Page last updated: 2024-12-08

abacavir

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Description

abacavir: a carbocyclic nucleoside with potent selective anti-HIV activity [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

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. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID441300
CHEMBL ID1380
CHEBI ID421707
SCHEMBL ID38632
MeSH IDM0277557

Synonyms (72)

Synonym
(1s,4r)-4-(2-amino-6-(cyclopropylamino)-9h-purin-9-yl)-2-cyclopentene-1-methanol
(-)-cis-4-(2-amino-6-(cyclopropylamino)-9h-purin-9-yl)-2-cyclopentene-1-methanol
AC-1299
avacavir
ziagen
abacavir (inn)
D07057
[(1s,4r)-4-[2-amino-6-(cyclopropylamino)purin-9-yl]cyclopent-2-en-1-yl]methanol
1592u89
(+/-)-abacavir
(+/-)-4-[2-amino-6-(cyclopropylamino)-9h-purin-9-yl]-2-cyclopentene-1-methanol
(1s,4r)-4-[2-amino-6-(cyclopropylamino)-9h-purin-9-yl]-2-cyclopentene-1-methanol
ABC ,
ziagen (tm)(*succinate salt*)
abacavir
C07624
136470-78-5
{(1s-cis)-4-[2-amino-6-(cyclopropylamino)-9h-purin-9-yl]cyclopent-2-en-1-yl}methanol
DB01048
NCGC00164560-01
NCGC00164560-02
2-cyclopentene-1-methanol, 4-(2-amino-6-(cyclopropylamino)-9h-purin-9-yl)-, (1s,4r)-
abacavir [inn:ban]
2-cyclopentene-1-methanol, 4-(2-amino-6-(cyclopropylamino)-9h-purin-9-yl)-, (1s-cis)-
abacavir [inn]
CHEMBL1380
nsc-742406
chebi:421707 ,
A807079
[(1s,4r)-4-[2-amino-6-(cyclopropylamino)purin-9-yl]cyclopent-2-en-1-yl]methanol;abacavir
{(1s,4r)-4-[2-amino-6-(cyclopropylamino)-9h-purin-9-yl]cyclopent-2-en-1-yl}methanol
136777-48-5
nsc 742406
wr2tip26vs ,
unii-wr2tip26vs
dtxsid4046444 ,
bdbm50366816
HY-17423
CS-1354
avacavir [vandf]
abacavir [vandf]
abacavir [ema epar]
abacavir [who-dd]
abacavir [mi]
abacavir [mart.]
EPITOPE ID:137341
S5215
MLS006010117
smr004701251
SCHEMBL38632
J-700136
[(1s,4r)-4-[2-amino-6-(cyclopropylamino)purin-9-yl]-1-cyclopent-2-enyl]methanol
MCGSCOLBFJQGHM-SCZZXKLOSA-N
(+/-)-cis-4-[2-amino-6-(cyclopropylamino)-9h-purin-9-yl]-2-cyclopentene-1-methanol
AKOS024464970
AB01566826_01
mfcd00903850
[(1s,4r)-4-[2-amino-6-(cyclopropylamino)-9h-purin-9-yl]cyclopent-2-en-1-yl]methanol
gtpl11152
2-cyclopentene-1-methanol, 4-[2-amino-6-(cyclopropylamino)-9h-purin-9-yl]-, (1s,4r)-
((1s,4r)-4-(2-amino-6-(cyclopropylamino)-9h-purin-9-yl)cyclopent-2-en-1-yl)methanol
((1s,4r)-4-(2-amino-6-(cyclopropylamino)-9h-purin-9-yl)cyclopent-2-enyl)methanol
BCP07728
Q304330
DT-0030
CCG-267342
NCGC00164560-05
A905952
NCGC00164560-17
SRCA-00004
BA166801
EN300-258000

Research Excerpts

Overview

Abacavir is a nucleoside reverse transcriptase inhibitor that is used as a component of the antiretroviral treatment regimen in the management of the human immunodeficiency virus for both adults and children. It can produce a severe hypersensitivity reaction (ABC-HSR) in about 5% of the patients.

ExcerptReferenceRelevance
"Abacavir is a nucleoside reverse transcriptase inhibitor recommended in paediatric HIV care. "( Safety and efficacy of abacavir for treating infants, children, and adolescents living with HIV: a systematic review and meta-analysis.
Jesson, J; Leroy, V; O'Rourke, J; Penazzato, M; Renaud, F; Revegue, MHDT; Saint-Lary, L; Townsend, CL, 2022
)
2.47
"Abacavir is a nucleoside reverse transcriptase inhibitor that is used as a component of the antiretroviral treatment regimen in the management of the human immunodeficiency virus for both adults and children. "( Severe abacavir hypersensitivity reaction in a patient with human immunodeficiency virus infection: a case report.
Ali, SM; Karoney, MJ; Kigen, G; Koech, MK, 2022
)
2.62
"Abacavir is a potential option for prophylaxis and early treatment of human immunodeficiency virus (HIV), but no data are available in neonates. "( Single Dose Abacavir Pharmacokinetics and Safety in Neonates Exposed to Human Immunodeficiency Virus (HIV).
Bekker, A; Cotton, MF; Cressey, TR; Decloedt, EH; Rabie, H; Slade, G, 2021
)
2.44
"Abacavir (ABC) is an HIV nucleotide-analogue reverse transcriptase inhibitor that can produce a severe hypersensitivity reaction (ABC-HSR) in about 5% of the patients. "( HCP5 rs2395029 is a rapid and inexpensive alternative to HLA-B*57:01 genotyping to predict abacavir hypersensitivity reaction in Spain.
Abad-Santos, F; Koller, D; Navares-Gómez, M; Saiz-Rodríguez, M; Villapalos-García, G; Zubiaur, P, 2021
)
2.28
"Abacavir is an effective antiretroviral drug and one of the most commonly used nucleoside reverse transcriptase inhibitors in Serbia. "( High Frequency of Human Leukocyte Antigen-B*57:01 Allele Carriers among HIV-Infected Patients in Serbia.
Cirkovic, V; Dragovic, G; Jevtovic, D; Pesic-Pavlovic, I; Ranin, J; Salemovic, D; Siljic, M; Stanojevic, M; Todorovic, M, 2017
)
1.9
"Abacavir is a widely used nucleotide reverse transcriptase inhibitor, for which cerebrospinal fluid (CSF) exposure has been previously assessed in twice-daily recipients. "( Cerebrospinal fluid abacavir concentrations in HIV-positive patients following once-daily administration.
Antinori, A; Bonora, S; Calcagno, A; D'Avolio, A; De Nicolò, A; Di Perri, G; Fedele, V; Gisslen, M; Pinnetti, C; Scarvaglieri, E; Tempestilli, M, 2018
)
2.25
"Abacavir is an antiretroviral drug used to reduce human immunodeficiency virus (HIV) replication and decrease the risk of developing acquired immune deficiency syndrome (AIDS). "( The Role of Conformational Dynamics in Abacavir-Induced Hypersensitivity Syndrome.
Borg, NA; Buckle, AM; Fodor, J; Kass, I; Riley, BT, 2019
)
2.23
"Abacavir is a nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of human immunodeficiency virus infection as part of a multidrug, highly active antiretroviral therapy regimen. "( Abacavir pharmacogenetics--from initial reports to standard of care.
Kroetz, DL; Martin, MA, 2013
)
3.28
"Abacavir is a nucleoside reverse transcriptase inhibitor indicated for human immunodeficiency virus (HIV) infection. "( Safety analysis of Ziagen® (abacavir sulfate) in postmarketing surveillance in Japan.
Kitaichi, T; Kitazono, Y; Kurita, T; Miura, T; Nagao, T, 2014
)
2.14
"Abacavir (ABC) is a commonly used nucleoside reverse-transcriptase inhibitor with potent antiviral activity against HIV-1. "( Development of multiplex pyrosequencing for HLA-B*57:01 screening using single nucleotide polymorphism haplotype.
Chantarangsu, S; Chantratita, W; Kiertiburanakul, S; Lulitanond, V; Sankuntaw, N; Sungkanuparph, S, 2014
)
1.85
"Abacavir is a nucleoside reverse transcriptase inhibitor used as part of combination antiretroviral therapy in HIV-1-infected patients. "( Comparison of methods for in-house screening of HLA-B*57:01 to prevent abacavir hypersensitivity in HIV-1 care.
Bonczkowski, P; Callens, S; Coucke, P; De Spiegelaere, W; De Wit, S; Emonds, MP; Kabeya, K; Kiselinova, M; Malatinkova, E; Philippé, J; Ruelle, J; Sermijn, E; Trypsteen, W; Van Acker, P; Van Sandt, V; Vandekerckhove, L; Verhofstede, C; Vervisch, K; Vogelaers, D, 2015
)
2.09
"Abacavir is a potent nucleoside analog reverse transcriptase inhibitor approved for the treatment of HIV infection. "( Current trends in screening across ethnicities for hypersensitivity to abacavir.
Rodriguez-Nóvoa, S; Soriano, V, 2008
)
2.02
"Abacavir is a nucleoside reverse transcriptase inhibitor (NRTI) that is used in combination antiretroviral therapy in HIV-infected patients. "( Successful implementation of a national HLA-B*5701 genetic testing service in Canada.
Angel, JB; Gill, MJ; Higgins, N; Lalonde, RG; Rachlis, A; Roger, M; Smith, G; Thomas, R; Trottier, B, 2010
)
1.8
"Abacavir (ABC) is a guanosine nucleoside reverse transcriptase inhibitor (NRTI) with potent antiretroviral activity. "( Absence of mitochondrial toxicity in hearts of transgenic mice treated with abacavir.
Abuin, A; Fields, E; Green, E; Hosseini, SH; Kohler, JJ; Lewis, W; Ludaway, T; Russ, R, 2010
)
2.03
"Abacavir (ABC) is an antiretroviral drug highly effective in the treatment of HIV, but its intake can cause severe hypersensitivity reaction (HSR). "( A fluorescence-based sequence-specific primer PCR for the screening of HLA-B(*)57:01.
Bramanti, P; Foti Cuzzola, V; Gambardella, S; Giardina, E; Novelli, G; Patrizi, MP; Pirazzoli, A; Stocchi, L; Zampatti, S, 2010
)
1.8
"Abacavir is a nucleoside reverse transcriptase inhibitor marketed since 1999 for the treatment of infection with the human immunodeficiency virus type 1 (HIV). "( Reactive aldehyde metabolites from the anti-HIV drug abacavir: amino acid adducts as possible factors in abacavir toxicity.
Antunes, AM; Charneira, C; Godinho, AL; Marques, MM; Monteiro, EC; Oliveira, MC; Pereira, SA, 2011
)
2.06
"Abacavir is an effective nucleoside analog reverse transcriptase inhibitor used to treat human immunodeficiency virus (HIV) infected patients. "( Studies on abacavir-induced hypersensitivity reaction: a successful example of translation of pharmacogenetics to personalized medicine.
Fuscoe, J; Guo, Y; Hong, H; Ning, B; Shi, L; Su, Z, 2013
)
2.22
"Abacavir (ZIAGEN) is a reverse transcriptase inhibitor marketed for the treatment of HIV-1 infection. "( The metabolic activation of abacavir by human liver cytosol and expressed human alcohol dehydrogenase isozymes.
Reese, MJ; Thurmond, LM; Walsh, JS, 2002
)
2.05
"Abacavir sulfate is a recent addition to the nucleoside reverse-transcriptase inhibitor class of antiretroviral agents used in the treatment of HIV infection. "( The abacavir hypersensitivity reaction: a review.
Clay, PG, 2002
)
2.32
"Abacavir is a nucleoside analogue reverse transcriptase inhibitor used in combination with other antiretroviral drugs for the treatment of HIV 1-infection. "( Enanthema as the first clinical manifestation of abacavir hypersensitivity reaction: a case report.
Concia, E; Faggian, F; Lanzafame, M; Lattuada, E; Trevenzoli, M; Vento, S, 2003
)
2.02
"Abacavir is an effective antiretroviral drug used to treat HIV-1 infection. "( Association of genetic variations in HLA-B region with hypersensitivity to abacavir in some, but not all, populations.
Bansal, AT; Davies, K; Haneline, SA; Hughes, AR; Lai, EH; Mosteller, M; Nangle, K; Roses, AD; Scott, T; Spreen, WR; Warren, LL, 2004
)
2
"Abacavir (ABC) is a generally well-tolerated NRTI. "( [Risk factors for Abacavir-induced hypersensibility syndrome in the "real world"].
Chirouze, C; Drobacheff, C; Estavoyer, JM; Faller, JP; Gil, H; Hénon, T; Hoen, B; Hustache-Mathieu, L; Lebrun, C; Rougeot, C, 2004
)
2.1
"Abacavir sulfate is a synthetic carbocyclic nucleoside analogue indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. "( Bioequivalence of abacavir generic and innovator formulations under fasting and fed conditions.
Borges, M; Dimarco, M; Garg, M; Marier, JF; Monif, T; Morelli, G; Plante, G; Singla, AK; Tippabhotla, SK; Vijan, T, 2006
)
2.11
"Abacavir is a carbocyclic 2'-deoxyguanosine nucleoside reverse transcriptase inhibitor that is used as either a 600-mg once-daily or 300-mg twice-daily regimen exclusively in the treatment of HIV infection. "( A review of the pharmacokinetics of abacavir.
Pakes, GE; Weller, S; Yuen, GJ, 2008
)
2.06
"Abacavir is a nucleoside analogue reverse transcriptase inhibitor that inhibits clinical isolates of HIV in vitro with a potency similar to that of zidovudine. "( Abacavir.
Faulds, D; Foster, RH, 1998
)
3.19
"Abacavir (1592U89) is a nucleoside analog reverse transcriptase inhibitor that has been demonstrated to have selective activity against human immunodeficiency virus (HIV) in vitro and favorable safety profiles in mice and monkeys. "( Safety and pharmacokinetics of abacavir (1592U89) following oral administration of escalating single doses in human immunodeficiency virus type 1-infected adults.
Hetherington, S; Kumar, PN; LaFon, S; Lou, Y; McDowell, JA; Sweet, DE; Symonds, W, 1999
)
2.03
"Abacavir is a nucleoside analogue reverse transcriptase inhibitor (NRTI). "( Coming therapies: abacavir.
Staszewski, S, 1999
)
2.08
"Abacavir is a novel nucleoside reverse transcriptase inhibitor for the treatment of HIV-1 infection. "( Quantitative determination of abacavir (1592U89), a novel nucleoside reverse transcriptase inhibitor, in human plasma using isocratic reversed-phase high-performance liquid chromatography with ultraviolet detection.
Beijnen, JH; Hoetelmans, RM; Sparidans, RW; Veldkamp, AI, 1999
)
2.03
"Abacavir (1592U89) is a nucleoside inhibitor of human immunodeficiency virus (HIV) type 1 reverse transcriptase (RT). "( Resistance profile of the human immunodeficiency virus type 1 reverse transcriptase inhibitor abacavir (1592U89) after monotherapy and combination therapy. CNA2001 Investigative Group.
Bloor, S; Griffin, P; Harrigan, PR; Kemp, S; Larder, B; Nájera, I; Stone, C; Tisdale, M, 2000
)
1.97
"Abacavir (1592U89) is a nucleoside reverse transcriptase inhibitor with potent activity against human immunodeficiency virus type 1 (HIV-1) when used alone or in combination with other antiretroviral agents. "( Multiple-dose pharmacokinetics and pharmacodynamics of abacavir alone and in combination with zidovudine in human immunodeficiency virus-infected adults.
Lou, Y; McDowell, JA; Stein, DS; Symonds, WS, 2000
)
2
"Abacavir is a carbocyclic 2'-deoxyguanosine nucleoside analogue. "( Abacavir: a review of its clinical potential in patients with HIV infection.
Hervey, PS; Perry, CM, 2000
)
3.19
"Abacavir (ABC) is a potent inhibitor of human immunodeficiency virus type 1 (HIV-1) reverse transcriptase. "( A randomized, double-blind study of triple nucleoside therapy of abacavir, lamivudine, and zidovudine versus lamivudine and zidovudine in previously treated human immunodeficiency virus type 1-infected children. The CNAA3006 Study Team.
Church, JA; Cutrell, A; Emmanuel, P; Hetherington, S; Mitchell, C; Nelson, RP; Richardson, CG; Sáez-Llorens, X; Sleasman, J; Spreen, W; Van Dyke, R; Wiznia, A, 2001
)
1.99
"Abacavir is a relatively safe drug, however, approximately 3 percent of people taking abacavir, have suffered from severe allergic reactions."( Abacavir's trials and tribulations.
Gilden, D, 1998
)
2.46
"Abacavir is a potent, novel 2'-deoxyguanosine analogue reverse transcriptase inhibitor (NRTI) which effectively suppresses HIV-1 replication. "( Pharmacokinetics of abacavir in HIV-1-infected patients with impaired renal function.
Aymard, G; Deray, G; Izzedine, H; Launay-Vacher, V; Legrand, M, 2001
)
2.08
"Abacavir (ABC) is a potent nucleoside reverse transcriptase inhibitor (NRTI) used in multi-drug antiretroviral regimens and in combination with other NRTIs, protease and/or non-nucleoside reverse transcriptase inhibitors (NNRTIs) in both treatment naive and treatment experienced patients."( Resistance and cross-resistance to abacavir.
Moyle, G, 2001
)
2.03
"Abacavir is a potent new carbocyclic nucleoside analogue. "( Pharmacodynamics of abacavir in an in vitro hollow-fiber model system.
Bilello, JA; Bilello, PA; Bye, A; Drusano, GL; McDowell, J; Stein, DS; Symonds, WT, 2002
)
2.08
"Abacavir sulfate is an inhibitor of HIV-1 reverse transcriptase. "( Understanding drug hypersensitivity: what to look for when prescribing abacavir.
Hetherington, S, 2001
)
1.99

Effects

Abacavir has been shown to select for multiple resistant mutations in the human immunodeficiency type 1 (HIV-1) pol gene. It has been suggested that preprescription genotyping for HLA-B*5701 in whites may reduce the incidence of hypersensitivity.

ExcerptReferenceRelevance
"Abacavir has an acceptable tolerability profile, although hypersensitivity reactions lead to discontinuation of therapy in approximately 3% of patients."( Coming therapies: abacavir.
Staszewski, S, 1999
)
1.36
"Abacavir has been associated with an increased risk of myocardial infarction, but the mechanism is unknown."( Changes in weight, body composition and metabolic parameters after switch to dolutegravir/lamivudine compared with continued treatment with dolutegravir/abacavir/lamivudine for virologically suppressed HIV infection (The AVERTAS trial): a randomised, open
Benfield, T; Gerstoft, J; Hove, JD; Knudsen, A; Møller, S; Pedersen, KBH; Siebner, HR, 2023
)
1.83
"Abacavir has replaced stavudine in antiretroviral therapy (ART) regimens because it has largely been phased out as a result of toxicity concerns; this loss has reduced further the already-limited drug options for children. "( Substituting Abacavir for Stavudine in Children Who Are Virally Suppressed Without Lipodystrophy: Randomized Clinical Trial in Johannesburg, South Africa.
Abrams, E; Arpadi, S; Coovadia, A; Kuhn, L; Patel, F; Pinillos, F; Shiau, S; Strehlau, R; Tsai, WY, 2018
)
2.29
"Abacavir use has been associated with an increased risk of cardiovascular disease (CVD) and metabolic events in HIV-infected patients, although this finding was not consistently found. "( Metabolic events in HIV-infected patients using abacavir are associated with erythrocyte inosine triphosphatase activity.
Andrinopoulou, ER; Bakker, JA; Bierau, J; Leers, MPG; Lowe, SH; Paulussen, ADC; Peltenburg, NC; Schippers, JA; van den Bosch, BJC; Verbon, A, 2019
)
2.21
"Abacavir (ABC) has been associated with ischaemic cardiovascular events in HIV-infected patients, but the pathogenic mechanisms are unknown. "( In vivo platelet activation and platelet hyperreactivity in abacavir-treated HIV-infected patients.
Baldelli, F; Belfiori, B; Bonora, S; Conti, V; Falcinelli, E; Francisci, D; Giannini, S; Gresele, P; Guglielmini, G; Malincarne, L; Mezzasoma, A; Petito, E; Sebastiano, M, 2013
)
2.07
"Abacavir has been associated with increased risk of cardiovascular events, for reasons that remain to be elucidated."( Association of abacavir and impaired endothelial function in treated and suppressed HIV-infected patients.
Deeks, SG; Ganz, P; Hatano, H; Ho, JE; Hsue, PY; Hunt, PW; Martin, JN; Schnell, A; Wu, Y; Xie, Y, 2009
)
1.43
"Abacavir has been associated with an increased risk of acute myocardial infarction, but the pathogenic mechanisms remain unknown. "( Early changes in inflammatory and pro-thrombotic biomarkers in patients initiating antiretroviral therapy with abacavir or tenofovir.
García, N; Gutiérrez, F; Jarrin, I; Masiá, M; Padilla, S; Tormo, C, 2011
)
2.02
"Abacavir use has been associated with cardiovascular risk, but it is unknown whether this association may be partly explained by patients with kidney disease being preferentially treated with abacavir to avoid tenofovir. "( Cardiovascular risks associated with abacavir and tenofovir exposure in HIV-infected persons.
Choi, AI; Deeks, SG; Li, Y; Shlipak, MG; Vittinghoff, E; Weekley, CC, 2011
)
2.08
"Abacavir has been reported to undergo bioactivation in vitro, yielding reactive species that bind covalently to human serum albumin, but the haptenation mechanism and its significance to the toxic events induced by this anti-HIV drug have yet to be elucidated."( Reactive aldehyde metabolites from the anti-HIV drug abacavir: amino acid adducts as possible factors in abacavir toxicity.
Antunes, AM; Charneira, C; Godinho, AL; Marques, MM; Monteiro, EC; Oliveira, MC; Pereira, SA, 2011
)
1.34
"Abacavir has been associated with myocardial infarction in several studies. "( Short communication: initiation of an abacavir-containing regimen in HIV-infected adults is associated with a smaller decrease in inflammation and endothelial activation markers compared to non-abacavir-containing regimens.
Debanne, SM; Hileman, CO; McComsey, GA; Tisch, DJ; Wohl, DA, 2012
)
2.09
"Abacavir has been shown to select for multiple resistant mutations in the human immunodeficiency type 1 (HIV-1) pol gene. "( Mechanistic studies to understand the progressive development of resistance in human immunodeficiency virus type 1 reverse transcriptase to abacavir.
Anderson, KS; Basavapathruni, A; Ray, AS, 2002
)
1.96
"Abacavir has been approved in the United States for the treatment of pediatric and adult HIV infection and current recommendations consist of combination therapy in children with HIV infection."( The antiviral activity, mechanism of action, clinical significance and resistance of abacavir in the treatment of pediatric AIDS.
Melroy, J; Nair, V, 2005
)
1.27
"For abacavir, it has been suggested that preprescription genotyping for HLA-B*5701 in whites may reduce the incidence of hypersensitivity."( Genetic factors in the predisposition to drug-induced hypersensitivity reactions.
Pirmohamed, M, 2006
)
0.81
"Abacavir has good oral bioavailability, as demonstrated in animals, and penetrates the CNS."( Abacavir.
Faulds, D; Foster, RH, 1998
)
2.46
"Abacavir has an acceptable tolerability profile, although hypersensitivity reactions lead to discontinuation of therapy in approximately 3% of patients."( Coming therapies: abacavir.
Staszewski, S, 1999
)
1.36
"Abacavir has even shown promise in viral load reductions when used alone."( The fuss over 1592.
Vazquez, E,
)
0.85
"Abacavir has contributed to lower viral loads in treatment naive patients when combined with ZDV and 3TC."( Dupont pharmaceuticals study 006 for Sustiva.
Bartlett, JG, 1998
)
1.02
"Abacavir resistance has also been observed in NRTI multidrug-resistant samples."( Prediction of abacavir resistance from genotypic data: impact of zidovudine and lamivudine resistance in vitro and in vivo.
Korn, K; Schmidt, B; Schwingel, E; Walter, H; Werwein, M, 2002
)
1.4

Actions

Abacavir can cause a multi-systemic hypersensitivity reaction (HSR) in 5-8% of the patients, which is related to HLA-B*57-01 allele. If abacvir or didanosine increase cardiovascular risk, it is likely not through the direct endothelial activation pathways tested in these experiments.

