48 (NCT01099579)
Timeframe: From Baseline to Week 48

InterventionLog10 c/mL (Mean)
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg-2.61
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg-2.93
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg-2.40

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Apparent Total Body Clearance (CLT/F) of Atazanavir and Ritonavir

Calculated as dose divided by AUC(TAU). AUC(TAU)=area under the concentration-time curve in 1 dosing interval from time 0 to 24 hours post observed dose. (NCT01099579)
Timeframe: At Week 2

,,
InterventionL/h (Geometric Mean)
CLT/F AtazanavirCLT/F Ritonavir (n=19, 18, 15
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg4.614.59
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg3.983.90
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg4.075.87

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Number of Participants With Centers for Disease Control (CDC) Class C AIDS Events

CDC Class C events are AIDS-defining events that include recurrent bacterial pneumonia (>=2 episodes in 12 months); candidiasis of the bronchi, trachea, lungs, or esophagus; invasive cervical carcinoma; disseminated or extrapulmonary coccidioidomycosis; extrapulmonary cryptococcosis; chronic intestinal cryptosporidiosis (>1 month); cytomegalovirus disease; HIV-related encephalopathy; herpes simplex: chronic ulcers, or bronchitis, pneumonitis, or esophagitis; disseminated or extrapulmonary histoplasmosis; chronic intestinal isosporiasis; Kaposi sarcoma; immunoblastic or primary brain Burkitt lymphoma; mycobacterium avium complex, kansasii, or tuberculosis; mycobacterium, other species; Pneumocystis carinii pneumonia; progressive multifocal leukoencephalopathy; Salmonella septicemia; recurrent toxoplasmosis of brain; HIV wasting syndrome (involuntary weight loss >10% of baseline body weight) with chronic diarrhea or chronic weakness and documented fever for ≥1 month. (NCT01099579)
Timeframe: From Day 1 to Week 48

InterventionParticipants (Number)
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg1
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg1
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg0

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Number of Participants Who Acquired Phenotypic Resistance to Atazanavir or Atazanovir/Ritonavir

Criteria for resistance testing= meeting at least 1 of the following: <1 log10 drop from baseline in HIV RNA level by Week 16 and confirmed by a second HIV RNA level; an HIV RNA level >200 copies/mL after Week 24, confirmed by a second HIV RNA level; repeated HIV RNA levels ≥50 copies/mL after Week 48; an HIV RNA level ≥400 copies/mL confirmed by a second HIV RNA level of ≥400 copies/mL at any time in a participant who had previously achieved a plasma HIV RNA level <50 copies/mL; or discontinued due to lack of efficacy. Virologic failure was defined as an incomplete virologic response to therapy or as a viral rebound after the achievement of virologic suppression. The phenotypic resistance to a drug is defined as a fold change (ie, ratio of the 50% inhibitory concentration [IC50] of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. (NCT01099579)
Timeframe: After Day 1 to Week 48

,
InterventionParticipants (Number)
AtazanavirRitonavir
ARV-experienced00
ARV-naive00

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Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT01099579)
Timeframe: From Day 1 to Week 48

,,
InterventionParticipants (Number)
DeathsSAEsAEs leading to discontinuation
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg054
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg021
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg040

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Time to Maximum Observed Concentration (Tmax) of Atazanavir and Ritonavir

(NCT01099579)
Timeframe: At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose

,,
InterventionHours (Median)
Tmax AtazanavirTmax Ritonavir
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg1.581.8
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg1.972.9
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg4.04.0

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Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight

The definition of virologic success included HIV RNA levels <50 c/mL or 400 c/mL at the Week 48 analysis window. . (NCT01099579)
Timeframe: At Week 48

,,
InterventionPercentage of participants (Number)
HIV RNA levels <50 c/mLHIV RNA levels <400 c/mL
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg47.666.7
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg68.473.7
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg71.485.7

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Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Prior Antiretroviral (ARV) Treatment Status

The definition of virologic success included HIV RNA levels <50 c/mL or <400 c/mL at the Week 48 analysis. (NCT01099579)
Timeframe: From Day 1 to Week 48

,
InterventionPercentage of participants (Number)
HIV RNA levels <50 c/mLHIV RNA levels <400 c/mL
ARV-experienced56.365.6
ARV-naive68.286.4

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Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir

(NCT01099579)
Timeframe: At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose

,,
Interventionng/mL (Geometric Mean)
Atazanavir CmaxAtazanavir CminRitonavir Cmax (n=19, 18, 15)Ritonavir Cmin (n=18, 16, 15)
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg4131336291941.8
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg51975722634143
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg6172698183851.0

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CD4 Cell Count Changes From Baseline at Week 48 by Treatment/Weight

(NCT01099579)
Timeframe: From Baseline to Week 48

InterventionCells/mm^3 (Mean)
Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg550.1
Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg225.3
Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg373.8

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CD4 Cell Count Changes From Baseline at Week 48 by Prior Antiretroviral (ARV) Treatment Status

(NCT01099579)
Timeframe: From Baseline to Week 48

InterventionCells/mm^3 (Mean)
ARV-experienced437.9
ARV-naive352.1

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Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses

The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods. (NCT01102972)
Timeframe: Week 24

,
Interventionpercentage of participants (Number)
Observed, n=181, 89M/D=F, n=199, 97SNAPSHOT, n=199, 97
ABC/3TC + ATV98.988.989.4
TDF/FTC + ATV/RTV98.988.789.7

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Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses

The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods. (NCT01102972)
Timeframe: Week 48

,
InterventionPercentage of participants (Number)
Observed, n=169, 82M/D=F, n=199, 97SNAPSHOT, n=199, 97
ABC/3TC + ATV968182
TDF/FTC + ATV/RTV1008285

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Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses

The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn through Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods. (NCT01102972)
Timeframe: Week 24

,
Interventionpercentage of participants (Number)
Observed, n=181, 89M/D=F, n=199, 97SNAPSHOT, n=199, 97
ABC/3TC + ATV94.584.984.9
TDF/FTC + ATV/RTV97.787.688.7

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Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses

The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods. (NCT01102972)
Timeframe: Week 48

,
InterventionPercentage of participants (Number)
TLOVR, n=199, 97Observed, n=169, 82M/D=F, n=199, 97SNAPSHOT, n=199, 97
ABC/3TC + ATV76.491.176.977.4
TDF/FTC + ATV/RTV79.496.379.481.4

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Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir

A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at Baseline. (NCT01102972)
Timeframe: From Baseline to Week 48

,
Interventionparticipants (Number)
HIV PAR with reduced abacavir susceptibilityHIV PAR with reduced lamivudine susceptibilityHIV PAR with reduced tenofovir susceptibilityHIV PAR with reduced emtricitabine susceptibilityHIV PAR with reduced atazanavir susceptibilityHIV PAR with reduced ritonavir susceptibility
ABC/3TC + ATV120222
TDF/FTC + ATV/RTV000000

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Change From Baseline in Cholesterol/HDL Ratio at Week 48

A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter. (NCT01102972)
Timeframe: Baseline and Week 48

Interventionratio (Mean)
ABC/3TC + ATV0.00
TDF/FTC + ATV/RTV0.00

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Change From Baseline in Cholesterol/HDL Ratio at Week 24

A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value. (NCT01102972)
Timeframe: Baseline and Week 24

Interventionratio (Mean)
ABC/3TC + ATV-0.20
TDF/FTC + ATV/RTV-0.01

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Change From Baseline in CD4+ Cell Count at Week 48

Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from Baseline was calculated as the Week 48 value minus the Baseline value. (NCT01102972)
Timeframe: Baseline and Week 48

Interventioncells per cubic millimeter (mm^3) (Mean)
ABC/3TC + ATV95.8
TDF/FTC + ATV/RTV57.2

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Change From Baseline in CD4+ Cell Count at Week 24

Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from Baseline was calculated as the Week 24 value minus the Baseline value. (NCT01102972)
Timeframe: Baseline and Week 24

Interventioncells per cubic millimeter (mm^3) (Mean)
ABC/3TC + ATV47.7
TDF/FTC + ATV/RTV8.3

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Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48

The number of participants that failed to remain virologically suppressed from baseline through 48 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA >=400 c/mL. (NCT01102972)
Timeframe: From Baseline to Week 48

Interventionparticipants (Number)
ABC/3TC + ATV4
TDF/FTC + ATV/RTV1

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Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis

The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit. (NCT01102972)
Timeframe: Week 24

Interventionpercentage of participants (Number)
ABC/3TC + ATV88.4
TDF/FTC + ATV/RTV86.6

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Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis

The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit. (NCT01102972)
Timeframe: Week 48

InterventionPercentage of participants (Number)
ABC/3TC + ATV81
TDF/FTC + ATV/RTV84

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Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis

The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/mL, or had an unconfirmed HIV RNA of at least 50 c/mL at the last visit. (NCT01102972)
Timeframe: Week 24

Interventionpercentage of participants (Number)
ABC/3TC + ATV86.9
TDF/FTC + ATV/RTV86.6

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Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24

Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured at Week 24. A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value for each parameter. (NCT01102972)
Timeframe: Baseline and Week 24

,
Interventionmilligrams per deciliter (mg/dL) (Mean)
Triglycerides, n=170, 81Total cholesterol, n=170, 81HDL cholesterol, n=170, 81LDL cholesterol (Calculation), n=166, 80
ABC/3TC + ATV-17.234.494.503.34
TDF/FTC + ATV/RTV-4.350.14-0.200.94

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Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48

Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured or calculated at Week 48. A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter. (NCT01102972)
Timeframe: Baseline and Week 48

,
Interventionmilligrams per deciliter (mg/dL) (Mean)
Triglycerides, n=152, 76Total cholesterol, n=152, 76HDL cholesterol, n=152, 76LDL cholesterol (Calculation), n=148, 71
ABC/3TC + ATV-9.287.623.115.28
TDF/FTC + ATV/RTV7.710.620.53-0.62

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Change From Baseline in HIV-1 RNA at Week 48

Change from Baseline was calculated as the Week 48 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load. (NCT01102972)
Timeframe: Baseline and Week 48

Interventionlog10 copies/mL (Mean)
ABC/3TC + ATV0.071
TDF/FTC + ATV/RTV-0.018

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Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24

A blood sample was drawn for particiapants with confirmed VF >=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. (NCT01102972)
Timeframe: From Baseline to Week 24

,
Interventionparticipants (Number)
PAR with treatment-emergent mutationsPAR with NRTI mutationsPAR with NNRTI mutationsPAR with major PI mutationsPAR with minor PI mutations
ABC/3TC + ATV21112
TDF/FTC + ATV/RTV10001

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Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48

A blood sample was drawn for particiapants with confirmed VF >=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. (NCT01102972)
Timeframe: From Baseline to Week 48

,
Interventionparticipants (Number)
PAR with treatment-emergent mutationsPAR with NRTI mutationsPAR with major NNRTI mutationsPAR with major PI mutationsPAR with minor PI mutations
ABC/3TC + ATV42124
TDF/FTC + ATV/RTV10001

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Number of Participants Who Experienced Death and/or Disease Progression

Death and clinical disease progression (as per CDC classification) were assessed from Baseline through Week 48. Disease progression is defined as progression from CDC Class A to B, Class A to C, or from Class B to C. AIDS CDC classifications are: Class A, Asymptomatic/lymphadenopathy/acute HIV; Class B, Symptomatic, not AIDS; Class C, AIDS indicator conditions. The CDC categorization of HIV/AIDS is based on the lowest documented CD4 cell count (Class A, >=500 cells per microliter [µl]; Class B, 200-499 cells/µl; Class C, <200 cells/µl) and on previously diagnosed HIV-related conditions. (NCT01102972)
Timeframe: From Baseline to Week 48

Interventionparticipants (Number)
ABC/3TC + ATV0
TDF/FTC + ATV/RTV0

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Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24

The number of participants that failed to remain virologically suppressed through 24 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA >=400 c/mL. (NCT01102972)
Timeframe: From Baseline to Week 24

Interventionparticipants (Number)
ABC/3TC + ATV2
TDF/FTC + ATV/RTV1

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Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir

A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at Baseline. (NCT01102972)
Timeframe: From Baseline to Week 24

,
Interventionparticipants (Number)
HIV PAR with reduced abacavir susceptibilityHIV PAR with reduced lamivudine susceptibilityHIV PAR with reduced tenofovir susceptibilityHIV PAR with reduced emtricitabine susceptibilityHIV PAR with reduced atazanavir susceptibilityHIV PAR with reduced ritonavir susceptibility
ABC/3TC + ATV110111
TDF/FTC + ATV/RTV000000

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Change From Baseline in HIV-1 RNA at Week 24

Change from Baseline was calculated as the Week 24 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load. (NCT01102972)
Timeframe: Baseline and Week 24

Interventionlog10 copies/mL (Mean)
ABC/3TC + ATV0.014
TDF/FTC + ATV/RTV0.008

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Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group

The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE. (NCT01102972)
Timeframe: From Baseline to Week 48

,
Interventionparticipants (Number)
Any EventUpper respiratory tract infectionDiarrhoeaDepressionBack painBronchitisInsomniaMuscle strainRashSinusitisMuscle spasms
ABC/3TC + ATV9011764463622
TDF/FTC + ATV/RTV447433303043

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Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group

The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE. (NCT01102972)
Timeframe: From Baseline to Week 24

,
Interventionparticipants (Number)
Upper respiratory tract infectionDiarrhoeaBronchitisRashMuscle strainMuscle spasmsSinusitis
ABC/3TC + ATV7546211
TDF/FTC + ATV/RTV6330333

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Change From Baseline in CD4 Cell Count at Week 48

(NCT01108510)
Timeframe: Baseline to Week 48

Interventioncells/μL (Mean)
ATV+COBI+FTC/TDF213
ATV+RTV+FTC/TDF219

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Change From Baseline in CD4 Cell Count at Week 192

(NCT01108510)
Timeframe: Baseline to Week 192

Interventioncells/μL (Mean)
ATV+COBI+FTC/TDF350
ATV+RTV+FTC/TDF343

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Change From Baseline in CD4 Cell Count at Week 144

(NCT01108510)
Timeframe: Baseline to Week 144

Interventioncells/μL (Mean)
ATV+COBI+FTC/TDF310
ATV+RTV+FTC/TDF332

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

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm. (NCT01108510)
Timeframe: Week 96

Interventionpercentage of participants (Number)
ATV+COBI+FTC/TDF77.9
ATV+RTV+FTC/TDF79.3

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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 analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status. (NCT01108510)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ATV+COBI+FTC/TDF85.2
ATV+RTV+FTC/TDF87.4

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 192 was analyzed using the snapshot algorithm. (NCT01108510)
Timeframe: Week 192

Interventionpercentage of participants (Number)
ATV+COBI+FTC/TDF71.6
ATV+RTV+FTC/TDF79.7

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

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm. (NCT01108510)
Timeframe: Week 144

Interventionpercentage of participants (Number)
ATV+COBI+FTC/TDF72.1
ATV+RTV+FTC/TDF74.1

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Change From Baseline in CD4 Cell Count at Week 96

(NCT01108510)
Timeframe: Baseline to Week 96

Interventioncells/μL (Mean)
ATV+COBI+FTC/TDF277
ATV+RTV+FTC/TDF287

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Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir

(NCT01232127)
Timeframe: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.

,,
Interventionng/mL (Geometric Mean)
Atazanavir CmaxAtazanavir CtroughRitonavir CmaxRitonavir Ctrough
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI3512496114145.8
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)4131602114849.2
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)3322494109647.3

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Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir

(NCT01232127)
Timeframe: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.

,,
Interventionng*h/mL (Geometric Mean)
Atazanavir AUCRitonavir AUC
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI325627317
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)378947430
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)314817052

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Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir

(NCT01232127)
Timeframe: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.

,,
InterventionHours (Median)
Atazanavir TmaxRitonavir Tmax
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI3.04.0
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)3.04.00
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)3.04.0

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Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest

An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT01232127)
Timeframe: Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.

,,
InterventionParticipants (Number)
DeathsSAEsAEs leading to discontinuationAEsAEs of clinical interest: NauseaAEs of clinical interest: Diarrhea
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI000600
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)000723
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)000500

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Number of Participants With Abnormalities in Vital Signs

Vital signs include temperature, respiratory rate, seated blood pressure, and heart rate. (NCT01232127)
Timeframe: Days 1, 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.

InterventionParticipants (Number)
Isolated decrease in heart rateSporadic respiration rate >16 bpm
All Treated211

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Number of Participants With Abnormalities in Laboratory Test Results

PreRX=pretreatment; ULN=upper limit of normal. Neutrophils, (absolute), low (10*3 c/uL): <0.85*PreRx, if PreRx <1.5; <1.5 if PreRx ≥1.5. Alanine aminotransferase, high (U/L): >1.25*PreRx if PreRx >ULN; >1.25*ULN if PreRx ≤ULN. Bilirubin, direct (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN. Bilirubin, total (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN. (NCT01232127)
Timeframe: Days 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.

,,
InterventionParticipants (Number)
WBC differential count (low)Neutrophils (absolute) (low)Alanine aminotransferase (high)Aspartate aminotransferase (high)Bilirubin, direct (high)Bilirubin, total (high)
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI100013
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)011007
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)000105

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Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings

ECG findings include heart rate, ECG intervals (including PR, QRS, QT, and corrections to QT using both Bazett's and Fridericia's formulae), and Investigator-identified ECG abnormalities. (NCT01232127)
Timeframe: Days 1 and 25 (end of study) and at study discharge for those who discontinued prematurely.

InterventionParticipants (Number)
Nonspecific ST/T wave abnormalityShort PR interval
All Treated11

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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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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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CD4 Cell Count Changes From Baseline on ATV Powder

CD4 cell count change from baseline using observed values (NCT01335698)
Timeframe: Baseline to Weeks 24 and 48

InterventionCells/mm^3 (Mean)
Week 24
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)67.8

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CD4 Cell Count Changes From Baseline on ATV Powder

CD4 cell count change from baseline using observed values (NCT01335698)
Timeframe: Baseline to Weeks 24 and 48

,,,
InterventionCells/mm^3 (Mean)
Week 24Week 48
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)218.7-409.8
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)247.1400.0
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)246.1335.4
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)145.8213.0

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Mean Change From Baseline in CD4 Percent on ATV Powder

Change in CD4 percent using observed values (NCT01335698)
Timeframe: Baseline to Weeks 24 and 48

InterventionPercent Change (Mean)
Week 24
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)4.0

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Mean Change From Baseline in HIV RNA on ATV Powder

Human immunodeficiency virus ribonucleic acid (HIV RNA) change from baseline using observed values (NCT01335698)
Timeframe: Baseline to Weeks 24 and 48

,,,,
InterventionLog copies per millileter (Mean)
Week 24Week 48
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)-2.10-2.31
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)-2.69-2.91
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)-3.07-4.06
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)-2.66-2.70
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)-2.24-3.97

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Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder

The CDC disease staging system assesses the severity of HIV disease by CD4 cell counts and by the presence of specific HIV-related conditions. CD4 counts are classified as 1: ≥500 cells/µL, 2: 200-499 cells/µL, and 3: <200 cells/µL. Children with HIV infection are also classified in each of several categories. Category N: Not symptomatic. Category A: Mildly symptomatic. Category B: Moderately symptomatic. Category C: Severely symptomatic. (NCT01335698)
Timeframe: Day one to week 300 (approximately 22-Jan-2018)

,,,,
InterventionParticipants (Number)
Pulmonary tuberculosisLymph node tuberculosisTuberculosisOropharyngeal Candidiasis
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)2001
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)1000
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)0000
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)0110
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)0000

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Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48

Newly emergent substitutions are on-treatment substitutions that were not detected at baseline.Viral rebound in the resistance analysis was defined as: Less than a 1 log10 drop from baseline in plasma HIV RNA level by Week 16, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, a plasma HIV RNA level >200 c/mL after Week 24, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, repeated plasma HIV RNA level ≥50 c/mL after Week 48. Viral rebound was defined as a plasma HIV RNA level ≥400 c/mL at any time in a patient who had previously achieved a plasma HIV RNA level <50 c/mL. Or, a plasma HIV RNA level ≥50 c/mL and <1,000 c/mL followed by a return to virologic suppression was considered a viral blip and not a viral rebound. NRTI=nucleoside reverse transcriptase inhibitor (NCT01335698)
Timeframe: Baseline through Week 48

,,,,
InterventionParticipants (Number)
Any PI substitutionsAny IAS-USA PI substitutionsAny select RT substitutionsNRTI
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)4121
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)4222
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)0011
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)3011
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)0000

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Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort

Virologic success includes patients with HIV RNA <50 copies/mL. Two cohorts were assessed: The Atazanavir Powder Cohort=patients who received treatment and did not switch to capsule before analysis Week 24 or before their HIV RNA Week 24 assessment, and the Eligible Week 48 Atazanavir Powder Cohort=patients who initiated study treatment at least 48 weeks before last person last visit and did not switch to capsule before analysis Week 48 or before their HIV RNA Week 48 assessment. (NCT01335698)
Timeframe: Day 1 of treatment to weeks 24 and 48

,,,,
InterventionParticipants (Number)
Week 24: HIV RNA<50 copies/mLWeek 24: HIV RNA<400 copies/mLWeek 48: HIV RNA<50 copies/mLWeek 48:HIV RNA<400 copies/mL
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)10151114
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)1015614
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)2501
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)19241822
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)5611

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Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder

Criteria of the Division of AIDS for grading the severity of adult and pediatric adverse events as follows: Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=potentially life-threatening. Neutrophils (absolute) (adult and infants >7 days): Gr 1=1.000-1300/mm^3; Gr 2=750-999 mm^3; Gr 3=500-749 mm^3; Gr 4= <500 mm^3. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase: Gr 1=1.25-2.5*upper limit of normal (ULN); Gr 2=2.6-5.0*ULN; Gr 3=5.1-10.0*ULN; Gr 4= >10.0*ULN. Bilirubin, total (adults and infants >14 days): Gr 1=1.1-1.5*ULN; Gr 2=1.6-2.5*ULN; Gr 3=2.6-5.0*ULN; Gr 4= >5.0*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. Bicarbonate, serum low: Gr 1=16.0 mEq/L-5.0*ULN. (NCT01335698)
Timeframe: Day one to week 300 (approximately 22-Jan-2018)

,,,,
InterventionParticipants (Number)
Neutrophils (absolute)Alanine aminotransferaseAspartate aminotransferaseAlkaline phosphataseTotal bilirubinAmylaseLipaseBicarbonateAlbuminCalcium, HighChloride, LowTotal Cholesterol, FastingLDL Cholesterol, FastingGlucose, Fasting, Low
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)042141532100000
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)411110600000111
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)01021720100000
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)62005620111000
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)00002110000000

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Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. (NCT01335698)
Timeframe: Day one to week 300 (approximately 22-Jan-2018)

,,,,
InterventionParticipants (Number)
DeathsAEs leading to discontinuationHyperbilirubinemia related adverse eventsJaundiceAtrioventricular block, first degreeTachycardiaRash
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)0320003
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)0293014
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)0200000
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)0273105
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)0100001

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Mean Change From Baseline in CD4 Percent on ATV Powder

Change in CD4 percent using observed values (NCT01335698)
Timeframe: Baseline to Weeks 24 and 48

,,,
InterventionPercent Change (Mean)
Week 24Week 48
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)5.12.8
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)5.48.9
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)6.37.5
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)-0.31.0

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Area Under the Concentration-Time Curve [AUC(TAU)]

To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - < 35 kg and/or 6 to < 11 years of age and for the new 5 - < 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV AUC (NCT01335698)
Timeframe: Baseline to Week 2

Interventionng.h./mL (Mean)
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)49387.12
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)59671.80
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)56356.00

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Maximum Observed Plasma Concentration (Cmax)

To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - < 35 kg and/or 6 to < 11 years of age and for the new 5 - < 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV Cmax (NCT01335698)
Timeframe: Baseline to Week 2

Interventionng/mL (Mean)
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)5776.70
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)5644.12
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)4893.75

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Minimum Plasma Concentration (Cmin)

To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - < 35 kg and/or 6 to < 11 years of age and for the new 5 - < 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV Cmin (NCT01335698)
Timeframe: Baseline to Week 2

Interventionng/mL (Mean)
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)718.90
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)857.06
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)1030.64

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Number of Participants Who Experienced a SAE on ATV Powder

SAE= any of the the following: is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event (defined as a medical event(s) that may not be immediately life threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the subject or may require intervention [eg, medical, surgical] to prevent one of the other serious outcomes listed in the definition above.) Examples of such events include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization (NCT01335698)
Timeframe: Day one to week 300 (approximately 22-Jan-2018)

Interventionparticipants (Number)
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)6
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)3
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)8
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)8
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)0

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Proportions of Subjects Experiencing Virologic Failure by Randomized Treatment Arm

For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart. (NCT01351740)
Timeframe: at or before 48 weeks.

InterventionParticipants (Count of Participants)
Switch2
Continuation6

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Proportions of Subjects in Each Randomized Treatment Arm With Atazanavir Trough Levels Below 150ng/mL

Therapeutic drug monitoring (TDM) to determine atazanavir trough plasma level will be performed once on all subjects at 4-8 weeks (NCT01351740)
Timeframe: 1 month (4-8 weeks)

InterventionParticipants (Count of Participants)
Switch14
Continuation3

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Number of Participants With Newly-emergent Genotypic Substitutions at Week 24

Participants who administered antiretroviral (ARV) with virologic failure (VF) were assessed. Genotypic substitution included assessment of Reverse Transcriptase (RT) substitution, Protease Inhibitor (PI) substitution and Integrase RAL substitution as per International Acquired Immune Deficiency Syndrome (AIDS) Society-USA (IAS-USA) list. ITT-E Resistance Tested through Week 24 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 24 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or met the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. (NCT01384734)
Timeframe: Up to Week 24

,,,,
InterventionParticipants (Count of Participants)
PI substitutionRT substitutionIntegrase substitution
ATV/r/RAL/TDF000
FTR 1200 mg QD/RAL/TDF011
FTR 400 mg BID/RAL/TDF000
FTR 600 mg QD/RAL/TDF001
FTR 800 mg BID/RAL/TDF000

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Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA

Maximum decrease from monotherapy Baseline in log10 plasma HIV-1 RNA during monotherapy to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. The data for monotherapy nadir has been presented where nadir represents the maximum decrease from Baseline. (NCT01384734)
Timeframe: Baseline and up to Day 8 of the monotherapy period

Interventionlog10 c/mL (Mean)
FTR 400 mg BID/RAL/TDF-0.770
FTR 800 mg BID/RAL/TDF-1.524
FTR 600 mg QD/RAL/TDF-1.250
FTR 1200 mg QD/RAL/TDF-1.399

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Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage confidence intervals (CI). Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. Intent-To-Treat-Exposed (ITT-E) Population includes all randomized participants who received at least one dose of study treatment. (NCT01384734)
Timeframe: Week 24

InterventionPercentage of Participants (Number)
FTR 400 mg BID/RAL/TDF80
FTR 800 mg BID/RAL/TDF69
FTR 600 mg QD/RAL/TDF76
FTR 1200 mg QD/RAL/TDF72
ATV/r/RAL/TDF75

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Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL . The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and up to Week 24

InterventionIC50 Fold Change (Mean)
FTR 400 mg BID/RAL/TDF-2.350
FTR 800 mg BID/RAL/TDF1014.748
FTR 600 mg QD/RAL/TDF101.627
FTR 1200 mg QD/RAL/TDF39.030

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Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and up to Week 96

InterventionIC50 Fold Change (Mean)
FTR 400 mg BID/RAL/TDF25.480
FTR 800 mg BID/RAL/TDF419.901
FTR 600 mg QD/RAL/TDF46.351
FTR 1200 mg QD/RAL/TDF777.818

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Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and up to Week 48

InterventionIC50 Fold Change (Mean)
FTR 400 mg BID/RAL/TDF-2.624
FTR 800 mg BID/RAL/TDF586.776
FTR 600 mg QD/RAL/TDF81.729
FTR 1200 mg QD/RAL/TDF449.092

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Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Baseline of combination therapy was assessed to evaluate the antiviral activity of four doses of FTR. Baseline of combination therapy was the Day 1 of the combination therapy. Virologic success or failure was determined using the non-missing viral load value at Baseline of combination therapy. The assessment closest to the window target Study Day was used for the analysis. Only those participants with data available at the specified time points were analyzed. (NCT01384734)
Timeframe: Up to Day 8 of the monotherapy period

InterventionPercentage of Participants (Number)
FTR 400 mg BID/RAL/TDF0
FTR 800 mg BID/RAL/TDF0
FTR 600 mg QD/RAL/TDF0
FTR 1200 mg QD/RAL/TDF11

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Change From Baseline in CD4+ T-cell Count

Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Weeks 24, 48 and 96 to evaluate the immunological activity of multiple doses of BMS-663068/GSK3684934. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). (NCT01384734)
Timeframe: Baseline and Weeks 24, 48 and 96

,,,,
InterventionCells per cubic millimeter (Mean)
Week 24, n=41, 38, 48, 42, 40Week 48, n=43, 34, 43, 41, 41Week 96, n=42, 28, 35, 28, 31
ATV/r/RAL/TDF119.4178.7250.1
FTR 1200 mg QD/RAL/TDF124.5155.4211.7
FTR 400 mg BID/RAL/TDF134.3199.1264.6
FTR 600 mg QD/RAL/TDF109.5140.5175.7
FTR 800 mg BID/RAL/TDF111.0158.7210.8