ExcerptReferenceRelevance
"Abacavir promotes arterial thrombosis through interference with purinergic signaling, suggesting a possible biological mechanism for the clinical association of abacavir with cardiovascular diseases."( Abacavir Induces Arterial Thrombosis in a Murine Model.
Álvarez, Á; Andujar, I; Blanch-Ruiz, MA; Blas-García, A; Collado-Diaz, V; Esplugues, JV; Martinez-Cuesta, MA; Orden, S; Sanchez-Lopez, A, 2018
)
3.37
"Abacavir can cause a multi-systemic hypersensitivity reaction (HSR) in 5-8% of the patients, which is related to HLA-B*57-01 allele. "( Low frequency of hypersensitivity reactions to abacavir in HIV infected patients in a referral center in Bahia, Brazil.
Barreto, RG; Brites, C,
)
1.83
"If abacavir or didanosine increase cardiovascular risk, it is likely not through the direct endothelial activation pathways tested in these experiments."( Abacavir, didanosine and tenofovir do not induce inflammatory, apoptotic or oxidative stress genes in coronary endothelial cells.
Clauss, M; Desta, Z; Deuter-Reinhard, M; Green, L; Gupta, SK; Kim, C; Taylor, BM, 2011
)
2.33

Treatment

Abacavir-based treatment without HLA-B*5701 testing resulted in a projected 30.93 years life expectancy, 16.23 discounted quality-adjusted life years, and $472,200 discounted lifetime cost per person. Treatment with abcavir, alone or in combination with ZDV, produced marked decreases in plasma HIV-1 RNA loads and increases in CD4+ cell counts in all groups.

ExcerptReferenceRelevance
"Abacavir-based treatment without HLA-B*5701 testing resulted in a projected 30.93 years life expectancy, 16.23 discounted quality-adjusted life years, and $472,200 discounted lifetime cost per person. "( The cost-effectiveness of HLA-B*5701 genetic screening to guide initial antiretroviral therapy for HIV.
Freedberg, KA; Losina, E; Sax, PE; Schackman, BR; Scott, CA; Walensky, RP, 2008
)
1.79
"Abacavir treated patients with HSR [confirmed (n=5) or suspected (n=12)] vs without HSR (n=42) displayed significantly higher numbers of abacavir-specific cells (82.3±23.0 or 10.5±4.5 vs -0.5±1.0 spot forming cells per million PBMC, p < .005 each)."( Detection of abacavir hypersensitivity by ELISpot method.
Esser, S; Heinemann, FM; Horn, PA; Jablonka, R; Jaeger, H; Lindemann, M; Reuter, S; Schadendorf, D; Schenk-Westkamp, P; von Krosigk, A, 2012
)
1.47
"In abacavir-treated individuals (n=982), codon 245 substitutions were predictive of premature abacavir discontinuation (P=.02)."( A simple screening approach to reduce B*5701-associated abacavir hypersensitivity on the basis of sequence variation in HIV reverse transcriptase.
Brumme, CJ; Brumme, ZL; Chui, CK; Harrigan, PR; Montaner, JS; Phillips, EJ; Yip, B, 2007
)
1.1
"Treatment with abacavir, alone or in combination with other anti-HIV agents (zidovudine, lamivudine, nevirapine, amprenavir and/or other protease inhibitors), decreased viral load and increased CD4+ cell count in patients with HIV infection."( Abacavir.
Faulds, D; Foster, RH, 1998
)
2.08
"Treatment with abacavir, alone or in combination with ZDV, produced marked decreases in plasma HIV-1 RNA loads and increases in CD4+ cell counts in all groups. "( Antiretroviral effect and safety of abacavir alone and in combination with zidovudine in HIV-infected adults. Abacavir Phase 2 Clinical Team.
Gazzard, BG; Kelleher, D; LaFon, S; Lancaster, D; Romero, C; Saag, MS; Schooley, RT; Sonnerborg, A; Spreen, W; Torres, RA, 1998
)
0.93

Toxicity

Abacavir is safe and effective when used in combination with a protease inhibitor. The single abacvir-related adverse event was rash, which occurred in 2 of 22 subjects. AbacavIR was well tolerated by all subjects; mild to moderate asthenia, mild tomoderate asthenic symptoms.

ExcerptReferenceRelevance
" Evaluation of safety and tolerance was based on clinical adverse events and laboratory analyses."( A dose-ranging study to evaluate the safety and efficacy of abacavir alone or in combination with zidovudine and lamivudine in antiretroviral treatment-naive subjects.
Cutrell, A; Harrer, T; Harrigan, RP; Katlama, C; Lanier, RE; Massip, P; Pearce, G; Staszewski, S; Steel, H; Tortell, SM; Yeni, P, 1998
)
0.54
" Abacavir was generally well tolerated with few clinically significant adverse events."( A dose-ranging study to evaluate the safety and efficacy of abacavir alone or in combination with zidovudine and lamivudine in antiretroviral treatment-naive subjects.
Cutrell, A; Harrer, T; Harrigan, RP; Katlama, C; Lanier, RE; Massip, P; Pearce, G; Staszewski, S; Steel, H; Tortell, SM; Yeni, P, 1998
)
1.45
" Safety was assessed by monitoring clinical adverse events and laboratory abnormalities during the 12-week period and for 4 weeks post-treatment."( Antiretroviral effect and safety of abacavir alone and in combination with zidovudine in HIV-infected adults. Abacavir Phase 2 Clinical Team.
Gazzard, BG; Kelleher, D; LaFon, S; Lancaster, D; Romero, C; Saag, MS; Schooley, RT; Sonnerborg, A; Spreen, W; Torres, RA, 1998
)
0.58
" Eight subjects (10%) discontinued the study prematurely because of adverse events; nausea (n = 4) and hypersensitivity (n = 3) were the most common reasons for withdrawal."( Antiretroviral effect and safety of abacavir alone and in combination with zidovudine in HIV-infected adults. Abacavir Phase 2 Clinical Team.
Gazzard, BG; Kelleher, D; LaFon, S; Lancaster, D; Romero, C; Saag, MS; Schooley, RT; Sonnerborg, A; Spreen, W; Torres, RA, 1998
)
0.58
" Abacavir was well tolerated by all subjects; mild to moderate asthenia, abdominal pain, headache, diarrhea, and dyspepsia were the most frequently reported adverse events, and these were not dose related."( Safety and pharmacokinetics of abacavir (1592U89) following oral administration of escalating single doses in human immunodeficiency virus type 1-infected adults.
Hetherington, S; Kumar, PN; LaFon, S; Lou, Y; McDowell, JA; Sweet, DE; Symonds, W, 1999
)
1.5
" The single abacavir-related adverse event was rash, which occurred in 2 of 22 subjects."( Safety and single-dose pharmacokinetics of abacavir (1592U89) in human immunodeficiency virus type 1-infected children.
Flynn, P; Hetherington, S; Hughes, W; Kline, MW; Lou, Y; McDowell, JA; Shenep, J; Symonds, W; Yogev, R, 1999
)
0.95
" Mild to moderate headache, nausea, lymphadenopathy, hematuria, musculoskeletal chest pain, neck stiffness, and fever were the most common adverse events reported by those who received abacavir."( Single-dose pharmacokinetics and safety of abacavir (1592U89), zidovudine, and lamivudine administered alone and in combination in adults with human immunodeficiency virus infection.
Chittick, GE; McDowell, JA; Wang, LH, 1999
)
0.76
" Safety was assessed by monitoring clinical adverse events and laboratory abnormalities."( Antiretroviral activity and safety of abacavir in combination with selected HIV-1 protease inhibitors in therapy-naive HIV-1-infected adults.
Cooney, E; Cutrell, A; Haas, DW; Haubrich, R; Horton, J; Kelleher, D; Lederman, M; Lee, D; McMahon, D; Mellors, JW; Ross, L; Spreen, W; Stanford, J, 2001
)
0.58
" Overall, the most common adverse events attributed to study drugs were diarrhoea, nausea, malaise/fatigue, headache and perioral paresthesia."( Antiretroviral activity and safety of abacavir in combination with selected HIV-1 protease inhibitors in therapy-naive HIV-1-infected adults.
Cooney, E; Cutrell, A; Haas, DW; Haubrich, R; Horton, J; Kelleher, D; Lederman, M; Lee, D; McMahon, D; Mellors, JW; Ross, L; Spreen, W; Stanford, J, 2001
)
0.58
"Abacavir is safe and effective when used in combination with a protease inhibitor."( Antiretroviral activity and safety of abacavir in combination with selected HIV-1 protease inhibitors in therapy-naive HIV-1-infected adults.
Cooney, E; Cutrell, A; Haas, DW; Haubrich, R; Horton, J; Kelleher, D; Lederman, M; Lee, D; McMahon, D; Mellors, JW; Ross, L; Spreen, W; Stanford, J, 2001
)
2.02
" Safety was evaluated by monitoring clinical adverse events and changes in laboratory values."( A dose-ranging study to evaluate the antiretroviral activity and safety of amprenavir alone and in combination with abacavir in HIV-infected adults with limited antiretroviral experience.
Antunes, F; Blake, D; Clumeck, N; Danner, SA; Haubrich, R; Millard, J; Mustafa, N; Myers, RE; Nacci, P; Schooley, RT; Sereni, D; Thompson, M; Tisdale, M; van Der Ende, ME, 2001
)
0.52
" Amprenavir was reasonably well tolerated with few treatment-limiting adverse events."( A dose-ranging study to evaluate the antiretroviral activity and safety of amprenavir alone and in combination with abacavir in HIV-infected adults with limited antiretroviral experience.
Antunes, F; Blake, D; Clumeck, N; Danner, SA; Haubrich, R; Millard, J; Mustafa, N; Myers, RE; Nacci, P; Schooley, RT; Sereni, D; Thompson, M; Tisdale, M; van Der Ende, ME, 2001
)
0.52
" Most patients experienced at least one drug-related adverse event that was not considered treatment-limiting by the investigator."( Efficacy and safety of a quadruple combination Combivir + abacavir + efavirenz regimen in antiretroviral treatment-naive HIV-1-infected adults: La Francilienne.
Chemlal, K; de Truchis, P; Devidas, A; Force, G; Mamet, JP; Mechali, D; Praindhui, D; Pulik, M; Rouveix, E; Welker, Y, 2002
)
0.56
"Safety and efficacy results from this study demonstrated that the quadruple regimen Combivir/abacavir/efavirenz is generally safe and displays potent and durable antiretroviral activity in antiretroviral treatment-naive HIV-1-infected patients, offering a promising therapeutic option in a PI-sparing strategy."( Efficacy and safety of a quadruple combination Combivir + abacavir + efavirenz regimen in antiretroviral treatment-naive HIV-1-infected adults: La Francilienne.
Chemlal, K; de Truchis, P; Devidas, A; Force, G; Mamet, JP; Mechali, D; Praindhui, D; Pulik, M; Rouveix, E; Welker, Y, 2002
)
0.78
"Simplification is safe and effective, but it should be offered to patients with shorter treatment duration, and in good clinical and immunovirological conditions."( Simplification of protease inhibitor-containing regimens with efavirenz, nevirapine or abacavir: safety and efficacy outcomes.
Adorni, F; Bini, T; Bongiovanni, M; Capetti, A; Castelnuovo, B; Chiesa, E; Cicconi, P; d'Arminio Monforte, A; Faggion, I; Melzi, S; Mussini, C; Rizzardini, G; Rusconi, S; Sollima, S; Tordato, F, 2003
)
0.54
"Research into the toxic effects of antiretroviral therapy has made tremendous progress, particularly over the 5 years since the earliest descriptions of the lipodystrophy syndrome."( Pharmacogenetics: a practical role in predicting antiretroviral drug toxicity?
Gaudieri, S; Mallal, S; Nolan, D, 2003
)
0.32
"The A/S/D regimen had a low efficacy and a high frequency of adverse events and cannot be recommended."( Low efficacy and high frequency of adverse events in a randomized trial of the triple nucleoside regimen abacavir, stavudine and didanosine.
Gerstoft, J; Katzenstein, TL; Kirk, O; Lundgren, JD; Mathiesen, L; Nielsen, H; Obel, N; Pedersen, C, 2003
)
0.53
"This data supports the strategy that in cases of symptomatic hyperlactatemia or lactic acidosis in which the toxicity is associated with stavudine, didanosine or both, it is safe and efficacious to reintroduce NRTI that are less potent inhibitors of mitochondria."( Safety and efficacy of switching to alternative nucleoside analogues following symptomatic hyperlactatemia and lactic acidosis.
Barber, RE; Lonergan, JT; Mathews, WC, 2003
)
0.32
"Identification of reliable markers to predict drug-related adverse events (DRAEs) is an important goal of the pharmaceutical industry and others within the healthcare community."( Pharmacogenetics to predict drug-related adverse events.
Danoff, TM; Hosford, DA; Lai, EH; Riley, JH; Roses, AD; Xu, CF,
)
0.13
"25%) patients discontinued therapy because of adverse events and 36 (4."( Effectiveness and safety of abacavir, lamivudine, and zidovudine in antiretroviral therapy-naive HIV-infected patients: results from a large multicenter observational cohort.
Bellón, JM; Berenguer, J; Camba, M; Flores, J; Gatell, JM; Hernández-Quero, J; Knobel, H; Miguélez, M; Pérez-Elías, MJ; Podzamczer, D; Resino, S; Rivas-González, P; Sala, M; Santos, I; Soriano, V, 2006
)
0.63
" However, this treatment may lead to adverse events, some of them potentially serious."( [Antiretroviral treatment associated life-threatening adverse events].
Morales-Conejo, M; Moreno-Cuerda, VJ; Rubio, R, 2006
)
0.33
" All available safety data (including data beyond 48 weeks) were used in all analyses, which included calculation of treatment emergent laboratory values, adverse events (AEs), serious AEs, fatalities, drug discontinuations and any summaries by study week of safety data."( Long-term safety and tolerability of the lamivudine/abacavir combination as components of highly active antiretroviral therapy.
Brothers, CH; Castillo, SA; Hernandez, JE, 2006
)
0.58
"This analysis indicates that the combination of lamivudine/abacavir is generally safe for the majority of patients when used as part of combination therapy."( Long-term safety and tolerability of the lamivudine/abacavir combination as components of highly active antiretroviral therapy.
Brothers, CH; Castillo, SA; Hernandez, JE, 2006
)
0.83
" Study medication administration was stopped for 14 children, mostly because of nonadherence (4 cases) or virologic rebound (5 cases) and because of adverse events (unrelated death and grade 2 liver toxicity) in 2 cases."( Once-daily highly active antiretroviral therapy for HIV-infected children: safety and efficacy of an efavirenz-containing regimen.
Bekker, V; Jurriaans, S; Kuijpers, TW; Lange, JM; Pajkrt, D; Scherpbier, HJ, 2007
)
0.34
" This represents the first fully powered, randomized, blinded, prospective study to determine the clinical utility of PGx screening to reduce drug-associated adverse events in any patient population."( PREDICT-1 (CNA106030): the first powered, prospective trial of pharmacogenetic screening to reduce drug adverse events.
Brothers, C; Hughes, A; Hughes, S; Spreen, W; Thorborn, D,
)
0.13
" All other combinations exhibited more pronounced adverse effects on mitochondrial endpoints."( Mitochondrial toxicity of tenofovir, emtricitabine and abacavir alone and in combination with additional nucleoside reverse transcriptase inhibitors.
Melkaoui, K; Setzer, B; Venhoff, N; Walker, UA, 2007
)
0.59
" The primary endpoint was any serious adverse event (SAE) definitely/probably or uncertain whether related to blinded nevirapine/abacavir."( Twenty-four-week safety and tolerability of nevirapine vs. abacavir in combination with zidovudine/lamivudine as first-line antiretroviral therapy: a randomized double-blind trial (NORA).
, 2008
)
0.79
"There was a trend towards a lower rate of serious adverse reactions in Ugandan adults with low CD4 starting ARV regimens with abacavir than with nevirapine."( Twenty-four-week safety and tolerability of nevirapine vs. abacavir in combination with zidovudine/lamivudine as first-line antiretroviral therapy: a randomized double-blind trial (NORA).
, 2008
)
0.8
" The growth of adverse event PGX studies involving marketed medicines generally uses relatively large numbers of affected patients, but has been productive."( The medical and economic roles of pipeline pharmacogenetics: Alzheimer's disease as a model of efficacy and HLA-B(*)5701 as a model of safety.
Roses, AD, 2009
)
0.35
" Drug toxicity/HLA associations have been best documented for immunologically mediated reactions, such as drug hypersensitivity reactions associated with the use of abacavir, and severe cutaneous adverse drug reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis induced by carbamazepine and allopurinol use, respectively."( HLA and drug-induced toxicity.
Mallal, SA; Phillips, EJ, 2009
)
0.55
" 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,
)
0.38
" An understanding of structure-activity relationships (SARs) of chemicals can make a significant contribution to the identification of potential toxic effects early in the drug development process and aid in avoiding such problems."( Developing structure-activity relationships for the prediction of hepatotoxicity.
Fisk, L; Greene, N; Naven, RT; Note, RR; Patel, ML; Pelletier, DJ, 2010
)
0.36
" Despite its clinical efficacy, abacavir administration has been associated with serious and sometimes fatal toxic events."( Reactive aldehyde metabolites from the anti-HIV drug abacavir: amino acid adducts as possible factors in abacavir toxicity.
Antunes, AM; Charneira, C; Godinho, AL; Marques, MM; Monteiro, EC; Oliveira, MC; Pereira, SA, 2011
)
0.9
" Lipodystrophy accounted for 87 of 96 toxic events."( Frequency of stavudine substitution due to toxicity in children receiving antiretroviral treatment in sub-Saharan Africa.
Chersich, M; Fairlie, L; Kuhn, L; Meyers, T; Moultrie, H; Palmer, M, 2013
)
0.39
"To evaluate the trends in abacavir (ABC) prescription among antiretroviral (ARV) medication-naive individuals following the presentation of the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) cohort study."( Impact of the Data Collection on Adverse Events of Anti-HIV Drugs cohort study on abacavir prescription among treatment-naive, HIV-infected patients in Canada.
Antoniou, T; Cooper, C; Gillis, J; Hogg, RS; Klein, MB; Loutfy, MR; Machouf, N; Montaner, JS; Raboud, JM; Rourke, SB; Tsoukas, C,
)
0.66
" Although individual susceptibilities to adverse effects differ among patients, abacavir is associated with idiosyncratic hypersensitivity drug reactions and an increased risk of cardiac dysfunction."( Bioactivation to an aldehyde metabolite--possible role in the onset of toxicity induced by the anti-HIV drug abacavir.
Antunes, AM; Charneira, C; Grilo, NM; Marques, MM; Monteiro, EC; Pereira, SA, 2014
)
0.84
" Adverse drug reaction (ADR) was defined as adverse event of which association with abacavir could not be "ruled out."( Safety analysis of Ziagen® (abacavir sulfate) in postmarketing surveillance in Japan.
Kitaichi, T; Kitazono, Y; Kurita, T; Miura, T; Nagao, T, 2014
)
0.92
" Serious adverse events were reported in 65 subjects; however, none of the three fatal cases were clearly associated with Ziagen use."( Safety analysis of Ziagen® (abacavir sulfate) in postmarketing surveillance in Japan.
Kitaichi, T; Kitazono, Y; Kurita, T; Miura, T; Nagao, T, 2014
)
0.7
" There are also concerns that abacavir use may lead to serious adverse events such as hypersensitivity reactions and has potential predisposition to developing cardiovascular diseases."( Antiviral efficacy and safety of abacavir-containing combination antiretroviral therapy as first-line treatment of HIV-infected children and adolescents: a systematic review protocol.
Adetokunboh, OO; Schoonees, A; Wiysonge, CS, 2014
)
0.97
" Eleven patients (92%) reported ≥1 adverse event (AE), considered in 2 patients to be at least possibly related to darunavir (gastrointestinal-related events and dizziness)."( Efficacy and safety of darunavir/ritonavir at 48 weeks in treatment-naïve, HIV-1-infected adolescents: results from a phase 2 open-label trial (DIONE).
Blanche, S; Flynn, P; Giaquinto, C; Kakuda, TN; Komar, S; Lathouwers, E; Noguera-Julian, A; Opsomer, M; Van de Casteele, T; Welch, S, 2014
)
0.4
"Prospective information was collected on 32,663 HIV-positive persons from 20 countries in Europe and Australia, who were free of CVD at entry into the Data-collection on Adverse Effects of Anti-HIV Drugs (D:A:D) study."( An updated prediction model of the global risk of cardiovascular disease in HIV-positive persons: The Data-collection on Adverse Effects of Anti-HIV Drugs (D:A:D) study.
Dabis, F; De Wit, S; Fontas, E; Friis-Møller, N; Kirk, O; Law, M; Lundgren, J; Monforte, AD; Phillips, A; Reiss, P; Ryom, L; Sabin, C; Smith, C; Weber, R, 2016
)
0.43
" We also found no significant differences between the two groups for adverse events and death."( Efficacy and safety of abacavir-containing combination antiretroviral therapy as first-line treatment of HIV infected children and adolescents: a systematic review and meta-analysis.
Adetokunboh, OO; Balogun, TA; Schoonees, A; Wiysonge, CS, 2015
)
0.73
" We did a systematic review and meta-analysis of adverse events among children and adolescents receiving regimens that contain abacavir, a widely used antiretroviral drug."( Adverse events associated with abacavir use in HIV-infected children and adolescents: a systematic review and meta-analysis.
Dahourou, DL; Jesson, J; Leroy, V; Penazzato, M; Renaud, F, 2016
)
0.93
" Incidence of adverse outcomes in patients taking abacavir (number of new events in a period divided by population at risk at the beginning of the study) and relative risks (RR) compared with non-abacavir regimens were pooled with random effects models."( Adverse events associated with abacavir use in HIV-infected children and adolescents: a systematic review and meta-analysis.
Dahourou, DL; Jesson, J; Leroy, V; Penazzato, M; Renaud, F, 2016
)
0.97
" Among children and adolescents taking abacavir, hypersensitivity reactions (eight studies) had a pooled incidence of 2·2% (95% CI 0·4-5·2); treatment switching or discontinuation (seven studies) pooled incidence was 10·9% (2·1-24·3); of grade 3-4 adverse events (six studies) pooled incidence was 9·9% (2·4-20·9); and adverse events other than hypersensitivity reaction (six studies) pooled incidence was 21·5% (2·8-48·4)."( Adverse events associated with abacavir use in HIV-infected children and adolescents: a systematic review and meta-analysis.
Dahourou, DL; Jesson, J; Leroy, V; Penazzato, M; Renaud, F, 2016
)
0.99
"Many adverse drug reactions are caused by the cytochrome P450 (CYP)-dependent activation of drugs into reactive metabolites."( Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
Jones, LH; Nadanaciva, S; Rana, P; Will, Y, 2016
)
0.43
" The aim of this study was to compare the rate of any discontinuation of antiretroviral (ARV) regimen because of virologic failure (VF), and/or adverse drug reaction (ADR) among patients receiving stable ARV regimens for at least 6 months."( Long-term efficacy and toxicity of abacavir/lamivudine/nevirapine compared to the most prescribed ARV regimens before 2013 in a French Nationwide Cohort Study.
Bani-Sadr, F; Cabie, A; Cotte, L; de Boissieu, P; Delobel, P; Dramé, M; Garraffo, R; Huleux, T; Poizot-Martin, I; Raffi, F; Rey, D, 2016
)
0.71
"There is no known reason to suspect an adverse drug interaction between dolutegravir-based antiretroviral therapy and sofosbuvir, simeprevir, or ledipasvir."( Clinical experience with dolutegravir/abacavir/lamivudine in HIV-HCV co-infected patients treated with a sofosbuvir-based regimen-safety and efficacy.
Bhattarai, S; Fallon, JP; Galang, H; Habeeb, R; Johnson, TM; Shukla, PP; Sison, R; Slim, J, 2016
)
0.71
" No patients ended therapy secondary to adverse events."( Clinical experience with dolutegravir/abacavir/lamivudine in HIV-HCV co-infected patients treated with a sofosbuvir-based regimen-safety and efficacy.
Bhattarai, S; Fallon, JP; Galang, H; Habeeb, R; Johnson, TM; Shukla, PP; Sison, R; Slim, J, 2016
)
0.71
" The form is designed to obtain information on the demographics of the patients, WHO clinical stage of their HIV infection, HAART regimen for the patients, and suspected adverse events associated with the antiretroviral drugs used by the patients."( A prospective study of adverse events to antiretroviral therapy in HIV- infected adults in Ekiti State, Nigeria.
Awodele, O; Oshikoya, KA; Popoola, TD, 2016
)
0.43
" About half (57%) of the participants reported clinical adverse events; 92% of which were reported within two weeks of HAART initiation."( A prospective study of adverse events to antiretroviral therapy in HIV- infected adults in Ekiti State, Nigeria.
Awodele, O; Oshikoya, KA; Popoola, TD, 2016
)
0.43
"Antiretroviral drugs exposure often presents with adverse events, an observation similar to other studies."( A prospective study of adverse events to antiretroviral therapy in HIV- infected adults in Ekiti State, Nigeria.
Awodele, O; Oshikoya, KA; Popoola, TD, 2016
)
0.43
" INSTIs have also been demonstrated as safe and tolerable."( Dolutegravir Neuropsychiatric Adverse Events: Specific Drug Effect or Class Effect.
Yombi, JC,
)
0.13
" This study investigated the toxic and genotoxic potential of ABC when administered alone or in combination with AZT and/or 3TC using the somatic mutation and recombination test in Drosophila melanogaster."( Toxicity and genotoxicity induced by abacavir antiretroviral medication alone or in combination with zidovudine and/or lamivudine in Drosophila melanogaster.
Bailão, E; Cardoso, CG; Chen-Chen, L; Cunha, KS; de Jesus Silva Carvalho, C; de Moraes Filho, AV; Spanó, MA; Véras, JH, 2019
)
0.79
" Ten neonates administered a single abacavir dose of 8 mg/kg before 15 days of life had substantially higher exposures than those reported in infants and children, with no reported adverse events."( Single Dose Abacavir Pharmacokinetics and Safety in Neonates Exposed to Human Immunodeficiency Virus (HIV).
Bekker, A; Cotton, MF; Cressey, TR; Decloedt, EH; Rabie, H; Slade, G, 2021
)
1.28
" Recently, HLA transgenic mice have been used to reproduce HLA-mediated idiosyncratic drug toxicity (IDT), a rare and unpredictable adverse drug reaction that can result in death."( HLA transgenic mice: application in reproducing idiosyncratic drug toxicity.
Aoki, S; Ito, K; Kuwahara, S; Shirayanagi, T; Susukida, T; Yamada, Y, 2020
)
0.56
" A total of 49 adverse events were observed in 31 out of 222 individuals (14."( Safety and effectiveness of switching to Abacavir/Lamivudine plus rilpivirine for maintenance therapy in virologically suppressed HIV-1 individuals in Singapore (SEALS).
Ang, JH; Ang, LW; Hoo, GS; Law, HL; Lee, CC; Leo, YS; Lim, ZC; Ng, OT; Teng, CB; Wong, CS, 2021
)
0.89
"ABC/3TC + RPV is a safe and effective switch option for maintenance therapy in virologically suppressed HIV-1 individuals with in Singapore."( Safety and effectiveness of switching to Abacavir/Lamivudine plus rilpivirine for maintenance therapy in virologically suppressed HIV-1 individuals in Singapore (SEALS).
Ang, JH; Ang, LW; Hoo, GS; Law, HL; Lee, CC; Leo, YS; Lim, ZC; Ng, OT; Teng, CB; Wong, CS, 2021
)
0.89
" No adverse events were related to study drugs."( Pharmacokinetics and Safety of the Abacavir/Lamivudine/Lopinavir/Ritonavir Fixed-Dose Granule Formulation (4-in-1) in Neonates: PETITE Study.
Andrieux-Meyer, I; Bekker, A; Capparelli, E; Cotton, MF; Cressey, R; Cressey, TR; du Toit, S; Groenewald, M; Kumar, M; Lallemant, M; Nielsen, J; Rabie, H; Salvadori, N; Than-In-At, K, 2022
)
1
" We extracted data related to study identifier, study design, study period, setting, population characteristics, ART treatment, and safety (any hypersensitivity reaction, death, grade 3 or 4 adverse events, treatment discontinuation, any other morbidities, and serious adverse events), and efficacy outcomes (HIV viral load and CD4 counts reported at 6 and 12 months after ART initiation)."( Safety and efficacy of abacavir for treating infants, children, and adolescents living with HIV: a systematic review and meta-analysis.
Jesson, J; Leroy, V; O'Rourke, J; Penazzato, M; Renaud, F; Revegue, MHDT; Saint-Lary, L; Townsend, CL, 2022
)
1.03

Pharmacokinetics

Children with stable HIV type-1 (HIV-1) RNA levels after 12 weeks treatment with twice-daily abacavir (8 mg/kg) with or without lamivudine (4 mg/ kg) underwent plasma pharmacokinetic sampling. AbacavIR was rapidly absorbed following oral administration, with the time to the peak concentration in plasma occurring at 1.

ExcerptReferenceRelevance
" To evaluate the potential pharmacokinetic interactions between these agents, 15 HIV-1-infected adults with a median CD4(+) cell count of 347 cells/mm3 (range, 238 to 570 cells/mm3) were enrolled in a randomized, seven-period crossover study."( Single-dose pharmacokinetics and safety of abacavir (1592U89), zidovudine, and lamivudine administered alone and in combination in adults with human immunodeficiency virus infection.
Chittick, GE; McDowell, JA; Wang, LH, 1999
)
0.57
"While in vitro results at clinically relevant concentrations do not predict abacavir (1592U89) interactions with drugs highly metabolized by cytochrome P450, the potential does exist for a pharmacokinetic interaction between abacavir and ethanol, as both are metabolized by alcohol dehydrogenase."( Pharmacokinetic interaction of abacavir (1592U89) and ethanol in human immunodeficiency virus-infected adults.
Chittick, GE; Edwards, KD; McDowell, JA; Stein, DS; Stevens, CP, 2000
)
0.82
" Plasma abacavir concentrations from sparse sampling were analyzed by standard population pharmacokinetic methods, and the effects of dose, combination therapy, gender, weight, and age on parameter estimates were investigated."( Population pharmacokinetics and pharmacodynamic modeling of abacavir (1592U89) from a dose-ranging, double-blind, randomized monotherapy trial with human immunodeficiency virus-infected subjects.
Lou, Y; Radomski, KM; Stein, DS; Weller, S, 2000
)
0.98
" Pharmacokinetic parameters were calculated for abacavir after administration of the first dose and at week 4 and for abacavir, zidovudine, and its glucuronide metabolite at week 12."( Multiple-dose pharmacokinetics and pharmacodynamics of abacavir alone and in combination with zidovudine in human immunodeficiency virus-infected adults.
Lou, Y; McDowell, JA; Stein, DS; Symonds, WS, 2000
)
0.81
"In a dose-ranging study of amprenavir (formerly 141W94), an inhibitor of the protease enzyme of human immunodeficiency virus (HIV) type 1, single-dose and steady-state pharmacokinetic parameters were estimated from plasma samples collected on day 1 and during week 3, respectively."( Pharmacokinetic and pharmacodynamic study of the human immunodeficiency virus protease inhibitor amprenavir after multiple oral dosing.
Gillotin, C; Lou, Y; Sadler, BM; Stein, DS, 2001
)
0.31
" To date, there is no pharmacokinetic study in patients with renal impairment."( Pharmacokinetics of abacavir in HIV-1-infected patients with impaired renal function.
Aymard, G; Deray, G; Izzedine, H; Launay-Vacher, V; Legrand, M, 2001
)
0.63
" A nonparametric pharmacokinetic analysis was then performed."( Pharmacokinetics of abacavir in HIV-1-infected patients with impaired renal function.
Aymard, G; Deray, G; Izzedine, H; Launay-Vacher, V; Legrand, M, 2001
)
0.63
" Furthermore, our pharmacokinetic data are similar to those obtained in patients with normal renal function."( Pharmacokinetics of abacavir in HIV-1-infected patients with impaired renal function.
Aymard, G; Deray, G; Izzedine, H; Launay-Vacher, V; Legrand, M, 2001
)
0.63
" We employed our hollow-fiber pharmacodynamic modeling system to examine the antiretroviral effects of different abacavir exposures, as well as the impact of the schedule of drug administration on efficacy."( Pharmacodynamics of abacavir in an in vitro hollow-fiber model system.
Bilello, JA; Bilello, PA; Bye, A; Drusano, GL; McDowell, J; Stein, DS; Symonds, WT, 2002
)
0.85
"A population pharmacokinetic model for abacavir was developed using data from 188 adult patients by the use of a nonlinear mixed effects modelling method performed with NONMEM."( Weight related differences in the pharmacokinetics of abacavir in HIV-infected patients.
Chappuy, H; Dimet, J; Dupin, N; Jullien, V; Pons, G; Rey, E; Salmon, D; Tréluyer, JM; Urien, S, 2005
)
0.85
" Individual Bayesian estimates of apparent plasma clearance were used to calculate individual abacavir area under the concentration curve (AUC)."( Abacavir pharmacokinetics in human immunodeficiency virus-infected children ranging in age from 1 month to 16 years: a population analysis.
Blanche, S; Chappuy, H; Dimet, J; Jullien, V; Pons, G; Rey, E; Tréluyer, JM; Urien, S, 2005
)
1.99
"AUC0-24 and Cmax of both 3TC and ABC q24h were not inferior to q12h dosing in children."( Plasma pharmacokinetics of once- versus twice-daily lamivudine and abacavir: simplification of combination treatment in HIV-1-infected children (PENTA-13).
Bergshoeff, A; Burger, D; Farrelly, L; Flynn, J; Gibb, D; Khoo, S; Le Prevost, M; Lyall, H; Novelli, V; Verweij, C; Walker, S, 2005
)
0.56
"The aim of this study was to characterise the pharmacokinetic and pharmacodynamic monitoring of low doses of mycophenolate mofetil (0."( Pharmacokinetics and pharmacodynamics of low dose mycophenolate mofetil in HIV-infected patients treated with abacavir, efavirenz and nelfinavir.
Brunet, M; Gallart, T; García, F; Gatell, JM; Martorell, J; Millán, O; Miró, JM; Plana, M; Pumarola, T; Rojo, I; Vidal, E, 2005
)
0.54
"Mycophenolate mofetil pharmacokinetic profiles in HIV patients under HAART are not significantly different from those found in transplant patients."( Pharmacokinetics and pharmacodynamics of low dose mycophenolate mofetil in HIV-infected patients treated with abacavir, efavirenz and nelfinavir.
Brunet, M; Gallart, T; García, F; Gatell, JM; Martorell, J; Millán, O; Miró, JM; Plana, M; Pumarola, T; Rojo, I; Vidal, E, 2005
)
0.54
"The distribution of abacavir into the cerebrospinal fluid (CSF) was assessed by use of a population pharmacokinetic analysis."( Population pharmacokinetics of abacavir in plasma and cerebrospinal fluid.
Capparelli, EV; Ellis, RJ; Holland, D; Letendre, SL; McCutchan, JA; Patel, P, 2005
)
0.94
"The Pediatric AIDS Clinical Trials Group P1026s study is an on-going, prospective, non-blinded pharmacokinetic study of pregnant women receiving one or more antiretroviral drugs for routine clinical care, including a cohort receiving abacavir 300 mg twice daily."( Impact of pregnancy on abacavir pharmacokinetics.
Best, BM; Burchett, SK; Capparelli, EV; Connor, JD; Holland, DT; Hu, C; Mirochnick, M; Read, JS; Smith, E; Spector, SA; Stek, A, 2006
)
0.83
"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
)
2.09
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" The area under the plasma concentration-time curve (AUC) and half-life of abacavir did not differ significantly between the age groups or by gender or race, and there were only modest associations of age with apparent abacavir clearance and with volume of distribution."( Abacavir pharmacokinetics during chronic therapy in HIV-1-infected adolescents and young adults.
Capparelli, EV; Cross, SJ; Heckman, BE; Kraimer, JM; Lindsey, JC; Neal, EF; Nikanjam, M; Pakes, GE; Poston, PA; Robbins, BL; Rose, CH; Sleasman, JW; Sprenger, HL; Tustin, NB, 2009
)
2.03
" Pharmacokinetic parameters were calculated using noncompartmental methods."( Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
Boffito, M; Fletcher, C; Guerini, EM; Hay, PE; Higgs, C; Lou, Y; Min, SS; Moyle, G; Song, IH; Yuen, GJ, 2009
)
0.63
" Statistical analyses were performed on pharmacokinetic parameters: the area under the concentration-time curve from 0 to 4 h (AUC(0-4)), the maximum concentration of the drug (C(max)), and the residual concentration of the drug at the end of the dosing interval (C(trough)) for plasma and the AUC(0-4) and C(trough) for intracellular data."( Pilot pharmacokinetic study of human immunodeficiency virus-infected patients receiving tenofovir disoproxil fumarate (TDF): investigation of systemic and intracellular interactions between TDF and abacavir, lamivudine, or lopinavir-ritonavir.
Ayen, R; Clotet, B; Grassi, J; Levi, M; Negredo, E; Pruvost, A; Puig, J; Théodoro, F, 2009
)
0.54
" We conducted a pharmacokinetic study of once-daily and twice-daily abacavir and lamivudine in children aged 3-<36 months."( Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months.
, 2010
)
0.84
"Children with stable HIV type-1 (HIV-1) RNA levels after 12 weeks treatment with twice-daily abacavir (8 mg/kg) with or without lamivudine (4 mg/kg) underwent plasma pharmacokinetic sampling."( Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months.
, 2010
)
0.83
"A total of 18 children (4, 6 and 8 in the 3-<12, 12-<24 and 24-<36 month age ranges, respectively) provided pharmacokinetic data for abacavir (17 for lamivudine)."( Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months.
, 2010
)
0.81
" Drug exposures in infants and toddlers were predicted using pharmacokinetic parameter distributions obtained from children, and the other way around."( Paediatric drug development: are population models predictive of pharmacokinetics across paediatric populations?
Burger, D; Cella, M; Danhof, M; Della Pasqua, O; Jacqz-Aigrain, E; Zhao, W, 2011
)
0.37
"The pharmacokinetic models (a two-compartment PK model for infants and toddlers and a one compartment PK model for children) accurately described the exposure in the population from which they were built."( Paediatric drug development: are population models predictive of pharmacokinetics across paediatric populations?
Burger, D; Cella, M; Danhof, M; Della Pasqua, O; Jacqz-Aigrain, E; Zhao, W, 2011
)
0.37
"These findings suggest that the assumption of an identical (linear or nonlinear) correlation between pharmacokinetic parameters and demographic factors may not hold true across age groups."( Paediatric drug development: are population models predictive of pharmacokinetics across paediatric populations?
Burger, D; Cella, M; Danhof, M; Della Pasqua, O; Jacqz-Aigrain, E; Zhao, W, 2011
)
0.37
"A population pharmacokinetic model was developed to describe both once and twice daily pharmacokinetic profiles of abacavir in infants and toddlers."( Population pharmacokinetics and maximum a posteriori probability Bayesian estimator of abacavir: application of individualized therapy in HIV-infected infants and toddlers.
Burger, D; Cella, M; Della Pasqua, O; Jacqz-Aigrain, E; Zhao, W, 2012
)
0.81
"To develop a population pharmacokinetic model for abacavir in HIV-infected infants and toddlers, which will be used to describe both once and twice daily pharmacokinetic profiles, identify covariates that explain variability and propose optimal time points to optimize the area under the concentration-time curve (AUC) targeted dosage and individualize therapy."( Population pharmacokinetics and maximum a posteriori probability Bayesian estimator of abacavir: application of individualized therapy in HIV-infected infants and toddlers.
Burger, D; Cella, M; Della Pasqua, O; Jacqz-Aigrain, E; Zhao, W, 2012
)
0.85
"The typical population pharmacokinetic parameters and relative standard errors (RSE) were apparent systemic clearance (CL) 13."( Population pharmacokinetics and maximum a posteriori probability Bayesian estimator of abacavir: application of individualized therapy in HIV-infected infants and toddlers.
Burger, D; Cella, M; Della Pasqua, O; Jacqz-Aigrain, E; Zhao, W, 2012
)
0.6
"The population pharmacokinetic model developed for abacavir in HIV-infected infants and toddlers accurately described both once and twice daily pharmacokinetic profiles."( Population pharmacokinetics and maximum a posteriori probability Bayesian estimator of abacavir: application of individualized therapy in HIV-infected infants and toddlers.
Burger, D; Cella, M; Della Pasqua, O; Jacqz-Aigrain, E; Zhao, W, 2012
)
0.85
" Dose-normalized area under curve (AUC)(0-12) and peak concentration (C(max)) for the tablet formulation were bioequivalent with those of the oral solution with respect to zidovudine and abacavir (e."( Pharmacokinetics of antiretroviral drug varies with formulation in the target population of children with HIV-1.
Adkison, KK; Bakeera-Kitaka, S; Burger, DM; Gibb, DM; Kasirye, P; Kekitiinwa, A; Kendall, L; Mhute, T; Nahirya-Ntege, P; Snowden, W; Ssenyonga, M; Tumusiime, C; Walker, AS, 2012
)
0.57
"In a clinical trial simulation setting, a paediatric study was simulated using a pharmacokinetic model previously developed for abacavir."( Adaptive trials in paediatric development: dealing with heterogeneity and uncertainty in pharmacokinetic differences in children.
Cella, M; Danhof, M; Della Pasqua, O, 2012
)
0.58
"HIV-infected subjects on abacavir (600 mg once daily) underwent steady-state pharmacokinetic assessments without and with darunavir/ritonavir or raltegravir."( Pharmacokinetics of abacavir and its anabolite carbovir triphosphate without and with darunavir/ritonavir or raltegravir in HIV-infected subjects.
Abongomera, G; Back, D; Boffito, M; Dickinson, L; Gazzard, B; Gedela, K; Jackson, A; Khoo, S; Moyle, G; Taylor, J, 2012
)
1.01
" A population pharmacokinetic analysis was performed using nonlinear mixed effects modelling VI."( Population pharmacokinetics of abacavir in infants, toddlers and children.
Burger, D; Danhof, M; Della Pasqua, O; Jacqz-Aigrain, E; Piana, C; Zhao, W, 2013
)
0.68
" There were no pharmacokinetic differences between the two formulations (tablet and solution)."( Population pharmacokinetics of abacavir in infants, toddlers and children.
Burger, D; Danhof, M; Della Pasqua, O; Jacqz-Aigrain, E; Piana, C; Zhao, W, 2013
)
0.68
" Intensive 24-h pharmacokinetic sampling was performed during the third trimester and at least 2 weeks after delivery."( The pharmacokinetics of abacavir 600 mg once daily in HIV-1-positive pregnant women.
Burger, D; Colbers, A; Hawkins, D; Konopnicki, D; Moltó, J; Schalkwijk, S; Taylor, G; Tenorio, CH; van der Ende, M; Weizsäcker, K; Wood, C, 2016
)
0.74
" In stage 1, term neonates exposed to HIV on standard antiretroviral prophylaxis (nevirapine ± zidovudine) received single dose(s) of the 4-in-1 formulation, followed by intensive pharmacokinetic sampling and safety assessments."( Pharmacokinetics and Safety of the Abacavir/Lamivudine/Lopinavir/Ritonavir Fixed-Dose Granule Formulation (4-in-1) in Neonates: PETITE Study.
Andrieux-Meyer, I; Bekker, A; Capparelli, E; Cotton, MF; Cressey, R; Cressey, TR; du Toit, S; Groenewald, M; Kumar, M; Lallemant, M; Nielsen, J; Rabie, H; Salvadori, N; Than-In-At, K, 2022
)
1
"Sixteen neonates, with a median (range) birth weight of 3130 g (2790-3590 g), completed 24 pharmacokinetic visits."( Pharmacokinetics and Safety of the Abacavir/Lamivudine/Lopinavir/Ritonavir Fixed-Dose Granule Formulation (4-in-1) in Neonates: PETITE Study.
Andrieux-Meyer, I; Bekker, A; Capparelli, E; Cotton, MF; Cressey, R; Cressey, TR; du Toit, S; Groenewald, M; Kumar, M; Lallemant, M; Nielsen, J; Rabie, H; Salvadori, N; Than-In-At, K, 2022
)
1
" We used abacavir pharmacokinetic data from neonates and infants to determine an exact abacavir dosing strategy (mg/kg) for infants aged 0-3 months and to propose dosing by WHO weight band for neonates."( Abacavir dosing in neonates from birth to 3 months of life: a population pharmacokinetic modelling and simulation study.
Bekker, A; Browning, R; Cababasay, M; Capparelli, EV; Cotton, MF; Cressey, TR; Decloedt, E; Mathiba, R; Mirochnick, M; Moye, J; Nakwa, FL; Rabie, H; Samson, P; Violari, A; Wang, J; Wiesner, L; Wiznia, A, 2022
)
2.58
"Abacavir pharmacokinetic and safety data were pooled from three completed studies (1997-2020): PACTG 321 (USA), the Tygerberg Cohort (South Africa), and IMPAACT P1106 (South Africa)."( Abacavir dosing in neonates from birth to 3 months of life: a population pharmacokinetic modelling and simulation study.
Bekker, A; Browning, R; Cababasay, M; Capparelli, EV; Cotton, MF; Cressey, TR; Decloedt, E; Mathiba, R; Mirochnick, M; Moye, J; Nakwa, FL; Rabie, H; Samson, P; Violari, A; Wang, J; Wiesner, L; Wiznia, A, 2022
)
3.61
" At first pharmacokinetic assessment, median postnatal age for PACTG 321 was 1 day and median bodyweight was 3·1 kg; for the Tygerberg Cohort it was 10 days and 3·3 kg; and for IMPAACT P1106 it was 73 days and 3·8 kg."( Abacavir dosing in neonates from birth to 3 months of life: a population pharmacokinetic modelling and simulation study.
Bekker, A; Browning, R; Cababasay, M; Capparelli, EV; Cotton, MF; Cressey, TR; Decloedt, E; Mathiba, R; Mirochnick, M; Moye, J; Nakwa, FL; Rabie, H; Samson, P; Violari, A; Wang, J; Wiesner, L; Wiznia, A, 2022
)
2.16

Compound-Compound Interactions

Abacavir, alone or in combination with ZDV, produced marked decreases in plasma HIV-1 RNA loads and increases in CD4+ cell counts. Fosamprenavir-ritonavir twice daily in treatment-naive patients provides similar antiviral efficacy, safety, tolerability, and emergence of resistance.