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Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy

Blood was collected and CD4+ and CD8+ proportion assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and Day 8

,,,
Interventioncells per cubic millimeter (Mean)
CD4+CD8+
FTR 1200 mg QD/RAL/TDF0.014-0.021
FTR 400 mg BID/RAL/TDF-0.005-0.003
FTR 600 mg QD/RAL/TDF0.008-0.009
FTR 800 mg BID/RAL/TDF0.023-0.040

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Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy

Blood was collected and CD4+ and CD8+ cell count assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and Day 8

,,,
Interventioncells per cubic millimeter (Mean)
CD4+CD8+
FTR 1200 mg QD/RAL/TDF63.467.6
FTR 400 mg BID/RAL/TDF58.4134.2
FTR 600 mg QD/RAL/TDF71.8188.0
FTR 800 mg BID/RAL/TDF134.8216.3

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Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period

Change from monotherapy Baseline in log10 HIV RNA to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. ITT-E Monotherapy Population comprised of participants that were randomized and participated in the monotherapy sub-study and received at least one dose of FTR Monotherapy. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). (NCT01384734)
Timeframe: Baseline and up to Day 8 of the monotherapy period

,,,
Interventionlog10 c/mL (Mean)
Day 2, n=7, 5, 10, 9Day 5, n=7, 4, 10, 10Day 6, n=7, 5, 10, 10Day 7, n=6, 5, 10, 10Day 8, n=6, 4, 9, 9
FTR 1200 mg QD/RAL/TDF0.126-0.767-1.053-1.198-1.470
FTR 400 mg BID/RAL/TDF0.220-0.340-0.530-0.556-0.691
FTR 600 mg QD/RAL/TDF0.126-0.593-0.822-1.086-1.218
FTR 800 mg BID/RAL/TDF0.149-0.811-1.082-1.443-1.372

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Number of Participants With Newly-emergent Genotypic Substitutions at Week 48

Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 48 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 48 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. (NCT01384734)
Timeframe: Up to Week 48

,,,,
InterventionParticipants (Count of Participants)
PI substitutionRT substitutionIntegrase substitution
ATV/r/RAL/TDF000
FTR 1200 mg QD/RAL/TDF122
FTR 400 mg BID/RAL/TDF101
FTR 600 mg QD/RAL/TDF001
FTR 800 mg BID/RAL/TDF001

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Number of Participants With Newly-emergent Genotypic Substitutions at Week 96

Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 96 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 96 Snapshot analysis window. The criteria for resistance tested was participants with virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. (NCT01384734)
Timeframe: Up to Week 96

,,,,
InterventionParticipants (Count of Participants)
PI substitutionRT substitutionIntegrase RAL substitution
ATV/r/RAL/TDF010
FTR 1200 mg QD/RAL/TDF223
FTR 400 mg BID/RAL/TDF322
FTR 600 mg QD/RAL/TDF221
FTR 800 mg BID/RAL/TDF112

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Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. (NCT01384734)
Timeframe: Up to Day 8 of the monotherapy period

,,,
InterventionParticipants (Count of Participants)
SAEAEs leading to discontinuation
FTR 1200 mg QD/RAL/TDF00
FTR 400 mg BID/RAL/TDF00
FTR 600 mg QD/RAL/TDF00
FTR 800 mg BID/RAL/TDF00

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Number of Participants With SAE and Discontinuation Due to AEs During Primary Study

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety Population comprised of participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week X (where X = 48 or 96) included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 48 and 96 visit snapshot window. (NCT01384734)
Timeframe: Weeks 48 and 96

,,,,
InterventionParticipants (Count of Participants)
SAE, Week 48SAE, Week 96AEs leading to discontinuation, Week 48AEs leading to discontinuation, Week 96
ATV/r/RAL/TDF5735
FTR 1200 mg QD/RAL/TDF2412
FTR 400 mg BID/RAL/TDF3511
FTR 600 mg QD/RAL/TDF4600
FTR 800 mg BID/RAL/TDF5722

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Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety population included all participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week 24 included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 24 visit snapshot window. (NCT01384734)
Timeframe: Up to Week 24

,,,,
InterventionParticipants (Count of Participants)
SAEAEs leading to discontinuation
ATV/r/RAL/TDF52
FTR 1200 mg QD/RAL/TDF21
FTR 400 mg BID/RAL/TDF31
FTR 600 mg QD/RAL/TDF40
FTR 800 mg BID/RAL/TDF42

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Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage CI. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. (NCT01384734)
Timeframe: Weeks 48 and 96

,,,,
InterventionPercentage of Participants (Number)
Week 48Week 96
ATV/r/RAL/TDF7157
FTR 1200 mg QD/RAL/TDF6858
FTR 400 mg BID/RAL/TDF8278
FTR 600 mg QD/RAL/TDF6963
FTR 800 mg BID/RAL/TDF6149

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Day 7 Atazanavir Oral Clearance

Measure atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors (NCT01388543)
Timeframe: Day 7

InterventionL/h/kg (Geometric Mean)
CYP3A5 Expressors.25
CYP3A5 Non-expressors.18

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Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)

(NCT01404572)
Timeframe: Study Day 1

,,
InterventionParticipants (Number)
DeathsAEsSAEs
Atazanavir, 15 mg/5 mL, With 10% Aspartame000
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame000
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose000

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Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir

Overall palatability was scored on a scale of 1 through 5, with 1 being least palatable and 5 being most palatable. Only whole score numbers were accepted. (NCT01404572)
Timeframe: Study Day 1

InterventionUnits on a scale (Mean)
Atazanavir, 15 mg/5 mL, With 10% Aspartame3.0
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame2.8
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose2.3

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Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir

Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness. (NCT01404572)
Timeframe: Study Day 1

InterventionUnits on a scale (Mean)
Atazanavir, 15 mg/5 mL, With 10% Aspartame1.3
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame1.4
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame+ 0.53% Sucralose1.0

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Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir

Overall palatability was scored on a scale of 1 through 5, with 1 being least palatable and 5 being most palatable. Only whole score numbers were accepted. (NCT01404572)
Timeframe: Study Day 1

InterventionUnits on a scale (Median)
Atazanavir, 15 mg/5 mL, With 10% Aspartame3
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame3
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose2

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Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir

Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness. (NCT01404572)
Timeframe: Study Day 1

InterventionUnits on a scale (Median)
Atazanavir, 15 mg/5 mL, With 10% Aspartame1.5
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame1.5
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose1.0

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Change in Brachial Artery Diameter

The primary endpoint is the difference in the change in brachial artery diameter in response to a flow stimulus at visit 2 and 3. It is anticipated that a response will occur following atazanavir therapy compared with baseline. The principal secondary endpoints are the serum measures of oxidant stress and antioxidant capacity. (NCT01421355)
Timeframe: Day 0 and Day 4

Interventionpercentage of dilation (Mean)
Atazanavir 300 mg BID-0.93

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Proportion of Patients With Treatment Failure (TF)

Proportion of patients with treatment failure defined as having one of the following events: confirmed viral rebound (CVR) or treatment discontinuation for any cause. CVR was established when 2 consecutive viral load values (HIV-1 RNA)>50 copies/mL occurred within 2 weeks during follow-up. In case of CVR, patients treated with atazanavir/ritonavir monotherapy had to re-introduce their previous 2NRTIs (re-intensification) and, if not suppressed (HIV-1 RNA <50 copies /ml) after 12 weeks, discontinued from the study. Re-intensification was considered as treatment failure in the primary analysis conducted according to the intention-to-treat principle (intention-to-treat analysis with re-intensification equal failure, ITT=Failure) while it was not in the secondary analysis (intention-to-treat analysis with re-intensification equal success, ITT=Success). (NCT01511809)
Timeframe: Up to week 48

,
Interventionpercentage of patients (Number)
ITT=Failure analysisITT=Success analysis
Atazanavir/Ritonavir Monotherapy27.57.9
Atazanavir/Ritonavir Triple Therapy15.415.4

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AUC Norethindrone

0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 21 (NCT01667978)
Timeframe: following 21 days of continuous ingestion

Interventionng*h/mL (Mean)
Protease Inhibitor37.81
Control25.21

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Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4

Hematocrit (%): Grade (Gr) 1= ≥28.5- <31.5; Gr 2= ≥24- <28.5; Gr 3= ≥19.5- <24; Gr 4= <19.5. Hemoglobin (g/dL): Grade (Gr)1=8.5-10.0; Gr 2=7.5-8.4; Gr 3=6.50-7.4; Gr 4= <6.5. Platelets (/mm^3): Gr 1=100,000-124,999; Gr 2=50,000-99,999; Gr 3=25,000-49,999; Gr 4= <25,000. White blood cells (/mm^3): Gr 1=2000-2500; Gr 2=1500-1999; Gr 3=1000-1499; Gr 4= <1000. Neutrophils (/mm^3): Gr 1=1000-1500; Gr 2= ≥750-1000; Gr 3= ≥500-750; Gr 4= <500. Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) (*upper limit of normal [ULN]): Gr 1=1.5-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10.0; Gr 4= >10.0. Total bilirubin (adult and pediatric >14 days) (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-2.5; Gr 3=2.6-5.0; Gr 4= >5.0. Albumin (g/dL): Gr 1= 3.1- 5. Lipase (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-3.0; Gr 3=3.1-5.0; Gr 4= >5.0. (NCT01691794)
Timeframe: After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)

,,
InterventionParticipants (Number)
HematocritHemoglobinPlateletsWhite blood cellsNeutrophils+bands (absolute)ALTASTALPTotal bilirubinAlbuminAmylaseLipase
Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)000011013220
Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)350313661126152715
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)001049512176148

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Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued)

Blood urea nitrogen (*upper limit of normal [ULN]): Grade (Gr) 1=1.25-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10; Gr 4= >10. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12; Gr 3=12.1-15.0; Gr 4= >15.0. Bicarbonate (mEqL): Gr 1= 19.0-21.0; Gr 2=15.0-18.0; Gr 3=41-45; Gr 4= >45. Calcium, low (mg/dL): Gr 1=7.8-8.4; Gr 2=7.0-7.7; Gr 3=6.1-6.9; Gr 4= <6.1.Potassium (mEq/L), high: Gr 1=5.6-6.0; Gr 2=6.1-6.5; Gr 3=6.6-7.0; Gr 4= >7.0. Potassium (mEq/L), low: Gr 1=3.1-3.4; Gr 2=2.5-2.9; Gr 3=2.0-2.4; Gr 4= <2.0. Sodium (mEq/L), low: Gr 1=130-135; Gr 2=125-129; Gr 3=121-124; Gr 4= <1. Total cholesterol, fasting (mg/dL): Gr 1=200-239; Gr 2=240-300; Gr 3= >300; Gr 4=Not applicable (NA). Low-density lipoprotein (LDL) cholesterol, fasting (mg/dL): Gr 1=130-159; Gr 2=160-190; Gr 3= >190; Gr 4= NA. Glucose, low (mg/dL): Gr 1= 55-64; Gr 2=40-54; Gr 3=30-39; Gr 4= <30. Glucose, fasting (mg/dL): Gr 1=110-125; Gr 2=126-250; Gr 3=251-500; Gr 4 >500. (NCT01691794)
Timeframe: After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)

,,
InterventionParticipants (Number)
Blood urea nitrogenUric acidBicarbonate, lowCalcium, lowPotassium, highPotassium, lowTotal cholesterol, fasting (n=3, 31, 21)Sodium, lowLDL cholesterol, fasting (n=3, 31, 21)Glucose, low (n=1, 11, 9)Glucose, fasting, high (3, 31, 22)Calcium, highChloride, highChloride, lowGlucose, Non-Fasting, HighSodium, highCreatinineTriglycerides, fasting
Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)003000010000000000
Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)322922210137332000110
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)0317310603010200100

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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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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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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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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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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 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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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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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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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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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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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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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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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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Maximum Observed Plasma Concentration (Cmax) of Cobicistat

Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Cmax was derived from plasma concentration versus time data. (NCT01837719)
Timeframe: Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)

Interventionng/mL (Geometric Mean)
Treatment A: Atazanavir + Cobicistat Coadministered1321
Treatment B: Atazanavir/Cobicistat FDC1348
Treatment C: Atazanavir + Cobicistat Coadministered952
Treatment D: Atazanavir/Cobicistat FDC1033
Treatment E: Atazanavir/Cobicistat FDC1060

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Apparent Terminal Half-life (T-HALF) of Atazanavir

Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. T-HALF was derived from plasma concentration versus time data. (NCT01837719)
Timeframe: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)

InterventionHours (Mean)
Treatment A: Atazanavir + Cobicistat Coadministered7.54
Treatment B: Atazanavir/Cobicistat FDC7.50
Treatment C: Atazanavir + Cobicistat Coadministered7.25
Treatment D: Atazanavir/Cobicistat FDC7.21
Treatment E: Atazanavir/Cobicistat FDC7.14

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Maximum Observed Plasma Concentration (Cmax) of Atazanavir

Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Cmax was derived from plasma concentration versus time data. (NCT01837719)
Timeframe: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)

Interventionng/mL (Geometric Mean)
Treatment A: Atazanavir + Cobicistat Coadministered3832
Treatment B: Atazanavir/Cobicistat FDC4104
Treatment C: Atazanavir + Cobicistat Coadministered2585
Treatment D: Atazanavir/Cobicistat FDC2941
Treatment E: Atazanavir/Cobicistat FDC2545

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Observed Concentration at 24 Hours (C24) of Atazanavir

Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. C24 was derived from plasma concentration versus time data. (NCT01837719)
Timeframe: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)

Interventionng/mL (Geometric Mean)
Treatment A: Atazanavir + Cobicistat Coadministered416
Treatment B: Atazanavir/Cobicistat FDC449
Treatment C: Atazanavir + Cobicistat Coadministered295
Treatment D: Atazanavir/Cobicistat FDC337
Treatment E: Atazanavir/Cobicistat FDC398

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T-HALF of Cobicistat

Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. T-HALF was derived from plasma concentration versus time data. (NCT01837719)
Timeframe: Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)

InterventionHours (Mean)
Treatment A: Atazanavir + Cobicistat Coadministered4.34
Treatment B: Atazanavir/Cobicistat FDC4.33
Treatment C: Atazanavir + Cobicistat Coadministered4.23
Treatment D: Atazanavir/Cobicistat FDC4.09
Treatment E: Atazanavir/Cobicistat FDC4.27

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Time of Maximum Observed Concentration (Tmax) of Atazanavir

Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Tmax was derived from plasma concentration versus time data. (NCT01837719)
Timeframe: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)

InterventionHours (Median)
Treatment A: Atazanavir + Cobicistat Coadministered3.00
Treatment B: Atazanavir/Cobicistat FDC2.50
Treatment C: Atazanavir + Cobicistat Coadministered2.00
Treatment D: Atazanavir/Cobicistat FDC2.00
Treatment E: Atazanavir/Cobicistat FDC3.54

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Time of Maximum Observed Concentration (Tmax) of Cobicistat

Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Tmax was derived from plasma concentration versus time data. (NCT01837719)
Timeframe: Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)

InterventionHours (Median)
Treatment A: Atazanavir + Cobicistat Coadministered2.52
Treatment B: Atazanavir/Cobicistat FDC2.52
Treatment C: Atazanavir + Cobicistat Coadministered2.00
Treatment D: Atazanavir/Cobicistat FDC2.00
Treatment E: Atazanavir/Cobicistat FDC4.00

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Area Under the Concentration Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and Area Under the Concentration Curve From Time 0 to Infinity (AUC[INF]) of Cobicistat

Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. AUC(0-T) and AUC(INF) were derived from plasma concentration versus time data. (NCT01837719)
Timeframe: Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)

,,,,
Interventionng*h/mL (Geometric Mean)
AUC(0-T)AUC(INF) (n=63, 62, 63, 63, 28)
Treatment A: Atazanavir + Cobicistat Coadministered87389045
Treatment B: Atazanavir/Cobicistat FDC88669178
Treatment C: Atazanavir + Cobicistat Coadministered65417884
Treatment D: Atazanavir/Cobicistat FDC72047408
Treatment E: Atazanavir/Cobicistat FDC79168298

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Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and From Time 0 to Infinity (AUC[INF]) for Atazanavir

Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. AUC(0-T) and AUC(INF) were derived from plasma concentration versus time data. (NCT01837719)
Timeframe: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)

,,,,
Interventionng*h/mL (Geometric Mean)
AUC(0-T)AUC(0-INF)
Treatment A: Atazanavir + Cobicistat Coadministered3277533523
Treatment B: Atazanavir/Cobicistat FDC3490535673
Treatment C: Atazanavir + Cobicistat Coadministered2501725547
Treatment D: Atazanavir/Cobicistat FDC2787528378
Treatment E: Atazanavir/Cobicistat FDC2587326510

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Number of Participants Who Died and With Serious Adverse Events (SAEs)

An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant who receives an investigational product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE is any untoward medical occurrence that at any dose results in death; is life-threatening; or requires or prolongs inpatient hospitalization. (NCT01837719)
Timeframe: On Day 24 or 31

,,,,
InterventionParticipants (Number)
DeathsSAEs
Treatment A: Atazanavir + Cobicistat Coadministered00
Treatment B: Atazanavir/Cobicistat FDC00
Treatment C: Atazanavir + Cobicistat Coadministered00
Treatment D: Atazanavir/Cobicistat FDC00
Treatment E: Atazanavir/Cobicistat FDC00

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Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests

LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment; h=high; hpf=high power field. Abnormal criteria: Leukocytes, low (*10^3 c/uL): <0.85*preRx if preRxULN. Neutrophils, low (*10^3 c/uL): <0.85*preRx if preRx<1.5; <1.5 if preRx=missing; <1.5 if preRx ≥1.5. Bilirubin, h (mg/dL): >1.1* ULN if preRx≤ULN; >1.1*ULN if preRx=missing; >1.25*preRx if preRx>ULN. Bilirubin, h (mg/dL): >1.1* ULN if preRx≤ULN; >1.1*ULN if preRx=missing; >1.25*preRx if preRx>ULN. Blood, urine, h: ≥2*preRx if preRx≥1; ≥2 if preRx <1; ≥2 if preRx=missing. RBCs/WBCs, h (hpf): ≥2 if preRx=missing ≥2 if preRx<2 ≥4 if preRx ≥2. Creatine kinase, h (U/L): >1.5*preRx if preRx>ULN; >1.5*ULN if preRx≤ULN; >1.5*ULN if preRx=missing; AST, h (U/L): >1.25* preRx if preRx>ULN; >1.25*ULN if preRx≤ULN; >1.25*ULN if preRx=missing. Lactate dehydrogenase, h (U/L): >1.25*ULN if preRx≤ULN; >1.25*ULN if preRx=missing; >1.5*preRx if preRx>ULN. (NCT01837719)
Timeframe: At Screening and on Days -1,4, 11, 18, and 31 (study discharge)

,,,,
InterventionParticipants (Number)
Leukocytes (low)Neutrophils, absolute (low)Bilirubin, total (high)Bilirubin, directBlood, urine (high)Red blood cells (RBC), urine (high)White blood cells (WBC), urine (high)Creatine kinase (high)Aspartate aminotransferase (AST) (high)Lactate dehydrogenase (high)
Treatment A: Atazanavir + Cobicistat Coadministered3210112000
Treatment B: Atazanavir/Cobicistat FDC2400000100
Treatment C: Atazanavir + Cobicistat Coadministered3300000111
Treatment D: Atazanavir/Cobicistat FDC1231103000
Treatment E: Atazanavir/Cobicistat FDC1141112000

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Number of Participants With Out-of-range Intervals on Electrocardiogram (ECG) Findings

A 12-lead ECG was recorded at predose and 4 hours post dose at screening, Days -1, 1, 8 15, 22, 29 and study discharge. ECGs were recorded after the patient had been supine for at least 5 minutes. All ECG readings post dosing (including unscheduled) were included. (NCT01837719)
Timeframe: At screening; on Day -1; predose and 4 hours postdose on Days 1, 18, 15, 22, and 29; and at study discharge (Day 31)

,,,,
InterventionParticipants (Number)
PR interval >210 msecQRS interval >120 msecQT interval >500 msecQTcF>450 msec
Treatment A: Atazanavir + Cobicistat Coadministered0101
Treatment B: Atazanavir/Cobicistat FDC0100
Treatment C: Atazanavir + Cobicistat Coadministered0000
Treatment D: Atazanavir/Cobicistat FDC1000
Treatment E: Atazanavir/Cobicistat FDC0000

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ATV PK Parameter Cmax Determined Based on ATV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the ATV PK parameter Cmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionng/mL (Median)
Cmax day 0Cmax day 21
NuvaRing With ATV/r Plus TDF ≥1 NRTIs4291.03583.0

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Ethinyl Estradiol Concentrations Obtained on Study Days 7 and 14.

This evaluates the effect of EFV and ATV/r on ethinyl estradiol by measuring ethinyl estradiol concentrations on all three study arms 7 and 14 days after NuvaRing administration. The assay lower limit of quantification for ethinyl estradiol was 5 pg/mL; values < 5 were assigned a value of half the lower limit (ie, 2.5 pg/mL). (NCT01903031)
Timeframe: Study days 7 and 14

,,
Interventionpg/mL (Median)
Concentration at Day 7Concentration at Day 14
NuvaRing and no ART18.0519.70
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs15.7016.55
NuvaRing With EFV Plus ≥2 NRTIs9.9810.50

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Etonogestrel Concentrations Obtained on Study Days 7 and 14

This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 7 and 14 days after NuvaRing administration. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values < 250 were assigned a value of half the lower limit (ie, 125 pg/mL). (NCT01903031)
Timeframe: Study days 7 and 14

,,
Interventionpg/mL (Median)
Concentration at Day 7Concentration at Day 14
NuvaRing and no ART1970.002070.00
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs3250.003530.00
NuvaRing With EFV Plus ≥2 NRTIs427.00437.00

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Proportion of Participants With Plasma HIV-1 RNA Levels <40 Copies/mL

This evaluates the short-term impact of Nuvaring on virologic suppression in participants who have been administered Nuvaring alone or together with EFV or ATV/r by measuring proportion of participants with plasma HIV-1 RNA levels <40 copies/mL at study day 0 (before vaginal ring placement) and study day 21 (three weeks after vaginal ring placement). An FDA-approved HIV-1 RNA assay was required. (NCT01903031)
Timeframe: Study day 0 and study day 21

,,
Interventionproportion of participants (Number)
Proportion with HIV-1 RNA <40 copies/mL at day 0Proportion with HIV-1 RNA <40 copies/mL at day 21
NuvaRing and no ART0.220.17
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs0.890.85
NuvaRing With EFV Plus ≥2 NRTIs0.930.85

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RTV PK Parameter Cmin Determined Based on RTV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter Cmin of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionng/mL (Median)
Cmin day 0Cmin day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs70.051.9

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Ritonavir (RTV) PK Parameter AUC(0-24h) Calculated Based on Intensive RTV PK Samples Obtained From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionh*ng/mL (Median)
AUC0-24h day 0AUC0-24h day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs10740.07210.7

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RTV PK Parameter CLss/F Determined Based on RTV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter CLss/F of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/F defines apparent oral clearance. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionhour (Median)
CLss/F day 0CLss/F day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs9.313.9

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RTV PK Parameter Tmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter Tmax of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Tmax defines time to maximum concentration since dose is initiated. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionhour (Median)
Tmax day 0Tmax day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs3.03.0

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ATV PK Parameter CLss/F Determined Based on ATV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the ATV PK parameter CLss/F obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/f defines apparent oral clearance. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

InterventionL/h (Median)
CLss/F day 0CLss/F day 21
NuvaRing With ATV/r Plus TDF ≥1 NRTIs6.88.2

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ATV PK Parameter Cmin Determined Based on ATV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the ATV PK parameter Cmin obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionng/mL (Median)
Cmin day 0Cmin day 21
NuvaRing With ATV/r Plus TDF ≥1 NRTIs796.7599.4

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ATV PK Parameter AUC(0-24h) Calculated Based on Intensive Atazanavir (ATV) PK Samples Obtained From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of ATV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionh*ng/mL (Median)
AUC0-24h day 0AUC0-24h day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs44313.736764.7

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Etonogestrel Concentrations at Study Day 21

This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 21 days after NuvaRing administration. The pharmacokinetic (PK) blood sample for measurement of etonogestrel on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values < 250 were assigned a value of half the lower limit (ie, 125 pg/mL). (NCT01903031)
Timeframe: Day 21

Interventionpg/mL (Median)
NuvaRing and no ART1860.00
NuvaRing With EFV Plus ≥2 NRTIs429.00
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs3290.00

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Ethinyl Estradiol Concentrations at Study Day 21

This evaluates the effect of EFV and ATV/r on ethinyl estradiol by measuring ethinyl estradiol concentrations on all three study arms 21 days after NuvaRing administration. The PK blood sample for measurement of ethinyl estradiol on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for ethinyl estradiol was 5 pg/mL ; values < 5 were assigned a value of half the lower limit (ie, 2.5 pg/mL). (NCT01903031)
Timeframe: Day 21

Interventionpg/mL (Median)
NuvaRing and no ART21.30
NuvaRing With EFV Plus ≥2 NRTIs11.40
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs16.05

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EFV PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B

This evaluates the effect of NuvaRing on the EFV PK parameter Cmin obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionng/mL (Median)
Cmin day 0Cmin day 21
NuvaRing With EFV Plus ≥2 NRTIs2121.51766.0

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ATV PK Parameter Time to Cmax (Tmax) Determined Based on ATV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the ATV PK parameter Tmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Tmax defines time to maximum concentration since dose is initiated. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionhour (Median)
Tmax day 0Tmax day 21
NuvaRing With ATV/r Plus TDF ≥1 NRTIs2.93.0

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EFV PK Parameter Area Under the Concentration-Time Curve (AUC0-24hours) Calculated Based on Intensive EFV PK Samples Obtained From Individual Participants Enrolled in Arm B

This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of EFV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionh*ng/mL (Median)
AUC0-24h day 0AUC0-24h day 21
NuvaRing With EFV Plus ≥2 NRTIs68949.157795.9

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EFV PK Parameter Clearance (CLss/F) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B

This evaluates the effect of NuvaRing on the EFV PK parameter CLss/F obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/F defines apparent oral clearance (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

InterventionL/h (Median)
CLss/F day 0CLss/F day 21
NuvaRing With EFV Plus ≥2 NRTIs8.710.4

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EFV PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B

This evaluates the effect of NuvaRing on the EFV PK parameter Cmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionng/mL (Median)
Cmax day 0Cmax day 21
NuvaRing With EFV Plus ≥2 NRTIs4541.03786.0

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RTV PK Parameter Cmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter Cmax of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionng/mL (Median)
Cmax day 0Cmax day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs1437.01063.0

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Proportion of Participants With Progesterone Levels Greater Than 5 ng/mL.