ExcerptReferenceRelevance
"To compare antiretroviral efficacy, safety and tolerance of three dosing regimens of the novel nucleoside reverse transcriptase inhibitor, abacavir (1592U89) over 24 weeks and its efficacy in open-label combination with zidovudine and lamivudine."( A dose-ranging study to evaluate the safety and efficacy of abacavir alone or in combination with zidovudine and lamivudine in antiretroviral treatment-naive subjects.
Cutrell, A; Harrer, T; Harrigan, RP; Katlama, C; Lanier, RE; Massip, P; Pearce, G; Staszewski, S; Steel, H; Tortell, SM; Yeni, P, 1998
)
0.74
"To evaluate, over 12 weeks, the antiretroviral activity and safety of abacavir, used alone and in combination with zidovudine (ZDV), as treatment for HIV-1-infected subjects who had limited or no antiretroviral treatment."( Antiretroviral effect and safety of abacavir alone and in combination with zidovudine in HIV-infected adults. Abacavir Phase 2 Clinical Team.
Gazzard, BG; Kelleher, D; LaFon, S; Lancaster, D; Romero, C; Saag, MS; Schooley, RT; Sonnerborg, A; Spreen, W; Torres, RA, 1998
)
0.81
"Treatment with abacavir, alone or in combination with ZDV, produced marked decreases in plasma HIV-1 RNA loads and increases in CD4+ cell counts in all groups."( Antiretroviral effect and safety of abacavir alone and in combination with zidovudine in HIV-infected adults. Abacavir Phase 2 Clinical Team.
Gazzard, BG; Kelleher, D; LaFon, S; Lancaster, D; Romero, C; Saag, MS; Schooley, RT; Sonnerborg, A; Spreen, W; Torres, RA, 1998
)
0.93
"In HIV-infected subjects who have received little or no prior antiretroviral therapy, treatment with abacavir alone or in combination with ZDV is well tolerated and resulted in sustained improvements in key immunologic and virologic efficacy parameters through 12 weeks."( Antiretroviral effect and safety of abacavir alone and in combination with zidovudine in HIV-infected adults. Abacavir Phase 2 Clinical Team.
Gazzard, BG; Kelleher, D; LaFon, S; Lancaster, D; Romero, C; Saag, MS; Schooley, RT; Sonnerborg, A; Spreen, W; Torres, RA, 1998
)
0.79
"To evaluate the pharmacokinetic features, safety, and tolerance of abacavir, given alone and in combination with other nucleoside antiretroviral agents, in symptomatic human immunodeficiency virus (HIV)-infected children."( A phase I study of abacavir (1592U89) alone and in combination with other antiretroviral agents in infants and children with human immunodeficiency virus infection. AIDS Clinical Trials Group 330 Team.
Blanchard, S; Brundage, RC; Culnane, M; Dankner, WM; Fletcher, CV; Hetherington, S; Kline, MW; Kovacs, A; McDowell, JA; McKinney, RE; Shenep, JL; Van Dyke, RB, 1999
)
0.87
" Three children experienced neutropenia while receiving abacavir in combination with another antiretroviral agent."( A phase I study of abacavir (1592U89) alone and in combination with other antiretroviral agents in infants and children with human immunodeficiency virus infection. AIDS Clinical Trials Group 330 Team.
Blanchard, S; Brundage, RC; Culnane, M; Dankner, WM; Fletcher, CV; Hetherington, S; Kline, MW; Kovacs, A; McDowell, JA; McKinney, RE; Shenep, JL; Van Dyke, RB, 1999
)
0.88
"Abacavir (1592U89) is a nucleoside reverse transcriptase inhibitor with potent activity against human immunodeficiency virus type 1 (HIV-1) when used alone or in combination with other antiretroviral agents."( Multiple-dose pharmacokinetics and pharmacodynamics of abacavir alone and in combination with zidovudine in human immunodeficiency virus-infected adults.
Lou, Y; McDowell, JA; Stein, DS; Symonds, WS, 2000
)
2
"To assess antiretroviral efficacy and safety of abacavir in combination with selected HIV-1 protease inhibitors."( Antiretroviral activity and safety of abacavir in combination with selected HIV-1 protease inhibitors in therapy-naive HIV-1-infected adults.
Cooney, E; Cutrell, A; Haas, DW; Haubrich, R; Horton, J; Kelleher, D; Lederman, M; Lee, D; McMahon, D; Mellors, JW; Ross, L; Spreen, W; Stanford, J, 2001
)
0.84
"Eighty-two antiretroviral naive HIV-1-infected adults (CD4 cell count > or = 100 cells/mm3, plasma HIV-1 RNA > or = 5,000 copies/ml) were randomly assigned to receive abacavir (300 mg twice daily) in combination with standard doses of one of five protease inhibitors: indinavir, saquinavir soft-gel, ritonavir, nelfinavir or amprenavir."( Antiretroviral activity and safety of abacavir in combination with selected HIV-1 protease inhibitors in therapy-naive HIV-1-infected adults.
Cooney, E; Cutrell, A; Haas, DW; Haubrich, R; Horton, J; Kelleher, D; Lederman, M; Lee, D; McMahon, D; Mellors, JW; Ross, L; Spreen, W; Stanford, J, 2001
)
0.78
"Abacavir is safe and effective when used in combination with a protease inhibitor."( Antiretroviral activity and safety of abacavir in combination with selected HIV-1 protease inhibitors in therapy-naive HIV-1-infected adults.
Cooney, E; Cutrell, A; Haas, DW; Haubrich, R; Horton, J; Kelleher, D; Lederman, M; Lee, D; McMahon, D; Mellors, JW; Ross, L; Spreen, W; Stanford, J, 2001
)
2.02
"To evaluate the antiretroviral activity and safety of multiple escalating doses of amprenavir administered alone, and in combination with abacavir in HIV-1-infected adults."( A dose-ranging study to evaluate the antiretroviral activity and safety of amprenavir alone and in combination with abacavir in HIV-infected adults with limited antiretroviral experience.
Antunes, F; Blake, D; Clumeck, N; Danner, SA; Haubrich, R; Millard, J; Mustafa, N; Myers, RE; Nacci, P; Schooley, RT; Sereni, D; Thompson, M; Tisdale, M; van Der Ende, ME, 2001
)
0.72
" One dose group received amprenavir 900 mg twice daily in combination with abacavir 300 mg twice daily for 4 weeks."( A dose-ranging study to evaluate the antiretroviral activity and safety of amprenavir alone and in combination with abacavir in HIV-infected adults with limited antiretroviral experience.
Antunes, F; Blake, D; Clumeck, N; Danner, SA; Haubrich, R; Millard, J; Mustafa, N; Myers, RE; Nacci, P; Schooley, RT; Sereni, D; Thompson, M; Tisdale, M; van Der Ende, ME, 2001
)
0.75
" We tested MPA alone and in combination with abacavir (ABC), didanosine (DDI), lamivudine (3TC) and tenofovir (TFV) against wild-type human immunodeficiency virus type-1 (HIV-1) and nucleoside reverse transcriptase inhibitor (NRTI)-resistant HIV-1."( Dose proportional inhibition of HIV-1 replication by mycophenolic acid and synergistic inhibition in combination with abacavir, didanosine, and tenofovir.
Coull, JJ; Drusano, GL; Hossain, MM; Margolis, DM, 2002
)
0.78
"From a study of 71 HIV-1-infected patients receiving abacavir in combination with 1 of 5 different HIV-1 protease inhibitors (indinavir, ritonavir, saquinavir, nelfinavir, or amprenavir), we found that the baseline HIV-1 RNA levels were highly predictive of the viral decay rates."( Viral dynamics and their relations to baseline factors and longer term virologic responses in treatment-naive HIV-1-infected patients receiving abacavir in combination with HIV-1 protease inhibitors.
Kelleher, D; Lederman, MM; McMahon, D; Mellors, J; Ruan, P; Wu, H, 2003
)
0.77
"Mutations selected or deselected during passage of human immunodeficiency virus strain HXB2 or resistant variants with tenofovir (TFV), abacavir (ABC), and lamivudine (3TC) differed depending on the drug combination and virus genotype."( Human immunodeficiency virus type 1 reverse transcriptase mutation selection during in vitro exposure to tenofovir alone or combined with abacavir or lamivudine.
Ait-Khaled, M; Craig, C; Griffin, P; Stone, C; Tisdale, M, 2004
)
0.73
" In this study, the novel RR inhibitors didox (DX; 3,4-dihydroxybenzohydroxamic acid), and trimidox (TX; 3,4,5-trihydroxybenzamidoxime) were evaluated along with HU for anti-retroviral efficacy in LPBM5-induced retro-viral disease (MAIDS) both as monotherapeutic regimens and in combination with the guanine containing NRTI abacavir (ABC)."( In vivo examination of hydroxyurea and the novel ribonucleotide reductase inhibitors trimidox and didox in combination with the reverse transcriptase inhibitor abacavir: suppression of retrovirus-induced immunodeficiency disease.
Duvall, W; Elford, HL; Gallicchio, VS; Hagan, E; Inayat, MS; Mayhew, CN; Sumpter, LR; Yost, EE, 2004
)
0.69
"Abacavir provided an effective and durable antiretroviral response that was noninferior to zidovudine, when combined with lamivudine and efavirenz."( Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults.
Bonny, T; Brand, JD; Brothers, CH; Buendia, CB; Castillo, SA; DeJesus, E; Gerstoft, J; Hernandez, J; Herrera, G; Lanier, ER; Scott, TR; Teofilo, E, 2004
)
3.21
"The combination of abacavir + lamivudine (ABC+3TC) versus didanosine + stavudine (ddI+d4T), each combined with other classes of antiretrovirals (ARVs) in ARV-naive patients, was compared for the combined endpoint of time to plasma HIV RNA >50 copies/mL (at or after the 8-month visit) or death (primary endpoint) in a nested substudy of an ongoing multicenter randomized trial."( Efficacy and safety of abacavir plus lamivudine versus didanosine plus stavudine when combined with a protease inhibitor, a nonnucleoside reverse transcriptase inhibitor, or both in HIV-1 positive antiretroviral-naive persons.
Besch, L; Chen, L; Dehlinger, M; Henley, C; Kozal, M; MacArthur, RD; Novak, RM; Peng, G; Schmetter, B; van den Berg-Wolf, M; Yurik, T,
)
0.77
" A randomized double-blind clinical trial compared the efficacy and safety of 600 mg of ABC administered once daily (n = 384) versus 300 mg of ABC administered twice daily (n = 386) in combination with 300 mg of lamivudine (3TC) and 600 mg of efavirenz (EFV) administered once daily in antiretroviral-naive patients over 48 weeks."( Abacavir once or twice daily combined with once-daily lamivudine and efavirenz for the treatment of antiretroviral-naive HIV-infected adults: results of the Ziagen Once Daily in Antiretroviral Combination Study.
Cahn, P; Castillo, SA; Craig, C; DeJesus, E; Gordon, DN; Moyle, GJ; Scott, TR; Zhao, H, 2005
)
1.77
" Fosamprenavir-ritonavir has shown similar efficacy and safety to lopinavir-ritonavir when each is combined with two nucleoside reverse transcriptase inhibitors."( The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial.
DeJesus, E; Eron, J; Estrada, V; Gathe, J; Katlama, C; Lackey, P; Patel, L; Shaefer, M; Staszewski, S; Sutherland-Phillips, D; Vavro, C; Wannamaker, P; Yau, L; Yeni, P; Yeo, J; Young, B, 2006
)
0.55
"Fosamprenavir-ritonavir twice daily in treatment-naive patients provides similar antiviral efficacy, safety, tolerability, and emergence of resistance as lopinavir-ritonavir, each in combination with abacavir-lamivudine."( The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial.
DeJesus, E; Eron, J; Estrada, V; Gathe, J; Katlama, C; Lackey, P; Patel, L; Shaefer, M; Staszewski, S; Sutherland-Phillips, D; Vavro, C; Wannamaker, P; Yau, L; Yeni, P; Yeo, J; Young, B, 2006
)
0.74
" Mutagenicity experiments with ABC alone, or in combination with AZT-3TC, were complicated by the extreme cytotoxicity of ABC."( Mutagenicity of zidovudine, lamivudine, and abacavir following in vitro exposure of human lymphoblastoid cells or in utero exposure of CD-1 mice to single agents or drug combinations.
Carter, MM; Cook, DL; Cordova, EM; McCash, CL; Olivero, OA; Poirier, MC; Torres, SM; Walker, DM; Walker, VE,
)
0.39
"We evaluated the mitochondrial toxicity of tenofovir (TFV), emtricitabine (FTC) and abacavir as carbovir (CBV) alone, with each other, and in combination with additional NRTIs."( Mitochondrial toxicity of tenofovir, emtricitabine and abacavir alone and in combination with additional nucleoside reverse transcriptase inhibitors.
Melkaoui, K; Setzer, B; Venhoff, N; Walker, UA, 2007
)
0.81
" In some patients on the nucleoside-sparing arm, the nucleoside-resistance mutation L74V was selected for in combination with the uncommonly occurring EFV-resistance mutations K103N+L100I; L74V was not detected as a minority variant, using clonal sequence analysis, when the nucleoside-sparing regimen was initiated."( Association of efavirenz hypersusceptibility with virologic response in ACTG 368, a randomized trial of abacavir (ABC) in combination with efavirenz (EFV) and indinavir (IDV) in HIV-infected subjects with prior nucleoside analog experience.
Bettendorf, D; DeGruttola, V; Demeter, LM; Eron, JJ; Eshleman, S; Fischl, M; Hammer, S; Koval, CE; Lustgarten, S; Nguyen, BY; Spreen, W; Squires, K,
)
0.35
" In addition, L74V, when combined with K103N+L100I, may confer a selective advantage to the virus that is independent of its effects on nucleoside resistance."( Association of efavirenz hypersusceptibility with virologic response in ACTG 368, a randomized trial of abacavir (ABC) in combination with efavirenz (EFV) and indinavir (IDV) in HIV-infected subjects with prior nucleoside analog experience.
Bettendorf, D; DeGruttola, V; Demeter, LM; Eron, JJ; Eshleman, S; Fischl, M; Hammer, S; Koval, CE; Lustgarten, S; Nguyen, BY; Spreen, W; Squires, K,
)
0.35
"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
)
0.61
"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
" This study investigated the toxic and genotoxic potential of ABC when administered alone or in combination with AZT and/or 3TC using the somatic mutation and recombination test in Drosophila melanogaster."( Toxicity and genotoxicity induced by abacavir antiretroviral medication alone or in combination with zidovudine and/or lamivudine in Drosophila melanogaster.
Bailão, E; Cardoso, CG; Chen-Chen, L; Cunha, KS; de Jesus Silva Carvalho, C; de Moraes Filho, AV; Spanó, MA; Véras, JH, 2019
)
0.79
" We did not find an elevated risk of AMI when abacavir-lamivudine was combined with efavirenz or raltegravir."( Acute myocardial infarction associated with abacavir and tenofovir based antiretroviral drug combinations in the United States.
Baxi, SM; Choden, T; Desai, M; Dorjee, K; Hubbard, AE; Reingold, AL, 2021
)
1.14

Bioavailability

Abacavir bioavailability decreased 36% during treatment with rifampin and LPV/r-4:4 but remained within the median adult recommended exposure, except for children in the 3- to 4-year-old range. Study A: To determine the absolute bioavailability of a single 300-mg abacavIR hemisulfate tablet. Study B: To assess the bioequivalence of a combined abac Cavir/lamivudine combination tablet.

ExcerptReferenceRelevance
" 1592U89 had excellent oral bioavailability (105% in the rat) and penetrated the CNS (rat brain and monkey cerebrospinal fluid) as well as AZT."( 1592U89, a novel carbocyclic nucleoside analog with potent, selective anti-human immunodeficiency virus activity.
Averett, DR; Boone, LR; Daluge, SM; Dornsife, RE; Faletto, MB; Good, SS; Krenitsky, TA; Miller, WH; Parry, NR; Reardon, JE; St Clair, MH; Tisdale, M, 1997
)
0.3
" The bioavailability of the caplet formulation relative to that of the oral solution was also assessed with the 300-mg dose."( Safety and pharmacokinetics of abacavir (1592U89) following oral administration of escalating single doses in human immunodeficiency virus type 1-infected adults.
Hetherington, S; Kumar, PN; LaFon, S; Lou, Y; McDowell, JA; Sweet, DE; Symonds, W, 1999
)
0.59
"Study A: to determine the absolute bioavailability of a single 300-mg abacavir hemisulfate tablet."( Abacavir: absolute bioavailability, bioequivalence of three oral formulations, and effect of food.
Chittick, GE; Edwards, KD; Gillotin, C; Lou, Y; McDowell, JA; Prince, WT; Stein, DS, 1999
)
1.98
" In study A, the geometric least square (GLS) mean absolute bioavailability of oral abacavir was 83% (range 65-107%)."( Abacavir: absolute bioavailability, bioequivalence of three oral formulations, and effect of food.
Chittick, GE; Edwards, KD; Gillotin, C; Lou, Y; McDowell, JA; Prince, WT; Stein, DS, 1999
)
1.97
"A single-center, open-label, three-way crossover study was conducted in 24 healthy subjects to assess (1) the bioequivalence of a combined abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg (A/L/Z) combination tablet relative to the separate brand-name components administered simultaneously and (2) the effect of food on the bioavailability of the drugs from the combination tablet."( Abacavir/lamivudine/zidovudine as a combined formulation tablet: bioequivalence compared with each component administered concurrently and the effect of food on absorption.
Allsup, TL; Hutman, HW; Lou, Y; Mahony, WB; Otto, VR; Thompson, NF; Yuen, GJ, 2001
)
1.96
" The membrane permeation characteristics of abacavir are consistent with its superior oral bioavailability and its impressive ability to penetrate the central nervous system."( Membrane permeation characteristics of abacavir in human erythrocytes and human T-lymphoblastoid CD4+ CEM cells: comparison with (-)-carbovir.
Daluge, SM; Domin, BA; Mahony, WB; Zimmerman, TP, 2004
)
0.85
"The bioavailability and targeted distribution of abacavir (ABC) and zidovudine (AZT) to viral reservoirs may be influenced by efflux transporters."( Abcg2/Bcrp1 mediates the polarized transport of antiretroviral nucleosides abacavir and zidovudine.
Elmquist, WF; Giri, N; Pan, G, 2007
)
0.82
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
" The absolute bioavailability of abacavir is approximately 83%."( A review of the pharmacokinetics of abacavir.
Pakes, GE; Weller, S; Yuen, GJ, 2008
)
0.9
" Encasement of MABC into poloxamer nanoparticles extended drug bioavailability for 2 weeks."( Development and characterization of a long-acting nanoformulated abacavir prodrug.
Alnouti, Y; Edagwa, B; Gautam, N; Gendelman, HE; Hilaire, J; McMillan, J; Palandri, D; Singh, D, 2016
)
0.67
"A phase 1, open-label, randomized study was conducted in healthy adults to evaluate the relative bioavailability of a novel dispersible FDC tablet of abacavir 150 mg/dolutegravir 10 mg/lamivudine 75 mg administered under 4 different dosing conditions compared with dolutegravir plus abacavir/lamivudine nondispersible, film-coated tablets."( Effects of Low- and High-Mineral Content Water on the Relative Bioavailability of a Coformulated Abacavir/Dolutegravir/Lamivudine Dispersible Tablet in Healthy Adults.
Buchanan, AM; Casillas, L; Joshi, S; Shaik, JSB; Shreeves, T; Singh, RP; Skoura, N, 2018
)
0.9
"Following administration of dispersible abacavir/dolutegravir/lamivudine, the relative bioavailability of dolutegravir was approximately 50% higher."( Effects of Low- and High-Mineral Content Water on the Relative Bioavailability of a Coformulated Abacavir/Dolutegravir/Lamivudine Dispersible Tablet in Healthy Adults.
Buchanan, AM; Casillas, L; Joshi, S; Shaik, JSB; Shreeves, T; Singh, RP; Skoura, N, 2018
)
0.97
" Abacavir PK was described by a 2-compartment model, patients randomized to early ART showed increased bioavailability of 31%."( Population pharmacokinetics of abacavir and lamivudine in severely malnourished human immunodeficiency virus-infected children in relation to treatment outcomes.
Archary, M; Bobat, R; Hennig, S; LaRussa, P; Mcllleron, H; Sibaya, T; Wiesner, L, 2019
)
1.71
"Increases in Abacavir's CL/F between day 1 to day 14, bioavailability and PK variability with early start of ART was found in this cohort of severely malnourished children; however, these changes did not influence virological outcomes."( Population pharmacokinetics of abacavir and lamivudine in severely malnourished human immunodeficiency virus-infected children in relation to treatment outcomes.
Archary, M; Bobat, R; Hennig, S; LaRussa, P; Mcllleron, H; Sibaya, T; Wiesner, L, 2019
)
1.17

Dosage Studied

Once-daily dosing of abacavir and lamivudine could provide an alternative dosing strategy for HIV-1-infected children, with high acceptability and strong preference suggesting the potential for improved adherence. The Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines were originally published in April 2012.

ExcerptRelevanceReference
" Triplicate in vitro dose-response matrices were prepared with MT-2 cells infected with HIV type 1 (HIV-1) strain IIIB."( Nucleoside analog 1592U89 and human immunodeficiency virus protease inhibitor 141W94 are synergistic in vitro.
Bilello, JA; Bilello, PA; Bye, A; D'Argenio, DZ; Drusano, GL; McDowell, J; Sadler, B; Symonds, W, 1998
)
0.3
"To compare antiretroviral efficacy, safety and tolerance of three dosing regimens of the novel nucleoside reverse transcriptase inhibitor, abacavir (1592U89) over 24 weeks and its efficacy in open-label combination with zidovudine and lamivudine."( A dose-ranging study to evaluate the safety and efficacy of abacavir alone or in combination with zidovudine and lamivudine in antiretroviral treatment-naive subjects.
Cutrell, A; Harrer, T; Harrigan, RP; Katlama, C; Lanier, RE; Massip, P; Pearce, G; Staszewski, S; Steel, H; Tortell, SM; Yeni, P, 1998
)
0.74
" This software automatically integrates the effect over a steady-state dosing interval and produces an estimate of the mean effect over a steady-state interval for each simulated subject."( Use of drug effect interaction modeling with Monte Carlo simulation to examine the impact of dosing interval on the projected antiviral activity of the combination of abacavir and amprenavir.
Barone, C; Bilello, JA; Bye, A; D'Argenio, DZ; Drusano, GL; LaFon, S; Preston, SL; Prince, W; Rogers, M; Symonds, W, 2000
)
0.5
" At steady state, abacavir pharmacokinetic parameters (area under the plasma concentration-time curve for a dosing interval [AUC(tau)] and peak concentration [C(max)]) were generally proportional to dose over the range of a 600- to 1,200-mg total daily dose."( Multiple-dose pharmacokinetics and pharmacodynamics of abacavir alone and in combination with zidovudine in human immunodeficiency virus-infected adults.
Lou, Y; McDowell, JA; Stein, DS; Symonds, WS, 2000
)
0.89
" Abacavir in combination with lamivudine and zidovudine provides a simple and convenient dosage regimen which is generally well tolerated, able to produce sustained suppression of viral replication and has the advantage of sparing other classes of antiretroviral drugs for subsequent use."( Abacavir: a review of its clinical potential in patients with HIV infection.
Hervey, PS; Perry, CM, 2000
)
2.66
") or three-times-daily dosage schedule to 62 HIV-infected adults, 59 of whom had pharmacokinetic data."( Pharmacokinetic and pharmacodynamic study of the human immunodeficiency virus protease inhibitor amprenavir after multiple oral dosing.
Gillotin, C; Lou, Y; Sadler, BM; Stein, DS, 2001
)
0.31
"Steady-state pharmacokinetics of ABC, 3TC, and ZDV were assessed after dosing with ABC-COM and the triple combination tablet."( A comparison of the steady-state pharmacokinetics and safety of abacavir, lamivudine, and zidovudine taken as a triple combination tablet and as abacavir plus a lamivudine-zidovudine double combination tablet by HIV-1-infected adults.
Crémieux, AC; Demarles, D; Gillotin, C; Katlama, C; Raffi, F; Yuen, GJ, 2001
)
0.55
" The dosage is 300 mg taken orally twice daily; however, optimal use of 1592 remains unknown."( Preliminary report on 1592.
, 1997
)
0.3
" All three drugs are currently available through expanded access programs, are dosed either once or twice daily, and can be taken with or without food."( I want a new drug. An overview of three new anti-HIV drugs.
Simmons, P, 1998
)
0.3
" The dosage regimens and limitations are described for each drug."( Four new antiretroviral medications will soon offer more options to HIV patients.
Murphy, MJ,
)
0.13
" Abacavir is also attracting attention due to its potency and dosing convenience."( Dupont pharmaceuticals study 006 for Sustiva.
Bartlett, JG, 1998
)
1.21
" On recommendation from Federal guidelines, many treatment regimens approved for adults are being prescribed for children, but these have little information available about dosing and long-term effects."( Antivirals and children.
, 1998
)
0.3
" As a potent alternative to HAART, NNRTI's offer easier dosing and appear to have similar results, albeit in the short-term."( Antivirals update.
, 1998
)
0.3
" Ziagen appears to have significant antiviral activity, and its dosage is one pill twice a day."( Glaxo Wellcome's two new drugs.
, 1998
)
0.3
" Results of clinical trials are summarized, and dosing options and side effects are detailed."( Product information.
Bartlett, JG, 1999
)
0.3
" Information on each drug, such as the name of the drug, the dosage normally prescribed, and cost of treatment is listed."( What they say about: nucleoside drugs.
,
)
0.13
" Information on dosing and side effects is given."( Abacavir update.
, 1998
)
1.74
" Several studies of regimens that include protease inhibitors compare dosing twice daily to three times a day."( Antivirals update.
, 1998
)
0.3
" Progress is also highlighted about dosing regimens, antiretroviral resistance, and reconstitution of the immune system."( Moving forward: a treatment overview from the 12th World AIDS Conference.
Agosto, M, 1998
)
0.3
" After an overnight fast, the subjects received their abacavir dosage (600 or 300 mg)."( Pharmacokinetics of abacavir in HIV-1-infected patients with impaired renal function.
Aymard, G; Deray, G; Izzedine, H; Launay-Vacher, V; Legrand, M, 2001
)
0.88
" Therefore, dosage adjustment is not necessary in patients with renal insufficiency."( Pharmacokinetics of abacavir in HIV-1-infected patients with impaired renal function.
Aymard, G; Deray, G; Izzedine, H; Launay-Vacher, V; Legrand, M, 2001
)
0.63
" However, at circa day 18 of the experiment, there was a small increase in viral output of p24 in the once-daily dosing unit."( Pharmacodynamics of abacavir in an in vitro hollow-fiber model system.
Bilello, JA; Bilello, PA; Bye, A; Drusano, GL; McDowell, J; Stein, DS; Symonds, WT, 2002
)
0.64
"37) were similar regardless of the dosing regimen."( Indinavir, efavirenz, and abacavir pharmacokinetics in human immunodeficiency virus-infected subjects.
Cha, R; DiCenzo, R; Fischl, MA; Forrest, A; Hammer, SM; Morse, GD; Squires, KE; Wu, H, 2003
)
0.62
" Compared with amprenavir 1,200 mg BID, both GW433908 1,395 mg BID and GW433908 1,860 mg BID delivered equivalent steady-state (ss) values for area under the plasma amprenavir concentration-time curve (AUC) at the end of a dosing interval (tau), lower maximum plasma amprenavir concentrations (30% lower), and higher plasma amprenavir concentrations at the end of a dosing interval (28% higher for GW433908 1,395 mg BID and 46% higher for GW433908 1,860 mg BID)."( Six-week randomized controlled trial to compare the tolerabilities, pharmacokinetics, and antiviral activities of GW433908 and amprenavir in human immunodeficiency virus type 1-infected patients.
Arasteh, K; Eron, J; Millard, J; Naderer, OJ; Pollard, RB; Raffi, F; Stellbrink, HJ; Teofilo, E; Wire, MB; Wood, R; Yeo, J, 2004
)
0.32
" GW433908 was generally well tolerated and provides a convenient dosing option without food or fluid restrictions."( The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naive HIV-1-infected patients.
Boghossian, J; Gray, GE; Millard, JM; Nadler, JP; Quinones, AR; Rodriguez-French, A; Sepulveda, GE; Wannamaker, PG, 2004
)
0.32
" Dosing schedule comprised (co-formulated) zidovudine, lamivudine, and abacavir bid."( Simplified therapy with zidovudine, lamivudine, and abacavir for very nonadherent, treatment-failing patients.
Carmona, A; Colomés, JL; Gimeno, JL; Gonzalez, A; Guelar, A; Knobel, H; Pedrol, E; Saballs, P; Soler, A; Vallecillo, G,
)
0.62
"To compare dosing convenience and adherence with abacavir (ABC) 300 mg plus a fixed-dose lamivudine 150 mg/zidovudine 300 mg combination tablet (COM) twice daily versus indinavir (IDV) plus COM twice daily in treatment-naïve, HIV-1-infected adults; and to evaluate the association among difficulty taking antiretroviral regimens, adherence, and virologic efficacy."( Predictors of adherence and virologic outcome in HIV-infected patients treated with abacavir- or indinavir-based triple combination HAART also containing lamivudine/zidovudine.
Cahn, P; Carosi, G; Jordan, JC; Pharo, CE; Schechter, M; Smaill, F; Soto-Ramirez, L; Steel, HM; Thomas, NE; Vibhagool, A, 2004
)
0.8
" The efficacy of the current recommended abacavir dosage for patients with high bodyweight should be evaluated in further studies."( Weight related differences in the pharmacokinetics of abacavir in HIV-infected patients.
Chappuy, H; Dimet, J; Dupin, N; Jullien, V; Pons, G; Rey, E; Salmon, D; Tréluyer, JM; Urien, S, 2005
)
0.84
" This study confirms the relevance of the current weight-based abacavir dosage regimen in pediatric patients."( Abacavir pharmacokinetics in human immunodeficiency virus-infected children ranging in age from 1 month to 16 years: a population analysis.
Blanche, S; Chappuy, H; Dimet, J; Jullien, V; Pons, G; Rey, E; Tréluyer, JM; Urien, S, 2005
)
2.01
" ABC administered once daily in combination with 3TC and EFV administered once daily was non-inferior to the ABC twice-daily dosing schedule when combined with 3TC and EFV over 48 weeks."( Abacavir once or twice daily combined with once-daily lamivudine and efavirenz for the treatment of antiretroviral-naive HIV-infected adults: results of the Ziagen Once Daily in Antiretroviral Combination Study.
Cahn, P; Castillo, SA; Craig, C; DeJesus, E; Gordon, DN; Moyle, GJ; Scott, TR; Zhao, H, 2005
)
1.77
"Several proofs of principle have established that pharmacogenetic testing for mutations altering expression and functions of genes associated with drug disposition and response can decrease the "trial-and-error" dosing and reduce the risk of adverse drug reactions."( Pharmacogenetic testing: proofs of principle and pharmacoeconomic implications.
Dervieux, T; Meshkin, B; Neri, B, 2005
)
0.33
" Intensive plasma PK sampling was performed at steady state, after which children switched to q24h dosing and PK sampling was repeated 4 weeks later."( Plasma pharmacokinetics of once- versus twice-daily lamivudine and abacavir: simplification of combination treatment in HIV-1-infected children (PENTA-13).
Bergshoeff, A; Burger, D; Farrelly, L; Flynn, J; Gibb, D; Khoo, S; Le Prevost, M; Lyall, H; Novelli, V; Verweij, C; Walker, S, 2005
)
0.56
"AUC0-24 and Cmax of both 3TC and ABC q24h were not inferior to q12h dosing in children."( Plasma pharmacokinetics of once- versus twice-daily lamivudine and abacavir: simplification of combination treatment in HIV-1-infected children (PENTA-13).
Bergshoeff, A; Burger, D; Farrelly, L; Flynn, J; Gibb, D; Khoo, S; Le Prevost, M; Lyall, H; Novelli, V; Verweij, C; Walker, S, 2005
)
0.56
"To review the safety and efficacy of a once-daily dosage regimen for abacavir, a nucleoside reverse transcriptase inhibitor."( Once-daily abacavir in place of twice-daily administration.
Goedken, AM; Herman, RA,
)
0.76
"Antiretroviral combinations that reduce the number of pills and dosing frequency have the potential to simplify therapy."( Early virologic nonresponse to tenofovir, abacavir, and lamivudine in HIV-infected antiretroviral-naive subjects.
Berger, DS; Gallant, JE; Johnson, J; Liao, Q; Lim, ML; Rodriguez, AE; Ross, L; Shaefer, MS; Weinberg, WG; Young, B, 2005
)
0.59
" It achieves comparable suppression of plasma HIV RNA with the pill's individual components dosed twice daily and with thymidine analogs combined with lamivudine."( Fixed dose combination abacavir/lamivudine in the treatment of HIV-1 infection.
Anderson, AM; Bartlett, JA, 2005
)
0.64
" Acceptability of once daily drugs was best when the whole regimen was dosed once daily."( Adherence and acceptability of once daily Lamivudine and abacavir in human immunodeficiency virus type-1 infected children.
Burger, DM; Clapson, M; Farrelly, L; Flynn, J; Gibb, DM; Green, H; Head, S; LePrevost, M; Lyall, H; Novelli, V; Walker, AS, 2006
)
0.58
" As adherence is crucial for treatment success, regimens with fewer pills, simpler dosing schedules and fewer adverse events have become the first choice for antiretroviral therapy."( Abacavir/lamividune combination in the treatment of HIV-1 infection: a review.
Moyle, G; Waters, L, 2006
)
1.78
" A formulation of abacavir sulfate/lamivudine/zidovudine allows a dosing schedule of one pill twice daily."( Abacavir sulfate/lamivudine/zidovudine fixed combination in the treatment of HIV infection.
Keiser, P; Nassar, N, 2007
)
2.12
" Depending on the intended indication and dosing regimen, PPL can delay or stop development of a compound in the drug discovery process."( Evaluation of a published in silico model and construction of a novel Bayesian model for predicting phospholipidosis inducing potential.
Gehlhaar, D; Greene, N; Johnson, TO; Pelletier, DJ; Tilloy-Ellul, A,
)
0.13
" TDM is useful to determine the best dosage regimen adapted to each patient."( Determination of abacavir, amprenavir, didanosine, efavirenz, nevirapine, and stavudine concentration in human plasma by MALDI-TOF/TOF.
Alonzi, T; Ascenzi, P; Mancone, C; Narciso, P; Notari, S; Tripodi, M, 2008
)
0.69
"Patients prefer fewer pills and once-daily (qd) dosing without food restrictions."( Switching from twice-daily abacavir and lamivudine to the once-daily fixed-dose combination tablet of abacavir and lamivudine improves patient adherence and satisfaction with therapy.
Gazzard, BG; Jackson, A; Maitland, D; Mandalia, S; Moyle, GJ; Osorio, J, 2008
)
0.64
"017); dosing compliance 97."( Switching from twice-daily abacavir and lamivudine to the once-daily fixed-dose combination tablet of abacavir and lamivudine improves patient adherence and satisfaction with therapy.
Gazzard, BG; Jackson, A; Maitland, D; Mandalia, S; Moyle, GJ; Osorio, J, 2008
)
0.64
" RBV dosing was 213."( Abacavir does not influence the rate of virological response in HIV-HCV-coinfected patients treated with pegylated interferon and weight-adjusted ribavirin.
Bonet, L; Cifuentes, C; Gatell, JM; Laguno, M; Laufer, N; Mallolas, J; Murillas, J; Perez, I; Veloso, S; Vidal, F, 2008
)
1.79
" In 27 evaluable subjects, the regimens provided bioequivalent ABC daily areas under the concentration-time curve from 0 to 24 h (AUC(0-24)) and comparable CBV-TP concentrations at the end of the dosing interval (C(tau))."( Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
Boffito, M; Fletcher, C; Guerini, EM; Hay, PE; Higgs, C; Lou, Y; Min, SS; Moyle, G; Song, IH; Yuen, GJ, 2009
)
0.63
" Statistical analyses were performed on pharmacokinetic parameters: the area under the concentration-time curve from 0 to 4 h (AUC(0-4)), the maximum concentration of the drug (C(max)), and the residual concentration of the drug at the end of the dosing interval (C(trough)) for plasma and the AUC(0-4) and C(trough) for intracellular data."( Pilot pharmacokinetic study of human immunodeficiency virus-infected patients receiving tenofovir disoproxil fumarate (TDF): investigation of systemic and intracellular interactions between TDF and abacavir, lamivudine, or lopinavir-ritonavir.
Ayen, R; Clotet, B; Grassi, J; Levi, M; Negredo, E; Pruvost, A; Puig, J; Théodoro, F, 2009
)
0.54
" Therefore, dosing adolescents as adults should be reexamined."( Abacavir and metabolite pharmacokinetics in HIV-1-infected children and adolescents.
Cross, SJ; D'angelo, LJ; Lindsey, JC; Robbins, BL; Rodman, JH; Rose, CH; Yuen, GJ, 2009
)
1.8
"The establishment of a rationale for determining dosing regimens in pediatric patients remains a challenge in drug development."( A model-based approach to dose selection in early pediatric development.
Burger, D; Cella, M; Danhof, M; Della Pasqua, O; Gorter de Vries, F, 2010
)
0.36
"Once-daily dosing of abacavir and lamivudine has been approved for adults, but paediatric data are insufficient."( Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months.
, 2010
)
0.93
"No data on once-daily dosing of nucleoside analogues in African children currently exist."( Pharmacokinetics and acceptability of once- versus twice-daily lamivudine and abacavir in HIV type-1-infected Ugandan children in the ARROW Trial.
Adkison, K; Bakeera-Kitaka, S; Burger, D; Gibb, DM; Kekitiinwa, A; Kendall, L; Mugyenyi, P; Musiime, V; Musoke, P; Odongo, F; Snowden, WB; Thomason, M; Walker, AS, 2010
)
0.59
" For both children and caregivers, once-daily dosing of lamivudine plus abacavir was highly acceptable and strongly preferred over twice-daily."( Pharmacokinetics and acceptability of once- versus twice-daily lamivudine and abacavir in HIV type-1-infected Ugandan children in the ARROW Trial.
Adkison, K; Bakeera-Kitaka, S; Burger, D; Gibb, DM; Kekitiinwa, A; Kendall, L; Mugyenyi, P; Musiime, V; Musoke, P; Odongo, F; Snowden, WB; Thomason, M; Walker, AS, 2010
)
0.82
" Once-daily dosing of abacavir and lamivudine could provide an alternative dosing strategy for HIV-1-infected children, with high acceptability and strong preference suggesting the potential for improved adherence."( Pharmacokinetics and acceptability of once- versus twice-daily lamivudine and abacavir in HIV type-1-infected Ugandan children in the ARROW Trial.
Adkison, K; Bakeera-Kitaka, S; Burger, D; Gibb, DM; Kekitiinwa, A; Kendall, L; Mugyenyi, P; Musiime, V; Musoke, P; Odongo, F; Snowden, WB; Thomason, M; Walker, AS, 2010
)
0.9
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."( FDA-approved drug labeling for the study of drug-induced liver injury.
Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011
)
0.37
" Standard dosage regimen is associated with large interindividual variability in abacavir concentrations."( Population pharmacokinetics and maximum a posteriori probability Bayesian estimator of abacavir: application of individualized therapy in HIV-infected infants and toddlers.
Burger, D; Cella, M; Della Pasqua, O; Jacqz-Aigrain, E; Zhao, W, 2012
)
0.83
"To develop a population pharmacokinetic model for abacavir in HIV-infected infants and toddlers, which will be used to describe both once and twice daily pharmacokinetic profiles, identify covariates that explain variability and propose optimal time points to optimize the area under the concentration-time curve (AUC) targeted dosage and individualize therapy."( Population pharmacokinetics and maximum a posteriori probability Bayesian estimator of abacavir: application of individualized therapy in HIV-infected infants and toddlers.
Burger, D; Cella, M; Della Pasqua, O; Jacqz-Aigrain, E; Zhao, W, 2012
)
0.85
"To assess whether an adaptive design in early clinical trials based on the paradigm of variable dosing and controlled exposure can provide better dosing recommendations compared with the standard fixed dose approach."( Adaptive trials in paediatric development: dealing with heterogeneity and uncertainty in pharmacokinetic differences in children.
Cella, M; Danhof, M; Della Pasqua, O, 2012
)
0.38
"Adaptive randomization can be used to optimize dosing regimens in early paediatric clinical trials."( Adaptive trials in paediatric development: dealing with heterogeneity and uncertainty in pharmacokinetic differences in children.
Cella, M; Danhof, M; Della Pasqua, O, 2012
)
0.38
" In April 2011 due to an augmentation in creatinine plasma levels, a reduction in lamivudine dosage to 100 mg/day and the prescription of abacavir 300 mg/day became necessary."( A case of adverse drug reaction induced by dispensing error.
Caroleo, B; De Sarro, G; Di Mizio, G; Gallelli, L; Palleria, C; Staltari, O, 2012
)
0.58
" Model-based predictions showed that equivalent systemic exposure was achieved after once and twice daily dosing regimens."( Population pharmacokinetics of abacavir in infants, toddlers and children.
Burger, D; Danhof, M; Della Pasqua, O; Jacqz-Aigrain, E; Piana, C; Zhao, W, 2013
)
0.68
" Through dose-response experiments, we established relative inhibitory potencies of NRTIs on in vitro telomerase activity as compared to the inhibitory potencies of the corresponding dideoxynucleotide triphosphates."( In vitro and ex vivo inhibition of human telomerase by anti-HIV nucleoside reverse transcriptase inhibitors (NRTIs) but not by non-NRTIs.
Côté, HC; Hukezalie, KR; Thumati, NR; Wong, JM, 2012
)
0.38
"Standard LPV dosing achieved therapeutic levels in pregnancy and no appreciable concentrations in breast milk."( Therapeutic levels of lopinavir in late pregnancy and abacavir passage into breast milk in the Mma Bana Study, Botswana.
Capparelli, E; Essex, M; Leidner, J; Lockman, S; Makhema, J; Moffat, C; Moss, M; Moyo, S; Ogwu, A; Rossi, S; Shapiro, RL, 2013
)
0.64
"Regimen simplification can be defined as a change in established effective therapy to reduce pill burden and dosing frequency, to enhance tolerability, or to decrease specific food and fluid requirements."( Abacavir-based triple nucleoside regimens for maintenance therapy in patients with HIV.
Bosco, O; Cruciani, M; Malena, M; Mengoli, C; Parisi, SG; Serpelloni, G, 2013
)
1.83
"The Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for HLA-B Genotype and Abacavir Dosing were originally published in April 2012."( Clinical Pharmacogenetics Implementation Consortium Guidelines for HLA-B Genotype and Abacavir Dosing: 2014 update.
Dong, BJ; Freimuth, RR; Haas, DW; Hicks, JK; Hoffman, JM; Klein, TE; Kroetz, DL; Martin, MA; Pirmohamed, M; Wilkinson, MR, 2014
)
0.84
" Thus, it seems unnecessary to adapt the ABC dosing regimen during pregnancy."( Population pharmacokinetics of abacavir in pregnant women.
Fauchet, F; Hirt, D; Pannier, E; Préta, LH; Treluyer, JM; Urien, S; Valade, E, 2014
)
0.69
" Absence of hypersensitivity reactions, superior resistance profile and once-daily dosing favours abacavir for African children, supporting WHO 2013 guidelines."( Abacavir, zidovudine, or stavudine as paediatric tablets for African HIV-infected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial.
Abongomera, G; Asiimwe, A; Burger, D; Chabala, C; Chintu, C; Cook, AD; Gibb, DM; Kekitiinwa, A; Kenny, J; Kityo, C; Klein, N; McIlleron, H; Mirembe, G; Mulenga, V; Musiime, V; Owen-Powell, E; Thomason, MJ; Walker, AS, 2016
)
2.09
" And while the drug elvitegravir has been inserted into a four-drug combination pill providing a once-daily dosing alternative, dolutegravir has demonstrated superiority in terms of its efficacy and resistance."( The preclinical discovery and development of dolutegravir for the treatment of HIV.
Bailly, F; Cotelle, P, 2015
)
0.42
" New drugs that offer new mechanisms of action, improvements in potency and activity even against multidrug-resistant viruses, dosing convenience, and tolerability have been approved."( [Companion Diagnostics for Selecting Antiretroviral Drugs against HIV-1].
Fukutake, K, 2015
)
0.42
" Once-daily dosing could improve adherence."( Once vs twice-daily abacavir and lamivudine in African children.
Cook, A; Gibb, DM; Kasirye, P; Mhute, T; Mugarura, L; Munjoma, M; Musiime, V; Nahirya-Ntege, P; Naidoo-James, B; Nankya, I; Ndashimye, E; Snowden, W; Spyer, MJ; Thomason, MJ; Thoofer, NK; Walker, AS, 2016
)
0.76
"Simplified dosing regimens are important for patients who face challenges in adhering to HIV-1 therapy."( Dolutegravir/abacavir/lamivudine versus current ART in virally suppressed patients (STRIIVING): a 48-week, randomized, non-inferiority, open-label, Phase IIIb study.
Aboud, M; Brennan, C; Brinson, C; Granier, C; Hopking, J; Koteff, JA; Lake, JE; Logue, K; Santiago, L; Trottier, B; Wynne, B, 2017
)
0.82
" The risk for cumulative exposure followed a bell-shaped dose-response curve peaking at 24-months of exposure."( Risk of cardiovascular events from current, recent, and cumulative exposure to abacavir among persons living with HIV who were receiving antiretroviral therapy in the United States: a cohort study.
Baxi, SM; Dorjee, K; Hubbard, A; Reingold, AL, 2017
)
0.68
" Alternative formulations with acceptable palatability and convenient dosing are needed for children who require smaller doses and have difficulty swallowing tablets."( Effects of Low- and High-Mineral Content Water on the Relative Bioavailability of a Coformulated Abacavir/Dolutegravir/Lamivudine Dispersible Tablet in Healthy Adults.
Buchanan, AM; Casillas, L; Joshi, S; Shaik, JSB; Shreeves, T; Singh, RP; Skoura, N, 2018
)
0.7
"A phase 1, open-label, randomized study was conducted in healthy adults to evaluate the relative bioavailability of a novel dispersible FDC tablet of abacavir 150 mg/dolutegravir 10 mg/lamivudine 75 mg administered under 4 different dosing conditions compared with dolutegravir plus abacavir/lamivudine nondispersible, film-coated tablets."( Effects of Low- and High-Mineral Content Water on the Relative Bioavailability of a Coformulated Abacavir/Dolutegravir/Lamivudine Dispersible Tablet in Healthy Adults.
Buchanan, AM; Casillas, L; Joshi, S; Shaik, JSB; Shreeves, T; Singh, RP; Skoura, N, 2018
)
0.9
" Neither the mineral content of the water nor dosing times affected the pharmacokinetics of individual components."( Effects of Low- and High-Mineral Content Water on the Relative Bioavailability of a Coformulated Abacavir/Dolutegravir/Lamivudine Dispersible Tablet in Healthy Adults.
Buchanan, AM; Casillas, L; Joshi, S; Shaik, JSB; Shreeves, T; Singh, RP; Skoura, N, 2018
)
0.7
" The study supports the use of weight-band dosage tables."( Population pharmacokinetics of abacavir and lamivudine in severely malnourished human immunodeficiency virus-infected children in relation to treatment outcomes.
Archary, M; Bobat, R; Hennig, S; LaRussa, P; Mcllleron, H; Sibaya, T; Wiesner, L, 2019
)
0.8
" partial least square (PLS) and genetic algorithm (GA) were utilized for the simultaneous determination of the vital ternary antiretroviral therapy dolutegravir (DTG), lamivudine (LMV), and abacavir (ACV) in their combined dosage form."( Analysis of the ternary antiretroviral therapy dolutegravir, lamivudine and abacavir using UV spectrophotometry and chemometric tools.
Abdelzaher, AM; Elmaaty, AA; Hasan, MA; Serag, A; Tolba, EH, 2022
)
1.14
"No evidence-based optimal dosing guidance is available for abacavir liquid formulation use from birth."( Abacavir dosing in neonates from birth to 3 months of life: a population pharmacokinetic modelling and simulation study.
Bekker, A; Browning, R; Cababasay, M; Capparelli, EV; Cotton, MF; Cressey, TR; Decloedt, E; Mathiba, R; Mirochnick, M; Moye, J; Nakwa, FL; Rabie, H; Samson, P; Violari, A; Wang, J; Wiesner, L; Wiznia, A, 2022
)
2.41
" A fixed weight-band dosing strategy of 8 mg (for 2-3 kg), 10 mg (3-4 kg), and 12 mg (4-5 kg) abacavir twice daily achieved target exposures throughout the first 4 weeks of life without the need for dose adjustment due to age or bodyweight changes."( Abacavir dosing in neonates from birth to 3 months of life: a population pharmacokinetic modelling and simulation study.
Bekker, A; Browning, R; Cababasay, M; Capparelli, EV; Cotton, MF; Cressey, TR; Decloedt, E; Mathiba, R; Mirochnick, M; Moye, J; Nakwa, FL; Rabie, H; Samson, P; Violari, A; Wang, J; Wiesner, L; Wiznia, A, 2022
)
2.38
"Integration of these dosing strategies into national and international guidelines for the abacavir liquid formulation will expand antiretroviral options from birth and simplify the clinical management of neonates with HIV."( Abacavir dosing in neonates from birth to 3 months of life: a population pharmacokinetic modelling and simulation study.
Bekker, A; Browning, R; Cababasay, M; Capparelli, EV; Cotton, MF; Cressey, TR; Decloedt, E; Mathiba, R; Mirochnick, M; Moye, J; Nakwa, FL; Rabie, H; Samson, P; Violari, A; Wang, J; Wiesner, L; Wiznia, A, 2022
)
2.39
"The pharmacokinetics of abacavir (ABC) in African children living with HIV (CLHIV) weighing <14 kg and receiving pediatric fixed dose combinations (FDC) according to WHO weight bands dosing are limited."( Abacavir Drug Exposures in African Children Under 14 kg Using Pediatric Solid Fixed Dose Combinations According to World Health Organization Weight Bands.
Bukusi, EA; Chupradit, S; Cressey, TR; Kekitiinwa, AR; Maleche-Obimbo, E; Mbuthia, JK; Musiime, V; Mwanga-Amumpaire, J; Nyandiko, WM; Punyawudho, B; Swanson, A; Wamalwa, DC, 2023
)
2.66
"Lowering the ABC dosage to 30 mg twice daily or 60 mg once daily for children weighing 3-5."( Abacavir Drug Exposures in African Children Under 14 kg Using Pediatric Solid Fixed Dose Combinations According to World Health Organization Weight Bands.
Bukusi, EA; Chupradit, S; Cressey, TR; Kekitiinwa, AR; Maleche-Obimbo, E; Mbuthia, JK; Musiime, V; Mwanga-Amumpaire, J; Nyandiko, WM; Punyawudho, B; Swanson, A; Wamalwa, DC, 2023
)
2.35
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