This evaluates alterations in progesterone levels due to the potential PK interaction between NuvaRing and the ARVs EFV and ATV/r by examining progesterone levels at study days 0 (before vaginal ring placement), 7, 14, and 21 (before vaginal ring removal), and study day 28, without regard to menstrual cycle status at study entry. (NCT01903031)
Timeframe: Study days 0, 7, 14, 21 and 28

,,
Interventionproportion of participants (Number)
Proportion with progesterone >5 at day 0Proportion with progesterone >5 at day 7Proportion with progesterone >5 at day 14Proportion with progesterone >5 at day 21Proportion with progesterone >5 at day 28
NuvaRing and no ART0.080.080.000.000.00
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs0.250.080.000.000.00
NuvaRing With EFV Plus ≥2 NRTIs0.040.240.040.000.00

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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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Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase

Absolute values in CD4+ cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionCells per cubic millimeter (Mean)
Baseline (Day 1), n=248, 247Week 4, n=245, 237Week 12, n=236, 224Week 24, n=226, 210Week 36, n=219, 204Week 48, n=208, 191
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase380.3455.1506.2542.5569.2608.5
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase369.7465.0509.5563.8592.8608.8

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Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase

Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. (NCT01910402)
Timeframe: Week 96 and Week 432

InterventionLog10 copies/mL (Mean)
Week 96, n=99Week 432, n=3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase1.5911.590

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Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase

Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionLog10 copies/mL (Mean)
Baseline (Day 1), n=248, 247Week 4, n=245, 238Week 12, n=236, 226Week 24, n=225, 212Week 36, n=221, 204Week 48, n=207, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase4.4412.5161.9081.7101.6581.657
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase4.4811.8951.7481.7241.6661.619

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Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline

Bone markers were assessed at indicated timepoints. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analyzed based on log transformed data. Estimates of adjusted mean and difference were calculated from an Analysis of covariance (ANCOVA) model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48

,
InterventionRatio (Number)
BSAP, n=202, 183PTP, n=202, 184Osteocalcin, n=194, 178Type 1 Collagen C-Telopeptide, n=202, 184Vitamin D, n=206, 186
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase1.6291.7522.0391.9181.158
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase1.1881.2141.2821.2570.987

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Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS

The 12-Item Short Form Health Survey (SF-12) is 12 item abbreviated form of SF-36 survey. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health. SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. SF-12 total score ranges from 20 to 60 and higher score indicate a higher level of functioning. SF-12 total score was calculated by a clinician scoring 12-question survey filled by participants. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48

,
InterventionScore on a scale (Mean)
Total Score, Week 48, n=205, 192MCS, Week 48, n=205, 192PCS, Week 48, n=205, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.12.3291.444
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.02.3971.905

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Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionInternational units per liter (Mean)
Alanine aminotransferase, Week 4, n= 245, 237Alanine aminotransferase, Week 12, n= 236, 226Alanine aminotransferase, Week 24, n= 225, 212Alanine aminotransferase, Week 36, n= 219, 204Alanine aminotransferase, Week 48, n= 208, 192Alkaline phosphatase, Week 4, n= 245, 237Alkaline phosphatase, Week 12, n= 236, 226Alkaline phosphatase, Week 24, n= 225, 212Alkaline phosphatase, Week 36, n= 219, 204Alkaline phosphatase, Week 48, n= 208, 192Aspartate aminotransferase, Week 4, n= 244, 237Aspartate aminotransferase, Week 12, n= 236, 226Aspartate aminotransferase, Week 24, n= 224, 212Aspartate aminotransferase, Week 36, n= 219, 204Aspartate aminotransferase, Week 48, n= 208, 192Creatine Kinase, Week 4, n= 245, 237Creatine Kinase, Week 12, n= 236, 226Creatine Kinase, Week 24, n= 225, 212Creatine Kinase, Week 36, n= 219, 204Creatine Kinase, Week 48, n= 208, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-3.4-2.3-3.7-5.3-1.59.415.122.420.421.9-3.6-4-5.1-6.5-3.735.67.35.87.23.8
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-3.3-5.2-5.4-4.9-5.7-1.5-2.10.50.62.9-3.3-6.2-6.3-6.4-7.5-0.36.910.311.923.8

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Change From Baseline in 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 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 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 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 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 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 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 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 Creatinine Clearance at Indicated Time Points

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionMilliliter per minute (Mean)
Week 4, n= 245, 237Week 12, n= 236, 226Week 24, n= 225, 212Week 36, n= 219, 204Week 48, n= 208, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-7.5-7-9.1-7.5-7.7
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-16.3-17.3-16.2-16.8-15.9

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Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points

Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionFemtoliter (Mean)
Week 4, n= 243, 234Week 12, n= 233, 220Week 24, n= 225, 211Week 36, n= 218, 203Week 48, n= 207, 190
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.51.93.13.13.7
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.93.45.56.07.1

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Change From Baseline in 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 Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase

Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 96 and Week 432

InterventionLog10 copies/mL (Mean)
Week 96, n=99Week 432, n=3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase-2.911-3.107

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Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase

Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionLog10 copies/mL (Mean)
Week 4, n=245, 238Week 12, n=236, 226Week 24, n=225, 212Week 36, n=221, 204Week 48, n=207, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-1.923-2.541-2.726-2.772-2.752
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-2.591-2.756-2.789-2.838-2.874

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Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionRatio (Mean)
Week 4, n= 1, 4Week 12, n= 233, 223Week 24, n= 224, 209Week 36, n= 212, 198Week 48, n= 207, 186
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.2159-0.1092-0.1922-0.1433-0.1444
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.1264-0.2736-0.3098-0.3286-0.2886

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Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints

Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Weeks 24 and 48

,
InterventionNanograms per liter (Mean)
Week 24, n=221, 207Week 48, n=202, 185
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase272.4267.9
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase89.875.9

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Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points

Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 24 and Week 48

,
Interventionmilligrams per millimole (Mean)
Week 24, n= 179, 186Week 48, n= 170, 164
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-1.03-0.10
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-1.15-0.68

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Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48

Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D, vitamin D2 and vitamin D3 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Weeks 24 and 48

,
InterventionNanomoles per liter (Mean)
Vitamin D, Week 24, n=223, 208Vitamin D, Week 48, n=206, 186Vitamin D2, Week 24, n=223, 208Vitamin D2, Week 48, n=206, 186Vitamin D3, Week 24, n=223, 208Vitamin D3, Week 48, n=206, 186
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase16.38.91.00.915.27.9
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase1.8-1.90.30.11.5-1.9

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HIVTSQs Total Score at Indicated Timepoints

The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. (NCT01910402)
Timeframe: Weeks 4, 12, 24 and 48

,
InterventionScore on a scale (Mean)
Week 4, n=243, 239Week 12, n=236, 226Week 24, n=225, 211Week 48, n=206, 191
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase51.953.654.355.4
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase54.056.156.857.0

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Number of Participants With AEs by Maximum Toxicity-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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Number of Participants With AEs by Maximum Toxicity-Randomized Phase

Number of participants with Grade 1-4 AEs by maximum toxicity were assessed from the start of study treatment and until end of the Randomization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. (NCT01910402)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
Grade 1Grade 2Grade 3Grade 4
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase6091379
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase7994183

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Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented. (NCT01910402)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
Any AEsAny SAEs
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase19720
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase19512

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Number of Participants With Any AEs, and SAEs in Continuation Phase

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
Any AEsAny SAEs
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase9313

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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase

Number of participants with grades 1-4 emergent chemistry toxicities were assessed in Continuation Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
Hyperglycaemia, Grade 1, n=143Hyperglycaemia, Grade 2, n=143Hyperglycaemia, Grade 3, n=143Hyperglycaemia, Grade 4, n=143Hypernatremia, Grade 1, n=146Hypernatremia, Grade 2, n=146Hypernatremia, Grade 3, n=146Hypernatremia, Grade 4, n=146Hypoglycaemia, Grade 1, n=143Hypoglycaemia, Grade 2, n=143Hypoglycaemia, Grade 3, n=143Hypoglycaemia, Grade 4, n=143Hypokalemia, Grade 1, n=146Hypokalemia, Grade 2, n=146Hypokalemia, Grade 3, n=146Hypokalemia, Grade 4, n=146Hyponatremia, Grade 1, n=146Hyponatremia, Grade 2, n=146Hyponatremia, Grade 3, n=146Hyponatremia, Grade 4, n=146Alanine aminotransferase, Grade 1, n=146Alanine aminotransferase, Grade 2, n=146Alanine aminotransferase, Grade 3, n=146Alanine aminotransferase, Grade 4, n=146Alkaline phosphatase, Grade 1, n=146Alkaline phosphatase, Grade 2, n=146Alkaline phosphatase, Grade 3, n=146Alkaline phosphatase, Grade 4, n=146Aspartate aminotransferase, Grade 1, n=146Aspartate aminotransferase, Grade 2, n=146Aspartate aminotransferase, Grade 3, n=146Aspartate aminotransferase, Grade 4, n=146Bilirubin, Grade 1, n=146Bilirubin, Grade 2, n=146Bilirubin, Grade 3, n=146Bilirubin, Grade 4, n=146Carbon dioxide, Grade 1, n=146Carbon dioxide, Grade 2, n=146Carbon dioxide, Grade 3, n=146Carbon dioxide, Grade 4, n=146Cholesterol, Grade 1, n=71Cholesterol, Grade 2, n=71Cholesterol, Grade 3, n=71Cholesterol, Grade 4, n=71Creatine kinase, Grade 1, n=146Creatine kinase, Grade 2, n=146Creatine kinase, Grade 3, n=146Creatine kinase, Grade 4, n=146Creatinine, Grade 1, n=146Creatinine, Grade 2, n=146Creatinine, Grade 3, n=146Creatinine, Grade 4, n=146LDL cholesterol calculation, Grade 1, n=70LDL cholesterol calculation, Grade 2, n=70LDL cholesterol calculation, Grade 3, n=70LDL cholesterol calculation, Grade 4, n=70LDL cholesterol direct, Grade 1, n=2LDL cholesterol direct, Grade 2, n=2LDL cholesterol direct, Grade 3, n=2LDL cholesterol direct, Grade 4, n=2Lipase, Grade 1, n=146Lipase, Grade 2, n=146Lipase, Grade 3, n=146Lipase, Grade 4, n=146Phosphate, Grade 1, n=146Phosphate, Grade 2, n=146Phosphate, Grade 3, n=146Phosphate, Grade 4, n=146Potassium, Grade 1, n=146Potassium, Grade 2, n=146Potassium, Grade 3, n=146Potassium, Grade 4, n=146Sodium, Grade 1, n=146Sodium, Grade 2, n=146Sodium, Grade 3, n=146Sodium, Grade 4, n=146Triglycerides, Grade 1, n=71Triglycerides, Grade 2, n=71Triglycerides, Grade 3, n=71Triglycerides, Grade 4, n=71Glucose, Grade 1, n=143Glucose, Grade 2, n=143Glucose, Grade 3, n=143Glucose, Grade 4, n=143
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase249302000100113000360007302500010202413058700993061115001582010009611215201300037000010024931

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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase

Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and end of Randomized Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hyperkalemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose. (NCT01910402)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
Hyperglycaemia, Grade 1Hyperglycaemia, Grade 2Hyperglycaemia, Grade 3Hyperglycaemia, Grade 4Hyperkalemia, Grade 1Hyperkalemia, Grade 2Hyperkalemia, Grade 3Hyperkalemia, Grade 4Hypernatremia, Grade 1Hypernatremia, Grade 2Hypernatremia, Grade 3Hypernatremia, Grade 4Hypoglycaemia, Grade 1Hypoglycaemia, Grade 2Hypoglycaemia, Grade 3Hypoglycaemia, Grade 4Hypokalemia, Grade 1Hypokalemia, Grade 2Hypokalemia, Grade 3Hypokalemia, Grade 4Hyponatremia, Grade 1Hyponatremia, Grade 2Hyponatremia, Grade 3Hyponatremia, Grade 4Alanine aminotransferase, Grade 1Alanine aminotransferase, Grade 2Alanine aminotransferase, Grade 3Alanine aminotransferase, Grade 4Albumin, Grade 1Albumin, Grade 2Albumin, Grade 3Albumin, Grade 4Alkaline phosphatase, Grade 1Alkaline phosphatase, Grade 2Alkaline phosphatase, Grade 3Alkaline phosphatase, Grade 4Aspartate aminotransferase, Grade 1Aspartate aminotransferase, Grade 2Aspartate aminotransferase, Grade 3Aspartate aminotransferase, Grade 4Bilirubin, Grade 1Bilirubin, Grade 2Bilirubin, Grade 3Bilirubin, Grade 4Carbon dioxide, Grade 1Carbon dioxide, Grade 2Carbon dioxide, Grade 3Carbon dioxide, Grade 4Cholesterol, Grade 1Cholesterol, Grade 2Cholesterol, Grade 3Cholesterol, Grade 4Creatine kinase, Grade 1Creatine kinase, Grade 2Creatine kinase, Grade 3Creatine kinase, Grade 4Creatinine, Grade 1Creatinine, Grade 2Creatinine, Grade 3Creatinine, Grade 4LDL cholesterol calculation, Grade 1LDL cholesterol calculation, Grade 2LDL cholesterol calculation, Grade 3LDL cholesterol calculation, Grade 4LDL cholesterol direct, Grade 1LDL cholesterol direct, Grade 2LDL cholesterol direct, Grade 3LDL cholesterol direct, Grade 4Lipase, Grade 1Lipase, Grade 2Lipase, Grade 3Lipase, Grade 4Phosphate, Grade 1Phosphate, Grade 2Phosphate, Grade 3Phosphate, Grade 4Potassium, Grade 1Potassium, Grade 2Potassium, Grade 3Potassium, Grade 4Sodium, Grade 1Sodium, Grade 2Sodium, Grade 3Sodium, Grade 4Triglycerides, Grade 1Triglycerides, Grade 2Triglycerides, Grade 3Triglycerides, Grade 4Glucose, Grade 1Glucose, Grade 2Glucose, Grade 3Glucose, Grade 4
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase11930010000005100190005700074202200141007420528657554300319205101730021920100073211192019100570000200151030
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase17164110001000631017100441005611300032001241120006540052284031303010381370310012530571018100451000520221941

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Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase

Number of participants with Grade 1-4 emergent hematology toxicities were assessed in Continuation Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
Hemoglobin, Grade 1Hemoglobin, Grade 2Hemoglobin, Grade 3Hemoglobin, Grade 4Leukocytes, Grade 1Leukocytes, Grade 2Leukocytes, Grade 3Leukocytes, Grade 4Neutrophils, Grade 1Neutrophils, Grade 2Neutrophils, Grade 3Neutrophils, Grade 4Platelets, Grade 1Platelets, Grade 2Platelets, Grade 3Platelets, Grade 4
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase51002010102113100

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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 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 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 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 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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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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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 Copies/mL at Week 48 by Subgroups

Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA [BPHR], Baseline CD4+ cell count [BCCC], Baseline Centers for Disease Control and Prevention [CDC] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Age, <50 Years, n=212, 212Age, >=50 Years, n=36, 35Race, White, n=115, 107Race, Non-White, n=133,140Race, African-American/African Heritage, n=102,108Non-African-American/African Heritage, n=146, 139BPHR, <1000, n=5, 10BPHR, 1000 to <10,000, n=66, 62BPHR, 10,000 to <50,000, n=83, 81BPHR, 50,000 to <=100,000, n=25, 28BPHR, >100,000, n=69, 66BCCC, <200, n=64, 49BCCC, >=200, n=184, 198BCCC, <50, n=9, 15BCCC, 50 to <200, n=55, 34BCCC, 200 to <350, n=66, 74BCCC, 350 to <500, n=56, 65BCCC, >=500, n=62, 59CDC category, A, n=210, 208CDC category, B, n=27, 30CDC category, C, n=11, 9HIV-1 subtype: B vs Non-B, B, n=95, 111HIV-1 subtype: B vs Non-B, non-B, n=140, 131Argentina, n=24, 20Canada, n=11, 9France, n=7, 8Italy, n=17, 11Mexico, n=6, 5Portugal, n=4, 5Russia, n=28, 22South Africa, n=33, 33Spain, n=23, 31Thailand, n=19, 21USA, n=62, 69United Kingdom, n=14, 11
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase809286787488608384808081826784897977818191808492911008810075896770957493

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

Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA [BPHR], Baseline CD4+ cell count [BCCC], Baseline Centers for Disease Control and Prevention [CDC] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Age, <50 Years, n=212, 212Age, >=50 Years, n=36, 35Race, White, n=115, 107Race, Non-White, n=133,140Race, African-American/African Heritage, n=102,108Non-African-American/African Heritage, n=146, 139BPHR, <1000, n=5, 10BPHR, 1000 to <10,000, n=66, 62BPHR, 10,000 to <50,000, n=83, 81BPHR, 50,000 to <=100,000, n=25, 28BPHR, >100,000, n=69, 66BCCC, <200, n=64, 49BCCC, >=200, n=184, 198BCCC, <50, n=9, 15BCCC, 50 to <200, n=55, 34BCCC, 200 to <350, n=66, 74BCCC, 350 to <500, n=56, 65BCCC, >=500, n=62, 59CDC category, A, n=210, 208CDC category, B, n=27, 30CDC category, C, n=11, 9HIV-1 subtype: B vs Non-B, B, n=95, 111HIV-1 subtype: B vs Non-B, non-B, n=140, 131Argentina, n=24, 20Canada, n=11, 9France, n=7, 8Italy, n=17, 11Mexico, n=6, 5Portugal, n=4, 5Puerto Rico, n=0, 2Russia, n=28, 22South Africa, n=33, 33Spain, n=23, 31Thailand, n=19, 21USA, n=62, 69United Kingdom, n=14, 11
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase7174806467758077746464697260747374687177566973808975646060100827677526764

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Change From Baseline in 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 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 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 Triglycerides at Week 48

Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48

InterventionMillimoles per liter (Least Squares Mean)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.045
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.070

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Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase4

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Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. (NCT01910402)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase10
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase17

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

Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells per millimeter cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48

InterventionPercentage of participants (Number)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase82
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase71

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Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 48

(NCT01967940)
Timeframe: Baseline; Week 48

Interventionlog10 copies/mL (Mean)
Part 2 E/C/F/TAF + ATV-3.04

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Part 1: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Day 10

(NCT01967940)
Timeframe: Baseline; Day 10

Interventionlog10 copies/mL (Mean)
Part 1 Sentinel Cohort TAF-0.72
Part 1 Randomized Cohort TAF-0.70
Part 1 Randomized Cohort Placebo-0.04

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Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10

(NCT01967940)
Timeframe: Day 10

Interventionpercentage of participants (Number)
Part 1 Sentinel Cohort TAF58.3
Part 1 Randomized Cohort TAF60.7
Part 1 Randomized Cohort Placebo0

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Part 2: Change From Baseline in CD4+ Cell Count at Week 24

(NCT01967940)
Timeframe: Baseline; Week 24

Interventioncells/μL (Mean)
Part 2 E/C/F/TAF + ATV76

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Part 2: Change From Baseline in CD4+ Cell Count at Week 48

(NCT01967940)
Timeframe: Baseline; Week 48

Interventioncells/μL (Mean)
Part 2 E/C/F/TAF + ATV125

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Part 2: Change From Baseline in CD4+ Percentage at Week 24

(NCT01967940)
Timeframe: Baseline; Week 24

Interventionpercentage change (Mean)
Part 2 E/C/F/TAF + ATV4.4

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Part 2: Change From Baseline in CD4+ Percentage at Week 48

(NCT01967940)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
Part 2 E/C/F/TAF + ATV5.7

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Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 24

(NCT01967940)
Timeframe: Baseline; Week 24

Interventionlog10 copies/mL (Mean)
Part 2 E/C/F/TAF + ATV-2.96

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Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 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. (NCT01967940)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Part 2 E/C/F/TAF + ATV94.6

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Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48

The percentage of participants with HIV-1 RNA < 400 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. (NCT01967940)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Part 2 E/C/F/TAF + ATV97.3

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Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 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. (NCT01967940)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Part 2 E/C/F/TAF + ATV86.5

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Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48

The percentage of participants with 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. (NCT01967940)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Part 2 E/C/F/TAF + ATV97.3

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Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 24

(NCT01967940)
Timeframe: Up to Week 24

Interventionpercentage of participants (Number)
Part 2 E/C/F/TAF + ATV75.7

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Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 48

(NCT01967940)
Timeframe: Up to Week 48

Interventionpercentage of participants (Number)
Part 2 E/C/F/TAF + ATV81.1

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Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 24

(NCT01967940)
Timeframe: Up to Week 24

Interventionpercentage of participants (Number)
Part 2 E/C/F/TAF + ATV37.8

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Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 48

(NCT01967940)
Timeframe: Up to Week 48

Interventionpercentage of participants (Number)
Part 2 E/C/F/TAF + ATV48.6

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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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HIV-1 RNA Viral Load

Percentage of subjects who have plasma HIV-1 RNA levels <400 cps/ml after 24 weeks of follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing 2 NRTIs + LPV/r (or ATV/r) (FDA Snapshot method). The FDA 'Snapshot' algorithm evaluates HIV RNA response using only the results at the week 24 time-point which also means that rebound at earlier time-points are not classified as treatment failure, unless it lead to discontinuation prior to the week 48. (NCT02155101)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
ART With 2 NRTIs Plus LPV/r (or ATV/r)37
Darunavir72

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HIV-1 RNA Viral Load

"Percentage of subjects who have plasma HIV-1 RNA levels <50 cps/ml after 24 weeks of follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing 2 NRTIs + LPV/r (or ATV/r), using the FDA Time to Loss of Virologic Response method. The FDA 'Snapshot' algorithm evaluates HIV RNA response using only the results at the week 24 time-point which also means that rebound at earlier time-points are not classified as treatment failure, unless it lead to discontinuation prior to the week 48." (NCT02155101)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
ART With 2 NRTIs Plus LPV/r (or ATV/r)36
Darunavir62

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HIV-1 RNA Viral Load

"Percentage of subjects who have plasma HIV-1 RNA levels <50 cps/ml after 12 weeks of follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing 2 NRTIs + LPV/r (or ATV/r), using the FDA Time to Loss of Virologic Response method. The FDA 'Snapshot' algorithm evaluates HIV RNA response using only the results at the week 12 time-point which also means that rebound at earlier time-points are not classified as treatment failure, unless it lead to discontinuation prior to the week 48." (NCT02155101)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
ART With 2 NRTIs Plus LPV/r (or ATV/r)35
Darunavir73

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Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1

The percentage of CD4+ cells was assessed using flow cytometry. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point. (NCT02386098)
Timeframe: Baseline and up to Week 72

,
InterventionPercentage of CD4+ cells (Mean)
Week 4; n=37, 33Week 8; n=36, 30Week 12; n=35, 32Week 16; n=34, 31Week 24; n=31, 28Week 32; n=23, 22Week 40; n=20, 15Week 48; n=7, 9Week 60; n=4, 2Week 72; n=1, 1
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD1.941.803.413.144.714.135.387.097.9512.50
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD1.821.692.883.664.724.815.387.1610.0510.70

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Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1

An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or medical events that may jeopardize the participant or require intervention (medical or surgical) to prevent one of the outcomes mentioned before. The number of participants with SAEs and AELDs are presented. (NCT02386098)
Timeframe: Up to Week 96

,
InterventionParticipants (Count of Participants)
SAEsAELD
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD42
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD31

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Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1

Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Response was assessed using the last plasma HIV-1 RNA value in the predefined visit window to classify a participant's response status. The percentage of responders with HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96 using mITT Population (observed) which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (October 10, 2016) is presented. The study was terminated early during the primary end point analysis of Stage 1; hence, data was not collected for Week 96 analysis. (NCT02386098)
Timeframe: Weeks 24, 48 and 96

,
InterventionPercentage of participants (Number)
Week 24; n=32, 29Week 48; n=8, 9
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD93.8100
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD89.7100

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Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1

The occurrence of new AIDS defining events that is, Centers for Disease Control (CDC) Class C events in participants is presented. (NCT02386098)
Timeframe: Up to Week 96

InterventionParticipants (Count of Participants)
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD1
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD0

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Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24-Stage 1

Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <40 c/mL at Week 24 was assessed using the Food and Drug Administration (FDA) snapshot algorithm which used the last on-treatment plasma HIV-1 RNA measurement, within an FDA-specified visit window (18 to 30 weeks), to determine response. Analysis was performed on the modified intent to treat (mITT) Population which comprised of all randomized participants who received atleast one dose of BMS-955176 or TDF. (NCT02386098)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD73.7
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD60.0

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Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1

The CD4+ cell count was assessed using flow cytometry. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point. (NCT02386098)
Timeframe: Baseline and up to Week 72

,
InterventionCells per microliter (Mean)
Week 4; n=37, 33Week 8; n=36, 30Week 12; n=35, 32Week 16; n=34, 31Week 24; n=31, 28Week 32; n=23, 22Week 40; n=20, 15Week 48; n=7, 9Week 60; n=4, 2Week 72; n=1, 1
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD57.677.690.483.2127.290.0139.5125.0127.00.0
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD26.753.7115.193.8109.5122.1137.1175.1158.5171.0

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Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1

Blood samples were collected for analysis of HIV-1 RNA. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point. (NCT02386098)
Timeframe: Baseline and up to Week 72

,
Interventionlog10 c/mL (Mean)
Week 2; n=10, 5Week 4; n=37, 33Week 8; n=37, 30Week 12; n=36, 32Week 16; n=34, 32Week 24; n=32, 29Week 32; n=23, 23Week 40; n=21, 15Week 48; n=8, 9Week 60; n=4, 3Week 72; n=1, 1
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD-4.232-4.400-4.103-4.394-4.402-4.220-4.381-4.366-4.508-5.037-3.326
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD-4.050-3.922-4.145-4.113-4.074-4.079-3.364-4.400-4.680-4.977-5.713

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Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1

Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Response was assessed using the last plasma HIV-1 RNA value in the predefined visit window to classify a participant's response status. The percentage of responders with HIV-1 RNA <40 c/mL at Weeks 48 and 96 using mITT Population (observed) which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (October 10, 2016) is presented. The study was terminated early during the primary end point analysis of Stage 1; hence, data was not collected for Week 96 analysis. (NCT02386098)
Timeframe: Weeks 48 and 96

,
InterventionPercentage of participants (Number)
Week 48; n=8, 9
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD75.0
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD66.7

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Change in Flow-mediated, Endothelium-dependent Vasodilation

The investigators will evaluate flow-mediated, brachial artery vasodilation (percentage increase in diameter in response to a 5 minute ischemic challenge) at study entry and then after 28 days, with the change between the two measurements being the primary endpoint. (NCT03019783)
Timeframe: 4 weeks

Interventionpercentage vasodilation (Mean)
Remains on Baseline HIV Regimen0.2
Atazanavir Switch0.8

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Change in Plasma Total Antioxidant Capacity

The investigators will evaluate plasma total antioxidant capacity at study entry and then after 28 days, with the change between the two measurements being the secondary endpoint. (NCT03019783)
Timeframe: 4 weeks

Interventionmicromolar (Mean)
Remains on Baseline HIV Regimen-21
Atazanavir Switch219