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

Drug Classes (1)

ClassDescription
2,6-diaminopurinesAny aminopurine that has amino substituents at positions 2 and 6, and their substituted derivatives.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (5)

PathwayProteinsCompounds
Abacavir ADME624
Abacavir transmembrane transport25
Abacavir metabolism423
Abacavir Action Pathway05
Drug ADME6387

Protein Targets (11)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
LuciferasePhotinus pyralis (common eastern firefly)Potency11.42390.007215.758889.3584AID624030
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency23.91850.01237.983543.2770AID1645841
cytochrome P450 2D6Homo sapiens (human)Potency30.11160.00108.379861.1304AID1645840
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency25.11890.035520.977089.1251AID504332
peripheral myelin protein 22Rattus norvegicus (Norway rat)Potency0.90740.005612.367736.1254AID624032
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-dependent translocase ABCB1Homo sapiens (human)IC50 (µMol)500.00000.00022.318510.0000AID1122141; AID1122142; AID1122143
Replicase polyprotein 1abSevere acute respiratory syndrome-related coronavirusIC50 (µMol)18.62500.00402.92669.9600AID1805801
Replicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2IC50 (µMol)18.62500.00022.45859.9600AID1805801
Reverse transcriptase/RNaseH Human immunodeficiency virus 1IC50 (µMol)0.13000.00011.076810.0000AID393069
Broad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)IC50 (µMol)385.00000.00401.966610.0000AID1873200
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
AlbuminHomo sapiens (human)Kd44.00000.08933.31358.0000AID1238542
Reverse transcriptase/RNaseH Human immunodeficiency virus 1EC50 (µMol)10.40000.00040.61539.7000AID200001; AID200002
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (32)

Processvia Protein(s)Taxonomy
cellular response to starvationAlbuminHomo sapiens (human)
negative regulation of mitochondrial depolarizationAlbuminHomo sapiens (human)
cellular response to calcium ion starvationAlbuminHomo sapiens (human)
cellular oxidant detoxificationAlbuminHomo sapiens (human)
transportAlbuminHomo sapiens (human)
G2/M transition of mitotic cell cycleATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic metabolic processATP-dependent translocase ABCB1Homo sapiens (human)
response to xenobiotic stimulusATP-dependent translocase ABCB1Homo sapiens (human)
phospholipid translocationATP-dependent translocase ABCB1Homo sapiens (human)
terpenoid transportATP-dependent translocase ABCB1Homo sapiens (human)
regulation of response to osmotic stressATP-dependent translocase ABCB1Homo sapiens (human)
transmembrane transportATP-dependent translocase ABCB1Homo sapiens (human)
transepithelial transportATP-dependent translocase ABCB1Homo sapiens (human)
stem cell proliferationATP-dependent translocase ABCB1Homo sapiens (human)
ceramide translocationATP-dependent translocase ABCB1Homo sapiens (human)
export across plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
transport across blood-brain barrierATP-dependent translocase ABCB1Homo sapiens (human)
positive regulation of anion channel activityATP-dependent translocase ABCB1Homo sapiens (human)
carboxylic acid transmembrane transportATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic detoxification by transmembrane export across the plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic transport across blood-brain barrierATP-dependent translocase ABCB1Homo sapiens (human)
regulation of chloride transportATP-dependent translocase ABCB1Homo sapiens (human)
symbiont-mediated perturbation of host ubiquitin-like protein modificationReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
lipid transportBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
organic anion transportBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
urate transportBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
biotin transportBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
sphingolipid biosynthetic processBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
riboflavin transportBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
urate metabolic processBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
transmembrane transportBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
transepithelial transportBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
renal urate salt excretionBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
export across plasma membraneBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
transport across blood-brain barrierBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
cellular detoxificationBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
xenobiotic transport across blood-brain barrierBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (43)

Processvia Protein(s)Taxonomy
oxygen bindingAlbuminHomo sapiens (human)
DNA bindingAlbuminHomo sapiens (human)
fatty acid bindingAlbuminHomo sapiens (human)
copper ion bindingAlbuminHomo sapiens (human)
protein bindingAlbuminHomo sapiens (human)
toxic substance bindingAlbuminHomo sapiens (human)
antioxidant activityAlbuminHomo sapiens (human)
pyridoxal phosphate bindingAlbuminHomo sapiens (human)
identical protein bindingAlbuminHomo sapiens (human)
protein-folding chaperone bindingAlbuminHomo sapiens (human)
exogenous protein bindingAlbuminHomo sapiens (human)
enterobactin bindingAlbuminHomo sapiens (human)
protein bindingATP-dependent translocase ABCB1Homo sapiens (human)
ATP bindingATP-dependent translocase ABCB1Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
efflux transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
ATP hydrolysis activityATP-dependent translocase ABCB1Homo sapiens (human)
transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
ubiquitin protein ligase bindingATP-dependent translocase ABCB1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
carboxylic acid transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
phosphatidylcholine floppase activityATP-dependent translocase ABCB1Homo sapiens (human)
phosphatidylethanolamine flippase activityATP-dependent translocase ABCB1Homo sapiens (human)
ceramide floppase activityATP-dependent translocase ABCB1Homo sapiens (human)
floppase activityATP-dependent translocase ABCB1Homo sapiens (human)
3'-5'-RNA exonuclease activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
RNA-dependent RNA polymerase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
cysteine-type endopeptidase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
mRNA 5'-cap (guanine-N7-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
mRNA (nucleoside-2'-O-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
5'-3' RNA helicase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
K63-linked deubiquitinase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
K48-linked deubiquitinase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
3'-5'-RNA exonuclease activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
RNA-dependent RNA polymerase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
cysteine-type endopeptidase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA 5'-cap (guanine-N7-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA (nucleoside-2'-O-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA guanylyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
RNA endonuclease activity, producing 3'-phosphomonoestersReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
ISG15-specific peptidase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
5'-3' RNA helicase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
protein guanylyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
protein bindingBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
ATP bindingBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
organic anion transmembrane transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
ABC-type xenobiotic transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
urate transmembrane transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
biotin transmembrane transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
efflux transmembrane transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
ATP hydrolysis activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
riboflavin transmembrane transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
ATPase-coupled transmembrane transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
identical protein bindingBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
protein homodimerization activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
xenobiotic transmembrane transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
sphingolipid transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (21)

Processvia Protein(s)Taxonomy
extracellular regionAlbuminHomo sapiens (human)
extracellular spaceAlbuminHomo sapiens (human)
nucleusAlbuminHomo sapiens (human)
endoplasmic reticulumAlbuminHomo sapiens (human)
endoplasmic reticulum lumenAlbuminHomo sapiens (human)
Golgi apparatusAlbuminHomo sapiens (human)
platelet alpha granule lumenAlbuminHomo sapiens (human)
extracellular exosomeAlbuminHomo sapiens (human)
blood microparticleAlbuminHomo sapiens (human)
protein-containing complexAlbuminHomo sapiens (human)
cytoplasmAlbuminHomo sapiens (human)
cytoplasmATP-dependent translocase ABCB1Homo sapiens (human)
plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
cell surfaceATP-dependent translocase ABCB1Homo sapiens (human)
membraneATP-dependent translocase ABCB1Homo sapiens (human)
apical plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
extracellular exosomeATP-dependent translocase ABCB1Homo sapiens (human)
external side of apical plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
double membrane vesicle viral factory outer membraneReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
double membrane vesicle viral factory outer membraneReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
nucleoplasmBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
plasma membraneBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
apical plasma membraneBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
brush border membraneBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
mitochondrial membraneBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
membrane raftBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
external side of apical plasma membraneBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
plasma membraneBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (247)