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SubstanceRelationship StrengthStudiesTrialsClassesRoles
gamma-aminobutyric acid
gamma-Aminobutyric Acid: The most common inhibitory neurotransmitter in the central nervous system.. gamma-aminobutyric acid : A gamma-amino acid that is butanoic acid with the amino substituent located at C-4.		2.0710amino acid zwitterion;
gamma-amino acid;
monocarboxylic acid		human metabolite;
neurotransmitter;
Saccharomyces cerevisiae metabolite;
signalling molecule
adenine
[no description available]		17.97115516-aminopurines;
purine nucleobase		Daphnia magna metabolite;
Escherichia coli metabolite;
human metabolite;
mouse metabolite;
Saccharomyces cerevisiae metabolite
betaine
glycine betaine : The amino acid betaine derived from glycine.		3.5311amino-acid betaine;
glycine derivative		fundamental metabolite
carbamates
[no description available]		15.136018amino-acid anion
methanol
Methanol: A colorless, flammable liquid used in the manufacture of FORMALDEHYDE and ACETIC ACID, in chemical synthesis, antifreeze, and as a solvent. Ingestion of methanol is toxic and may cause blindness.. primary alcohol : A primary alcohol is a compound in which a hydroxy group, -OH, is attached to a saturated carbon atom which has either three hydrogen atoms attached to it or only one other carbon atom and two hydrogen atoms attached to it.. methanol : The primary alcohol that is the simplest aliphatic alcohol, comprising a methyl and an alcohol group.		3.4611alkyl alcohol;
one-carbon compound;
primary alcohol;
volatile organic compound		amphiprotic solvent;
Escherichia coli metabolite;
fuel;
human metabolite;
mouse metabolite;
Mycoplasma genitalium metabolite
inositol
Inositol: An isomer of glucose that has traditionally been considered to be a B vitamin although it has an uncertain status as a vitamin and a deficiency syndrome has not been identified in man. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1379) Inositol phospholipids are important in signal transduction.. inositol : Any cyclohexane-1,2,3,4,5,6-hexol.. 1D-chiro-inositol : Belonging to the inositol family of compounds, D-chiro-inositol (DCI) is an isomer of glucose. It is an important secondary messenger in insulin signal transduction.. muco-inositol : An inositol that is cyclohexane-1,2,3,4,5,6-hexol having a (1R,2R,3r,4R,5S,6r)-configuration.		2.0710cyclitol;
hexol
nitrites
Nitrites: Salts of nitrous acid or compounds containing the group NO2-. The inorganic nitrites of the type MNO2 (where M=metal) are all insoluble, except the alkali nitrites. The organic nitrites may be isomeric, but not identical with the corresponding nitro compounds. (Grant & Hackh's Chemical Dictionary, 5th ed)		2.1110monovalent inorganic anion;
nitrogen oxoanion;
reactive nitrogen species		human metabolite
phosphorylcholine
Phosphorylcholine: Calcium and magnesium salts used therapeutically in hepatobiliary dysfunction.. phosphocholine : The phosphate of choline; and the parent compound of the phosphocholine family.		2.1310phosphocholinesallergen;
epitope;
hapten;
human metabolite;
mouse metabolite
uracil
2,4-dihydroxypyrimidine: a urinary biomarker for bipolar disorder		2.1310pyrimidine nucleobase;
pyrimidone		allergen;
Daphnia magna metabolite;
Escherichia coli metabolite;
human metabolite;
mouse metabolite;
prodrug;
Saccharomyces cerevisiae metabolite
uric acid
Uric Acid: An oxidation product, via XANTHINE OXIDASE, of oxypurines such as XANTHINE and HYPOXANTHINE. It is the final oxidation product of purine catabolism in humans and primates, whereas in most other mammals URATE OXIDASE further oxidizes it to ALLANTOIN.. uric acid : An oxopurine that is the final oxidation product of purine metabolism.. 6-hydroxy-1H-purine-2,8(7H,9H)-dione : A tautomer of uric acid having oxo groups at C-2 and C-8 and a hydroxy group at C-6.. 7,9-dihydro-1H-purine-2,6,8(3H)-trione : An oxopurine in which the purine ring is substituted by oxo groups at positions 2, 6, and 8.		2.0610uric acidEscherichia coli metabolite;
human metabolite;
mouse metabolite
urea
pseudourea: clinical use; structure. isourea : A carboximidic acid that is the imidic acid tautomer of urea, H2NC(=NH)OH, and its hydrocarbyl derivatives.		3.1210isourea;
monocarboxylic acid amide;
one-carbon compound		Daphnia magna metabolite;
Escherichia coli metabolite;
fertilizer;
flour treatment agent;
human metabolite;
mouse metabolite;
Saccharomyces cerevisiae metabolite
phenytoin
[no description available]		2.2510imidazolidine-2,4-dioneanticonvulsant;
drug allergen;
sodium channel blocker;
teratogenic agent
ag-1549
capravirine: a non-nucleoside reverse transcriptase inhibitor		2.4120
albuterol
Albuterol: A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol.. albuterol : A member of the class of phenylethanolamines that is 4-(2-amino-1-hydroxyethyl)-2-(hydroxymethyl)phenol having a tert-butyl group attached to the nirogen atom. It acts as a beta-adrenergic agonist used in the treatment of asthma and chronic obstructive pulmonary disease (COPD).		2.0310phenols;
phenylethanolamines;
secondary amino compound		beta-adrenergic agonist;
bronchodilator agent;
environmental contaminant;
xenobiotic
alendronate
alendronic acid : A 1,1-bis(phosphonic acid) that is methanebis(phosphonic acid) in which the two methylene hydrogens are replaced by hydroxy and 3-aminopropyl groups.		2.11101,1-bis(phosphonic acid);
primary amino compound		bone density conservation agent;
EC 2.5.1.1 (dimethylallyltranstransferase) inhibitor
theophylline
[no description available]		2.0510dimethylxanthineadenosine receptor antagonist;
anti-asthmatic drug;
anti-inflammatory agent;
bronchodilator agent;
drug metabolite;
EC 3.1.4.* (phosphoric diester hydrolase) inhibitor;
fungal metabolite;
human blood serum metabolite;
immunomodulator;
muscle relaxant;
vasodilator agent
amlodipine
Amlodipine: A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.. amlodipine : A fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative, which is used for the treatment of hypertension, chronic stable angina and confirmed or suspected vasospastic angina.		2.1110dihydropyridine;
ethyl ester;
methyl ester;
monochlorobenzenes;
primary amino compound		antihypertensive agent;
calcium channel blocker;
vasodilator agent
amodiaquine
Amodiaquine: A 4-aminoquinoline compound with anti-inflammatory properties.. amodiaquine : A quinoline having a chloro group at the 7-position and an aryl amino group at the 4-position.		2.3110aminoquinoline;
organochlorine compound;
phenols;
secondary amino compound;
tertiary amino compound		anticoronaviral agent;
antimalarial;
drug allergen;
EC 2.1.1.8 (histamine N-methyltransferase) inhibitor;
non-steroidal anti-inflammatory drug;
prodrug
berberine
[no description available]		2.0510alkaloid antibiotic;
berberine alkaloid;
botanical anti-fungal agent;
organic heteropentacyclic compound		antilipemic drug;
antineoplastic agent;
antioxidant;
EC 1.1.1.141 [15-hydroxyprostaglandin dehydrogenase (NAD(+))] inhibitor;
EC 1.1.1.21 (aldehyde reductase) inhibitor;
EC 1.13.11.52 (indoleamine 2,3-dioxygenase) inhibitor;
EC 1.21.3.3 (reticuline oxidase) inhibitor;
EC 2.1.1.116 [3'-hydroxy-N-methyl-(S)-coclaurine 4'-O-methyltransferase] inhibitor;
EC 2.1.1.122 [(S)-tetrahydroprotoberberine N-methyltransferase] inhibitor;
EC 2.7.11.10 (IkappaB kinase) inhibitor;
EC 3.1.1.4 (phospholipase A2) inhibitor;
EC 3.1.1.7 (acetylcholinesterase) inhibitor;
EC 3.1.1.8 (cholinesterase) inhibitor;
EC 3.1.3.48 (protein-tyrosine-phosphatase) inhibitor;
EC 3.4.14.5 (dipeptidyl-peptidase IV) inhibitor;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
geroprotector;
hypoglycemic agent;
metabolite;
potassium channel blocker
candesartan
candesartan: a nonpeptide angiotensin II receptor antagonist. candesartan : A benzimidazolecarboxylic acid that is 1H-benzimidazole-7-carboxylic acid substituted by an ethoxy group at position 2 and a ({2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl}methyl) group at position 1. It is a angiotensin receptor antagonist used for the treatment of hypertension.		2.7220benzimidazolecarboxylic acid;
biphenylyltetrazole		angiotensin receptor antagonist;
antihypertensive agent;
environmental contaminant;
xenobiotic
carbamazepine
Carbamazepine: A dibenzazepine that acts as a sodium channel blocker. It is used as an anticonvulsant for the treatment of grand mal and psychomotor or focal SEIZURES. It may also be used in the management of BIPOLAR DISORDER, and has analgesic properties.. carbamazepine : A dibenzoazepine that is 5H-dibenzo[b,f]azepine carrying a carbamoyl substituent at the azepine nitrogen, used as an anticonvulsant.		2.8730dibenzoazepine;
ureas		analgesic;
anticonvulsant;
antimanic drug;
drug allergen;
EC 3.5.1.98 (histone deacetylase) inhibitor;
environmental contaminant;
glutamate transporter activator;
mitogen;
non-narcotic analgesic;
sodium channel blocker;
xenobiotic
chloroquine
Chloroquine: The prototypical antimalarial agent with a mechanism that is not well understood. It has also been used to treat rheumatoid arthritis, systemic lupus erythematosus, and in the systemic therapy of amebic liver abscesses.. chloroquine : An aminoquinoline that is quinoline which is substituted at position 4 by a [5-(diethylamino)pentan-2-yl]amino group at at position 7 by chlorine. It is used for the treatment of malaria, hepatic amoebiasis, lupus erythematosus, light-sensitive skin eruptions, and rheumatoid arthritis.		2.8330aminoquinoline;
organochlorine compound;
secondary amino compound;
tertiary amino compound		anticoronaviral agent;
antimalarial;
antirheumatic drug;
autophagy inhibitor;
dermatologic drug
clomipramine
Clomipramine: A tricyclic antidepressant similar to IMIPRAMINE that selectively inhibits the uptake of serotonin in the brain. It is readily absorbed from the gastrointestinal tract and demethylated in the liver to form its primary active metabolite, desmethylclomipramine.. clomipramine : A dibenzoazepine that is 10,11-dihydro-5H-dibenzo[b,f]azepine which is substituted by chlorine at position 3 and in which the hydrogen attached to the nitrogen is replaced by a 3-(dimethylamino)propyl group. One of the more sedating tricyclic antidepressants, it is used as the hydrochloride salt for the treatment of depression as well as obsessive-compulsive disorder and phobias.		2.1710dibenzoazepineanticoronaviral agent;
antidepressant;
EC 1.8.1.12 (trypanothione-disulfide reductase) inhibitor;
serotonergic antagonist;
serotonergic drug;
serotonin uptake inhibitor
clonidine
Clonidine: An imidazoline sympatholytic agent that stimulates ALPHA-2 ADRENERGIC RECEPTORS and central IMIDAZOLINE RECEPTORS. It is commonly used in the management of HYPERTENSION.. clonidine (amino form) : A clonidine that is 4,5-dihydro-1H-imidazol-2-amine in which one of the amino hydrogens is replaced by a 2,6-dichlorophenyl group.		2.1710clonidine;
imidazoline
dapsone
[no description available]		2.0710substituted aniline;
sulfone		anti-inflammatory drug;
antiinfective agent;
antimalarial;
leprostatic drug
dipyridamole
Dipyridamole: A phosphodiesterase inhibitor that blocks uptake and metabolism of adenosine by erythrocytes and vascular endothelial cells. Dipyridamole also potentiates the antiaggregating action of prostacyclin. (From AMA Drug Evaluations Annual, 1994, p752). dipyridamole : A pyrimidopyrimidine that is 2,2',2'',2'''-(pyrimido[5,4-d]pyrimidine-2,6-diyldinitrilo)tetraethanol substituted by piperidin-1-yl groups at positions 4 and 8 respectively. A vasodilator agent, it inhibits the formation of blood clots.		2.8330piperidines;
pyrimidopyrimidine;
tertiary amino compound;
tetrol		adenosine phosphodiesterase inhibitor;
EC 3.5.4.4 (adenosine deaminase) inhibitor;
platelet aggregation inhibitor;
vasodilator agent
valproic acid
Valproic Acid: A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.. valproic acid : A branched-chain saturated fatty acid that comprises of a propyl substituent on a pentanoic acid stem.		2.0410branched-chain fatty acid;
branched-chain saturated fatty acid		anticonvulsant;
antimanic drug;
EC 3.5.1.98 (histone deacetylase) inhibitor;
GABA agent;
neuroprotective agent;
psychotropic drug;
teratogenic agent
erythrosine
Fluoresceins: A family of spiro(isobenzofuran-1(3H),9'-(9H)xanthen)-3-one derivatives. These are used as dyes, as indicators for various metals, and as fluorescent labels in immunoassays.		2.0810
famotidine
Famotidine: A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion.		3.45111,3-thiazoles;
guanidines;
sulfonamide		anti-ulcer drug;
H2-receptor antagonist;
P450 inhibitor
felodipine
Felodipine: A dihydropyridine calcium antagonist with positive inotropic effects. It lowers blood pressure by reducing peripheral vascular resistance through a highly selective action on smooth muscle in arteriolar resistance vessels.. felodipine : The mixed (methyl, ethyl) diester of 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic acid. A calcium-channel blocker, it lowers blood pressure by reducing peripheral vascular resistance through a highly selective action on smooth muscle in arteriolar resistance vessels. It is used in the management of hypertension and angina pectoris.		2.3110dichlorobenzene;
dihydropyridine;
ethyl ester;
methyl ester		anti-arrhythmia drug;
antihypertensive agent;
calcium channel blocker;
vasodilator agent
fluconazole
Fluconazole: Triazole antifungal agent that is used to treat oropharyngeal CANDIDIASIS and cryptococcal MENINGITIS in AIDS.. fluconazole : A member of the class of triazoles that is propan-2-ol substituted at position 1 and 3 by 1H-1,2,4-triazol-1-yl groups and at position 2 by a 2,4-difluorophenyl group. It is an antifungal drug used for the treatment of mucosal candidiasis and for systemic infections including systemic candidiasis, coccidioidomycosis, and cryptococcosis.		2.610conazole antifungal drug;
difluorobenzene;
tertiary alcohol;
triazole antifungal drug		environmental contaminant;
P450 inhibitor;
xenobiotic
miltefosine
miltefosine: hexadecyl phosphocholine derivative of cisplatin; did not substantially activate HIV long terminal repeat; less toxic than cisplatin. miltefosine : A phospholipid that is the hexadecyl monoester of phosphocholine.		2.1310phosphocholines;
phospholipid		anti-inflammatory agent;
anticoronaviral agent;
antifungal agent;
antineoplastic agent;
antiprotozoal drug;
apoptosis inducer;
immunomodulator;
protein kinase inhibitor
hydroxychloroquine
Hydroxychloroquine: A chemotherapeutic agent that acts against erythrocytic forms of malarial parasites. Hydroxychloroquine appears to concentrate in food vacuoles of affected protozoa. It inhibits plasmodial heme polymerase. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p970). hydroxychloroquine : An aminoquinoline that is chloroquine in which one of the N-ethyl groups is hydroxylated at position 2. An antimalarial with properties similar to chloroquine that acts against erythrocytic forms of malarial parasites, it is mainly used as the sulfate salt for the treatment of lupus erythematosus, rheumatoid arthritis, and light-sensitive skin eruptions.		5.8763aminoquinoline;
organochlorine compound;
primary alcohol;
secondary amino compound;
tertiary amino compound		anticoronaviral agent;
antimalarial;
antirheumatic drug;
dermatologic drug
indapamide
Indapamide: A benzamide-sulfonamide-indole derived DIURETIC that functions by inhibiting SODIUM CHLORIDE SYMPORTERS.. indapamide : A sulfonamide formed by condensation of the carboxylic group of 4-chloro-3-sulfamoylbenzoic acid with the amino group of 2-methyl-2,3-dihydro-1H-indol-1-amine.		2.3110indoles;
organochlorine compound;
sulfonamide		antihypertensive agent;
diuretic
avapro
Irbesartan: A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease.. irbesartan : A biphenylyltetrazole that is an angiotensin II receptor antagonist used mainly for the treatment of hypertension.		2.0510azaspiro compound;
biphenylyltetrazole		angiotensin receptor antagonist;
antihypertensive agent;
environmental contaminant;
xenobiotic
ketoconazole
1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine : A dioxolane that is 1,3-dioxolane which is substituted at positions 2, 2, and 4 by imidazol-1-ylmethyl, 2,4-dichlorophenyl, and [para-(4-acetylpiperazin-1-yl)phenoxy]methyl groups, respectively.		4.3641dichlorobenzene;
dioxolane;
ether;
imidazoles;
N-acylpiperazine;
N-arylpiperazine
ketorolac
Ketorolac: A pyrrolizine carboxylic acid derivative structurally related to INDOMETHACIN. It is an NSAID and is used principally for its analgesic activity. (From Martindale The Extra Pharmacopoeia, 31st ed). ketorolac : A racemate comprising equimolar amounts of (R)-(+)- and (S)-(-)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid. While only the (S)-(-) enantiomer is a COX1 and COX2 inhibitor, the (R)-(+) enantiomer exhibits potent analgesic activity. A non-steroidal anti-inflammatory drug, ketorolac is mainly used (generally as the tromethamine salt) for its potent analgesic properties in the short-term management of post-operative pain, and in eye drops to relieve the ocular itching associated with seasonal allergic conjunctivitis. It was withdrawn from the market in many countries in 1993 following association with haemorrhage and renal failure.. 5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid : A member of the class of pyrrolizines that is 2,3-dihydro-1H-pyrrolizine which is substituted at positions 1 and 5 by carboxy and benzoyl groups, respectively.		2.110amino acid;
aromatic ketone;
monocarboxylic acid;
pyrrolizines;
racemate		analgesic;
cyclooxygenase 1 inhibitor;
cyclooxygenase 2 inhibitor;
non-steroidal anti-inflammatory drug
lamotrigine
[no description available]		2.04101,2,4-triazines;
dichlorobenzene;
primary arylamine		anticonvulsant;
antidepressant;
antimanic drug;
calcium channel blocker;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
environmental contaminant;
excitatory amino acid antagonist;
geroprotector;
non-narcotic analgesic;
xenobiotic
lansoprazole
Lansoprazole: A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers.		3.8221benzimidazoles;
pyridines;
sulfoxide		anti-ulcer drug;
EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor
losartan
Losartan: An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.. losartan : A biphenylyltetrazole where a 1,1'-biphenyl group is attached at the 5-position and has an additional trisubstituted imidazol-1-ylmethyl group at the 4'-position		2.1310biphenylyltetrazole;
imidazoles		angiotensin receptor antagonist;
anti-arrhythmia drug;
antihypertensive agent;
endothelin receptor antagonist
mefenamic acid
Mefenamic Acid: A non-steroidal anti-inflammatory agent with analgesic, anti-inflammatory, and antipyretic properties. It is an inhibitor of cyclooxygenase.. mefenamic acid : An aminobenzoic acid that is anthranilic acid in which one of the hydrogens attached to the nitrogen is replaced by a 2,3-dimethylphenyl group. Although classed as a non-steroidal anti-inflammatory drug, its anti-inflammatory properties are considered to be minor. It is used to relieve mild to moderate pain, including headaches, dental pain, osteoarthritis and rheumatoid arthritis.		3.5111aminobenzoic acid;
secondary amino compound		analgesic;
antipyretic;
antirheumatic drug;
EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
environmental contaminant;
non-steroidal anti-inflammatory drug;
xenobiotic
metformin
Metformin: A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289). metformin : A member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1.		2.1710guanidinesenvironmental contaminant;
geroprotector;
hypoglycemic agent;
xenobiotic
methadone
Methadone: A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3). methadone : A racemate comprising equimolar amounts of dextromethadone and levomethadone. It is a opioid analgesic which is used as a painkiller and as a substitute for heroin in the treatment of heroin addiction.. 6-(dimethylamino)-4,4-diphenylheptan-3-one : A ketone that is heptan-3-one substituted by a dimethylamino group at position 6 and two phenyl groups at position 4.		5.1750benzenes;
diarylmethane;
ketone;
tertiary amino compound
metronidazole
Metronidazole: A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS.. metronidazole : A member of the class of imidazoles substituted at C-1, -2 and -5 with 2-hydroxyethyl, nitro and methyl groups respectively. It has activity against anaerobic bacteria and protozoa, and has a radiosensitising effect on hypoxic tumour cells. It may be given by mouth in tablets, or as the benzoate in an oral suspension. The hydrochloride salt can be used in intravenous infusions. Metronidazole is a prodrug and is selective for anaerobic bacteria due to their ability to intracellularly reduce the nitro group of metronidazole to give nitroso-containing intermediates. These can covalently bind to DNA, disrupting its helical structure, inducing DNA strand breaks and inhibiting bacterial nucleic acid synthesis, ultimately resulting in bacterial cell death.		2.110C-nitro compound;
imidazoles;
primary alcohol		antiamoebic agent;
antibacterial drug;
antimicrobial agent;
antiparasitic agent;
antitrichomonal drug;
environmental contaminant;
prodrug;
radiosensitizing agent;
xenobiotic
nevirapine
Nevirapine: A potent, non-nucleoside reverse transcriptase inhibitor used in combination with nucleoside analogues for treatment of HIV INFECTIONS and AIDS.. nevirapine : A dipyridodiazepine that is 5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepine which is substituted by methyl, oxo, and cyclopropyl groups at positions 4, 6, and 11, respectively. A non-nucleoside reverse transcriptase inhibitor with activity against HIV-1, it is used in combination with other antiretrovirals for the treatment of HIV infection.		12.15326cyclopropanes;
dipyridodiazepine		antiviral drug;
HIV-1 reverse transcriptase inhibitor
nitroglycerin
Nitroglycerin: A volatile vasodilator which relieves ANGINA PECTORIS by stimulating GUANYLATE CYCLASE and lowering cytosolic calcium. It is also sometimes used for TOCOLYSIS and explosives.. nitroglycerol : A nitrate ester that is glycerol in which nitro group(s) replace the hydrogen(s) attached to one or more of the hydroxy groups.. nitroglycerin : A nitroglycerol that is glycerol in which the hydrogen atoms of all three hydroxy groups are replaced by nitro groups. It acts as a prodrug, releasing nitric oxide to open blood vessels and so alleviate heart pain.		3.4511nitroglycerolexplosive;
muscle relaxant;
nitric oxide donor;
prodrug;
tocolytic agent;
vasodilator agent;
xenobiotic
omeprazole
Omeprazole: A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.. omeprazole : A racemate comprising equimolar amounts of (R)- and (S)-omeprazole.. 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole : A member of the class of benzimidazoles that is 1H-benzimidazole which is substituted by a [4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl group at position 2 and a methoxy group at position 5.		6.13113aromatic ether;
benzimidazoles;
pyridines;
sulfoxide
oxybutynin
oxybutynin: RN given refers to parent cpd. oxybutynin : A racemate comprising equimolar amounts of (R)-oxybutynin and esoxybutynin. An antispasmodic used for the treatment of overactive bladder.		2.0210acetylenic compound;
carboxylic ester;
racemate;
tertiary alcohol;
tertiary amino compound		antispasmodic drug;
calcium channel blocker;
local anaesthetic;
muscarinic antagonist;
muscle relaxant;
parasympatholytic
pioglitazone
Pioglitazone: A thiazolidinedione and PPAR GAMMA agonist that is used in the treatment of TYPE 2 DIABETES MELLITUS.. pioglitazone : A member of the class of thiazolidenediones that is 1,3-thiazolidine-2,4-dione substituted by a benzyl group at position 5 which in turn is substituted by a 2-(5-ethylpyridin-2-yl)ethoxy group at position 4 of the phenyl ring. It exhibits hypoglycemic activity.		2.610aromatic ether;
pyridines;
thiazolidinediones		antidepressant;
cardioprotective agent;
EC 2.7.1.33 (pantothenate kinase) inhibitor;
EC 6.2.1.3 (long-chain-fatty-acid--CoA ligase) inhibitor;
ferroptosis inhibitor;
geroprotector;
hypoglycemic agent;
insulin-sensitizing drug;
PPARgamma agonist;
xenobiotic
probenecid
Probenecid: The prototypical uricosuric agent. It inhibits the renal excretion of organic anions and reduces tubular reabsorption of urate. Probenecid has also been used to treat patients with renal impairment, and, because it reduces the renal tubular excretion of other drugs, has been used as an adjunct to antibacterial therapy.. probenecid : A sulfonamide in which the nitrogen of 4-sulfamoylbenzoic acid is substituted with two propyl groups.		3.5111benzoic acids;
sulfonamide		uricosuric drug
probucol
Probucol: A drug used to lower LDL and HDL cholesterol yet has little effect on serum-triglyceride or VLDL cholesterol. (From Martindale, The Extra Pharmacopoeia, 30th ed, p993).. probucol : A dithioketal that is propane-2,2-dithiol in which the hydrogens attached to both sulfur atoms are replaced by 3,5-di-tert-butyl-4-hydroxyphenyl groups. An anticholesteremic drug with antioxidant and anti-inflammatory properties, it is used to treat high levels of cholesterol in blood.		2.4110dithioketal;
polyphenol		anti-inflammatory drug;
anticholesteremic drug;
antilipemic drug;
antioxidant;
cardiovascular drug
rabeprazole
Rabeprazole: A 4-(3-methoxypropoxy)-3-methylpyridinyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.		3.8621benzimidazoles;
pyridines;
sulfoxide		anti-ulcer drug;
EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor
delavirdine
Delavirdine: A potent, non-nucleoside reverse transcriptase inhibitor with activity specific for HIV-1.. delavirdine : The amide resulting from the formal condensation of 5-[(methylsulfonyl)amino]-1H-indole-2-carboxylic acid and 4-amino group of 1-[3-(isopropylamino)pyridin-2-yl]piperazine, delavirdine is a non-nucleoside reverse transcriptase inhibitor with activity specific for HIV-1. Viral resistance emerges rapidly when delavirdine is used alone, so it is therefore used (as the methanesulfonic acid salt) with other antiretrovirals for combination therapy of HIV infection.		2.1310aminopyridine;
indolecarboxamide;
N-acylpiperazine;
sulfonamide		antiviral drug;
HIV-1 reverse transcriptase inhibitor
urethane
[no description available]		3.1210carbamate esterfungal metabolite;
mutagen
zopiclone
zopiclone: S(+)-enantiomer of racemic zopiclone; azabicyclo(4.3.0)nonane; a nonbenzodiazepine; one of the so-called of Z drugs (zopiclone, eszopiclone, zolpidem, and zaleplon) for which there is some correlation with tumors; was term of zopiclone 2004-2007. zopiclone : A pyrrolo[3,4-b]pyrazine compound having a 4-methylpiperazine-1-carboxyl group at the 5-position, a 5-chloropyridin-2-yl group at the 6-position and an oxo-substituent at the 7-position.		3.1310monochloropyridine;
pyrrolopyrazine		central nervous system depressant;
sedative
lynestrenol
Lynestrenol: A synthetic progestational hormone used often in mixtures with estrogens as an oral contraceptive (CONTRACEPTIVES, ORAL).		3.1210steroid
prednisone
Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.. prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid.		2.773011-oxo steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antineoplastic agent;
immunosuppressive agent;
prodrug
estrone
Hydroxyestrones: Estrone derivatives substituted with one or more hydroxyl groups in any position. They are important metabolites of estrone and other estrogens.		2.051017-oxo steroid;
3-hydroxy steroid;
phenolic steroid;
phenols		antineoplastic agent;
bone density conservation agent;
estrogen;
human metabolite;
mouse metabolite
alanine
Alanine: A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.. alanine : An alpha-amino acid that consists of propionic acid bearing an amino substituent at position 2.		6.5741alanine zwitterion;
alanine;
L-alpha-amino acid;
proteinogenic amino acid;
pyruvate family amino acid		EC 4.3.1.15 (diaminopropionate ammonia-lyase) inhibitor;
fundamental metabolite
ethinyl estradiol
Ethinyl Estradiol: A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.. 17alpha-ethynylestradiol : A 3-hydroxy steroid that is estradiol substituted by a ethynyl group at position 17. It is a xenoestrogen synthesized from estradiol and has been shown to exhibit high estrogenic potency on oral administration.		8.377617-hydroxy steroid;
3-hydroxy steroid;
terminal acetylenic compound		xenoestrogen
apomorphine
Apomorphine: A derivative of morphine that is a dopamine D2 agonist. It is a powerful emetic and has been used for that effect in acute poisoning. It has also been used in the diagnosis and treatment of parkinsonism, but its adverse effects limit its use.		3.1310aporphine alkaloidalpha-adrenergic drug;
antidyskinesia agent;
antiparkinson drug;
dopamine agonist;
emetic;
serotonergic drug
carbostyril
Quinolones: A group of derivatives of naphthyridine carboxylic acid, quinoline carboxylic acid, or NALIDIXIC ACID.. quinolin-2(1H)-one : A quinolone that is 1,2-dihydroquinoline substituted by an oxo group at position 2.		12.141610monohydroxyquinoline;
quinolone		bacterial xenobiotic metabolite
phenylephrine
Phenylephrine: An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.. phenylephrine : A member of the class of the class of phenylethanolamines that is (1R)-2-(methylamino)-1-phenylethan-1-ol carrying an additional hydroxy substituent at position 3 on the phenyl ring.		2.110phenols;
phenylethanolamines;
secondary amino compound		alpha-adrenergic agonist;
cardiotonic drug;
mydriatic agent;
nasal decongestant;
protective agent;
sympathomimetic agent;