Assay IDTitleYearJournalArticle
AID555987Weight normalized AUC (0 to 24 hrs) in HIV infected male patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID548829Antiviral activity against HIV1 isolate 188 harboring reverse transcriptase T215Y/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548808Antiviral activity against HIV1 isolate 212 harboring reverse transcriptase L210W/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548833Antiviral activity against HIV1 isolate 201 harboring reverse transcriptase M41L/L210W/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548585Antiviral activity against HIV1 isolate 162 harboring reverse transcriptase A62V/V75I/F77L/Y115F/F116Y/Q151M/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548810Antiviral activity against HIV1 isolate 217 harboring reverse transcriptase D67N/K70E/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID261861Inhibition of HBV L180M/ M204V mutant transfected in D88 cell line2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Inhibition of hepatitis B virus (HBV) replication by pyrimidines bearing an acyclic moiety: effect on wild-type and mutant HBV.
AID548814Antiviral activity against HIV1 isolate 061 harboring reverse transcriptase M41L/D67N/K70R/M184V/L210W/T215Y/K219E mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID555748Weight normalized Cmax in HIV infected patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID236437Area under the plasma concentration-time curve in monkey after peroral dosage2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID548572Antiviral activity against HIV1 isolate 057 expressing wild type reverse transcriptase gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548839Antiviral activity against HIV1 isolate 215 harboring reverse transcriptase D67N/K70E mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID246207Effective concentration against human immunodeficiency virus type 1 in PBL cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID246210Effective concentration against human immunodeficiency virus type 2 in MT-4 cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID317374Antiviral activity against HIV with reverse transcriptase K65R mutation in MT4 cells assessed as fold resistance relative to wild type2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Synthesis, anti-HIV activity, and resistance profiles of ribose modified nucleoside phosphonates.
AID328843Inhibition of human MRP3 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID548815Antiviral activity against HIV1 isolate 063 harboring reverse transcriptase M41L/D67N/K70R/M184V/L210W/T215Y/K219E mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548806Antiviral activity against HIV1 isolate 206 harboring reverse transcriptase D67N/K70R mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID246206Effective concentration against human immunodeficiency virus type 1 in MT-4 cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID556003Weight normalized Cmax in HIV infected female patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID1269246Cytotoxicity against human TZM-bl cells after 2 days by colorimetric XTT assay2016Bioorganic & medicinal chemistry letters, Jan-15, Volume: 26, Issue:2
Aspernigrins with anti-HIV-1 activities from the marine-derived fungus Aspergillus niger SCSIO Jcsw6F30.
AID422693Antiviral activity against HIV1 with reverse transcriptase K70E M184V and K70G M184V mutation by antivirogram biological cutoffs assay relative to wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID548823Antiviral activity against HIV1 isolate 160 harboring reverse transcriptase S68G/V75(I/T)/F77L/Y115F/F116Y /Q151M mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID588208Literature-mined public compounds from Lowe et al phospholipidosis modelling dataset2010Molecular pharmaceutics, Oct-04, Volume: 7, Issue:5
Predicting phospholipidosis using machine learning.
AID317371Inhibition of wild type HIV reverse transcriptase2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Synthesis, anti-HIV activity, and resistance profiles of ribose modified nucleoside phosphonates.
AID555993AUC (0 to 24 hrs) in HIV infected female patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID200001In vitro antiviral activity against HIV-1 Reverse transcriptase M184V mutant2003Bioorganic & medicinal chemistry letters, Jun-16, Volume: 13, Issue:12
The role of 2',3'-unsaturation on the antiviral activity of anti-HIV nucleosides against 3TC-resistant mutant (M184V).
AID556524Antiviral activity against Human immunodeficiency virus 1 clone pNL4-3-Q145M harboring K102Q, Q145M, S162C, K277R, I293V mutation in reverse transcriptase by phenosense assay relative to wild type2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Human immunodeficiency virus type 1 isolates with the reverse transcriptase (RT) mutation Q145M retain nucleoside and nonnucleoside RT inhibitor susceptibility.
AID1122141Inhibition of P-gp in human CMEC/D3 cells assessed as inhibition of NBD-Aba efflux after 30 mins by flow cytometry
AID548588Antiviral activity against HIV1 isolate 180 harboring reverse transcriptase K65R mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID393073Antiviral activity against HIV1 3a with reverse transcriptase M184V mutation in human MT2 cells assessed as inhibition of viral-induced cytopathic effect by XTT assay relative to wild type2009Bioorganic & medicinal chemistry, Feb-15, Volume: 17, Issue:4
Design, synthesis, and anti-HIV activity of 4'-modified carbocyclic nucleoside phosphonate reverse transcriptase inhibitors.
AID548805Antiviral activity against HIV1 isolate 204 harboring reverse transcriptase M41L/L210W/T215Y/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID555986Drug level at the end of dosing interval in HIV infected male patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID548807Antiviral activity against HIV1 isolate 211 harboring reverse transcriptase D67N/K70R/T215F/K219E/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548825Antiviral activity against HIV1 isolate 166 harboring reverse transcriptase L74V mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548817Antiviral activity against HIV1 isolate 067 harboring reverse transcriptase A62V/D67G/T69SVG/V75I/T215I mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID555985Cmax in HIV infected male patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID246383Effective concentration against thymidine kinase deficient herpes simplex virus (HSV-2) in B2006 cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID548799Antiviral activity against HIV1 isolate 188 harboring reverse transcriptase T215Y/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548818Antiviral activity against HIV1 isolate 069 harboring reverse transcriptase D67E/T69SSG/V75M/M184V/L210W/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID200144Ratio for inhibition of HIV-1 RT to that of type and HIV-1 RT M184V mutant was determined2003Bioorganic & medicinal chemistry letters, Jun-16, Volume: 13, Issue:12
The role of 2',3'-unsaturation on the antiviral activity of anti-HIV nucleosides against 3TC-resistant mutant (M184V).
AID517837Antiviral activity against drug resistant HBV infected in M204I cells assessed as inhibition of viral DNA replication2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Antiviral activity of various 1-(2'-deoxy-β-D-lyxofuranosyl), 1-(2'-fluoro-β-D-xylofuranosyl), 1-(3'-fluoro-β-D-arabinofuranosyl), and 2'-fluoro-2',3'-didehydro-2',3'-dideoxyribose pyrimidine nucleoside analogues against duck hepatitis B virus (DHBV) and
AID328842Inhibition of human MRP2 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID1055510Antiviral activity against HIV2 ROD infected in human CEM cells assessed as virus-induced giant cell formation after 4 days by microscopic analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID548583Antiviral activity against HIV1 isolate 157 harboring reverse transcriptase L74V/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548828Antiviral activity against HIV1 isolate 185 harboring reverse transcriptase T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1636357Drug activation in human Hep3B cells assessed as human CYP3A4-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID612651Activity of recombinant human ADAL1 expressed in Escherichia coli by UV-spectrophotometry2011Journal of medicinal chemistry, Aug-25, Volume: 54, Issue:16
Adenosine deaminase-like protein 1 (ADAL1): characterization and substrate specificity in the hydrolysis of N(6)- or O(6)-substituted purine or 2-aminopurine nucleoside monophosphates.
AID1269247Selectivity index, ratio of CC50 for human TZM-bl cells to IC50 for HIV-1 SF162 infected in TZM-bl cells2016Bioorganic & medicinal chemistry letters, Jan-15, Volume: 26, Issue:2
Aspernigrins with anti-HIV-1 activities from the marine-derived fungus Aspergillus niger SCSIO Jcsw6F30.
AID548804Antiviral activity against HIV1 isolate 203 harboring reverse transcriptase M41L/L210W/T215Y/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID266286Antiviral activity against HBV L180M/M204V mutant transfected in D88 cell line at 10 ug/mL2006Journal of medicinal chemistry, Jun-15, Volume: 49, Issue:12
Effect of various pyrimidines possessing the 1-[(2-hydroxy-1-(hydroxymethyl)ethoxy)methyl] moiety, able to mimic natural 2'-deoxyribose, on wild-type and mutant hepatitis B virus replication.
AID555988Weight normalized Cmax in HIV infected male patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID548574Antiviral activity against HIV1 isolate 060 harboring reverse transcriptase M41L/D67N/K70R/L210W/T215Y/K219E mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID555758Cmax in HIV infected patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID517841Antiviral activity against drug resistant HBV infected in M204I cells assessed as inhibition of viral DNA replication at 1 to 5 ug/mL2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Antiviral activity of various 1-(2'-deoxy-β-D-lyxofuranosyl), 1-(2'-fluoro-β-D-xylofuranosyl), 1-(3'-fluoro-β-D-arabinofuranosyl), and 2'-fluoro-2',3'-didehydro-2',3'-dideoxyribose pyrimidine nucleoside analogues against duck hepatitis B virus (DHBV) and
AID1873200Inhibition of human ABCG2 expressed in dog MDCK-II-BCRP cells mediated pheophorbide A efflux preincubated with PhA followed by compound addition and measured after 60 mins by flow cytometry2022European journal of medicinal chemistry, Jul-05, Volume: 237Targeting breast cancer resistance protein (BCRP/ABCG2): Functional inhibitors and expression modulators.
AID556526Antiviral activity against Human immunodeficiency virus 1 clone Q9016 harboring K122E, Q145M, I202V, F214L mutation in reverse transcriptase by phenosense assay relative to wild type2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Human immunodeficiency virus type 1 isolates with the reverse transcriptase (RT) mutation Q145M retain nucleoside and nonnucleoside RT inhibitor susceptibility.
AID1122136Inhibition of P-gp in human MCF7/DX1 cells assessed as cellular accumulation of BODIPY-prazosin up to 100 uM after 30 mins by flow cytometry
AID548575Antiviral activity against HIV1 isolate 061 harboring reverse transcriptase M41L/D67N/K70R/M184V/L210W/T215Y/K219E mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID555751Weight normalized Cmax in HIV infected patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID423157Antiviral activity against wild type HIV1 NL4-3 produced from full length pR9deltaApa infected in human MAGIC-5A cells assessed as inhibition of Lac+ foci expression after 40 hrs2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Human immunodeficiency virus types 1 and 2 exhibit comparable sensitivities to Zidovudine and other nucleoside analog inhibitors in vitro.
AID1055509Cytotoxicity against human CEM cells2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID263531Antiviral activity against HIV1 replication in CEM cell line2006Bioorganic & medicinal chemistry letters, Apr-15, Volume: 16, Issue:8
Abacavir prodrugs: microwave-assisted synthesis and their evaluation of anti-HIV activities.
AID548822Antiviral activity against HIV1 isolate 157 harboring reverse transcriptase L74V/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548821Antiviral activity against HIV1 isolate 153 harboring reverse transcriptase L74V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID245901Cytostatic concentration required to inhibit MT-4 cell proliferation2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID548816Antiviral activity against HIV1 isolate 066 harboring reverse transcriptase 184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548824Antiviral activity against HIV1 isolate 162 harboring reverse transcriptase A62V/V75I/F77L/Y115F/F116Y/Q151M/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID328844Inhibition of human MRP2 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence at 10 uM by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID317369Antiviral activity against wild type HIV2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Synthesis, anti-HIV activity, and resistance profiles of ribose modified nucleoside phosphonates.
AID1122135Inhibition of P-gp in human MCF7/DX1 cells assessed as cellular accumulation of doxorubicin up to 100 uM after 30 mins by flow cytometry
AID555990Weight normalized AUC (0 to 24 hrs) in HIV infected male patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID555752Weight normalized AUC (0 to 24 hrs) in HIV infected patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID555992Weight normalized Drug level at the end of dosing interval in HIV infected male patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID423158Antiviral activity against wild type HIV2 ROD produced from full length pROD9 infected in human MAGIC-5A cells assessed as inhibition of Lac+ foci expression after 40 hrs2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Human immunodeficiency virus types 1 and 2 exhibit comparable sensitivities to Zidovudine and other nucleoside analog inhibitors in vitro.
AID555756Drug level at the end of dosing interval in HIV infected patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID555753Cmax in HIV infected patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID317370Cytotoxicity against human MT2 cells2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Synthesis, anti-HIV activity, and resistance profiles of ribose modified nucleoside phosphonates.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID548571Antiviral activity against HIV1 isolate 056 expressing wild type reverse transcriptase gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID246257Effective concentration against human immunodeficiency virus type 2 (ROD) in CEM cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID393072Antiviral activity against HIV1 3a with reverse transcriptase K65R mutation in human MT2 cells assessed as inhibition of viral-induced cytopathic effect by XTT assay relative to wild type2009Bioorganic & medicinal chemistry, Feb-15, Volume: 17, Issue:4
Design, synthesis, and anti-HIV activity of 4'-modified carbocyclic nucleoside phosphonate reverse transcriptase inhibitors.
AID548578Antiviral activity against HIV1 isolate 067 harboring reverse transcriptase A62V/D67G/T69SVG/V75I/T215I mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548577Antiviral activity against HIV1 isolate 066 harboring reverse transcriptase 184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID555780Ratio of weight normalized Cmax in HIV infected patient at 600 mg QD to weight normalized Cmax in HIV infected patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID261858Inhibition of HBV M204I mutant transfected in B1 cell line at 10 ug/mL2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Inhibition of hepatitis B virus (HBV) replication by pyrimidines bearing an acyclic moiety: effect on wild-type and mutant HBV.
AID548831Antiviral activity against HIV1 isolate 194 harboring reverse transcriptase M41L/T215Y/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1604132Inhibition of P-gp in human 12D7-MDR cells up to 500 uM using NBD-Aba as substrate after 30 mins by flow cytometric analysis relative to control2020Journal of medicinal chemistry, 03-12, Volume: 63, Issue:5
Potential Tools for Eradicating HIV Reservoirs in the Brain: Development of Trojan Horse Prodrugs for the Inhibition of P-Glycoprotein with Anti-HIV-1 Activity.
AID555750Weight normalized Drug level at the end of dosing interval in HIV infected patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID548801Antiviral activity against HIV1 isolate 194 harboring reverse transcriptase M41L/T215Y/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID393071Cytotoxicity against human MT2 cells after 5 days2009Bioorganic & medicinal chemistry, Feb-15, Volume: 17, Issue:4
Design, synthesis, and anti-HIV activity of 4'-modified carbocyclic nucleoside phosphonate reverse transcriptase inhibitors.
AID548840Antiviral activity against HIV1 isolate 217 harboring reverse transcriptase D67N/K70E/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID555982Cmax in HIV infected male patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID556006Ratio of AUC in HIV infected female patient assessed as assessed as carbovir-triphosphate level per million cells to AUC in HIV infected female patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID245917Cytostatic concentration required to inhibit Hep G2.2.15 cell proliferation2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID422695Ratio of IC50 for HIV1 with reverse transcriptase K70G mutation to IC50 for wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID263532Cytotoxicity against CEM cell line2006Bioorganic & medicinal chemistry letters, Apr-15, Volume: 16, Issue:8
Abacavir prodrugs: microwave-assisted synthesis and their evaluation of anti-HIV activities.
AID1604114Inhibition of P-gp in human 12D7-MDR cells up to 500 uM using calcein-AM as substrate after 30 mins by flow cytometric analysis relative to control2020Journal of medicinal chemistry, 03-12, Volume: 63, Issue:5
Potential Tools for Eradicating HIV Reservoirs in the Brain: Development of Trojan Horse Prodrugs for the Inhibition of P-Glycoprotein with Anti-HIV-1 Activity.
AID556527Antiviral activity against Human immunodeficiency virus 1 clone 14682 harboring 122E, 135V, Q145V, 200A mutation in reverse transcriptase by phenosense assay relative to wild type2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Human immunodeficiency virus type 1 isolates with the reverse transcriptase (RT) mutation Q145M retain nucleoside and nonnucleoside RT inhibitor susceptibility.
AID548830Antiviral activity against HIV1 isolate 192 harboring reverse transcriptase M41L/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548836Antiviral activity against HIV1 isolate 206 harboring reverse transcriptase D67N/K70R mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID244631Ratio of CC50 to that of EC50 against human immunodeficiency virus type 1 in CEM cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID555996AUC (0 to 24 hrs) in HIV infected female patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID555997Cmax in HIV infected female patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID556005Ratio of AUC in HIV infected male patient assessed as assessed as carbovir-triphosphate level per million cells to AUC in HIV infected male patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID555747Weight normalized Drug level at the end of dosing interval in HIV infected patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID1269245Antiviral activity against HIV-1 SF162 infected in TZM-bl cells after 2 days by luciferase reporter gene assay2016Bioorganic & medicinal chemistry letters, Jan-15, Volume: 26, Issue:2
Aspernigrins with anti-HIV-1 activities from the marine-derived fungus Aspergillus niger SCSIO Jcsw6F30.
AID548826Antiviral activity against HIV1 isolate 174 harboring reverse transcriptase M184V mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID317372Antiviral activity against HIV with reverse transcriptase M184V mutation in MT4 cells assessed as fold resistance relative to wild type2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Synthesis, anti-HIV activity, and resistance profiles of ribose modified nucleoside phosphonates.
AID252389Intracellular concentration of metabolites (CBVTP) from 35-38 hrs in CEM cells after incubation with the compound (10 uM)2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID236448Area under the plasma concentration-time curve in monkey after intravenous dosage2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID266280Antiviral activity against HBV M204I mutant transfected in B1 cell line2006Journal of medicinal chemistry, Jun-15, Volume: 49, Issue:12
Effect of various pyrimidines possessing the 1-[(2-hydroxy-1-(hydroxymethyl)ethoxy)methyl] moiety, able to mimic natural 2'-deoxyribose, on wild-type and mutant hepatitis B virus replication.
AID246205Effective concentration against human immunodeficiency virus type 1 in CEM cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID555755AUC (0 to 24 hrs) in HIV infected patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID266288Antiviral activity against HBV M204I mutant transfected in B1 cell line at 10 ug/mL2006Journal of medicinal chemistry, Jun-15, Volume: 49, Issue:12
Effect of various pyrimidines possessing the 1-[(2-hydroxy-1-(hydroxymethyl)ethoxy)methyl] moiety, able to mimic natural 2'-deoxyribose, on wild-type and mutant hepatitis B virus replication.
AID548835Antiviral activity against HIV1 isolate 204 harboring reverse transcriptase M41L/L210W/T215Y/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1122143Inhibition of P-gp overexpressed in human 12D7-MDR cells assessed as inhibition of calcein-AM efflux after 30 mins by flow cytometry
AID556525Antiviral activity against Human immunodeficiency virus 1 clone 38086 harboring K49R, V60I, I135V, Q145M, Q174H, G196E, Q207E, R211K, V245K mutation in reverse transcriptase by phenosense assay relative to wild type2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Human immunodeficiency virus type 1 isolates with the reverse transcriptase (RT) mutation Q145M retain nucleoside and nonnucleoside RT inhibitor susceptibility.
AID236965Time of maximum concentration was observed in monkey after oral dosage2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID237307Terminal elimination half-life in monkey after intravenous dosage; NA = not applicable2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID393069Inhibition on HIV1 reverse transcriptase p66/p512009Bioorganic & medicinal chemistry, Feb-15, Volume: 17, Issue:4
Design, synthesis, and anti-HIV activity of 4'-modified carbocyclic nucleoside phosphonate reverse transcriptase inhibitors.
AID328841Inhibition of human MRP1 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID556001Weight normalized Drug level at the end of dosing interval in HIV infected female patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID328845Inhibition of human MRP3 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence at 10 uM by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID548832Antiviral activity against HIV1 isolate 200 harboring reverse transcriptase M41L/L210W/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID555749Weight normalized AUC (0 to 24 hrs) in HIV infected patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID1636356Drug activation in human Hep3B cells assessed as human CYP2C9-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID555995Drug level at the end of dosing interval in HIV infected female patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID423280Antiviral activity against multinucleoside-resistant HIV1 NL4-3 harboring A62V, V75I, F77L, F116Y, Q151M mutation in viral reverse transcriptase infected in human MAGIC-5A cells assessed as inhibition of Lac+ foci expression after 40 hrs2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Human immunodeficiency virus types 1 and 2 exhibit comparable sensitivities to Zidovudine and other nucleoside analog inhibitors in vitro.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID540235Phospholipidosis-negative literature compound
AID246401Effective concentration against thymidine kinase deficient herpes simplex virus (HSV-2) in VMW-1837 cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID548837Antiviral activity against HIV1 isolate 211 harboring reverse transcriptase D67N/K70R/T215F/K219E/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID555765Ratio of AUC in HIV infected patient assessed as carbovir-triphosphate level per million cells to AUC in HIV infected patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID555991Weight normalized Cmax in HIV infected male patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID422692Ratio of IC50 for HIV1 with reverse transcriptase K70G/M184V mutation to IC50 for wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1604130Antiviral activity against HIV1 LAI infected in human 12D7 cells overexpressing p-gp assessed as reduction in P24 level at 0.08 to 1.25 uM incubated for 3 days followed by replacement of fresh medium containing compound and measured after 3 days by ELISA2020Journal of medicinal chemistry, 03-12, Volume: 63, Issue:5
Potential Tools for Eradicating HIV Reservoirs in the Brain: Development of Trojan Horse Prodrugs for the Inhibition of P-Glycoprotein with Anti-HIV-1 Activity.
AID1122142Inhibition of P-gp overexpressed in human 12D7-MDR cells assessed as inhibition of NBD-Aba efflux after 30 mins by flow cytometry
AID548820Antiviral activity against HIV1 isolate 071 harboring reverse transcriptase 65R/S68N/184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548573Antiviral activity against HIV1 isolate 058 harboring reverse transcriptase M41L/D67N/K70R/L210W/T215F/K219Q mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID555984AUC (0 to 24 hrs) in HIV infected male patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID393070Antiviral activity against HIV1 3a infected human MT2 cells assessed as inhibition of viral-induced cytopathic effect after 3 days by XTT assay2009Bioorganic & medicinal chemistry, Feb-15, Volume: 17, Issue:4
Design, synthesis, and anti-HIV activity of 4'-modified carbocyclic nucleoside phosphonate reverse transcriptase inhibitors.
AID1055512Antiviral activity against HIV1 3B infected in human CEM cells assessed as virus-induced giant cell formation after 4 days by microscopic analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID555981AUC (0 to 24 hrs) in HIV infected male patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID246046Effective concentration against HBV in Hep G2.2.15 cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID555766Ratio of AUC in HIV infected patient assessed as assessed as carbovir-triphosphate level per million cells to AUC in HIV infected patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID548841Antiviral activity against HIV1 isolate 220 harboring reverse transcriptase K70E/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID422694Antiviral activity against HIV1 with reverse transcriptase K70E M184V and K70G M184V mutation by vircotype clinical cutoffs assay relative to wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID548838Antiviral activity against HIV1 isolate 212 harboring reverse transcriptase L210W/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1055518Cytostatic activity against human CEM cells assessed as growth inhibition after 3 days by particle counting analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID244632Ratio of CC50 to that of EC50 against human immunodeficiency virus type 2 in CEM cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID245914Cytostatic concentration required to inhibit C3H/3T3 cell proliferation2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID200002In vitro antiviral activity against HIV-1 Reverse transcriptase wild type2003Bioorganic & medicinal chemistry letters, Jun-16, Volume: 13, Issue:12
The role of 2',3'-unsaturation on the antiviral activity of anti-HIV nucleosides against 3TC-resistant mutant (M184V).
AID1238542Binding affinity to human serum albumin with excitation at 280 nm after 2 hrs by spectrofluorimetric analysis2015Bioorganic & medicinal chemistry letters, Aug-15, Volume: 25, Issue:16
Ionic derivatives of betulinic acid exhibit antiviral activity against herpes simplex virus type-2 (HSV-2), but not HIV-1 reverse transcriptase.
AID556004Weight normalized Drug level at the end of dosing interval in HIV infected female patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID548587Antiviral activity against HIV1 isolate 174 harboring reverse transcriptase M184V mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID423281Selectivity ratio of EC50 for multinucleoside-resistant HIV1 NL4-3 harboring A62V, V75I, F77L, F116Y, Q151M mutation in viral reverse transcriptase to EC50 for wild type HIV1 NL4-32008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Human immunodeficiency virus types 1 and 2 exhibit comparable sensitivities to Zidovudine and other nucleoside analog inhibitors in vitro.
AID246045Effective concentration againstHBV in Hep G2.2.15 cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID555994Cmax in HIV infected female patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID548579Antiviral activity against HIV1 isolate 069 harboring reverse transcriptase D67E/T69SSG/V75M/M184V/L210W/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548798Antiviral activity against HIV1 isolate 185 harboring reverse transcriptase T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID236215Total plasma clearance in monkey after intravenous dosage; (n=3); NA = not applicable2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID548581Antiviral activity against HIV1 isolate 071 harboring reverse transcriptase 65R/S68N/184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID252391Intracellular concentration of metabolites (CBV-MP) from 11-13 hrs in CEM cells after incubation with the compound (10 uM)2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID1636440Drug activation in human Hep3B cells assessed as human CYP2D6-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID237577Apparent half life value in monkey after oral dosage2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID548800Antiviral activity against HIV1 isolate 192 harboring reverse transcriptase M41L/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID245898Cytostatic concentration required to inhibit CEM cell proliferation2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID328846Inhibition of human MRP1 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence at 10 uM by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID252384Intracellular concentration of metabolites (ABCMP) from 6-8 hrs in CEM cells after incubation with the compound (10 uM)2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID245913Cytostatic concentration required to inhibit Hep G2 cell proliferation2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID422691Ratio of IC50 for HIV1 with reverse transcriptase K70E/M184V mutation to IC50 for wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID517842Cytotoxicity against HuH7 cells2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Antiviral activity of various 1-(2'-deoxy-β-D-lyxofuranosyl), 1-(2'-fluoro-β-D-xylofuranosyl), 1-(3'-fluoro-β-D-arabinofuranosyl), and 2'-fluoro-2',3'-didehydro-2',3'-dideoxyribose pyrimidine nucleoside analogues against duck hepatitis B virus (DHBV) and
AID556000Weight normalized Cmax in HIV infected female patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID625276FDA Liver Toxicity Knowledge Base Benchmark Dataset (LTKB-BD) drugs of most concern for DILI2011Drug discovery today, Aug, Volume: 16, Issue:15-16
FDA-approved drug labeling for the study of drug-induced liver injury.
AID246347Effective concentration against thymidine kinase competent herpes simplex virus (HSV-2) in G cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID548802Antiviral activity against HIV1 isolate 200 harboring reverse transcriptase M41L/L210W/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1122134Inhibition of P-gp in human MCF7/DX1 cells assessed as cellular accumulation of [3H]-daunomycin up to 100 uM after 30 mins by scintillation counting analysis
AID555983Drug level at the end of dosing interval in HIV infected male patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID548813Antiviral activity against HIV1 isolate 060 harboring reverse transcriptase M41L/D67N/K70R/L210W/T215Y/K219E mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548576Antiviral activity against HIV1 isolate 063 harboring reverse transcriptase M41L/D67N/K70R/M184V/L210W/T215Y/K219E mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID556008Ratio of AUC in HIV infected male patient assessed as carbovir-triphosphate level per million cells to AUC in HIV infected male patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID548809Antiviral activity against HIV1 isolate 215 harboring reverse transcriptase D67N/K70E mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID236624Maximum concentration was observed in monkey after oral dosage2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID261859Inhibition of HBV M204I mutant transfected in B1 cell line2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Inhibition of hepatitis B virus (HBV) replication by pyrimidines bearing an acyclic moiety: effect on wild-type and mutant HBV.
AID548803Antiviral activity against HIV1 isolate 201 harboring reverse transcriptase M41L/L210W/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID555744Ratio of Drug level at the end of dosing interval in HIV infected patient at 600 mg QD to Drug level at the end of dosing interval in HIV infected patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID555781Ratio of weight normalized Drug level at the end of dosing interval in HIV infected patient at 600 mg QD to weight normalized Drug level at the end of dosing interval in HIV infected patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID317373Antiviral activity against HIV with reverse transcriptase 6TAMs mutation in MT4 cells assessed as fold resistance relative to wild type2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Synthesis, anti-HIV activity, and resistance profiles of ribose modified nucleoside phosphonates.
AID1055520Cytostatic activity against mouse L1210 cells assessed as growth inhibition after 2 days by particle counting analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID252390Intracellular concentration of metabolites (ABC +CBV) from 2-3 hrs in CEM cells after incubation with the compound (10 uM)2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID548580Antiviral activity against HIV1 isolate 070 harboring reverse transcriptase 65R/S68G mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID555989Weight normalized Drug level at the end of dosing interval in HIV infected male patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID548819Antiviral activity against HIV1 isolate 070 harboring reverse transcriptase 65R/S68G mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID246363Effective concentration against thymidine kinase competent herpes simplex virus (HSV-1) in KOS cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID548582Antiviral activity against HIV1 isolate 153 harboring reverse transcriptase L74V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID555746Ratio of AUC in HIV infected patient at 600 mg QD to AUC in HIV infected patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID266281Antiviral activity against HBV L180M/M204V mutant transfected in D88 cell line2006Journal of medicinal chemistry, Jun-15, Volume: 49, Issue:12
Effect of various pyrimidines possessing the 1-[(2-hydroxy-1-(hydroxymethyl)ethoxy)methyl] moiety, able to mimic natural 2'-deoxyribose, on wild-type and mutant hepatitis B virus replication.
AID555779Ratio of weight normalized AUC in HIV infected patient at 600 mg QD to weight normalized AUC in HIV infected patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID548811Antiviral activity against HIV1 isolate 220 harboring reverse transcriptase K70E/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548827Antiviral activity against HIV1 isolate 180 harboring reverse transcriptase K65R mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID588209Literature-mined public compounds from Greene et al multi-species hepatotoxicity modelling dataset2010Chemical research in toxicology, Jul-19, Volume: 23, Issue:7
Developing structure-activity relationships for the prediction of hepatotoxicity.
AID548586Antiviral activity against HIV1 isolate 166 harboring reverse transcriptase L74V mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1122133Inhibition of P-gp in human MCF7/DX1 cells assessed as cellular accumulation of NBD-Aba up to 100 uM after 30 mins by flow cytometry
AID556007Ratio of AUC in HIV infected female patient assessed as carbovir-triphosphate level per million cells to AUC in HIV infected female patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID245899Cytostatic concentration required to inhibit HEL cell proliferation2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID1055516Cytostatic activity against human HeLa cells assessed as growth inhibition after 3 days by particle counting analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID556002Weight normalized AUC (0 to 24 hrs) in HIV infected female patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID555999Weight normalized AUC (0 to 24 hrs) in HIV infected female patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID555754Drug level at the end of dosing interval in HIV infected patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID261860Inhibition of HBV L180M/ M204V mutant transfected in D88 cell line at 10 ug/mL2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Inhibition of hepatitis B virus (HBV) replication by pyrimidines bearing an acyclic moiety: effect on wild-type and mutant HBV.
AID548584Antiviral activity against HIV1 isolate 160 harboring reverse transcriptase S68G/V75(I/T)/F77L/Y115F/F116Y /Q151M mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID555998Drug level at the end of dosing interval in HIV infected female patient at 600 mg QD by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID555757AUC (0 to 24 hrs) in HIV infected patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID246190Effective concentration against murine moloney sarcoma virus in C3H/3T3 cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID555745Ratio of Cmax in HIV infected patient at 600 mg QD to Cmax in HIV infected patient at 300 mg BID by HPLC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
Steady-state pharmacokinetics of abacavir in plasma and intracellular carbovir triphosphate following administration of abacavir at 600 milligrams once daily and 300 milligrams twice daily in human immunodeficiency virus-infected subjects.
AID548834Antiviral activity against HIV1 isolate 203 harboring reverse transcriptase M41L/L210W/T215Y/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID246209Effective concentration against human immunodeficiency virus type 2 in CEM cells2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID548812Antiviral activity against HIV1 isolate 058 harboring reverse transcriptase M41L/D67N/K70R/L210W/T215F/K219Q mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID252388Intracellular concentration of metabolites (CBVDP) from 19-21 hrs in CEM cells after incubation with the compound (10 uM)2005Journal of medicinal chemistry, May-19, Volume: 48, Issue:10
Application of phosphoramidate pronucleotide technology to abacavir leads to a significant enhancement of antiviral potency.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1745855NCATS anti-infectives library activity on the primary C. elegans qHTS viability assay2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1745854NCATS anti-infectives library activity on HEK293 viability as a counter-qHTS vs the C. elegans viability qHTS2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1805801Various Assay from Article 10.1021/acs.jmedchem.1c00409: \\Perspectives on SARS-CoV-2 Main Protease Inhibitors.\\2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
Perspectives on SARS-CoV-2 Main Protease Inhibitors.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,193)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's107 (8.97)18.2507
2000's571 (47.86)29.6817
2010's442 (37.05)24.3611
2020's73 (6.12)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 70.07