vasoconstrictor agent
edetic acid
Edetic Acid: A chelating agent that sequesters a variety of polyvalent cations such as CALCIUM. It is used in pharmaceutical manufacturing and as a food additive.		2.0310ethylenediamine derivative;
polyamino carboxylic acid;
tetracarboxylic acid		anticoagulant;
antidote;
chelator;
copper chelator;
geroprotector
adenosine monophosphate
Adenosine Monophosphate: Adenine nucleotide containing one phosphate group esterified to the sugar moiety in the 2'-, 3'-, or 5'-position.		5.3131adenosine 5'-phosphate;
purine ribonucleoside 5'-monophosphate		adenosine A1 receptor agonist;
cofactor;
EC 3.1.3.1 (alkaline phosphatase) inhibitor;
EC 3.1.3.11 (fructose-bisphosphatase) inhibitor;
fundamental metabolite;
micronutrient;
nutraceutical
colchicine
(S)-colchicine : A colchicine that has (S)-configuration. It is a secondary metabolite, has anti-inflammatory properties and is used to treat gout, crystal-induced joint inflammation, familial Mediterranean fever, and many other conditions.		2.610alkaloid;
colchicine		anti-inflammatory agent;
gout suppressant;
mutagen
cytidine
[no description available]		2.3110cytidinesEscherichia coli metabolite;
human metabolite;
mouse metabolite;
Saccharomyces cerevisiae metabolite
norethindrone
Norethindrone: A synthetic progestational hormone with actions similar to those of PROGESTERONE but functioning as a more potent inhibitor of ovulation. It has weak estrogenic and androgenic properties. The hormone has been used in treating amenorrhea, functional uterine bleeding, endometriosis, and for CONTRACEPTION.. norethisterone : A 17beta-hydroxy steroid that is testosterone in which the hydrogen at position 17 is replaced by an ethynyl group and in which the methyl group attached to position 10 is replaced by hydrogen.		4.411117beta-hydroxy steroid;
3-oxo-Delta(4) steroid;
terminal acetylenic compound;
tertiary alcohol		progestin;
synthetic oral contraceptive
asparagine
Asparagine: A non-essential amino acid that is involved in the metabolic control of cell functions in nerve and brain tissue. It is biosynthesized from ASPARTIC ACID and AMMONIA by asparagine synthetase. (From Concise Encyclopedia Biochemistry and Molecular Biology, 3rd ed). asparagine : An alpha-amino acid in which one of the hydrogens attached to the alpha-carbon of glycine is substituted by a 2-amino-2-oxoethyl group.		4.3511amino acid zwitterion;
asparagine;
aspartate family amino acid;
L-alpha-amino acid;
proteinogenic amino acid		Escherichia coli metabolite;
human metabolite;
micronutrient;
mouse metabolite;
nutraceutical;
plant metabolite;
Saccharomyces cerevisiae metabolite
valine
Valine: A branched-chain essential amino acid that has stimulant activity. It promotes muscle growth and tissue repair. It is a precursor in the penicillin biosynthetic pathway.. valine : A branched-chain amino acid that consists of glycine in which one of the hydrogens attached to the alpha-carbon is substituted by an isopropyl group.. L-valine : The L-enantiomer of valine.		6.2762L-alpha-amino acid zwitterion;
L-alpha-amino acid;
proteinogenic amino acid;
pyruvate family amino acid;
valine		algal metabolite;
Escherichia coli metabolite;
human metabolite;
micronutrient;
mouse metabolite;
nutraceutical;
Saccharomyces cerevisiae metabolite
acetonitrile
acetonitrile: RN given refers to unlabeled cpd. acetonitrile : A nitrile that is hydrogen cyanide in which the hydrogen has been replaced by a methyl group.		3.8321aliphatic nitrile;
volatile organic compound		EC 3.5.1.4 (amidase) inhibitor;
NMR chemical shift reference compound;
polar aprotic solvent
triamcinolone acetonide
Triamcinolone Acetonide: An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.. triamcinolone acetonide : A synthetic glucocorticoid that is the 16,17-acetonide of triamcinolone. Used to treat various skin infections.		2.061011beta-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
cyclic ketal;
fluorinated steroid;
glucocorticoid;
primary alpha-hydroxy ketone		anti-allergic agent;
anti-inflammatory drug
methylprednisolone
Methylprednisolone: A PREDNISOLONE derivative with similar anti-inflammatory action.. 6alpha-methylprednisolone : The 6alpha-stereoisomer of 6-methylprednisolone.		2.25106-methylprednisolone;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antiemetic;
environmental contaminant;
neuroprotective agent;
xenobiotic
rotenone
Derris: A plant genus of the family FABACEAE. The root is a source of rotenoids (ROTENONE) and flavonoids. Some species of Pongamia have been reclassified to this genus and some to MILLETTIA. Some species of Deguelia have been reclassified to this genus.. rotenoid : Members of the class of tetrahydrochromenochromene that consists of a cis-fused tetrahydrochromeno[3,4-b]chromene skeleton and its substituted derivatives. The term was originally restricted to natural products, but is now also used to describe semi-synthetic and fully synthetic compounds.		2.1310organic heteropentacyclic compound;
rotenones		antineoplastic agent;
metabolite;
mitochondrial NADH:ubiquinone reductase inhibitor;
phytogenic insecticide;
piscicide;
toxin
quinoxalines
quinoxaline : A naphthyridine in which the nitrogens are at positions 1 and 4.		3.5911mancude organic heterobicyclic parent;
naphthyridine;
ortho-fused heteroarene
2-naphthylamine
2-Naphthylamine: A naphthalene derivative with carcinogenic action.. 2-naphthylamine : A naphthylamine carrying the amino group at position 2.		2.1310naphthylaminecarcinogenic agent
pyrroles
1H-pyrrole : A tautomer of pyrrole that has the double bonds at positions 2 and 4.. pyrrole : A five-membered monocyclic heteroarene comprising one NH and four CH units which forms the parent compound of the pyrrole group of compounds. Its five-membered ring structure has three tautomers. A 'closed class'.. azole : Any monocyclic heteroarene consisting of a five-membered ring containing nitrogen. Azoles can also contain one or more other non-carbon atoms, such as nitrogen, sulfur or oxygen.		8.184pyrrole;
secondary amine
thiophenes
Thiophenes: A monocyclic heteroarene furan in which the oxygen atom is replaced by a sulfur.. thiophenes : Compounds containing at least one thiophene ring.		3.1310mancude organic heteromonocyclic parent;
monocyclic heteroarene;
thiophenes;
volatile organic compound		non-polar solvent
nitrilotriacetic acid
Nitrilotriacetic Acid: A derivative of acetic acid, N(CH2COOH)3. It is a complexing (sequestering) agent that forms stable complexes with Zn2+. (From Miall's Dictionary of Chemistry, 5th ed.)		2.0810NTA;
tricarboxylic acid		carcinogenic agent;
nephrotoxic agent
quinazolines
Quinazolines: A group of aromatic heterocyclic compounds that contain a bicyclic structure with two fused six-membered aromatic rings, a benzene ring and a pyrimidine ring.. quinazoline : A mancude organic heterobicyclic parent that is naphthalene in which the carbon atoms at positions 1 and 3 have been replaced by nitrogen atoms.. quinazolines : Any organic heterobicyclic compound based on a quinazoline skeleton and its substituted derivatives.		210azaarene;
mancude organic heterobicyclic parent;
ortho-fused heteroarene;
quinazolines
adamantane
Adamantane: A tricyclo bridged hydrocarbon.		3.4411adamantanes;
polycyclic alkane
thiazoles
[no description available]		11.221491,3-thiazoles;
mancude organic heteromonocyclic parent;
monocyclic heteroarene
pyrazines
Pyrazines: A heterocyclic aromatic organic compound with the chemical formula C4H4N2.. pyrazine : A diazine that is benzene in which the carbon atoms at positions 1 and 4 have been replaced by nitrogen atoms.		2.3110diazine;
pyrazines		Daphnia magna metabolite
hydrazine
diamine : Any polyamine that contains two amino groups.		2.0610azane;
hydrazines		EC 4.3.1.10 (serine-sulfate ammonia-lyase) inhibitor
fluorobenzenes
Fluorobenzenes: Derivatives of BENZENE that contain FLUORINE.. monofluorobenzene : The simplest member of the class of monofluorobenzenes that is benzene carrying a single fluoro substituent.. fluorobenzenes : Any fluoroarene that is a benzene or a substituted benzene carrying at least one fluoro group.		7.8855monofluorobenzenesNMR chemical shift reference compound
thymoquinone
thymoquinone: constituent of cedarwood; can cause dermatitis; structure. thymoquinone : A member of the class of 1,4-benzoquinones that is 1,4-bezoquinone in which the hydrogens at positions 2 and 5 are replaced by methyl and isopropyl groups, respectively. It is a natural compound isolated from Nigella sativa which has demonstrated promising chemotherapeutic activity.		2.05101,4-benzoquinonesadjuvant;
anti-inflammatory agent;
antidepressant;
antineoplastic agent;
antioxidant;
cardioprotective agent;
plant metabolite
alpha-aminopyridine
alpha-aminopyridine: RN given refers to parent cpd; structure in Merck Index, 9th ed, #485. aminopyridine : Compounds containing a pyridine skeleton substituted by one or more amine groups.		3.5111
azomycin
azomycin: RN given refers to parent cpd with specified locant; structure		2.0610C-nitro compound;
imidazoles		antitubercular agent
methamphetamine
Methamphetamine: A central nervous system stimulant and sympathomimetic with actions and uses similar to DEXTROAMPHETAMINE. The smokable form is a drug of abuse and is referred to as crank, crystal, crystal meth, ice, and speed.. methamphetamine : A member of the class of amphetamines in which the amino group of (S)-amphetamine carries a methyl substituent.		2.8630amphetamines;
secondary amine		central nervous system stimulant;
environmental contaminant;
neurotoxin;
psychotropic drug;
xenobiotic
acetylcysteine
N-acetyl-L-cysteine : An N-acetyl-L-amino acid that is the N-acetylated derivative of the natural amino acid L-cysteine.		4.0221acetylcysteine;
L-cysteine derivative;
N-acetyl-L-amino acid		antidote to paracetamol poisoning;
antiinfective agent;
antioxidant;
antiviral drug;
ferroptosis inhibitor;
geroprotector;
human metabolite;
mucolytic;
radical scavenger;
vulnerary
deoxycytidine
[no description available]		16.356538pyrimidine 2'-deoxyribonucleosideEscherichia coli metabolite;
human metabolite;
mouse metabolite;
Saccharomyces cerevisiae metabolite
stavudine
Stavudine: A dideoxynucleoside analog that inhibits reverse transcriptase and has in vitro activity against HIV.. stavudine : A nucleoside analogue obtained by formal dehydration across positions 2 and 3 of thymidine. An inhibitor of HIV-1 reverse transcriptase		8.87126dihydrofuran;
nucleoside analogue;
organic molecular entity		antimetabolite;
antiviral agent;
EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor
camptothecin
NSC 100880: carboxylate (opened lactone) form of camptothecin; RN refers to (S)-isomer; structure given in first source		3.1410delta-lactone;
pyranoindolizinoquinoline;
quinoline alkaloid;
tertiary alcohol		antineoplastic agent;
EC 5.99.1.2 (DNA topoisomerase) inhibitor;
genotoxin;
plant metabolite
zinc sulfate
Zinc Sulfate: A compound given in the treatment of conditions associated with zinc deficiency such as acrodermatitis enteropathica. Externally, zinc sulfate is used as an astringent in lotions and eye drops. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995). zinc sulfate : A metal sulfate compound having zinc(2+) as the counterion.		3.4711metal sulfate;
zinc molecular entity		fertilizer
tricalcium phosphate
tricalcium phosphate: a form of tricalcium phosphate used as bioceramic bone replacement material; see also records for alpha-tricalcium phosphate, beta-tricalcium phosphate, calcium phosphate; apatitic tricalcium phosphate Ca9(HPO4)(PO4)5(OH) is the calcium orthophosphate leading to beta tricalcium phosphate Ca3(PO4)2 (b-TCP). calcium phosphate : A calcium salt composed of calcium and phosphate/diphosphate ions; present in milk and used for the mineralisation of calcified tissues.		2.0310calcium phosphate
deuterium
Deuterium: The stable isotope of hydrogen. It has one neutron and one proton in the nucleus.		2.0810dihydrogen
ferric nitrilotriacetate
ferric nitrilotriacetate: induces diabetes in animals (iron loading)		2.0810iron chelatecarcinogenic agent;
mutagen
fluorides
[no description available]		2.0810halide anion;
monoatomic fluorine
phenyl acetate
phenyl acetate: The ester formed between phenol and acetic acid. Don't confuse with phenylacetic acid derivatives listed under PHENYLACETATES.. phenyl acetate : An acetate ester obtained by the formal condensation of phenol with acetic acid.		4.331benzenes;
phenyl acetates
benzonidazole
benzonidazole: used in treatment of Chagas' disease. benznidazole : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of (2-nitroimidazol-1-yl)acetic acid with the aromatic amino group of benzylamine. Used for treatment of Chagas disease.		2.0610C-nitro compound;
imidazoles;
monocarboxylic acid amide		antiprotozoal drug
tridemorph
tridemorph: RN given refers to cpd with unspecified isomeric designation; structure. tridemorph : A mixture of 4-alkyl-2,6-dimethylmorpholines, where 'alkyl' is a mixture of C11 to C14 homologues of which 60-70% is tridecyl. A systemic fungicide, it is no longer approved for use within the European Union.. 2,6-dimethyl-4-tridecylmorpholine : A member of the class of morpholines that is 2,6-dimethylmorpholine in which the hydrogen attached to the nitrogen is replaced by a tridecyl group. The configuration at positions 2 and 6 is unknown or unspecified.		2.3110morpholines;
tertiary amino compound		antifungal agrochemical
calcium oxalate
Calcium Oxalate: The calcium salt of oxalic acid, occurring in the urine as crystals and in certain calculi.. calcium oxalate : The calcium salt of oxalic acid, which in excess in the urine may lead to formation of oxalate calculi (kidney stones).		2.110organic calcium salt
oxcarbazepine
Oxcarbazepine: A carbamazepine derivative that acts as a voltage-gated sodium channel blocker. It is used for the treatment of PARTIAL SEIZURES with or without secondary generalization. It is also an inducer of CYTOCHROME P-450 CYP3A4.. oxcarbazepine : A dibenzoazepine derivative, having a carbamoyl group at the ring nitrogen, substituted with an oxo group at C-4 of the azepeine ring which is also hydrogenated at C-4 and C-5. It is a anticholinergic anticonvulsant and mood stabilizing drug, used primarily in the treatment of epilepsy.		2.2510cyclic ketone;
dibenzoazepine		anticonvulsant;
drug allergen
zidovudine
Zidovudine: A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by an azido group. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA during reverse transcription. It improves immunologic function, partially reverses the HIV-induced neurological dysfunction, and improves certain other clinical abnormalities associated with AIDS. Its principal toxic effect is dose-dependent suppression of bone marrow, resulting in anemia and leukopenia.. zidovudine : A pyrimidine 2',3'-dideoxyribonucleoside compound having a 3'-azido substituent and thymine as the nucleobase.		11.31168azide;
pyrimidine 2',3'-dideoxyribonucleoside		antimetabolite;
antiviral drug;
HIV-1 reverse transcriptase inhibitor
ribavirin
Rebetron: Rebetron is tradename		5.31411-ribosyltriazole;
aromatic amide;
monocarboxylic acid amide;
primary carboxamide		anticoronaviral agent;
antiinfective agent;
antimetabolite;
antiviral agent;
EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor
desogestrel
Desogestrel: A synthetic progestational hormone used often as the progestogenic component of combined oral contraceptive agents (ORAL CONTRACEPTIVES, COMBINED).		5.273117beta-hydroxy steroid;
terminal acetylenic compound		contraceptive drug;
progestin;
synthetic oral contraceptive
nitazoxanide
nitazoxanide: a 5-nitrothiazolyl derivative used for a broad range of intestinal parasitic infections including CRYPTOSPORIDIUM and GIARDIA; it is a redox-active nitrothiazolyl-salicylamide prodrug		5.0221benzamides;
carboxylic ester
simvastatin
Simvastatin: A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.. simvastatin : A member of the class of hexahydronaphthalenes that is lovastatin in which the 2-methylbutyrate ester moiety has been replaced by a 2,2-dimethylbutyrate ester group. It is used as a cholesterol-lowering and anti-cardiovascular disease drug.		7.544delta-lactone;
fatty acid ester;
hexahydronaphthalenes;
statin (semi-synthetic)		EC 1.1.1.34/EC 1.1.1.88 (hydroxymethylglutaryl-CoA reductase) inhibitor;
EC 3.4.24.83 (anthrax lethal factor endopeptidase) inhibitor;
ferroptosis inducer;
geroprotector;
prodrug
pravastatin
Pravastatin: An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).. pravastatin : A carboxylic ester resulting from the formal condensation of (S)-2-methylbutyric acid with the hydroxy group adjacent to the ring junction of (3R,5R)-7-[(1S,2S,6S,8S,8aR)-6,8-dihydroxy-2-methyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid. Derived from microbial transformation of mevastatin, pravastatin is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA). The sodium salt is used for lowering cholesterol and preventing cardiovascular disease. It is one of the lower potency statins, but has the advantage of fewer side effects compared with lovastatin and simvastatin.		3.16503-hydroxy carboxylic acid;
carbobicyclic compound;
carboxylic ester;
hydroxy monocarboxylic acid;
secondary alcohol;
statin (semi-synthetic)		anticholesteremic drug;
environmental contaminant;
metabolite;
xenobiotic
itraconazole
Itraconazole: A triazole antifungal agent that inhibits cytochrome P-450-dependent enzymes required for ERGOSTEROL synthesis.. itraconazole : An N-arylpiperazine that is cis-ketoconazole in which the imidazol-1-yl group is replaced by a 1,2,4-triazol-1-yl group and in which the actyl group attached to the piperazine moiety is replaced by a p-[(+-)1-sec-butyl-5-oxo-1,5-dihydro-4H-1,2,4-triazol-4-yl]phenyl group. A potent P-glycoprotein and CYP3A4 inhibitor, it is used as an antifungal drug for the treatment of various fungal infections, including aspergillosis, blastomycosis, candidiasis, chromoblastomycosis, coccidioidomycosis, cryptococcosis, histoplasmosis, and sporotrichosis.		2.610aromatic ether;
conazole antifungal drug;
cyclic ketal;
dichlorobenzene;
dioxolane;
N-arylpiperazine;
triazole antifungal drug;
triazoles		EC 3.6.3.44 (xenobiotic-transporting ATPase) inhibitor;
Hedgehog signaling pathway inhibitor;
P450 inhibitor
salmeterol xinafoate
Salmeterol Xinafoate: A selective ADRENERGIC BETA-2 RECEPTOR agonist that functions as a BRONCHODILATOR when administered by inhalation. It is used to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.		2.0310naphthoic acid
imiquimod
Imiquimod: A topically-applied aminoquinoline immune modulator that induces interferon production. It is used in the treatment of external genital and perianal warts, superficial CARCINOMA, BASAL CELL; and ACTINIC KERATOSIS.. imiquimod : An imidazoquinoline fused [4,5-c] carrying isobutyl and amino substituents at N-1 and C-4 respectively. A prescription medication, it acts as an immune response modifier and is used to treat genital warts, superficial basal cell carcinoma, and actinic keratosis.		2.0210imidazoquinolineantineoplastic agent;
interferon inducer
adefovir
adefovir: inhibitor of African swine fever virus. adefovir(1-) : A organophosphonate oxoanion obtained by removal of a proton from the phosphonate group of adefovir, a nucleoside reverse transcriptase inhibitor. It is the major microspecies at pH 7.3 (according to Marvin v 6.2.0.).. adefovir : A member of the class of phosphonic acids that is methylphosphonic acid in which one of the methyl hydrogens has been replaced by a 2-(6-amino-9H-purin-9-yl)ethoxy group. An inhibitor of HIV-1 reverse transcriptase, the bis(t-butoxycarbonyloxymethyl) ester (dipivoxil ester) prodrug is used to treat chronic hepatitis B viral infection.		2.05106-aminopurines;
ether;
phosphonic acids		antiviral drug;
DNA synthesis inhibitor;
drug metabolite;
HIV-1 reverse transcriptase inhibitor;
nephrotoxic agent
atorvastatin
[no description available]		8.0465aromatic amide;
dihydroxy monocarboxylic acid;
monofluorobenzenes;
pyrroles;
statin (synthetic)		environmental contaminant;
xenobiotic
lamivudine
[no description available]		167332monothioacetal;
nucleoside analogue;
oxacycle;
primary alcohol		allergen;
anti-HBV agent;
antiviral drug;
EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor;
HIV-1 reverse transcriptase inhibitor;
prodrug
duloxetine hydrochloride
Duloxetine Hydrochloride: A thiophene derivative and selective NEUROTRANSMITTER UPTAKE INHIBITOR for SEROTONIN and NORADRENALINE (SNRI). It is an ANTIDEPRESSIVE AGENT and ANXIOLYTIC, and is also used for the treatment of pain in patients with DIABETES MELLITUS and FIBROMYALGIA.. (S)-duloxetine hydrochloride : A duloxetine hydrochloride in which the duloxetine moiety has S configuration.		3.1310duloxetine hydrochlorideantidepressant
irinotecan
[no description available]		3.1410carbamate ester;
delta-lactone;
N-acylpiperidine;
pyranoindolizinoquinoline;
ring assembly;
tertiary alcohol;
tertiary amino compound		antineoplastic agent;
apoptosis inducer;
EC 5.99.1.2 (DNA topoisomerase) inhibitor;
prodrug
emtricitabine
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.. 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.		16.887944monothioacetal;
nucleoside analogue;
organofluorine compound;
pyrimidone		antiviral drug;
HIV-1 reverse transcriptase inhibitor
efavirenz
efavirenz: HIV-1 reverse transcriptase inhibitor. efavirenz : 1,4-Dihydro-2H-3,1-benzoxazin-2-one substituted at the 4 position by cyclopropylethynyl and trifluoromethyl groups (S configuration) and at the 6 position by chlorine. A non-nucleoside reverse transcriptase inhibitor with activity against HIV, it is used with other antiretrovirals for combination therapy of HIV infection.		16.599823acetylenic compound;
benzoxazine;
cyclopropanes;
organochlorine compound;
organofluorine compound		antiviral drug;
HIV-1 reverse transcriptase inhibitor
nelfinavir
Nelfinavir: A potent HIV protease inhibitor. It is used in combination with other antiviral drugs in the treatment of HIV in both adults and children.. nelfinavir : An aryl sulfide that is used (as its mesylate salt) for treatment of HIV and also exhibits some anticancer properties.		11.38385aryl sulfide;
benzamides;
organic heterobicyclic compound;
phenols;
secondary alcohol;
tertiary amino compound		antineoplastic agent;
HIV protease inhibitor
amprenavir
[no description available]		9.4243carbamate ester;
sulfonamide;
tetrahydrofuryl ester		antiviral drug;
HIV protease inhibitor
oseltamivir
Oseltamivir: An acetamido cyclohexene that is a structural homolog of SIALIC ACID and inhibits NEURAMINIDASE.. oseltamivir : A cyclohexenecarboxylate ester that is the ethyl ester of oseltamivir acid. An antiviral prodrug (it is hydrolysed to the active free carboxylic acid in the liver), it is used to slow the spread of influenza.		2.0210acetamides;
amino acid ester;
cyclohexenecarboxylate ester;
primary amino compound		antiviral drug;
EC 3.2.1.18 (exo-alpha-sialidase) inhibitor;
environmental contaminant;
prodrug;
xenobiotic
telmisartan
Telmisartan: A biphenyl compound and benzimidazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION.. telmisartan : A member of the class of benzimidazoles used widely in the treatment of hypertension.		2.0510benzimidazoles;
biphenyls;
carboxybiphenyl		angiotensin receptor antagonist;
antihypertensive agent;
EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor;
environmental contaminant;
xenobiotic
triazoles
Triazoles: Heterocyclic compounds containing a five-membered ring with two carbon atoms and three nitrogen atoms with the molecular formula C2H3N3.. triazoles : An azole in which the five-membered heterocyclic aromatic skeleton contains three N atoms and two C atoms.		6.26941,2,3-triazole
zoledronic acid
Zoledronic Acid: An imidobisphosphonate inhibitor of BONE RESORPTION that is used for the treatment of malignancy-related HYPERCALCEMIA; OSTEITIS DEFORMANS; and OSTEOPOROSIS.. zoledronic acid : An imidazole compound having a 2,2-bis(phosphono)-2-hydroxyethane-1-yl substituent at the 1-position.		2.1101,1-bis(phosphonic acid);
imidazoles		bone density conservation agent
drospirenone
drospirenone: a progestational compound with antimineralocorticoid and antiandrogenic activity; structure given in first source		3.59113-oxo-Delta(4) steroid;
steroid lactone		aldosterone antagonist;
contraceptive drug;
progestin
voriconazole
Voriconazole: A triazole antifungal agent that specifically inhibits STEROL 14-ALPHA-DEMETHYLASE and CYTOCHROME P-450 CYP3A.. voriconazole : A triazole-based antifungal agent used for the treatment of esophageal candidiasis, invasive pulmonary aspergillosis, and serious fungal infections caused by Scedosporium apiospermum and Fusarium spp. It is an inhibitor of cytochrome P450 2C9 (CYP2C9) and CYP3A4.		2.7930conazole antifungal drug;
difluorobenzene;
pyrimidines;
tertiary alcohol;
triazole antifungal drug		P450 inhibitor
atovaquone
Atovaquone: A hydroxynaphthoquinone that has antimicrobial activity and is being used in antimalarial protocols.. atovaquone : A naphthoquinone compound having a 4-(4-chlorophenyl)cyclohexyl group at the 2-position and a hydroxy substituent at the 3-position.		5.2621hydroxy-1,2-naphthoquinone
cholest-5-ene-3,4-diol
cholest-5-ene-3,4-diol: RN given refers to (3beta,4beta)-isomer		4.3411
fibrinogen
Fibrinogen: Plasma glycoprotein clotted by thrombin, composed of a dimer of three non-identical pairs of polypeptide chains (alpha, beta, gamma) held together by disulfide bonds. Fibrinogen clotting is a sol-gel change involving complex molecular arrangements: whereas fibrinogen is cleaved by thrombin to form polypeptides A and B, the proteolytic action of other enzymes yields different fibrinogen degradation products.. D-iditol : The D-enantiomer of iditol.		2.0710iditolfungal metabolite
lopinavir
[no description available]		18.6819353amphetamines;
dicarboxylic acid diamide		anticoronaviral agent;
antiviral drug;
HIV protease inhibitor
eudragit rs
Eudragit RS: copolymer of acrylic & methacrylic acid esters & quaternary ammonium groups; used for microcapsules		2.1310
artesunic acid
[no description available]		2.7220
pyronaridine
[no description available]		2.3110aminoquinoline
perindopril
Perindopril: An angiotensin-converting enzyme inhibitor. It is used in patients with hypertension and heart failure.. perindopril : An alpha-amino acid ester that is the ethyl ester of N-{(2S)-1-[(2S,3aS,7aS)-2-carboxyoctahydro-1H-indol-1-yl]-1-oxopropan-2-yl}-L-norvaline		2.1110alpha-amino acid ester;
dicarboxylic acid monoester;
ethyl ester;
organic heterobicyclic compound		antihypertensive agent;
EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor
parthenolide
[no description available]		2.0610germacranolide
deoxyglucose
Deoxyglucose: 2-Deoxy-D-arabino-hexose. An antimetabolite of glucose with antiviral activity.. deoxyglucose : A deoxyhexose comprising glucose having at least one hydroxy group replaced by hydrogen.		2.4420
tadalafil
[no description available]		2.0210benzodioxoles;
pyrazinopyridoindole		EC 3.1.4.35 (3',5'-cyclic-GMP phosphodiesterase) inhibitor;
vasodilator agent
amdoxovir
amdoxovir: structure in first source; RN given refers to (2R-cis)-isomer		210
fosamprenavir
fosamprenavir: a prodrug of the protease inhibitor amprenavir. fosamprenavir : A sulfonamide with a structure based on that of sulfanilamide substituted on the sulfonamide nitrogen by a (2R,3S)-4-phenyl-2-(phosphonooxy)-3-({[(3S)-tetrahydrofuran-3-yloxy]carbonyl}amino)butyl group. It is a pro-drug of the HIV protease inhibitor and antiretroviral drug amprenavir.		11.16215sulfonamideprodrug
ivabradine
Ivabradine: A benzazepine derivative and selective HYPERPOLARIZATION-ACTIVATED CYCLIC NUCLEOTIDE-GATED CHANNELS inhibitor that lowers the heart rate. It is used in the treatment of CHRONIC STABLE ANGINA in patients unable to take BETA-ADRENERGIC BLOCKERS, and in the treatment of HEART FAILURE.. ivabradine : A member of the class of benzazepines that is 7,8-dimethoxy-1,3,4,5-tetrahydro-3-benzazepin-2-one in which the amide hydrogen is replaced by a [{[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino]propyl} group. Used (as its hydrochloride salt) to treat patients with angina who have intolerance to beta blockers and/or heart failure.		2.5220aromatic ether;
benzazepine;
carbobicyclic compound;
tertiary amino compound		cardiotonic drug
proline
Proline: A non-essential amino acid that is synthesized from GLUTAMIC ACID. It is an essential component of COLLAGEN and is important for proper functioning of joints and tendons.. proline : An alpha-amino acid that is pyrrolidine bearing a carboxy substituent at position 2.		3.8921amino acid zwitterion;
glutamine family amino acid;
L-alpha-amino acid;
proline;
proteinogenic amino acid		algal metabolite;
compatible osmolytes;
Escherichia coli metabolite;
micronutrient;
mouse metabolite;
nutraceutical;
Saccharomyces cerevisiae metabolite
drospirenone and ethinyl estradiol combination
drospirenone and ethinyl estradiol combination: female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes)		7.544
methylinositol
methylinositol: from Ebenus haussknechtii; structure in first source. pinitol : A cyclitol ether formed by etherification of the 3-hydroxy group of chiro-inositol. It is plant metabolite isolated from the leaves of Sutherlandia frutescens.. 1D-4-O-methyl-myo-inositol : A member of the class of methyl myo-inositols that is cyclohexane-1,2,3,4,5-pentol substituted by a methoxy group at position 6 (the 1R,2S,3S,4S,5S,6S-isomer).. D-pinitol : The D-enantiomer of pinitol.		2.0710
organophosphonates
hydrogenphosphite : A divalent inorganic anion resulting from the removal of a proton from two of the hydroxy groups of phosphorous acid.		17.8311451divalent inorganic anion;
phosphite ion
etravirine
[no description available]		4.6240aminopyrimidine;
aromatic ether;
dinitrile;
organobromine compound		antiviral agent;
HIV-1 reverse transcriptase inhibitor
uic-94003
UIC-94003: structure in first source		3.1210
ramelteon
ramelteon: melatonin MT1/MT2 receptor agonist		3.1310indanes
darunavir
Darunavir: An HIV PROTEASE INHIBITOR that is used in the treatment of AIDS and HIV INFECTIONS. Due to the emergence of ANTIVIRAL DRUG RESISTANCE when used alone, it is administered in combination with other ANTI-HIV AGENTS.. darunavir : An N,N-disubstituted benzenesulfonamide bearing an unsubstituted amino group at the 4-position, used for the treatment of HIV infection. A second-generation HIV protease inhibitor, darunavir was designed to form robust interactions with the protease enzyme from many strains of HIV, including those from treatment-experienced patients with multiple resistance mutations to other protease inhibitors.		17.3210831carbamate ester;
furofuran;
sulfonamide		antiviral drug;
HIV protease inhibitor
benzofurans
Benzofurans: Compounds that contain a BENZENE ring fused to a furan ring.		3.5911
trimethoprim, sulfamethoxazole drug combination
Trimethoprim, Sulfamethoxazole Drug Combination: A drug combination with broad-spectrum antibacterial activity against both gram-positive and gram-negative organisms. It is effective in the treatment of many infections, including PNEUMOCYSTIS PNEUMONIA in AIDS.. co-trimoxazole : A two-component mixture comprising trimethoprim and sulfamethoxazole.		3.140
ritonavir
Ritonavir: An HIV protease inhibitor that works by interfering with the reproductive cycle of HIV. It also inhibits CYTOCHROME P-450 CYP3A.. ritonavir : An L-valine derivative that is L-valinamide in which alpha-amino group has been acylated by a [(2-isopropyl-1,3-thiazol-4-yl)methyl]methylcarbamoyl group and in which a hydrogen of the carboxamide amino group has been replaced by a (2R,4S,5S)-4-hydroxy-1,6-diphenyl-5-{[(1,3-thiazol-5-ylmethoxy)carbonyl]amino}hexan-2-yl group. A CYP3A inhibitor and antiretroviral drug from the protease inhibitor class used to treat HIV infection and AIDS, it is often used as a fixed-dose combination with another protease inhibitor, lopinavir. Also used in combination with dasabuvir sodium hydrate, ombitasvir and paritaprevir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver.		22.94941741,3-thiazoles;
carbamate ester;
carboxamide;
L-valine derivative;
ureas		antiviral drug;
environmental contaminant;
HIV protease inhibitor;
xenobiotic
dihydropyridines
Dihydropyridines: Pyridine moieties which are partially saturated by the addition of two hydrogen atoms in any position.		2.1710
glycogen
glycogen : A polydisperse, highly branched glucan composed of chains of D-glucopyranose residues in alpha(1->4) glycosidic linkage, joined together by alpha(1->6) glycosidic linkages. A small number of alpha(1->3) glycosidic linkages and some cumulative alpha(1->6) links also may occur. The branches in glycogen typically contain 8 to 12 glucose residues.		3.411
canavanine
L-canavanine : A non-proteinogenic L-alpha-amino acid that is L-homoserine substituted at oxygen with a guanidino (carbamimidamido) group. Although structurally related to L-arginine, it is non-proteinogenic.		2.0710amino acid zwitterion;
non-proteinogenic L-alpha-amino acid		phytogenic insecticide;
plant metabolite
saquinavir
Saquinavir: An HIV protease inhibitor which acts as an analog of an HIV protease cleavage site. It is a highly specific inhibitor of HIV-1 and HIV-2 proteases, and also inhibits CYTOCHROME P-450 CYP3A.. saquinavir : An aspartic acid derivative obtained by formal condensation of the primary amino group of (2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)octahydroisoquinolin-2(1H)-yl]-3-hydroxy-1-phenylbutan-2-ylamine with the carboxy group of N(2)(-quinolin-2-ylcarbonyl)-L-asparagine. An inhibitor of HIV-1 protease.		12.41488L-asparagine derivative;
quinolines		antiviral drug;
HIV protease inhibitor
abacavir
abacavir: a carbocyclic nucleoside with potent selective anti-HIV activity. abacavir : A 2,6-diaminopurine that is (1S)-cyclopent-2-en-1-ylmethanol in which the pro-R hydrogen at the 4-position is substituted by a 2-amino-6-(cyclopropylamino)-9H-purin-9-yl group. A nucleoside analogue reverse transcriptase inhibitor (NRTI) with antiretroviral activity against HIV, it is used (particularly as the sulfate) with other antiretrovirals in combination therapy of HIV infection.		12.292562,6-diaminopurinesantiviral drug;
drug allergen;
HIV-1 reverse transcriptase inhibitor
ryanodine
Ryanodine: A methylpyrrole-carboxylate from RYANIA that disrupts the RYANODINE RECEPTOR CALCIUM RELEASE CHANNEL to modify CALCIUM release from SARCOPLASMIC RETICULUM resulting in alteration of MUSCLE CONTRACTION. It was previously used in INSECTICIDES. It is used experimentally in conjunction with THAPSIGARGIN and other inhibitors of CALCIUM ATPASE uptake of calcium into SARCOPLASMIC RETICULUM.. ryanodine : An insecticide alkaloid isolated from South American plant Ryania speciosa.		2.3110
naringin
[no description available]		2.1510(2S)-flavan-4-one;
4'-hydroxyflavanones;
dihydroxyflavanone;
disaccharide derivative;
neohesperidoside		anti-inflammatory agent;
antineoplastic agent;
metabolite
betadex
beta-Cyclodextrins: Cyclic GLUCANS consisting of seven (7) glucopyranose units linked by 1,4-glycosidic bonds.		2.1710cyclodextrin
oleic acid
Oleic Acid: An unsaturated fatty acid that is the most widely distributed and abundant fatty acid in nature. It is used commercially in the preparation of oleates and lotions, and as a pharmaceutical solvent. (Stedman, 26th ed). oleic acid : An octadec-9-enoic acid in which the double bond at C-9 has Z (cis) stereochemistry.		2.7220octadec-9-enoic acidantioxidant;
Daphnia galeata metabolite;
EC 3.1.1.1 (carboxylesterase) inhibitor;
Escherichia coli metabolite;
mouse metabolite;
plant metabolite;
solvent
tacrolimus
Tacrolimus: A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.. tacrolimus (anhydrous) : A macrolide lactam containing a 23-membered lactone ring, originally isolated from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis.		2.5120macrolide lactambacterial metabolite;
immunosuppressive agent
sr 12813
SR 12813: structure given in first source. SR12813 : An organic phosphonate that is the tetraethyl ester of [2-(3,5-di-tert-butyl-4-hydroxyphenyl)ethene-1,1-diyl]bis(phosphonic acid).		2.0510organic phosphonate;
phenols		pregnane X receptor agonist
bevirimat
bevirimat: an HIV inhibitor; disrupts late step in processing HIV Major Core Protein p24, preventing the capsid precursor p25 from being converted to mature capsid p24. bevirimat : A pentacyclic triterpenoid obtained by the formal condensation of 2,2-dimethylsuccinic acid with the 3-hydroxy group of betulinic acid. It is isolated from the Chinese herb Syzygium claviflorum. The first in the class of HIV-1 maturation inhibitors to be studied in humans, bevirimat was identified as a potent HIV drug candidate and several clinical trials were conducted, but development into a new drug was plagued by numerous resistance-related problems.		3.4311dicarboxylic acid monoester;
monocarboxylic acid;
pentacyclic triterpenoid		HIV-1 maturation inhibitor;
metabolite
tenofovir
tenofovir (anhydrous) : A member of the class of phosphonic acids that is methylphosphonic acid in which one of the methyl hydrogens is replaced by a [(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy group. An inhibitor of HIV-1 reverse transcriptase, the bis(isopropyloxycarbonyloxymethyl) ester (disoproxil ester) prodrug is used as the fumaric acid salt in combination therapy for the treatment of HIV infection.		18.9514963nucleoside analogue;
phosphonic acids		antiviral drug;
drug metabolite;
HIV-1 reverse transcriptase inhibitor
posaconazole
[no description available]		3.8921aromatic ether;
conazole antifungal drug;
N-arylpiperazine;
organofluorine compound;
oxolanes;
triazole antifungal drug;
triazoles		trypanocidal drug
dmp 850
DMP 850: structure in first source		3.1210
efinaconazole
efinaconazole: an antifungal agent; structure in first source. efinaconazole : A member of the class of triazoles that is butan-2-ol which is substituted at positions 1, 2, and 3 by 1,2,4-triazol-1-yl, 2,4-difluorophenyl, and 4-methylenepiperidin-1-yl groups, respectively (the 2R,3R stereoisomer). It is an antifungal drug used for the topical treatment of onychomycosis (a nail infection caused mainly by dermatophytes).		2.110conazole antifungal drug;
olefinic compound;
organofluorine compound;
piperidines;
tertiary alcohol;
tertiary amino compound;
triazole antifungal drug		EC 1.14.13.70 (sterol 14alpha-demethylase) inhibitor
favipiravir
favipiravir : A member of the class of pyrazines that is pyrazine substituted by aminocarbonyl, hydroxy and fluoro groups at positions 2, 3 and 6, respectively. It is an anti-viral agent that inhibits RNA-dependent RNA polymerase of several RNA viruses and is approved for the treatment of influenza in Japan.		2.3110hydroxypyrazine;
organofluorine compound;
primary carboxamide		anticoronaviral agent;
antiviral drug;
EC 2.7.7.48 (RNA-directed RNA polymerase) inhibitor
desmethylclomipramine
desmethylclomipramine: RN given refers to parent cpd		2.1710dibenzoazepine
glycosides
[no description available]		2.0710
buprenorphine
Buprenorphine: A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.. buprenorphine : A morphinane alkaloid that is 7,8-dihydromorphine 6-O-methyl ether in which positions 6 and 14 are joined by a -CH2CH2- bridge, one of the hydrogens of the N-methyl group is substituted by cyclopropyl, and a hydrogen at position 7 is substituted by a 2-hydroxy-3,3-dimethylbutan-2-yl group. It is highly effective for the treatment of opioid use disorder and is also increasingly being used in the treatment of chronic pain.		3.8740morphinane alkaloiddelta-opioid receptor antagonist;
kappa-opioid receptor antagonist;
mu-opioid receptor agonist;
opioid analgesic
sesquiterpenes
[no description available]		2.0610
curcumin
Curcumin: A yellow-orange dye obtained from tumeric, the powdered root of CURCUMA longa. It is used in the preparation of curcuma paper and the detection of boron. Curcumin appears to possess a spectrum of pharmacological properties, due primarily to its inhibitory effects on metabolic enzymes.. curcumin : A beta-diketone that is methane in which two of the hydrogens are substituted by feruloyl groups. A natural dyestuff found in the root of Curcuma longa.		2.2510aromatic ether;
beta-diketone;
diarylheptanoid;
enone;
polyphenol		anti-inflammatory agent;
antifungal agent;
antineoplastic agent;
biological pigment;
contraceptive drug;
dye;
EC 1.1.1.205 (IMP dehydrogenase) inhibitor;
EC 1.1.1.21 (aldehyde reductase) inhibitor;
EC 1.1.1.25 (shikimate dehydrogenase) inhibitor;
EC 1.6.5.2 [NAD(P)H dehydrogenase (quinone)] inhibitor;
EC 1.8.1.9 (thioredoxin reductase) inhibitor;
EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor;
EC 3.5.1.98 (histone deacetylase) inhibitor;
flavouring agent;
food colouring;
geroprotector;
hepatoprotective agent;
immunomodulator;
iron chelator;
ligand;
lipoxygenase inhibitor;
metabolite;
neuroprotective agent;
nutraceutical;
radical scavenger
estrone sulfate
estrone sulfate: sulfoconjugated estrone; RN given refers to parent cpd		2.051017-oxo steroid;
steroid sulfate		human metabolite;
mouse metabolite
ranitidine
Ranitidine: A non-imidazole blocker of those histamine receptors that mediate gastric secretion (H2 receptors). It is used to treat gastrointestinal ulcers.. ranitidine : A member of the class of furans used to treat peptic ulcer disease (PUD) and gastroesophageal reflux disease.		3.4311C-nitro compound;
furans;
organic sulfide;
tertiary amino compound		anti-ulcer drug;
drug allergen;
environmental contaminant;
H2-receptor antagonist;
xenobiotic
maraviroc
[no description available]		5.362tropane alkaloid
telaprevir
[no description available]		5.5151cyclopentapyrrole;
cyclopropanes;
oligopeptide;
pyrazines		antiviral drug;
hepatitis C protease inhibitor;
peptidomimetic
sodium dodecyl sulfate
Sodium Dodecyl Sulfate: An anionic surfactant, usually a mixture of sodium alkyl sulfates, mainly the lauryl; lowers surface tension of aqueous solutions; used as fat emulsifier, wetting agent, detergent in cosmetics, pharmaceuticals and toothpastes; also as research tool in protein biochemistry.. sodium dodecyl sulfate : An organic sodium salt that is the sodium salt of dodecyl hydrogen sulfate.		2.4820organic sodium saltdetergent;
protein denaturant
rhodamine 123
Rhodamine 123: A fluorescent probe with low toxicity which is a potent substrate for ATP BINDING CASSETTE TRANSPORTER, SUBFAMILY B, MEMBER 1 and the bacterial multidrug efflux transporter. It is used to assess mitochondrial bioenergetics in living cells and to measure the efflux activity of ATP BINDING CASSETTE TRANSPORTER, SUBFAMILY B, MEMBER 1 in both normal and malignant cells. (Leukemia 1997;11(7):1124-30). rhodamine 123(1+) : A cationic fluorescent dye derived from 9-phenylxanthene.		2.0410organic cation;
xanthene dye		fluorochrome
abacavir, lamivudine drug combination
abacavir, lamivudine drug combination: combination of Epivir and Ziagen		10.64158
jtk-303
[no description available]		12.141610aromatic ether;
monochlorobenzenes;
organofluorine compound;
quinolinemonocarboxylic acid;
quinolone		HIV-1 integrase inhibitor
bilirubin
[no description available]		12.865315biladienes;
dicarboxylic acid		antioxidant;
human metabolite;
mouse metabolite
amphotericin b
Amphotericin B: Macrolide antifungal antibiotic produced by Streptomyces nodosus obtained from soil of the Orinoco river region of Venezuela.. amphotericin B : A macrolide antibiotic used to treat potentially life-threatening fungal infections.		2.0710antibiotic antifungal drug;
macrolide antibiotic;
polyene antibiotic		antiamoebic agent;
antiprotozoal drug;
bacterial metabolite
pulmicort
Budesonide: A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.. budesonide : A glucocorticoid steroid having a highly oxygenated pregna-1,4-diene structure. It is used mainly in the treatment of asthma and non-infectious rhinitis and for treatment and prevention of nasal polyposis.		2.061011beta-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
cyclic acetal;
glucocorticoid;
primary alpha-hydroxy ketone		anti-inflammatory drug;
bronchodilator agent;
drug allergen
montelukast
montelukast: a leukotriene D4 receptor antagonist		2.7220aliphatic sulfide;
monocarboxylic acid;
quinolines		anti-arrhythmia drug;
anti-asthmatic drug;
leukotriene antagonist
sdz psc 833
valspodar: nonimmunosuppressive cyclosporin analog which is a potent multidrug resistance modifier; 7-10 fold more potent than cyclosporin A; a potent P glycoprotein inhibitor; MW 1215		2.0510homodetic cyclic peptide
cilnidipine
[no description available]		2.17102-methoxyethyl ester;
C-nitro compound;
dihydropyridine		antihypertensive agent;
calcium channel blocker;
cardiovascular drug
pitavastatin
pitavastatin : A dihydroxy monocarboxylic acid that is (6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]hept-6-enoic acid in which the two hydroxy groups are located at positions 3 and 5 (the 3R,5S-stereoisomer). Used as its calcium salt for treatment of hypercholesterolemia (elevated levels of cholesterol in the blood) on patients unable to sufficiently lower their cholesterol levels by diet and exercise.		4.4311cyclopropanes;
dihydroxy monocarboxylic acid;
monofluorobenzenes;
quinolines;
statin (synthetic)		antioxidant
levetiracetam
Levetiracetam: A pyrrolidinone and acetamide derivative that is used primarily for the treatment of SEIZURES and some movement disorders, and as a nootropic agent.. levetiracetam : A pyrrolidinone and carboxamide that is N-methylpyrrolidin-2-one in which one of the methyl hydrogens is replaced by an aminocarbonyl group, while another is replaced by an ethyl group (the S enantiomer). An anticonvulsant, it is used for the treatment of epilepsy in both human and veterinary medicine.		2.2510pyrrolidin-2-onesanticonvulsant;
environmental contaminant;
xenobiotic
naloxone
Naloxone: A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.. naloxone : A synthetic morphinane alkaloid that is morphinone in which the enone double bond has been reduced to a single bond, the hydrogen at position 14 has been replaced by a hydroxy group, and the methyl group attached to the nitrogen has been replaced by an allyl group. A specific opioid antagonist, it is used (commonly as its hydrochloride salt) to reverse the effects of opioids, both following their use of opioids during surgery and in cases of known or suspected opioid overdose.		2.9810morphinane alkaloid;
organic heteropentacyclic compound;
tertiary alcohol		antidote to opioid poisoning;
central nervous system depressant;
mu-opioid receptor antagonist
sirolimus
Sirolimus: A macrolide compound obtained from Streptomyces hygroscopicus that acts by selectively blocking the transcriptional activation of cytokines thereby inhibiting cytokine production. It is bioactive only when bound to IMMUNOPHILINS. Sirolimus is a potent immunosuppressant and possesses both antifungal and antineoplastic properties.. sirolimus : A macrolide lactam isolated from Streptomyces hygroscopicus consisting of a 29-membered ring containing 4 trans double bonds, three of which are conjugated. It is an antibiotic, immunosupressive and antineoplastic agent.		2.1710antibiotic antifungal drug;
cyclic acetal;
cyclic ketone;
ether;
macrolide lactam;
organic heterotricyclic compound;
secondary alcohol		antibacterial drug;
anticoronaviral agent;
antineoplastic agent;
bacterial metabolite;
geroprotector;
immunosuppressive agent;
mTOR inhibitor
morphine
Meconium: The thick green-to-black mucilaginous material found in the intestines of a full-term fetus. It consists of secretions of the INTESTINAL GLANDS; BILE PIGMENTS; FATTY ACIDS; AMNIOTIC FLUID; and intrauterine debris. It constitutes the first stools passed by a newborn.		3.4720morphinane alkaloid;
organic heteropentacyclic compound;
tertiary amino compound		anaesthetic;
drug allergen;
environmental contaminant;
geroprotector;
mu-opioid receptor agonist;
opioid analgesic;
plant metabolite;
vasodilator agent;
xenobiotic
fluticasone
Fluticasone: A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS.. fluticasone : A trifluorinated corticosteroid used in the form of its propionate ester for treatment of allergic rhinitis.		2.442011beta-hydroxy steroid;
17alpha-hydroxy steroid;
3-oxo-Delta(4) steroid;
corticosteroid;
fluorinated steroid;
thioester		anti-allergic agent;
anti-asthmatic drug
goserelin
Goserelin: A synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE. Goserelin is used in treatments of malignant NEOPLASMS of the prostate, uterine fibromas, and metastatic breast cancer.		3.5110organic molecular entity
indinavir sulfate
Indinavir: A potent and specific HIV protease inhibitor that appears to have good oral bioavailability.		10.14332dicarboxylic acid diamide;
N-(2-hydroxyethyl)piperazine;
piperazinecarboxamide		HIV protease inhibitor
sulfur
Sulfur: An element that is a member of the chalcogen family. It has an atomic symbol S, atomic number 16, and atomic weight [32.059; 32.076]. It is found in the amino acids cysteine and methionine.		2.4120chalcogen;
nonmetal atom		macronutrient
fumarates
Fumarates: Compounds based on fumaric acid.. fumarate(2-) : A C4-dicarboxylate that is the E-isomer of but-2-enedioate(2-)		3.9911butenedioate;
C4-dicarboxylate		human metabolite;
metabolite;
Saccharomyces cerevisiae metabolite
proguanil
Proguanil: A biguanide compound which metabolizes in the body to form cycloguanil, an anti-malaria agent.. proguanil : A biguanide compound which has isopropyl and p-chlorophenyl substituents on the terminal N atoms. A prophylactic antimalarial drug, it works by inhibiting the enzyme dihydrofolate reductase, which is involved in the reproduction of the malaria parasites Plasmodium falciparum and P. vivax within the red blood cells.		2.9710biguanides;
monochlorobenzenes		antimalarial;
antiprotozoal drug;
EC 1.5.1.3 (dihydrofolate reductase) inhibitor
rifamycin sv
rifamycin SV: RN given refers to parent cpd; structure in Merck Index, 9th ed, #8009. rifamycin SV : A member of the class of rifamycins that exhibits antibiotic and antitubercular properties.		2.110acetate ester;
cyclic ketal;
lactam;
macrocycle;
organic heterotetracyclic compound;
polyphenol;
rifamycins		antimicrobial agent;
antitubercular agent;
bacterial metabolite
selenium
Selenium: An element with the atomic symbol Se, atomic number 34, and atomic weight 78.97. It is an essential micronutrient for mammals and other animals but is toxic in large amounts. Selenium protects intracellular structures against oxidative damage. It is an essential component of GLUTATHIONE PEROXIDASE.		3.4811chalcogen;
nonmetal atom		micronutrient
cgp-56697
Artemether, Lumefantrine Drug Combination: Drug combination of artemether and lumefantrine that is used to treat PLASMODIUM FALCIPARUM MALARIA.		3.2310
rilpivirine
[no description available]		2.6320aminopyrimidine;
nitrile		EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor;
HIV-1 reverse transcriptase inhibitor
verlukast
verlukast: LTD4 receptor antagonist		2.0510
etonogestrel
[no description available]		5.273117beta-hydroxy steroid;
3-oxo-Delta(4) steroid;
terminal acetylenic compound		contraceptive drug;
female contraceptive drug;
progestin
ciclesonide
ciclesonide: nasal spray approved for seasonal and perennial allergic rhinitis		2.3110organic molecular entity
s 1743
Esomeprazole: The S-isomer of omeprazole.. esomeprazole : A 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole that has S configuration at the sulfur atom. An inhibitor of gastric acid secretion, it is used (generally as its sodium or magnesium salt) for the treatment of gastro-oesophageal reflux disease, dyspepsia, peptic ulcer disease, and Zollinger-Ellison syndrome.		2.0310magnesium saltanti-ulcer drug;
EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor
tri-cyclen
[no description available]		2.0610
gs-7340
tenofovir alafenamide: component of Biktarvy. tenofovir alafenamide : An L-alanine derivative that is isopropyl L-alaninate in which one of the amino hydrogens is replaced by an (S)-({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)(phenoxy)phosphoryl group. A prodrug for tenofovir, it is used (as the fumarate salt) in combination therapy for the treatment of HIV-1 infection.		3.25106-aminopurines;
ether;
isopropyl ester;
L-alanine derivative;
phosphoramidate ester		antiviral drug;
HIV-1 reverse transcriptase inhibitor;
prodrug
efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination: Inhibitor of reverse transcriptases or of RNA-directed DNA polymerases.		2.7530
pentagastrin
Pentagastrin: A synthetic pentapeptide that has effects like gastrin when given parenterally. It stimulates the secretion of gastric acid, pepsin, and intrinsic factor, and has been used as a diagnostic aid.		2.0310organic molecular entity
mocetinostat
mocetinostat: undergoing phase II clinical trials for treatment of cancer. mocetinostat : A benzamide obtained by formal condensation of the carboxy group of 4-({[4-(pyridin-3-yl)pyrimidin-2-yl]amino}methyl)benzoic acid with one of the amino groups of benzene-1,2-diamine. It is an orally active and isotype-selective HDAC inhibitor which exhibits antitumour activity (IC50 = 0.15, 0.29, 1.66 and 0.59 muM for HDAC1, HDAC2, HDAC3 and HDAC11).		2.1310aminopyrimidine;
benzamides;
pyridines;
secondary amino compound;
secondary carboxamide;
substituted aniline		antineoplastic agent;
apoptosis inducer;
autophagy inducer;
cardioprotective agent;
EC 3.5.1.98 (histone deacetylase) inhibitor;
hepatotoxic agent
3,9-bis((ethylthio)methyl)-k-252a
3,9-bis((ethylthio)methyl)-K-252a: RN given for (9S-(9alpha,10beta,12alpha))-isomer; mixed lineage kinase inhibitor, neuroprotective agent, and neurotrophic agent derived from K-252a; structure in first source		2.0810
edoxaban
edoxaban : A monocarboxylic acid amide that is used (as its tosylate monohydrate) for the treatment of deep vein thrombosis and pulmonary embolism.		2.1110chloropyridine;
monocarboxylic acid amide;
tertiary amino compound;
thiazolopyridine		anticoagulant;
EC 3.4.21.6 (coagulation factor Xa) inhibitor;
platelet aggregation inhibitor
lurasidone hydrochloride
Lurasidone Hydrochloride: A thiazole derivative and atypical ANTIPSYCHOTIC AGENT that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST; SEROTONIN 5-HT2 RECEPTOR ANTAGONIST, serotonin 5-HT7 receptor antagonist, and antagonist of the adrenergic α2A and α2C receptors, as well as a partial SEROTONIN 5-HT1A RECEPTOR AGONIST. It is used in the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER.. lurasidone hydrochloride : A hydrochloride obtained by reaction of lurasidone with one equivalent of hydrochloric acid. An atypical antipsychotic agent used for the treatment of schizophrenia.		2.1310hydrochlorideadrenergic antagonist;
dopaminergic antagonist;
second generation antipsychotic;
serotonergic antagonist
buprenorphine, naloxone drug combination
Buprenorphine, Naloxone Drug Combination: A pharmaceutical preparation that combines buprenorphine, an OPIOID ANALGESICS with naloxone, a NARCOTIC ANTAGONISTS to reduce the potential for NARCOTIC DEPENDENCE in the treatment of pain. It may also be used for OPIOID SUBSTITUTION THERAPY.		2.9810
bms-626529
[no description available]		3.511
bms-663068
fostemsavir: an HIV-1 attachment inhibitor; structure in first source		4.4922
losartan potassium
Erythropoietin: Glycoprotein hormone, secreted chiefly by the KIDNEY in the adult and the LIVER in the FETUS, that acts on erythroid stem cells of the BONE MARROW to stimulate proliferation and differentiation.		2.4820
norgestimate
[no description available]		2.0610
emtricitabine, tenofovir disoproxil fumarate drug combination
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination: A pharmaceutical preparation of emtricitabine and tenofovir that is used as an ANTI-HIV AGENT in the treatment and prevention of HIV INFECTIONS.		4.9642
dextrothyroxine
[no description available]		2.3110
rifamycins
[no description available]		2.110
enfuvirtide
Enfuvirtide: A synthetic 36-amino acid peptide that corresponds to the heptad repeat sequence of HIV-1 gp41. It blocks HIV cell fusion and viral entry and is used with other anti-retrovirals for combination therapy of HIV INFECTIONS and AIDS.. enfuvirtide : A synthetic 36-amino acid peptide consisting of N-acetyltyrosyl, threonyl, seryl, leucyl, isoleucyl, histidyl, seryl, leucyl, isoleucyl, alpha-glutamyl, alpha-glutamyl, seryl, glutaminyl, asparaginyl, glutaminyl, glutaminyl, alpha-glutamyl, lysyl, asparaginyl, alpha-glutamyl, alpha-glutamyl, alpha-glutamyl, leucyl, leucyl, alpha-glutamyl, leucyl, alpha-aspartyl, lysyl, tryptophyl, alanyl, seryl, leucyl, tryptophyl, asparaginyl, tryptophyl, and phenylalaninamide residues joined in sequence. An HIV fusion inhibitor, it was the first of a novel class of antiretroviral drugs used in combination therapy for the treatment of HIV-1 infection. It interferes with entry of HIV into cells by binding to the gp41 sub-unit of the viral envelope glycoprotein, so inhibiting fusion of viral and cellular membranes.		4.5540
liraglutide
[no description available]		2.1110lipopeptide;
polypeptide		glucagon-like peptide-1 receptor agonist;
neuroprotective agent
phosphatidylcholines
Phosphatidylcholines: Derivatives of PHOSPHATIDIC ACIDS in which the phosphoric acid is bound in ester linkage to a CHOLINE moiety.		2.25101,2-diacyl-sn-glycero-3-phosphocholine
osteum
[no description available]		2.2510organic molecular entity
raltegravir potassium
Raltegravir Potassium: A pyrrolidinone derivative and HIV INTEGRASE INHIBITOR that is used in combination with other ANTI-HIV AGENTS for the treatment of HIV INFECTION.		15.365726
sodium ethylxanthate
Sex: The totality of characteristics of reproductive structure, functions, PHENOTYPE, and GENOTYPE, differentiating the MALE from the FEMALE organism.		2.0410
quetiapine fumarate
Quetiapine Fumarate: A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER.		2.0510fumarate salt
cobicistat
[no description available]		19.1828151,3-thiazoles;
carbamate ester;
monocarboxylic acid amide;
morpholines;
ureas		P450 inhibitor
bms-790052
daclatasvir: an HCV NS5A inhibitor. daclatasvir : A member of the class of biphenyls that is a potent inhibitor of nonstructural protein 5A and is used (as its hydrochloride salt) for treatment of hepatitis C.		6.1252biphenyls;
carbamate ester;
carboxamide;
imidazoles;
valine derivative		antiviral drug;
nonstructural protein 5A inhibitor
baricitinib
[no description available]		2.4110azetidines;
nitrile;
pyrazoles;
pyrrolopyrimidine;
sulfonamide		anti-inflammatory agent;
antirheumatic drug;
antiviral agent;
EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor;
immunosuppressive agent
idx 899
IDX 899: a reverse transcriptase inhibitor		7.544
quad pill
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination: A pharmaceutical preparation of the ANTI-HIV AGENTS elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate that is used in the treatment of HIV INFECTIONS.		2.1510
grazoprevir
grazoprevir: has antiviral activity; component of Zepatier. grazoprevir : An azamacrocyclic compound that is a hepatitis C protease inhibitor used in combination with elbasvir (under the brand name Zepatier) for treatment of chronic HCV genotypes 1 or 4 infection in adults.		3.5911aromatic ether;
azamacrocycle;
carbamate ester;
cyclopropanes;
lactam;
N-sulfonylcarboxamide;
quinoxaline derivative		antiviral drug;
hepatitis C protease inhibitor;
hepatoprotective agent
abt-450
paritaprevir: inhibits HCV NS3 protease. paritaprevir : An azamacrocycle which is used which is in combination with dasabuvir sodium hydrate, ombitasvir and ritonavir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver.		2.1310
sofosbuvir
Sofosbuvir: A uridine monophosphate analog inhibitor of HEPATITIS C VIRUS (HCV) polymerase NS5B that is used as an ANTIVIRAL AGENT in the treatment of CHRONIC HEPATITIS C.. sofosbuvir : A nucleotide conjugate that is used in combination with ledipasvir (under the trade name Harvoni) for the treatment of chronic hepatitis C genotype 1 infection.		2.1510isopropyl ester;
L-alanyl ester;
nucleotide conjugate;
organofluorine compound;
phosphoramidate ester		antiviral drug;
hepatitis C protease inhibitor;
prodrug
g 52
GRL-0519: an HIV-1 protease inhibitor; structure in first source		2.0810
pradigastat
[no description available]		3.5111
oxytetracycline, anhydrous
Oxytetracycline: A TETRACYCLINE analog isolated from the actinomycete STREPTOMYCES RIMOSUS and used in a wide variety of clinical conditions.. oxytetracycline : A tetracycline used for treatment of infections caused by a variety of Gram positive and Gram negative microorganisms including Mycoplasma pneumoniae, Pasteurella pestis, Escherichia coli, Haemophilus influenzae (respiratory infections), and Diplococcus pneumoniae.		2.7220
minocycline
Minocycline: A TETRACYCLINE analog, having a 7-dimethylamino and lacking the 5 methyl and hydroxyl groups, which is effective against tetracycline-resistant STAPHYLOCOCCUS infections.. minocycline : A tetracycline analogue having a dimethylamino group at position 7 and lacking the methyl and hydroxy groups at position 5.		2.0410
acenocoumarol
Acenocoumarol: A coumarin that is used as an anticoagulant. Its actions and uses are similar to those of WARFARIN. (From Martindale, The Extra Pharmacopoeia, 30th ed, p233). acenocoumarol : A hydroxycoumarin that is warfarin in which the hydrogen at position 4 of the phenyl substituent is replaced by a nitro group.		2.0610C-nitro compound;
hydroxycoumarin;
methyl ketone		anticoagulant;
EC 1.6.5.2 [NAD(P)H dehydrogenase (quinone)] inhibitor
warfarin
Warfarin: An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.. warfarin : A racemate comprising equal amounts of (R)- and (S)-warfarin. Extensively used as both an anticoagulant drug and as a pesticide against rats and mice.. 4-hydroxy-3-(3-oxo-1-phenylbutyl)-1-benzopyran-2-one : A member of the class of coumarins that is 4-hydroxycoumarin which is substituted at position 3 by a 1-phenyl-3-oxo-1-butyl group.		2.1510benzenes;
hydroxycoumarin;
methyl ketone
tipranavir
tipranavir: inhibits HIV-1 protease. tipranavir : A pyridine-2-sulfonamide substituted at C-5 by a trifluoromethyl group and at the sulfonamide nitrogen by a dihydropyrone-containing m-tolyl substituent. It is an HIV-1 protease inhibitor.		8.18201sulfonamideantiviral drug;
HIV protease inhibitor
dolutegravir
[no description available]		9.28193difluorobenzene;
monocarboxylic acid amide;
organic heterotricyclic compound;
secondary carboxamide		HIV-1 integrase inhibitor
urmc-099
URMC-099: inhibits mixed lineage kinase 3		2.8430
abt-267
ombitasvir: inhibits HCV NS5A protein, component of Viekirax. ombitasvir : A dipeptide derivative which is used which is in combination with dasabuvir sodium hydrate, paritaprevir and ritonavir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver.		2.1310aromatic amide;
carbamate ester;
dipeptide;
pyrrolidines		antiviral drug;
hepatitis C virus nonstructural protein 5A inhibitor
abt-333
dasabuvir: an antiviral agent. dasabuvir : A member of the class of pyrimidone, which is (as the monohydrate of its sodium salt) in combination with ombitasvir, paritaprevir and ritonavir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver.		2.1310aromatic ether;
naphthalenes;
pyrimidone;
sulfonamide		antiviral drug;
nonnucleoside hepatitis C virus polymerase inhibitor
clay
Clay: A naturally-occurring rock or soil constituent characterized by particles with a diameter of less than 0.005 mm. It is composed primarily of hydrous aluminum silicates, trace amounts of metal OXIDES, and organic matter.		2.610
bay 85-3934
[no description available]		2.3110
ledipasvir
ledipasvir : A benzimidazole derivative that is used in combination with sofosbuvir (under the trade name Harvoni) for the treatment of chronic hepatitis C genotype 1 infection.		2.7220azaspiro compound;
benzimidazole;
bridged compound;
carbamate ester;
carboxamide;
fluorenes;
imidazoles;
L-valine derivative;
N-acylpyrrolidine;
organofluorine compound		antiviral drug;
hepatitis C protease inhibitor
mk-8742
elbasvir: inhibits NS5A protein of hepatitis C virus. elbasvir : A complex organic heterotetracyclic compound that is a hepatitis C virus nonstructural protein 5A inhibitor used in combination with grazoprevir (under the brand name Zepatier) for treatment of chronic HCV genotypes 1 or 4 infection in adults.		3.5911carbamate ester;
imidazoles;
L-valine derivative;
N-acylpyrrolidine;
organic heterotetracyclic compound;
ring assembly		antiviral drug;
hepatitis C virus nonstructural protein 5A inhibitor;
hepatoprotective agent
m8-nelfinavir
M8-nelfinavir: structure in first source		2.0310
epoetin alfa
Epoetin Alfa: A recombinant glycosylated form of erythropoietin which stimulates the differentiation and proliferation of erythroid precursors. It is used for the treatment of ANEMIA associated with CHRONIC RENAL FAILURE in dialysis and predialysis patients.		2.0210
norgestrel
Norgestrel: A synthetic progestational agent with actions similar to those of PROGESTERONE. This racemic or (+-)-form has about half the potency of the levo form (LEVONORGESTREL). Norgestrel is used as a contraceptive, ovulation inhibitor, and for the control of menstrual disorders and endometriosis.		2.0610
s 8932
[no description available]		5.3131aromatic amine;
C-nucleoside;
carboxylic ester;
nitrile;
phosphoramidate ester;
pyrrolotriazine		anticoronaviral agent;
antiviral drug;
prodrug
cyclosporine
Cyclosporine: A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).		2.4720
digitonin
Digitonin: A glycoside obtained from Digitalis purpurea; the aglycone is digitogenin which is bound to five sugars. Digitonin solubilizes lipids, especially in membranes and is used as a tool in cellular biochemistry, and reagent for precipitating cholesterol. It has no cardiac effects.. digitonin : A spirostanyl glycoside that is digitogenin in which the 3-hydroxy group is substituted by a beta-D-glucopyranosyl-(1->3)-beta-D-galactopyranosyl-(1->2)-[beta-D-xylopyranosyl-(1->3)]-beta-D-glucopyranosyl-(1->4)-beta-D-galactopyranosyl group. It is a steroidal saponin isolated from the foxglove plant, Digitalis purpurea. It is used extensively as a mild non-ionic detergent for extracting proteins from membranes for structure and function studies.		2.0510
guanosine
ribonucleoside : Any nucleoside where the sugar component is D-ribose.		210guanosines;
purines D-ribonucleoside		fundamental metabolite
folic acid
folcysteine: used to promote fertility in chickens. vitamin B9 : Any B-vitamin that exhibits biological activity against vitamin B9 deficiency. Vitamin B9 refers to the many forms of folic acid and its derivatives, including tetrahydrofolic acid (the active form), methyltetrahydrofolate (the primary form found in blood), methenyltetrahydrofolate, folinic acid amongst others. They are present in abundance in green leafy vegetables, citrus fruits, and animal products. Lack of vitamin B9 leads to anemia, a condition in which the body cannot produce sufficient number of red blood cells. Symptoms of vitamin B9 deficiency include fatigue, muscle weakness, and pale skin.		3.1950folic acids;
N-acyl-amino acid		human metabolite;
mouse metabolite;
nutrient
neopterin
[no description available]		3.4811
rifampin
Rifampin: A semisynthetic antibiotic produced from Streptomyces mediterranei. It has a broad antibacterial spectrum, including activity against several forms of Mycobacterium. In susceptible organisms it inhibits DNA-dependent RNA polymerase activity by forming a stable complex with the enzyme. It thus suppresses the initiation of RNA synthesis. Rifampin is bactericidal, and acts on both intracellular and extracellular organisms. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p1160)		6.7872cyclic ketal;
hydrazone;
N-iminopiperazine;
N-methylpiperazine;
rifamycins;
semisynthetic derivative;
zwitterion		angiogenesis inhibitor;
antiamoebic agent;
antineoplastic agent;
antitubercular agent;
DNA synthesis inhibitor;
EC 2.7.7.6 (RNA polymerase) inhibitor;
Escherichia coli metabolite;
geroprotector;
leprostatic drug;
neuroprotective agent;
pregnane X receptor agonist;
protein synthesis inhibitor
didanosine
Didanosine: A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by a hydrogen. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. Didanosine is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA by binding to reverse transcriptase; ddI is then metabolized to dideoxyadenosine triphosphate, its putative active metabolite.. didanosine : A purine 2',3'-dideoxyribonucleoside that is inosine in which the hydroxy groups at both the 2' and the 3' positions on the sugar moiety have been replaced by hydrogen. An antiviral drug, it is used as a medication to treat HIV/AIDS.		7.0974purine 2',3'-dideoxyribonucleosideantimetabolite;
antiviral drug;
EC 2.4.2.1 (purine-nucleoside phosphorylase) inhibitor;
geroprotector;
HIV-1 reverse transcriptase inhibitor
2-aminopurine dioxolane
(4-2-aminopurin-9-yl)-1,3-dioxolane-2-methanol: structure in first source		210
sildenafil citrate
Sildenafil Citrate: A PHOSPHODIESTERASE TYPE-5 INHIBITOR; VASODILATOR AGENT and UROLOGICAL AGENT that is used in the treatment of ERECTILE DYSFUNCTION and PRIMARY PULMONARY HYPERTENSION.. sildenafil citrate : The citrate salt of sildenafil.		2.0210citrate saltEC 3.1.4.35 (3',5'-cyclic-GMP phosphodiesterase) inhibitor;
vasodilator agent
vardenafil dihydrochloride
Vardenafil Dihydrochloride: A piperazine derivative, PHOSPHODIESTERASE 5 INHIBITOR and VASODILATOR AGENT that is used as a UROLOGICAL AGENT in the treatment of ERECTILE DYSFUNCTION.		2.0210
molnupiravir
molnupiravir: prodrug that’s metabolized into N4-hydroxycytidine (NHC), a ribonucleoside analog. molnupiravir : A nucleoside analogue that is N(4)-hydroxycytidine in which the 5'-hydroxy group is replaced by a (2-methylpropanoyl)oxy group. It is the prodrug of the active antiviral ribonucleoside analog N(4)-hydroxycytidine (EIDD-1931), has activity against a number of RNA viruses including SARS-CoV-2, MERS-CoV, and seasonal and pandemic influenza viruses. It is currently in phase III trials for the treatment of patients with COVID-19.		2.3110isopropyl ester;
ketoxime;
nucleoside analogue		anticoronaviral agent;
antiviral drug;
prodrug
pyrimidinones
Pyrimidinones: Heterocyclic compounds known as 2-pyrimidones (or 2-hydroxypyrimidines) and 4-pyrimidones (or 4-hydroxypyrimidines) with the general formula C4H4N2O.		16.2110331
ConditionIndicatedRelationship StrengthStudiesTrials
HIV Coinfection
[description not available]		025.17835249
HIV Infections
Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).		129.931,670498
2019 Novel Coronavirus Disease
[description not available]		08.65134
Complications, Infectious Pregnancy
[description not available]		011.7285
Pregnancy
The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.		013.36457
Arrhythmia
[description not available]		02.520
Arrhythmias, Cardiac
Any disturbances of the normal rhythmic beating of the heart or MYOCARDIAL CONTRACTION. Cardiac arrhythmias can be classified by the abnormalities in HEART RATE, disorders of electrical impulse generation, or impulse conduction.		02.520
Glucose Metabolic Disorder
[description not available]		02.4110
HIV
Human immunodeficiency virus. A non-taxonomic and historical term referring to any of two species, specifically HIV-1 and/or HIV-2. Prior to 1986, this was called human T-lymphotropic virus type III/lymphadenopathy-associated virus (HTLV-III/LAV). From 1986-1990, it was an official species called HIV. Since 1991, HIV was no longer considered an official species name; the two species were designated HIV-1 and HIV-2.		011.44315
Low Bone Density
[description not available]		02.7620
Bone Diseases, Metabolic
Diseases that affect the METABOLIC PROCESSES of BONE TISSUE.		02.7620
Preterm Birth
[description not available]		02.6120
Premature Birth
CHILDBIRTH before 37 weeks of PREGNANCY (259 days from the first day of the mother's last menstrual period, or 245 days after FERTILIZATION).		02.6120
Aging, Premature
Changes in the organism associated with senescence, occurring at an accelerated rate.		02.610
Innate Inflammatory Response
[description not available]		09.85189
Inflammation
A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.		09.85189
Late Onset Diseases
[description not available]		02.2110
Urinary Lithiasis
[description not available]		07.15121
Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted
[description not available]		07.56183
Hepatitis C
INFLAMMATION of the LIVER in humans caused by HEPATITIS C VIRUS, a single-stranded RNA virus. Its incubation period is 30-90 days. Hepatitis C is transmitted primarily by contaminated blood parenterally and is often associated with transfusion and intravenous drug abuse. However, in a significant number of cases, the source of hepatitis C infection is unknown.		07.56183
Urolithiasis
Formation of stones in any part of the URINARY TRACT, usually in the KIDNEY; URINARY BLADDER; or the URETER.		07.15121
Adult Fanconi Syndrome
[description not available]		02.5220
Rhabdomyolysis
Necrosis or disintegration of skeletal muscle often followed by myoglobinuria.		02.5120
Heroin Abuse
[description not available]		03.4220
Diarrhea
An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.		09.79109
Heroin Dependence
Strong dependence or addiction, both physiological and emotional, upon HEROIN.		03.4220
Infections, Respiratory Syncytial Virus
[description not available]		02.2510
Cardiovascular Stroke
[description not available]		04.6180
Myocardial Infarction
NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).		04.6180
Respiratory Syncytial Virus Infections
Pneumovirus infections caused by the RESPIRATORY SYNCYTIAL VIRUSES. Humans and cattle are most affected but infections in goats and sheep have been reported.		02.2510
Cardiovascular Diseases
Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.		010.5174
Chronic Illness
[description not available]		03.9820
Acute Kidney Failure
[description not available]		04.77110
AIDS Nephropathy
[description not available]		03.6930
Chronic Disease
Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2).		03.9820
AIDS-Associated Nephropathy
Renal syndrome in human immunodeficiency virus-infected patients characterized by nephrotic syndrome, severe proteinuria, focal and segmental glomerulosclerosis with distinctive tubular and interstitial changes, enlarged kidneys, and peculiar tubuloreticular structures. The syndrome is distinct from heroin-associated nephropathy as well as other forms of kidney disease seen in HIV-infected patients.		03.6930
Acute Kidney Injury
Abrupt reduction in kidney function. Acute kidney injury encompasses the entire spectrum of the syndrome including acute kidney failure; ACUTE KIDNEY TUBULAR NECROSIS; and other less severe conditions.		04.77110
Insulin Sensitivity
[description not available]		011.03206
Insulin Resistance
Diminished effectiveness of INSULIN in lowering blood sugar levels: requiring the use of 200 units or more of insulin per day to prevent HYPERGLYCEMIA or KETOSIS.		011.03206
Obesity
A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY).		02.5420
Disease Exacerbation
[description not available]		07.5962
Infections, Coronavirus
[description not available]		04.5541
Altered Level of Consciousness
[description not available]		02.2510
Brain Inflammation
[description not available]		04.8821
Absence Seizure
[description not available]		02.8230
Encephalitis
Inflammation of the BRAIN due to infection, autoimmune processes, toxins, and other conditions. Viral infections (see ENCEPHALITIS, VIRAL) are a relatively frequent cause of this condition.		04.8821
Pneumonia, Viral
Inflammation of the lung parenchyma that is caused by a viral infection.		04.5541
Seizures
Clinical or subclinical disturbances of cortical function due to a sudden, abnormal, excessive, and disorganized discharge of brain cells. Clinical manifestations include abnormal motor, sensory and psychic phenomena. Recurrent seizures are usually referred to as EPILEPSY or seizure disorder.		02.8230
Coronavirus Infections
Virus diseases caused by the CORONAVIRUS genus. Some specifics include transmissible enteritis of turkeys (ENTERITIS, TRANSMISSIBLE, OF TURKEYS); FELINE INFECTIOUS PERITONITIS; and transmissible gastroenteritis of swine (GASTROENTERITIS, TRANSMISSIBLE, OF SWINE).		04.5541
Dyslipidemia
[description not available]		010.67165
Benign Neoplasms
[description not available]		04.821
Diabetes Mellitus
A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.		03.6411
Neoplasms
New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.		04.821
Dyslipidemias
Abnormalities in the serum levels of LIPIDS, including overproduction or deficiency. Abnormal serum lipid profiles may include high total CHOLESTEROL, high TRIGLYCERIDES, low HIGH DENSITY LIPOPROTEIN CHOLESTEROL, and elevated LOW DENSITY LIPOPROTEIN CHOLESTEROL.		010.67165
Cognitive Decline
[description not available]		03.5120
Cognitive Dysfunction
Diminished or impaired mental and/or intellectual function.		03.5120
Acute Ischemic Stroke
[description not available]		02.2510
Bilirubinemia
[description not available]		012.77457
Ischemic Stroke
Stroke due to BRAIN ISCHEMIA resulting in interruption or reduction of blood flow to a part of the brain. When obstruction is due to a BLOOD CLOT formed within in a cerebral blood vessel it is a thrombotic stroke. When obstruction is formed elsewhere and moved to block a cerebral blood vessel (see CEREBRAL EMBOLISM) it is referred to as embolic stroke. Wake-up stroke refers to ischemic stroke occurring during sleep while cryptogenic stroke refers to ischemic stroke of unknown origin.		02.2510
Child Development Deviations
[description not available]		02.2510
Fetal Growth Restriction
[description not available]		02.2510
Stunted Growth
[description not available]		02.2510
Abnormal Deep Tendon Reflex
[description not available]		02.2510
Sensation Disorders
Disorders of the special senses (i.e., VISION; HEARING; TASTE; and SMELL) or somatosensory system (i.e., afferent components of the PERIPHERAL NERVOUS SYSTEM).		02.2510
Delayed Effects, Prenatal Exposure
[description not available]		05.7780
Developmental Disabilities
Disorders in which there is a delay in development based on that expected for a given age level or stage of development. These impairments or disabilities originate before age 18, may be expected to continue indefinitely, and constitute a substantial impairment. Biological and nonbiological factors are involved in these disorders. (From American Psychiatric Glossary, 6th ed)		02.2510
Fetal Growth Retardation
Failure of a FETUS to attain expected GROWTH.		02.2510
Growth Disorders
Deviations from the average values for a specific age and sex in any or all of the following: height, weight, skeletal proportions, osseous development, or maturation of features. Included here are both acceleration and retardation of growth.		02.2510
Reflex, Abnormal
An abnormal response to a stimulus applied to the sensory components of the nervous system. This may take the form of increased, decreased, or absent reflexes.		02.2510
Lipodystrophy
A collection of heterogenous conditions resulting from defective LIPID METABOLISM and characterized by ADIPOSE TISSUE atrophy. Often there is redistribution of body fat resulting in peripheral fat wasting and central adiposity. They include generalized, localized, congenital, and acquired lipodystrophy.		03.8721
Infections, Plasmodium
[description not available]		03.4220
Malaria
A protozoan disease caused in humans by four species of the PLASMODIUM genus: PLASMODIUM FALCIPARUM; PLASMODIUM VIVAX; PLASMODIUM OVALE; and PLASMODIUM MALARIAE; and transmitted by the bite of an infected female mosquito of the genus ANOPHELES. Malaria is endemic in parts of Asia, Africa, Central and South America, Oceania, and certain Caribbean islands. It is characterized by extreme exhaustion associated with paroxysms of high FEVER; SWEATING; shaking CHILLS; and ANEMIA. Malaria in ANIMALS is caused by other species of plasmodia.		03.4220
Epidermolysis Bullosa Junctionalis, Disentis Type
[description not available]		02.3110
Epidermolysis Bullosa, Junctional
Form of epidermolysis bullosa having onset at birth or during the neonatal period and transmitted through autosomal recessive inheritance. It is characterized by generalized blister formation, extensive denudation, and separation and cleavage of the basal cell plasma membranes from the basement membrane.		02.3110
Granuloma, Hodgkin
[description not available]		02.3110
Hodgkin Disease
A malignant disease characterized by progressive enlargement of the lymph nodes, spleen, and general lymphoid tissue. In the classical variant, giant usually multinucleate Hodgkin's and REED-STERNBERG CELLS are present; in the nodular lymphocyte predominant variant, lymphocytic and histiocytic cells are seen.		02.3110
Overweight
A status with BODY WEIGHT that is above certain standards. In the scale of BODY MASS INDEX, overweight is defined as having a BMI of 25.0-29.9 kg/m2. Overweight may or may not be due to increases in body fat (ADIPOSE TISSUE), hence overweight does not equal over fat.		03.711
Leanness
[description not available]		03.711
Atherogenesis
[description not available]		07.2772
Atherosclerosis
A thickening and loss of elasticity of the walls of ARTERIES that occurs with formation of ATHEROSCLEROTIC PLAQUES within the ARTERIAL INTIMA.		07.2772
Electrocardiogram QT Prolonged
[description not available]		05.2940
Long QT Syndrome
A condition that is characterized by episodes of fainting (SYNCOPE) and varying degree of ventricular arrhythmia as indicated by the prolonged QT interval. The inherited forms are caused by mutation of genes encoding cardiac ion channel proteins. The two major forms are ROMANO-WARD SYNDROME and JERVELL-LANGE NIELSEN SYNDROME.		05.2940
Kidney Diseases
Pathological processes of the KIDNEY or its component tissues.		09.12123
Apoplexy
[description not available]		03.4320
Stroke
A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)		03.4320
Disease Models, Animal
Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.		03.1950
Alveolitis, Fibrosing
[description not available]		02.1710
Pulmonary Fibrosis
A process in which normal lung tissues are progressively replaced by FIBROBLASTS and COLLAGEN causing an irreversible loss of the ability to transfer oxygen into the bloodstream via PULMONARY ALVEOLI. Patients show progressive DYSPNEA finally resulting in death.		02.1710
Acquired Immune Deficiency Syndrome
[description not available]		011.15207
Infection, Toxoplasma gondii
[description not available]		02.1710
Acquired-Immune Deficiency Syndrome Dementia Complex
[description not available]		04.1531
Cerebral Cryptococcosis
[description not available]		02.1710
Encephalitis, JC Polyomavirus
[description not available]		02.1710
AIDS-Related Opportunistic Infections
Opportunistic infections found in patients who test positive for human immunodeficiency virus (HIV). The most common include PNEUMOCYSTIS PNEUMONIA, Kaposi's sarcoma, cryptosporidiosis, herpes simplex, toxoplasmosis, cryptococcosis, and infections with Mycobacterium avium complex, Microsporidium, and Cytomegalovirus.		05.6361
Acquired Immunodeficiency Syndrome
An acquired defect of cellular immunity associated with infection by the human immunodeficiency virus (HIV), a CD4-positive T-lymphocyte count under 200 cells/microliter or less than 14% of total lymphocytes, and increased susceptibility to opportunistic infections and malignant neoplasms. Clinical manifestations also include emaciation (wasting) and dementia. These elements reflect criteria for AIDS as defined by the CDC in 1993.		011.15207
Leukoencephalopathy, Progressive Multifocal
An opportunistic viral infection of the central nervous system associated with conditions that impair cell-mediated immunity (e.g., ACQUIRED IMMUNODEFICIENCY SYNDROME and other IMMUNOLOGIC DEFICIENCY SYNDROMES; HEMATOLOGIC NEOPLASMS; IMMUNOSUPPRESSION; and COLLAGEN DISEASES). The causative organism is JC Polyomavirus (JC VIRUS) which primarily affects oligodendrocytes, resulting in multiple areas of demyelination. Clinical manifestations include DEMENTIA; ATAXIA; visual disturbances; and other focal neurologic deficits, generally progressing to a vegetative state within 6 months. (From Joynt, Clinical Neurology, 1996, Ch26, pp36-7)		02.1710
Toxoplasmosis
The acquired form of infection by Toxoplasma gondii in animals and man.		02.1710
AIDS Dementia Complex
A neurologic condition associated with the ACQUIRED IMMUNODEFICIENCY SYNDROME and characterized by impaired concentration and memory, slowness of hand movements, ATAXIA, incontinence, apathy, and gait difficulties associated with HIV-1 viral infection of the central nervous system. Pathologic examination of the brain reveals white matter rarefaction, perivascular infiltrates of lymphocytes, foamy macrophages, and multinucleated giant cells. (From Adams et al., Principles of Neurology, 6th ed, pp760-1; N Engl J Med, 1995 Apr 6;332(14):934-40)		04.1531
Meningitis, Cryptococcal
Meningeal inflammation produced by CRYPTOCOCCUS NEOFORMANS, an encapsulated yeast that tends to infect individuals with ACQUIRED IMMUNODEFICIENCY SYNDROME and other immunocompromised states. The organism enters the body through the respiratory tract, but symptomatic infections are usually limited to the lungs and nervous system. The organism may also produce parenchymal brain lesions (torulomas). Clinically, the course is subacute and may feature HEADACHE; NAUSEA; PHOTOPHOBIA; focal neurologic deficits; SEIZURES; cranial neuropathies; and HYDROCEPHALUS. (From Adams et al., Principles of Neurology, 6th ed, pp721-2)		02.1710
Icterus
[description not available]		06.3481
Jaundice
A clinical manifestation of HYPERBILIRUBINEMIA, characterized by the yellowish staining of the SKIN; MUCOUS MEMBRANE; and SCLERA. Clinical jaundice usually is a sign of LIVER dysfunction.		06.3481
Body Weight
The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.		03.1750
Impaired Glucose Tolerance
[description not available]		02.1510
Cardiometabolic Syndrome
A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components not only include metabolic dysfunctions of METABOLIC SYNDROME but also HYPERTENSION, and ABDOMINAL OBESITY.		02.9740
Glucose Intolerance
A pathological state in which BLOOD GLUCOSE level is less than approximately 140 mg/100 ml of PLASMA at fasting, and above approximately 200 mg/100 ml plasma at 30-, 60-, or 90-minute during a GLUCOSE TOLERANCE TEST. This condition is seen frequently in DIABETES MELLITUS, but also occurs with other diseases and MALNUTRITION.		02.1510
Metabolic Syndrome
A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components of metabolic syndrome include ABDOMINAL OBESITY; atherogenic DYSLIPIDEMIA; HYPERTENSION; HYPERGLYCEMIA; INSULIN RESISTANCE; a proinflammatory state; and a prothrombotic (THROMBOSIS) state.		02.9740
Adverse Drug Event
[description not available]		010.031311
Drug-Related Side Effects and Adverse Reactions
Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.		010.031311
Cirrhosis
[description not available]		02.5120
Fibrosis
Any pathological condition where fibrous connective tissue invades any organ, usually as a consequence of inflammation or other injury.		02.5120
Hypertrophy
General increase in bulk of a part or organ due to CELL ENLARGEMENT and accumulation of FLUIDS AND SECRETIONS, not due to tumor formation, nor to an increase in the number of cells (HYPERPLASIA).		02.1710
Leishmania Infection
[description not available]		02.5420
Leishmaniasis
A disease caused by any of a number of species of protozoa in the genus LEISHMANIA. There are four major clinical types of this infection: cutaneous (Old and New World) (LEISHMANIASIS, CUTANEOUS), diffuse cutaneous (LEISHMANIASIS, DIFFUSE CUTANEOUS), mucocutaneous (LEISHMANIASIS, MUCOCUTANEOUS), and visceral (LEISHMANIASIS, VISCERAL).		02.5420
Clerambault Syndrome
[description not available]		03.5611
Metaplasia
A condition in which there is a change of one adult cell type to another similar adult cell type.		02.1710
Interstitial Nephritis
[description not available]		03.1550
Nephritis, Interstitial
Inflammation of the interstitial tissue of the kidney. This term is generally used for primary inflammation of KIDNEY TUBULES and/or surrounding interstitium. For primary inflammation of glomerular interstitium, see GLOMERULONEPHRITIS. Infiltration of the inflammatory cells into the interstitial compartment results in EDEMA, increased spaces between the tubules, and tubular renal dysfunction.		03.1550
Addiction, Opioid
[description not available]		03.6830
Opioid-Related Disorders
Disorders related to or resulting from abuse or misuse of OPIOIDS.		03.6830
AIDS Seroconversion
[description not available]		07.03121
Parasitemia
The presence of parasites (especially malarial parasites) in the blood. (Dorland, 27th ed)		02.2110
Babesia Infection
[description not available]		02.2110
Hyperlipemia
[description not available]		08.59135
Hyperlipidemias
Conditions with excess LIPIDS in the blood.		08.59135
Atrioventricular Conduction Block
[description not available]		02.0810
Atrioventricular Nodal Re-Entrant Tachycardia
[description not available]		03.3820
Tachycardia, Ventricular
An abnormally rapid ventricular rhythm usually in excess of 150 beats per minute. It is generated within the ventricle below the BUNDLE OF HIS, either as autonomic impulse formation or reentrant impulse conduction. Depending on the etiology, onset of ventricular tachycardia can be paroxysmal (sudden) or nonparoxysmal, its wide QRS complexes can be uniform or polymorphic, and the ventricular beating may be independent of the atrial beating (AV dissociation).		03.3820
Atrioventricular Block
Impaired impulse conduction from HEART ATRIA to HEART VENTRICLES. AV block can mean delayed or completely blocked impulse conduction.		02.0810
Acute Liver Injury, Drug-Induced
[description not available]		05.1260
Co-infection
[description not available]		09.97206
Chemical and Drug Induced Liver Injury
A spectrum of clinical liver diseases ranging from mild biochemical abnormalities to ACUTE LIVER FAILURE, caused by drugs, drug metabolites, herbal and dietary supplements and chemicals from the environment.		05.1260
Gallstone Disease
[description not available]		02.7830
Cholelithiasis
Presence or formation of GALLSTONES in the BILIARY TRACT, usually in the gallbladder (CHOLECYSTOLITHIASIS) or the common bile duct (CHOLEDOCHOLITHIASIS).		02.7830
Chronic Kidney Diseases
[description not available]		06.8951
Renal Insufficiency, Chronic
Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)		06.8951
Chronic Kidney Failure
[description not available]		03.6630
Kidney Failure, Chronic
The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.		03.6630
HIV Lipodystrophy Syndrome
[description not available]		09.28152
Aging
The gradual irreversible changes in structure and function of an organism that occur as a result of the passage of time.		06.4731
HIV-Associated Lipodystrophy Syndrome
Defective metabolism leading to fat maldistribution in patients infected with HIV. The etiology appears to be multifactorial and probably involves some combination of infection-induced alterations in metabolism, direct effects of antiretroviral therapy, and patient-related factors.		09.28152
Precordial Catch
[description not available]		02.110
Chest Pain
Pressure, burning, or numbness in the chest.		02.110
Nephrolithiasis
Formation of stones in the KIDNEY.		03.4670
Chronic Hepatitis C
[description not available]		07.7281
Hepatitis C, Chronic
INFLAMMATION of the LIVER in humans that is caused by HEPATITIS C VIRUS lasting six months or more. Chronic hepatitis C can lead to LIVER CIRRHOSIS.		07.7281
Koch's Disease
[description not available]		05.9351
Tuberculosis
Any of the infectious diseases of man and other animals caused by species of MYCOBACTERIUM TUBERCULOSIS.		05.9351
Recrudescence
[description not available]		02.110
Ureteral Calculi
Stones in the URETER that are formed in the KIDNEY. They are rarely more than 5 mm in diameter for larger renal stones cannot enter ureters. They are often lodged at the ureteral narrowing and can cause excruciating renal colic.		02.9840
Cirrhosis, Liver
[description not available]		05.4550
Liver Cirrhosis
Liver disease in which the normal microcirculation, the gross vascular anatomy, and the hepatic architecture have been variably destroyed and altered with fibrous septa surrounding regenerated or regenerating parenchymal nodules.		05.4550
Aura
[description not available]		02.110
Epilepsy
A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313)		02.110
Kidney Stones
[description not available]		03.3160
Kidney Calculi
Stones in the KIDNEY, usually formed in the urine-collecting area of the kidney (KIDNEY PELVIS). Their sizes vary and most contains CALCIUM OXALATE.		03.3160
Aspergilloses, Bronchopulmonary
[description not available]		02.110
Pulmonary Aspergillosis
Infections of the respiratory tract with fungi of the genus ASPERGILLUS.		02.110
Angiogenesis, Pathologic
[description not available]		02.110
Hutchinson Gilford Progeria Syndrome
[description not available]		02.110
Progeria
An abnormal congenital condition, associated with defects in the LAMIN TYPE A gene, which is characterized by premature aging in children, where all the changes of cell senescence occur. It is manifested by premature graying; hair loss; hearing loss (DEAFNESS); cataracts (CATARACT); ARTHRITIS; OSTEOPOROSIS; DIABETES MELLITUS; atrophy of subcutaneous fat; skeletal hypoplasia; elevated urinary HYALURONIC ACID; and accelerated ATHEROSCLEROSIS. Many affected individuals develop malignant tumors, especially SARCOMA.		02.110
Muscular Weakness
[description not available]		02.1110
Muscle Pain
[description not available]		02.1110
Muscle Weakness
A vague complaint of debility, fatigue, or exhaustion attributable to weakness of various muscles. The weakness can be characterized as subacute or chronic, often progressive, and is a manifestation of many muscle and neuromuscular diseases. (From Wyngaarden et al., Cecil Textbook of Medicine, 19th ed, p2251)		02.1110
Myalgia
Painful sensation in the muscles.		02.1110
Autoimmune Diabetes
[description not available]		03.511
Diabetes Mellitus, Type 1
A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.		03.511
Alopecia Cicatrisata
[description not available]		02.7630
Cutaneous T-Cell Lymphoma
[description not available]		02.4920
AIDS-Associated Lymphoma
[description not available]		02.1110
Alopecia
Absence of hair from areas where it is normally present.		02.7630
Lymphoma, T-Cell, Cutaneous
A group of lymphomas exhibiting clonal expansion of malignant T-lymphocytes arrested at varying stages of differentiation as well as malignant infiltration of the skin. MYCOSIS FUNGOIDES; SEZARY SYNDROME; LYMPHOMATOID PAPULOSIS; and PRIMARY CUTANEOUS ANAPLASTIC LARGE CELL LYMPHOMA are the best characterized of these disorders.		02.4920
Lymphoma, AIDS-Related
B-cell lymphoid tumors that occur in association with AIDS. Patients often present with an advanced stage of disease and highly malignant subtypes including BURKITT LYMPHOMA; IMMUNOBLASTIC LARGE-CELL LYMPHOMA; PRIMARY EFFUSION LYMPHOMA; and DIFFUSE, LARGE B-CELL, LYMPHOMA. The tumors are often disseminated in unusual extranodal sites and chromosomal abnormalities are frequently present. It is likely that polyclonal B-cell lymphoproliferation in AIDS is a complex result of EBV infection, HIV antigenic stimulation, and T-cell-dependent HIV activation.		02.1110
Hepatitis B Virus Infection
[description not available]		03.3920
Hepatitis B
INFLAMMATION of the LIVER in humans caused by a member of the ORTHOHEPADNAVIRUS genus, HEPATITIS B VIRUS. It is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.		03.3920
Chronic Hepatitis B
[description not available]		06.260
Hepatitis B, Chronic
INFLAMMATION of the LIVER in humans caused by HEPATITIS B VIRUS lasting six months or more. It is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.		06.260
Genetic Predisposition
[description not available]		04.1330
Amphetamine Abuse
[description not available]		02.1310
Amphetamine-Related Disorders
Disorders related or resulting from use of amphetamines.		02.1310
P carinii Pneumonia
[description not available]		04.821
Central Nervous System Toxoplasmosis
[description not available]		04.4311
Pneumonia, Pneumocystis
A pulmonary disease in humans occurring in immunodeficient or malnourished patients or infants, characterized by DYSPNEA, tachypnea, and HYPOXEMIA. Pneumocystis pneumonia is a frequently seen opportunistic infection in AIDS. It is caused by the fungus PNEUMOCYSTIS JIROVECII. The disease is also found in other MAMMALS where it is caused by related species of Pneumocystis.		04.821
Toxoplasmosis, Cerebral
Infections of the BRAIN caused by the protozoan TOXOPLASMA gondii that primarily arise in individuals with IMMUNOLOGIC DEFICIENCY SYNDROMES (see also AIDS-RELATED OPPORTUNISTIC INFECTIONS). The infection may involve the brain diffusely or form discrete abscesses. Clinical manifestations include SEIZURES, altered mentation, headache, focal neurologic deficits, and INTRACRANIAL HYPERTENSION. (From Joynt, Clinical Neurology, 1998, Ch27, pp41-3)		04.4311
Colicky Pain
[description not available]		02.1310
Acute Porphyria
[description not available]		02.1310
Abdominal Pain
Sensation of discomfort, distress, or agony in the abdominal region.		02.1310
Porphyria, Acute Intermittent
An autosomal dominant porphyria that is due to a deficiency of HYDROXYMETHYLBILANE SYNTHASE in the LIVER, the third enzyme in the 8-enzyme biosynthetic pathway of HEME. Clinical features are recurrent and life-threatening neurologic disturbances, ABDOMINAL PAIN, and elevated level of AMINOLEVULINIC ACID and PORPHOBILINOGEN in the urine.		02.1310
Bradyarrhythmia
[description not available]		02.1310
Cardiac Failure
[description not available]		02.4820
Bradycardia
Cardiac arrhythmias that are characterized by excessively slow HEART RATE, usually below 50 beats per minute in human adults. They can be classified broadly into SINOATRIAL NODE dysfunction and ATRIOVENTRICULAR BLOCK.		02.1310
Heart Failure
A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.		02.4820
Cognition Disorders
Disorders characterized by disturbances in mental processes related to learning, thinking, reasoning, and judgment.		04.7132
Infant, Newborn, Diseases
Diseases of newborn infants present at birth (congenital) or developing within the first month of birth. It does not include hereditary diseases not manifesting at birth or within the first 30 days of life nor does it include inborn errors of metabolism. Both HEREDITARY DISEASES and METABOLISM, INBORN ERRORS are available as general concepts.		02.1310
Proteinuria
The presence of proteins in the urine, an indicator of KIDNEY DISEASES.		03.7330
Black Fever
[description not available]		02.1310
Leishmaniasis, Visceral
A chronic disease caused by LEISHMANIA DONOVANI and transmitted by the bite of several sandflies of the genera Phlebotomus and Lutzomyia. It is commonly characterized by fever, chills, vomiting, anemia, hepatosplenomegaly, leukopenia, hypergammaglobulinemia, emaciation, and an earth-gray color of the skin. The disease is classified into three main types according to geographic distribution: Indian, Mediterranean (or infantile), and African.		02.1310
Elevated Cholesterol
[description not available]		05.5932
Hypercholesterolemia
A condition with abnormally high levels of CHOLESTEROL in the blood. It is defined as a cholesterol value exceeding the 95th percentile for the population.		05.5932
Albuminuria
The presence of albumin in the urine, an indicator of KIDNEY DISEASES.		02.1310
Achlorhydria
A lack of HYDROCHLORIC ACID in GASTRIC JUICE despite stimulation of gastric secretion.		03.5311
Chemical Dependence
[description not available]		02.9740
Substance-Related Disorders
Disorders related to substance use or abuse.		02.9740
Calculosis
[description not available]		02.7730
Biliary Tract Diseases
Diseases in any part of the BILIARY TRACT including the BILE DUCTS and the GALLBLADDER.		02.5120
Sensitivity and Specificity
Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)		03.9120
Ureteral Obstruction
Blockage in any part of the URETER causing obstruction of urine flow from the kidney to the URINARY BLADDER. The obstruction may be congenital, acquired, unilateral, bilateral, complete, partial, acute, or chronic. Depending on the degree and duration of the obstruction, clinical features vary greatly such as HYDRONEPHROSIS and obstructive nephropathy.		02.0410
Cardiac Diseases
[description not available]		02.4420
Heart Diseases
Pathological conditions involving the HEART including its structural and functional abnormalities.		02.4420
Central Nervous System Disease
[description not available]		02.9610
Allergy, Drug
[description not available]		03.8420
Central Nervous System Diseases
Diseases of any component of the brain (including the cerebral hemispheres, diencephalon, brain stem, and cerebellum) or the spinal cord.		02.9610
Drug Hypersensitivity
Immunologically mediated adverse reactions to medicinal substances used legally or illegally.		03.8420
Liver Dysfunction
[description not available]		05.531
Liver Diseases
Pathological processes of the LIVER.		05.531
Infections, Retroviridae
[description not available]		02.9610
Retroviridae Infections
Virus diseases caused by the RETROVIRIDAE.		02.9610
Viremia
The presence of viruses in the blood.		08.4486
Coronary Heart Disease
[description not available]		05.4451
Coronary Disease
An imbalance between myocardial functional requirements and the capacity of the CORONARY VESSELS to supply sufficient blood flow. It is a form of MYOCARDIAL ISCHEMIA (insufficient blood supply to the heart muscle) caused by a decreased capacity of the coronary vessels.		05.4451
Chronic Delta Hepatitis
[description not available]		03.3620
Hepatic Failure
[description not available]		02.0510
Liver Failure
Severe inability of the LIVER to perform its normal metabolic functions, as evidenced by severe JAUNDICE and abnormal serum levels of AMMONIA; BILIRUBIN; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; LACTATE DEHYDROGENASES; and albumin/globulin ratio. (Blakiston's Gould Medical Dictionary, 4th ed)		02.0510
Torsade de Pointes
[description not available]		03.3620
Great Pox
[description not available]		02.0510
Hepatitis
INFLAMMATION of the LIVER.		02.4620
Syphilis
A contagious venereal disease caused by the spirochete TREPONEMA PALLIDUM.		02.0510
Inner Ear Disease
[description not available]		02.0510
Parotid Diseases
Diseases involving the PAROTID GLAND.		02.0510
Labyrinth Diseases
Pathological processes of the inner ear (LABYRINTH) which contains the essential apparatus of hearing (COCHLEA) and balance (SEMICIRCULAR CANALS).		02.0510
Birth Weight
The mass or quantity of heaviness of an individual at BIRTH. It is expressed by units of pounds or kilograms.		02.0510
Biliary Calculi
[description not available]		02.0510
Choledocholithiasis
Presence or formation of GALLSTONES in the COMMON BILE DUCT.		02.0510
Acute Disease
Disease having a short and relatively severe course.		02.7230
Gallstones
Solid crystalline precipitates in the BILIARY TRACT, usually formed in the GALLBLADDER, resulting in the condition of CHOLELITHIASIS. Gallstones, derived from the BILE, consist mainly of calcium, cholesterol, or bilirubin.		02.0510
Viral Diseases
[description not available]		02.0510
Virus Diseases
A general term for diseases caused by viruses.		02.0510
Cholera Infantum
[description not available]		05.7241
Compensatory Hyperinsulinemia
A GLUCOSE-induced HYPERINSULINEMIA, a marker of insulin-resistant state. It is a mechanism to compensate for reduced sensitivity to insulin.		02.9610
Hyperinsulinism
A syndrome with excessively high INSULIN levels in the BLOOD. It may cause HYPOGLYCEMIA. Etiology of hyperinsulinism varies, including hypersecretion of a beta cell tumor (INSULINOMA); autoantibodies against insulin (INSULIN ANTIBODIES); defective insulin receptor (INSULIN RESISTANCE); or overuse of exogenous insulin or HYPOGLYCEMIC AGENTS.		02.9610
Direct Hyperbilirubinemia, Neonatal
[description not available]		03.3720
Pyrexia
[description not available]		04.3611
Opportunistic Infections
An infection caused by an organism which becomes pathogenic under certain conditions, e.g., during immunosuppression.		04.3611
Fever
An abnormal elevation of body temperature, usually as a result of a pathologic process.		04.3611
Nausea
An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.		06.532
Viral Hepatitis, Human
[description not available]		02.0510
Hepatitis, Viral, Human
INFLAMMATION of the LIVER in humans due to infection by VIRUSES. There are several significant types of human viral hepatitis with infection caused by enteric-transmission (HEPATITIS A; HEPATITIS E) or blood transfusion (HEPATITIS B; HEPATITIS C; and HEPATITIS D).		02.0510
Colitis, Mucous
[description not available]		03.4411
Irritable Bowel Syndrome
A disorder with chronic or recurrent colonic symptoms without a clearcut etiology. This condition is characterized by chronic or recurrent ABDOMINAL PAIN, bloating, MUCUS in FECES, and an erratic disturbance of DEFECATION.		03.4411
American Trypanosomiasis
[description not available]		02.0610
Chagas Disease
Infection with the protozoan parasite TRYPANOSOMA CRUZI, a form of TRYPANOSOMIASIS endemic in Central and South America. It is named after the Brazilian physician Carlos Chagas, who discovered the parasite. Infection by the parasite (positive serologic result only) is distinguished from the clinical manifestations that develop years later, such as destruction of PARASYMPATHETIC GANGLIA; CHAGAS CARDIOMYOPATHY; and dysfunction of the ESOPHAGUS or COLON.		02.0610
Diabetes Mellitus, Adult-Onset
[description not available]		03.4511
Diabetes Mellitus, Type 2
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.		03.4511
Autosomal Recessive Chronic Granulomatous Disease
[description not available]		02.0610
Granulomatous Disease, Chronic
A defect of leukocyte function in which phagocytic cells ingest but fail to digest bacteria, resulting in recurring bacterial infections with granuloma formation. When chronic granulomatous disease is caused by mutations in the CYBB gene, the condition is inherited in an X-linked recessive pattern. When chronic granulomatous disease is caused by CYBA, NCF1, NCF2, or NCF4 gene mutations, the condition is inherited in an autosomal recessive pattern.		02.0610
Chronic Liver Failure
[description not available]		02.0610
End Stage Liver Disease
Final stage of a liver disease when the liver failure is irreversible and LIVER TRANSPLANTATION is needed.		02.0610
Urinary Calculi
Low-density crystals or stones in any part of the URINARY TRACT. Their chemical compositions often include CALCIUM OXALATE, magnesium ammonium phosphate (struvite), CYSTINE, or URIC ACID.		02.0610
Deep Vein Thrombosis
[description not available]		02.0610
Venous Thrombosis
The formation or presence of a blood clot (THROMBUS) within a vein.		02.0610
Icterus Gravis Neonatorum
[description not available]		02.0610
Jaundice, Neonatal
Yellow discoloration of the SKIN; MUCOUS MEMBRANE; and SCLERA in the NEWBORN. It is a sign of NEONATAL HYPERBILIRUBINEMIA. Most cases are transient self-limiting (PHYSIOLOGICAL NEONATAL JAUNDICE) occurring in the first week of life, but some can be a sign of pathological disorders, particularly LIVER DISEASES.		02.0610
Encephalitis, Viral
Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.		02.0710
Cushing's Syndrome
[description not available]		02.9640
Cushing Syndrome
A condition caused by prolonged exposure to excess levels of cortisol (HYDROCORTISONE) or other GLUCOCORTICOIDS from endogenous or exogenous sources. It is characterized by upper body OBESITY; OSTEOPOROSIS; HYPERTENSION; DIABETES MELLITUS; HIRSUTISM; AMENORRHEA; and excess body fluid. Endogenous Cushing syndrome or spontaneous hypercortisolism is divided into two groups, those due to an excess of ADRENOCORTICOTROPIN and those that are ACTH-independent.		02.9640
Bone Fractures
[description not available]		04.3711
Age-Related Osteoporosis
[description not available]		04.3711
Osteoporosis
Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.		04.3711
Fractures, Bone
Breaks in bones.		04.3711
Acute Confusional Senile Dementia
[description not available]		02.0710
Alzheimer Disease
A degenerative disease of the BRAIN characterized by the insidious onset of DEMENTIA. Impairment of MEMORY, judgment, attention span, and problem solving skills are followed by severe APRAXIAS and a global loss of cognitive abilities. The condition primarily occurs after age 60, and is marked pathologically by severe cortical atrophy and the triad of SENILE PLAQUES; NEUROFIBRILLARY TANGLES; and NEUROPIL THREADS. (From Adams et al., Principles of Neurology, 6th ed, pp1049-57)		02.0710
Kaposi Sarcoma
[description not available]		02.4620
Sarcoma, Kaposi
A multicentric, malignant neoplastic vascular proliferation characterized by the development of bluish-red cutaneous nodules, usually on the lower extremities, most often on the toes or feet, and slowly increasing in size and number and spreading to more proximal areas. The tumors have endothelium-lined channels and vascular spaces admixed with variably sized aggregates of spindle-shaped cells, and often remain confined to the skin and subcutaneous tissue, but widespread visceral involvement may occur. Kaposi's sarcoma occurs spontaneously in Jewish and Italian males in Europe and the United States. An aggressive variant in young children is endemic in some areas of Africa. A third form occurs in about 0.04% of kidney transplant patients. There is also a high incidence in AIDS patients. (From Dorland, 27th ed & Holland et al., Cancer Medicine, 3d ed, pp2105-7) HHV-8 is the suspected cause.		02.4620
Hospital-Acquired Condition
[description not available]		02.4620
Adrenal Gland Hypofunction
[description not available]		02.4520
Itching
[description not available]		02.0610
Adrenal Insufficiency
Conditions in which the production of adrenal CORTICOSTEROIDS falls below the requirement of the body. Adrenal insufficiency can be caused by defects in the ADRENAL GLANDS, the PITUITARY GLAND, or the HYPOTHALAMUS.		02.4520
Pruritus
An intense itching sensation that produces the urge to rub or scratch the skin to obtain relief.		02.0610
Actinomycetoma
[description not available]		02.0610
Mycetoma
A chronic progressive subcutaneous infection caused by species of fungi (eumycetoma), or actinomycetes (actinomycetoma). It is characterized by tumefaction, abscesses, and tumor-like granules representing microcolonies of pathogens, such as MADURELLA fungi and bacteria ACTINOMYCETES, with different grain colors.		02.0610
Anemia, Hemolytic, Acquired
[description not available]		02.0710
Anemia, Hemolytic
A condition of inadequate circulating red blood cells (ANEMIA) or insufficient HEMOGLOBIN due to premature destruction of red blood cells (ERYTHROCYTES).		02.0710
Constitutional Liver Dysfunction
[description not available]		03.6530
Deficiency of Glucose-6-Phosphate Dehydrogenase
[description not available]		02.0710
Glucosephosphate Dehydrogenase Deficiency
A disease-producing enzyme deficiency subject to many variants, some of which cause a deficiency of GLUCOSE-6-PHOSPHATE DEHYDROGENASE activity in erythrocytes, leading to hemolytic anemia.		02.0710
Cancer of Stomach
[description not available]		02.0710
Extranodal NK-T-Cell Lymphoma
[description not available]		02.0710
Stomach Neoplasms
Tumors or cancer of the STOMACH.		02.0710
Besnier-Boeck Disease
[description not available]		02.0710
Sarcoidosis
An idiopathic systemic inflammatory granulomatous disorder comprised of epithelioid and multinucleated giant cells with little necrosis. It usually invades the lungs with fibrosis and may also involve lymph nodes, skin, liver, spleen, eyes, phalangeal bones, and parotid glands.		02.0710
Abnormalities, Drug-Induced
Congenital abnormalities caused by medicinal substances or drugs of abuse given to or taken by the mother, or to which she is inadvertently exposed during the manufacture of such substances. The concept excludes abnormalities resulting from exposure to non-medicinal chemicals in the environment.		02.0710
Hyperplasia, Reactive Lymphoid
[description not available]		02.0710
Drug Abuse, Intravenous
[description not available]		02.0710
Leishmaniasis, American
[description not available]		02.0710
Leishmaniasis, Cutaneous
An endemic disease that is characterized by the development of single or multiple localized lesions on exposed areas of skin that typically ulcerate. The disease has been divided into Old and New World forms. Old World leishmaniasis is separated into three distinct types according to epidemiology and clinical manifestations and is caused by species of the L. tropica and L. aethiopica complexes as well as by species of the L. major genus. New World leishmaniasis, also called American leishmaniasis, occurs in South and Central America and is caused by species of the L. mexicana or L. braziliensis complexes.		02.0710
Biliary or Urinary Stones
[description not available]		02.0710
Glycosuria
The appearance of an abnormally large amount of GLUCOSE in the urine, such as more than 500 mg/day in adults. It can be due to HYPERGLYCEMIA or genetic defects in renal reabsorption (RENAL GLYCOSURIA).		02.0810
Salivary Gland Calculi
Calculi occurring in a salivary gland. Most salivary gland calculi occur in the submandibular gland, but can also occur in the parotid gland and in the sublingual and minor salivary glands.		02.0810
Palmoplantaris Pustulosis
[description not available]		02.9910
Psoriasis
A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.		02.9910
Bilateral Headache
[description not available]		03.3320
Headache
The symptom of PAIN in the cranial region. It may be an isolated benign occurrence or manifestation of a wide variety of HEADACHE DISORDERS.		03.3320
Lactic Acidosis
[description not available]		04.3111
Acidosis, Lactic
Acidosis caused by accumulation of lactic acid more rapidly than it can be metabolized. It may occur spontaneously or in association with diseases such as DIABETES MELLITUS; LEUKEMIA; or LIVER FAILURE.		04.3111
Aneurysm, False
Not an aneurysm but a well-defined collection of blood and CONNECTIVE TISSUE outside the wall of a blood vessel or the heart. It is the containment of a ruptured blood vessel or heart, such as sealing a rupture of the left ventricle. False aneurysm is formed by organized THROMBUS and HEMATOMA in surrounding tissue.		02.0210
Blood Loss, Postoperative
[description not available]		02.0210
Group A Strep Infection
[description not available]		02.0210
Streptococcal Infections
Infections with bacteria of the genus STREPTOCOCCUS.		02.0210
Esophageal Reflux
[description not available]		02.0210
Gastroesophageal Reflux
Retrograde flow of gastric juice (GASTRIC ACID) and/or duodenal contents (BILE ACIDS; PANCREATIC JUICE) into the distal ESOPHAGUS, commonly due to incompetence of the LOWER ESOPHAGEAL SPHINCTER.		02.0210
Hypertriglyceridemia
A condition of elevated levels of TRIGLYCERIDES in the blood.		03.8221
Sex Disorders
[description not available]		02.4320
Sexual Dysfunction, Physiological
Physiological disturbances in normal sexual performance in either the male or the female.		02.4320
Dermatitis Medicamentosa
[description not available]		02.4320
Blood Pressure, High
[description not available]		02.0310
Hypertension
Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.		02.0310
Behavior Disorders
[description not available]		02.9410
Mental Disorders
Psychiatric illness or diseases manifested by breakdowns in the adaptational process expressed primarily as abnormalities of thought, feeling, and behavior producing either distress or impairment of function.		02.9410
Hydronephrosis
Abnormal enlargement or swelling of a KIDNEY due to dilation of the KIDNEY CALICES and the KIDNEY PELVIS. It is often associated with obstruction of the URETER or chronic kidney diseases that prevents normal drainage of urine into the URINARY BLADDER.		02.0310
Congenital Thrombotic Thrombocytopenic Purpura
[description not available]		02.0310
Purpura, Thrombotic Thrombocytopenic
An acquired, congenital, or familial disorder caused by PLATELET AGGREGATION with THROMBOSIS in terminal arterioles and capillaries. Clinical features include THROMBOCYTOPENIA; HEMOLYTIC ANEMIA; AZOTEMIA; FEVER; and thrombotic microangiopathy. The classical form also includes neurological symptoms and end-organ damage, such as RENAL FAILURE. Mutations in the ADAMTS13 PROTEIN gene have been identified in familial cases.		02.0310
Emesis
[description not available]		03.4211
Vomiting
The forcible expulsion of the contents of the STOMACH through the MOUTH.		03.4211
Anterior Fascicular Block
[description not available]		02.0310
Heavy Menstrual Bleeding
[description not available]		02.0310
Menorrhagia
Excessive uterine bleeding during MENSTRUATION.		02.0310
Glial Cell Tumors
[description not available]		02.0310
Glioma
Benign and malignant central nervous system neoplasms derived from glial cells (i.e., astrocytes, oligodendrocytes, and ependymocytes). Astrocytes may give rise to astrocytomas (ASTROCYTOMA) or glioblastoma multiforme (see GLIOBLASTOMA). Oligodendrocytes give rise to oligodendrogliomas (OLIGODENDROGLIOMA) and ependymocytes may undergo transformation to become EPENDYMOMA; CHOROID PLEXUS NEOPLASMS; or colloid cysts of the third ventricle. (From Escourolle et al., Manual of Basic Neuropathology, 2nd ed, p21)		02.0310
Cardiomyopathy, Congestive
[description not available]		02.0410
Edema, Pulmonary
[description not available]		02.0410
Cardiomyopathy, Dilated
A form of CARDIAC MUSCLE disease that is characterized by ventricular dilation, VENTRICULAR DYSFUNCTION, and HEART FAILURE. Risk factors include SMOKING; ALCOHOL DRINKING; HYPERTENSION; INFECTION; PREGNANCY; and mutations in the LMNA gene encoding LAMIN TYPE A, a NUCLEAR LAMINA protein.		02.0410
Pulmonary Edema
Excessive accumulation of extravascular fluid in the lung, an indication of a serious underlying disease or disorder. Pulmonary edema prevents efficient PULMONARY GAS EXCHANGE in the PULMONARY ALVEOLI, and can be life-threatening.		02.0410