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

MetricThis Compound (vs All)
Research Demand Index70.07 (24.57)
Research Supply Index7.33 (2.92)
Research Growth Index4.88 (4.65)
Search Engine Demand Index123.80 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (70.07)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials240 (18.75%)5.53%
Reviews142 (11.09%)6.00%
Case Studies102 (7.97%)4.05%
Observational19 (1.48%)0.25%
Other777 (60.70%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (155)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Open-Label, Fixed-Sequence, Crossover Study To Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects [NCT01220232]Phase 114 participants (Actual)Interventional2010-11-30Completed
A Pilot Clinical Trial of Reverse Transcriptase Inhibitors in Children With Aicardi-Goutières Syndrome (AGS) [NCT02363452]Phase 211 participants (Actual)Interventional2015-09-10Completed
A Randomized, Open-Label, Single-Dose, 2 Period Crossover Pharmacokinetic and Bioequivalence Study, With a Lead-In Dose Period, Evaluating Oral Abacavir Acetate (Prurisol™) and Oral Abacavir Sulfate (Ziagen®) in Healthy Volunteers [NCT02101216]Phase 118 participants (Actual)Interventional2014-03-31Completed
A Randomized, Open-Label, Single-Dose, 3-Period, Crossover Evaluation of the Relative Bioavailability of Two Experimental Fixed-Dose Combination Tablet Formulations of Dolutegravir 50 mg/Abacavir 600 mg/Lamivudine 300 mg Compared to Co-Administered Dolute [NCT01366547]Phase 118 participants (Actual)Interventional2011-06-30Completed
A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects [NCT00118898]Phase 31,864 participants (Actual)Interventional2005-09-30Completed
Multicenter Study of Options for Second-Line Effective Combination Therapy (SELECT) [NCT01352715]Phase 3515 participants (Actual)Interventional2012-03-13Completed
A Phase III, Randomized, Open-Label Trial to Evaluate Strategies for Providing Antiretroviral Therapy to Infants Shortly After Primary Infection in a Resource Poor Setting [NCT00102960]Phase 3377 participants (Actual)Interventional2005-07-31Completed
A Prosp., Multic., Randomized, Open-label Trial to Assess the Safety, Tolerability and Efficacy of Dual Therapy With Boosted Darunavir + Dolutegravir When Switching From SOC ART in HIV-patients With Sustained Virological Suppr. [NCT02486133]Phase 3269 participants (Actual)Interventional2015-07-31Completed
Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age [NCT03760458]Phase 1/Phase 257 participants (Actual)Interventional2020-09-09Completed
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum [NCT00042289]1,578 participants (Actual)Observational2003-06-09Completed
MULTICENTRE STUDY TO ASSESS CHANGES IN BONE MINERAL DENSITY OF THE SWITCH FROM TENOFOVIR TO ABACAVIR IN HIV-1-INFECTED SUBJECTS WITH LOSS OF BONE MINERAL DENSITY [NCT01153217]Phase 354 participants (Actual)Interventional2010-07-31Completed
Pilot Single-Arm Clinical Trial to Evaluate the Efficacy, PK Interactions and Safety of Dolutegravir Plus 2 NRTIs in HIV-1-Infected Solid Organ Transplant Patients [NCT03360682]Phase 420 participants (Anticipated)Interventional2018-04-12Active, not recruiting
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Efficacy of ZIAGEN® Administered in Korean Patients According to the Prescribing Information [NCT01205243]671 participants (Actual)Observational2010-11-01Completed
A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects [NCT01263015]Phase 3844 participants (Actual)Interventional2011-02-01Completed
A Study Investigating Plasma Abacavir and Its Intracellular Anabolite Carbovir-triphosphate Pharmacokinetics in the Absence and in the Presence of Darunavir/Ritonavir or Raltegravir in HIV-infected Subjects. [NCT00765271]Phase 129 participants (Actual)Interventional2008-05-31Completed
A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe [NCT00834457]Phase 2/Phase 349 participants (Actual)Interventional2007-06-30Completed
Evaluation of the Capacity of a Weekly Strategy of 4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV-1 Infected Patients With Undetectable Viral Load for at Least 12 Months, to Maintain a Virological Success With This Intermittent M [NCT02157311]Phase 3100 participants (Actual)Interventional2014-07-31Completed
Cellular Pharmacology and Platelet Effects of Abacavir and Lamivudine Anabolites [NCT04301661]25 participants (Actual)Observational2020-03-06Completed
A Randomized, Open-Label Study of the Long-Term Effectiveness of Three Initial Highly Active Antiretroviral Therapy (HAART) Strategies in HAART-Niave, HIV-Infected Persons [NCT00000922]1,710 participants InterventionalCompleted
Phase 2 Multicentric Open-label Study of Switch From Abacavir/Lamivudine Fixed Dose Combination Plus Nevirapine to Abacavir/Lamivudine/Dolutegravir in Virologically Suppressed HIV-1 Infected Adults [NCT02067767]Phase 253 participants (Actual)Interventional2014-02-28Completed
An Open Label Randomized Clinical Trial, to Evaluate the Treatment With Darunavir/Ritonavir + Lamivudine Once Daily Versus Continuing With Darunavir/Ritonavir Once Daily + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject With Suppres [NCT02159599]Phase 4249 participants (Actual)Interventional2014-07-31Completed
Changes in Coagulation and Platelet Reactivity in HIV-1 Infected Patients Switching Between Abacavir and Tenofovir Containing Antiretroviral Regimens [NCT02093585]Phase 443 participants (Actual)Interventional2014-01-31Completed
An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE®), Abacavir and Amprenavir in HIV-1 Infected NNRTI Naive Adults [NCT02182765]Phase 18 participants (Actual)Interventional1999-04-30Terminated
Study of Once-Daily Abacavir/Lamivudine Versus Tenofovir/Emtricitabine, Administered With Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects [NCT00549198]Phase 4392 participants (Actual)Interventional2007-06-30Completed
Phase IIb Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Tenofovir+Emtricitabine+Raltegravir or to Lamivudine+Abacavir+Raltegravir in Patients With Optimal Virological Control and Toxicity to the Current Co [NCT00958100]Phase 240 participants (Actual)Interventional2009-08-31Completed
Multicentric, Non-inferiority, Randomized, Non-blinded Phase 3 Trial Comparing Virological Response at 48 Weeks of 3 Antiretroviral Treatment Regimens in HIV-1-infected Patients With Treatment Failure After 1st Line Antiretroviral Therapy (Cameroon, Burki [NCT00928187]Phase 3454 participants (Actual)Interventional2009-11-30Completed
A Prospective, Single Arm, Open-label 96 Week Observational Trial of the Tolerability, Adherence and Efficacy of a Dolutegravir/Abacavir/Lamivudine Single Tablet Regimen in HIV-1 Antibody Positive People Living With HIV With a History of Injection Drug Us [NCT02659761]Phase 450 participants (Anticipated)Interventional2016-11-30Recruiting
A Randomized, Phase II, Placebo Controlled Trial of Abacavir (ABC, 1592U89) in Combination With Open-Label Indinavir Sulfate (IDV) and Efavirenz (EFV, DMP-266) in HIV-Infected Subjects With Nucleoside Analog Experience: A Rollover Study for ACTG 320 [NCT00001086]Phase 2300 participants InterventionalCompleted
Efficacy and Safety of Switching From AZT to Tenofovir [NCT00647244]Phase 440 participants (Actual)Interventional2008-06-30Completed
A Phase II, Open-Label, Multicentre, Randomised, Comparator Study of Substitution With Tenofovir or Abacavir in HIV-1 Infected Individuals, With a Viral Load < 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of Their Highly [NCT00647946]Phase 2100 participants (Actual)Interventional2003-02-28Completed
A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89 [NCT00002141]Phase 118 participants Interventional1994-07-31Completed
A Pilot Study Of Open-Label Fixed Dose Combination Zidovudine/Lamivudine/Abacavir In HIV-Infected Persons With Tuberculosis In Moshi, Tanzania; Tuberculosis And HIV Immune Reconstitution Syndrome Trial (THIRST) [NCT00851630]Phase 470 participants (Actual)Interventional2004-06-30Completed
Randomized Clinical Trial to Evaluate the Efficacy of a Dolutegravir Monotherapy (Tivicay®) Versus the Maintenance of a Successful Triple Therapy Using Abacavir + Lamivudine + Dolutegravir (Triumeq®) in HIV-1- Infected Patients [NCT02596334]Phase 3158 participants (Actual)Interventional2015-12-23Terminated(stopped due to 5 patients on tivicay had virological failure)
See Detailed Description [NCT00440947]Phase 3515 participants (Actual)Interventional2007-03-31Completed
Bioequivalence Study of CRushed TriUMeq With or Without Drip Feed Compared to the Whole Tablet (SCRUM) [NCT02569346]Phase 122 participants (Actual)Interventional2016-03-31Completed
See Detailed Description [NCT00094367]Phase 3900 participants Interventional2004-07-31Completed
A Prospective, Randomized, Open Label Phase IV Study to Evaluate the Rationale of Switching From Fixed Dose Abacavir (ABC)/Lamivudine (3TC) to Fixed Dose Tenofovir DF (TDF)/Emtricitabine (FTC) in Virologically Suppressed, HIV-1 Infected Patients Maintaine [NCT00724711]Phase 4312 participants (Actual)Interventional2008-07-31Completed
A Phase III, Randomised, Multicenter, Parallel, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of GW433908 (1400 Mg Bid) and Nelfinavir (1250 Mg Bid) Over 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Adults [NCT00008554]Phase 3210 participants Interventional2000-11-30Active, not recruiting
Study of Protease Inhibitor and/or Non-Nucleoside Reverse Transcriptase Inhibitor With Dual Nucleosides in Initial Therapy of HIV Infection [NCT00000919]900 participants InterventionalCompleted
Single Dose Pharmacokinetic Study of Abacavir in HIV-Infected Children and Adolescents [NCT00011479]Phase 124 participants InterventionalCompleted
Continued Salvage Anti-Retroviral Therapy With Abacavir, Amprenavir, and Efavirenz [NCT00001758]Phase 225 participants Interventional1997-11-30Completed
Switching to Tenofovir Alafenamide Fumarate or Abacavir in Patients With Tenofovir Disoproxil Fumarate Associated eGFR Decline. A Randomized Trial. [NCT02957864]Phase 480 participants (Anticipated)Interventional2016-10-31Recruiting
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
Efficacy and Safety of an Initial Regimen Raltegravir (RAL) + Lamivudine/Abacavir Fixed-Dose Combination (3TC/ABC FDC) for 48 Weeks in ART-naïve, HIV/TB Co-Infected Adult Subjects Receiving Rifabutin-containing, 1-line Anti-TB Therapy [NCT01059422]Phase 410 participants (Anticipated)Interventional2010-10-31Recruiting
Determining the Effect of Abacavir on Platelet Activation in Virologically Suppressed HIV Positive Men: an Open Label Interventional Study [NCT01886638]Phase 423 participants (Actual)Interventional2013-08-31Completed
A Prospective, Open-label Trial of Two Abacavir/Lamivudine Based Regimen (ABC/3TC + Darunavir/Ritonavir or ABC/3TC + Raltegravir) in Late Presenter naïve Patients (With CD4 Count <200 Cells/µL - Advanced HIV Disease) [NCT01900106]Phase 347 participants (Actual)Interventional2013-11-30Completed
Treatment Options for Protease Inhibitor-exposed Children [NCT01146873]Phase 3300 participants (Actual)Interventional2010-07-31Completed
A Randomized, Pilot Study on the Antiviral Activity and Immunological Effects of Lopinavir/Ritonavir vs. Efavirenz in Treatment-naïve HIV-Infected Patients With CD4 Cell Counts Below 100 Cells/mm3 [NCT00386659]Phase 460 participants InterventionalTerminated
Randomized, Controlled, Open Label, Multi-Center Phase III Trial Comparing the Safety and Antiviral Activity of a Protease-Containing Regimen (d4T/ddI/IDV/RTV) Versus a Protease-Sparing Regimen (d4T/ddI/EFV) and the Ability of Interleukin-2 to Purge HIV F [NCT00006154]Phase 3165 participants (Anticipated)InterventionalCompleted
A Phase II Trial to Evaluate the Safety and Efficacy of Induction Treatment With Lamivudine Plus Stavudine Plus Abacavir Plus Amprenavir/Ritonavir Followed by Supervised Treatment Interruption in Subjects With Acute HIV Infection or Recent Seroconversion [NCT00000940]Phase 2121 participants (Actual)Interventional1999-05-31Completed
Nucleoside Switch Pilot for Virologically Controlled HIV Subjects With Decreasing CD4 Cells Who Have Received TDF-based ARV Therapy [NCT01608269]Phase 430 participants (Anticipated)Interventional2010-11-30Completed
A Pilot Study of Highly Active Antiretroviral Therapy Using Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Antiretroviral Naive HIV-Infected Subjects [NCT00740064]Phase 430 participants (Anticipated)Interventional2008-05-31Active, not recruiting
The Effects of Switching From Dolutegravir/Lamivudine/Abacavir (d/l/a) to Bictegravir/Emtricitabine/Tenofovir Alafenamide (b/f/Taf) in Patients With Suppressed Viral Load on Neuropsychiatric Side Effects and Neurocognitive Function [NCT04155554]Phase 3100 participants (Anticipated)Interventional2020-01-29Recruiting
Phase 2a Open Label Study, Safety and Tolerability of Combination Antiretroviral Therapy (Triumeq) in Participants With Amyotrophic Lateral Sclerosis (ALS) - The Lighthouse Project. [NCT02868580]Phase 243 participants (Actual)Interventional2016-10-31Completed
Determination of Plasma and Intracellular Levels of Nucleoside Reverse Transcriptase Inhibitors (NRTI) and of Nucleotide Analog Tenofovir Disoproxil Fumarate (TDF) in Patients Treated With Abacavir and/or Lamivudine Given With or Without TDF. [NCT00335192]Phase 432 participants (Actual)Interventional2005-01-31Completed
A Randomized, Prospective Study of the Efficacy, Safety and Tolerability of Two Doses of GW433908Ritonavir Given With Abacavir/Lamivudine Fixed Dose Combination [NCT00335270]Phase 4100 participants Interventional2006-03-31Completed
Analysis of Lipodystrophy in HIV-Infected Individuals A Prospective, Non-randomised, 48 Week Study of the Effect of PI Containing and Non-PI Containing Antiretroviral Regimens on the Expression of Adipocyte Specific Genes, Protein Levels and Cellular Stru [NCT00192660]Phase 480 participants (Actual)Interventional2003-02-28Completed
A Phase III Randomized Trial of the Safety and Antiretroviral Effects of Zidovudine/Lamivudine/Abacavir Versus Zidovudine/Lamivudine/Lopinavir/Ritonavir in the Prevention of Perinatal Transmission of HIV [NCT00086359]Phase 319 participants (Actual)Interventional2004-07-31Completed
A Phase II, Restrictively Randomized, Open-Label, Pilot Study of Treatment Intensification of Early Virologic Failure [NCT00006152]Phase 242 participants InterventionalCompleted
A Phase II, Open Label, Single Arm Trial to Evaluate the Pharmacokinetics,Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Antiretroviral Naive HIV-1 Infected Adolescents and Children Aged >= 6 to <18 Years [NCT00799864]Phase 254 participants (Actual)Interventional2011-01-07Completed
An Evaluation of the Bioequivalence of a Combined Formulated Tablet (50mg/600mg/300mg Dolutegravir/Abacavir/Lamivudine) Compared to One Dolutegravir 50mg Tablet and One EPZICOM† (600mg/300mg Abacavir/Lamivudine) Tablet Administered Concurrently and the Ef [NCT01622790]Phase 166 participants (Actual)Interventional2012-06-30Completed
Phase I Study of Safety, Tolerance, and Pharmacokinetics of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy In Neonates Born to HIV-1 Infected Women [NCT00000864]Phase 160 participants InterventionalCompleted
A Study to Evaluate the Single-Dose and Steady-State Pharmacokinetics/Dynamics of 1592U89 and Its Active Moiety, 1144U88 5'-Triphosphate (1144U88-TP) Following Six Different Dosing Regimens of 1592U89 in HIV-1 Infected Subjects [NCT00002388]Phase 148 participants InterventionalCompleted
Post-Marketing Clinical Study of EPZICOM Tablet (Lamivudine / Abacavir Sulfate) - Pharmacokinetic Study in HIV-Infected Patients - [NCT00337922]Phase 48 participants Interventional2006-07-31Completed
Study of Changes in CD4 Lymphocyte Count in Patients With a HAART Regimen Including DDI + Tenofovir and With Viral Suppression Following the Replacement of Tenofovir With Abacavir Once Daily or Following the Double Replacement of DDI + Tenofovir With Abac [NCT00338390]Phase 375 participants (Actual)Interventional2005-04-30Completed
Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study [NCT00537966]2,017 participants (Anticipated)Interventional2002-01-31Recruiting
A Randomized, Open Label, Multicenter Study Comparing the Safety and Efficacy of Once Daily Regimen Containing Epzicom or Truvada Combined With Ritonavir Boosted Atazanavir as Initial Therapy for HIV-1 Infection (ET Study) [NCT00544128]Phase 4109 participants (Actual)Interventional2007-10-31Completed
A Phase II, Randomized Trial of Amprenavir as Part of Dual Protease Inhibitor Regimens (Placebo-Controlled) in Combination With Abacavir, Efavirenz, and Adefovir Dipivoxil Versus Amprenavir Alone in HIV-Infected Subjects With Prior Exposure to Approved Pr [NCT00000912]Phase 2475 participants InterventionalCompleted
A Pilot Study of Once-Daily Therapy With Amprenavir, Ritonavir, Lamivudine and Abacavir in HIV-Infected, Antiretroviral-Naive Patients [NCT00001968]Phase 125 participants Interventional2000-01-31Completed
An Exploratory Study of the Antiretroviral Activity of 1592U89 When Administered in Combination With Other Specific Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in NRTI Experienced Patients [NCT00002364]Phase 240 participants InterventionalCompleted
A 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40mg BID) Plus Lamivudine (150mg BID) Plus Nelfinavir (1250mg BID) Versus Abacavir (300mg BID) Plus Combivir (3TC 150 [NCT00005106]Phase 4230 participants Interventional1999-09-30Completed
Open-Label, Single-Centre, Randomised Pilot Study to Evaluate Immunovirological and Clinical Evolution of a Combination With Nucleoside Analogues/Nucleotides (Trizivir +Tenofovir) in Multiresistant Patients With Virological Failure [NCT00356616]Phase 424 participants (Actual)Interventional2005-09-30Terminated(stopped due to terminated)
An Open Label, Randomized Study to Compare Antiretroviral Therapy (ART) Initiation When CD4 is Between 15% to 24% to ART Initiation When CD4 Falls Below 15% in Children With HIV Infection and Moderate Immune Suppression [NCT00234091]Phase 3300 participants (Actual)Interventional2006-04-30Completed
Phase II, Open-Label,Randomised, Comparator Study of Substitution w/Tenofovir or Abacavir in HIV-1 Infected Individuals, w/Viral Load Less 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of HAART. [NCT00270556]Phase 2100 participants Interventional2003-01-31Completed
Combivir, 1592U89, 141W94 Triple Antiretroviral, Experienced Patient Trial [NCT00002217]0 participants InterventionalCompleted
Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults [NCT00087945]30 participants Interventional2004-07-31Completed
Multicentre, Open Label, Prospective, Randomised Clinical Trial of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily [NCT00314626]Phase 399 participants (Actual)Interventional2004-11-30Completed
See Detailed Description [NCT00085943]Phase 3866 participants Interventional2004-05-31Completed
A Phase II, Randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Two Antiretroviral Therapeutic Strategies: A Dual PI-Based HAART Regimen Versus a Multi-NRTI ART Regimen, in ART-Experienced Children and Youth Who Have Experienced Virol [NCT00102206]Phase 26 participants (Actual)InterventionalCompleted
Randomized, Open-Label Study of Continued Stavudine Versus Abacavir Substitution With or Without Riboflavin and Thiamine Supplementation in HIV-Infected Patients Who Have Elevated Venous Lactic Acid While on Stavudine-Based Therapy (DAVE) [NCT00143702]Phase 2/Phase 380 participants (Anticipated)Interventional2001-08-31Completed
Contribution of the Integrase Inhibitor Dolutegravir to Obesity and Cardiovascular Disease in Persons Living With HIV [NCT04340388]Phase 410 participants (Actual)Interventional2020-09-17Completed
A Study of the Effects of Combination Antiretroviral Therapy in Acute HIV-1 Infection With an Emphasis on Immunological Responses [NCT00001119]288 participants Interventional1999-10-31Completed
A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of GW433908/Ritonavir QD to Nelfinavir BID When Used in Combination With Abacavir and Lamivudine for 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Subjects [NCT00009061]Phase 3624 participants Interventional2000-11-30Active, not recruiting
A Study to Investigate Whether There is a Pharmacokinetic Interaction Between 1592U89 and Ethanol Following Their Co-Administration to HIV-Infected Subjects. [NCT00002198]Phase 10 participants InterventionalCompleted
A Phase II Randomized, Blinded, Dose-Ranging Multicenter Study to Evaluate the Safety and Efficacy of Different Regimens of 1592U89 Monotherapy Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy-Naive Patients [NCT00002390]Phase 20 participants InterventionalCompleted
Evaluation of the Relationship Between Immunologic Recovery After Highly Active Antiretroviral Therapy and the Ability to Mobilize CD34+ Stem Cells Following G-CSF Administration [NCT00006578]0 participants (Actual)InterventionalWithdrawn
An Open-Label, Single Center Trial to Evaluate the Efficacy and Safety of Quadruple Chemotherapy (Zidovudine, EPIVIR, 1592U89, and 141W94) in Subjects Infected With HIV-1 (GW QUAD) [NCT00006617]25 participants InterventionalCompleted
Phase II, Randomized, Open-Label Study of Switching to Protease Inhibitor-Sparing Regimens for Improvement of Metabolic Abnormalities [NCT00021463]Phase 2342 participants InterventionalCompleted
A Phase IV Multicenter Study of the Efficacy and Safety of 48-Week Induction Treatment With TRIZIVIR (Abacavir 300 Mg/Lamivudine 150 Mg/Zidovudine 300 Mg Combination Tablet BID) With Efavirenz (600 Mg QD) Followed by 48-Week Randomized, Open-Label, Mainte [NCT00011895]Phase 4400 participants Interventional2001-02-28Active, not recruiting
A Phase IV, Open-label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-daily for 48 Weeks in HIV-infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensifi [NCT00038506]Phase 4100 participants Interventional2002-03-31Completed
Pharmacokinetic Interactions Between Ritonavir, Amprenavir and Efavirenz and Nelfinavir, Amprenavir, and Efavirenz in People Infected With HIV [NCT00001766]Phase 122 participants Interventional1998-08-31Completed
A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV [NCT00053638]Phase 3345 participants Interventional2003-02-28Completed
Delaying HIV Disease Progression With Punctuated Antiretroviral Therapy in HIV-Associated Tuberculosis [NCT00078247]Phase 3350 participants (Anticipated)Interventional2004-10-31Completed
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 Phase I/II Study of the Safety, Tolerability, and Antiretroviral Activity of Mycophenolate Mofetil As an Adjunct to Abacavir Therapy in HIV-Infected Subjects With Treatment Failure and Extensive Prior Antiretroviral Exposure [NCT00021489]Phase 20 participants (Actual)InterventionalWithdrawn
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
Multicenter, Pilot Study of Telbivudine (LdT) Anti-HBV Treatment Prior to the Initiation of Highly Active Antiretroviral Therapy Containing Lamivudine in Subjects Coinfected With HBV and HIV [NCT00051090]0 participants (Actual)InterventionalWithdrawn
A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex [NCT00002163]Phase 30 participants InterventionalCompleted
Augmenting the Magnitude of HAART-Induced Immune Restoration With the Use of Cyclosporine [NCT00031070]Phase 240 participants InterventionalCompleted
Free Study: a Randomised, Open Label, Multicentre Strategic Study to Evaluate the Efficacy and Toxicity of an Early Switch From a PI-containing Regimen to Trizivir ® on Guidance of Viral Load in HIV-1 Infected , Antiretroviral naïve Adults [NCT00405925]Phase 3207 participants (Actual)Interventional2003-03-31Completed
See Detailed Description [NCT00044577]Phase 3166 participants Interventional2002-07-16Completed
A Phase III, 48-Week, Open-Label, Randomized, Multicenter Study of the Safety and Efficacy of the Abacavir/Lamivudine Fixed-Dose Combination Tablet Administered QD Versus Abacavir + Lamivudine Administered BID in Combination With a PI or NNRTI in Antiretr [NCT00046176]Phase 3240 participants Interventional2002-08-26Completed
A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study. [NCT00192634]Phase 4357 participants (Actual)Interventional2005-12-31Completed
Optimizing Pediatric HIV-1 Treatment in Infants With Prophylactic Exposure to Nevirapine, Nairobi, Kenya (6-12 Month RCT) [NCT00427297]Phase 334 participants (Actual)Interventional2007-09-30Terminated(stopped due to There is no longer equipoise. DSMB recommended termination.)
A Phase II, Open-Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Drv/Rtv Once Daily in Treatment-Naive HIV-1 Infected Adolescents Aged Between 12 and < 18 Years [NCT00915655]Phase 212 participants (Actual)Interventional2009-07-31Completed
A 1592U89 Open-Label Protocol for Adult Patients With HIV-1 Infection. [NCT00002200]0 participants InterventionalCompleted
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
An Open-Label, Two-Period, Crossover, Pharmacokinetic Study of Abacavir and Its Intracellular Anabolite Carbovir Triphosphate Following Once-Daily and Twice-Daily Administration of Abacavir in HIV-Infected Subjects. [NCT00320307]Phase 130 participants (Actual)Interventional2005-09-30Completed
A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*5701) for Susceptibility to Abacavir Hypersensitivity [NCT00340080]Phase 41,806 participants Interventional2006-04-30Completed
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
Pharmacokinetics of Abacavir Once Daily vs. Twice Daily and Lamivudine Once Daily vs. Twice Daily in HIV-infected Thai Children [NCT01656122]Phase 2/Phase 330 participants (Actual)Interventional2012-07-31Completed
Inhibition of Reverse Transcription in Type I Interferon Mediated Neuropathology [NCT04731103]Phase 224 participants (Anticipated)Interventional2022-08-24Recruiting
Single-Dose Fasting and Fed Pilot BE Study in Healthy Males and Females Not of Childbearing Potential [NCT05030025]Early Phase 143 participants (Actual)Interventional2021-08-01Completed
A Phase II Study of the Prolongation of Virologic Success (ACTG 372A) and Options for Virologic Failure (ACTG B/C/D) in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320 [NCT00000885]Phase 2440 participants InterventionalCompleted
A Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety and Efficacy of the Combination of 1592U89/Zidovudine (ZDV)/Lamivudine (3TC) Versus the Combination of Zidovudine (ZDV)/Lamivudine (3TC) in HIV-1 Therapy-Experienced Pediatric Patients. [NCT00002391]Phase 30 participants InterventionalCompleted
A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects. [NCT00002199]Phase 3550 participants InterventionalCompleted
An Open-Label Study to Evaluate the Efficacy and Safety of Amprenavir (141W94) and Abacavir Combination Therapy in Protease Inhibitor Experienced Subjects With HIV-1 Infection Who Are Failing Their Current Antiretroviral Treatment Regimen [NCT00002205]0 participants InterventionalCompleted
A Phase IIIB, Open-Label, Randomized Study of the Effect of an Education Intervention on Virological Outcomes, Adherence, Immunological Outcome, and Health Outcomes in HIV-Infected Subjects From Under-Represented Populations Treated With Triple Nucleoside [NCT00002409]Phase 3200 participants InterventionalCompleted
Pharmacokinetic Interactions of Ribavirin and Abacavir in Hepatitis-C Mono-infected Male Subjects Who Previously Failed Ribavirin-based Treatment [NCT01052701]Phase 126 participants (Actual)Interventional2009-12-31Completed
A Pilot Study of Early Treatment Intensification of Antiretroviral Therapy [NCT00001132]Phase 280 participants Interventional1999-11-30Completed
A Randomized, Open-Label Superiority Trial Comparing Emtricitabine to Abacavir Within a Triple Drug Combination in Antiretroviral-Drug Naive HIV-1 Infected Patients [NCT00002362]Phase 30 participants Interventional1999-08-31Suspended
An Open-Label, Phase II Trial to Evaluate the Steady-State Pharmacokinetics, Safety, and Efficacy of 1592U89 in Combination With Selected HIV-1 Protease Inhibitors in Antiretroviral-Naive, HIV-1-Infected Patients. [NCT00002440]Phase 280 participants InterventionalCompleted
Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL) [NCT00005764]Phase 4100 participants Interventional2000-05-31Completed
Changes in Weight and Body Composition After Switch to Dolutegravir/Lamivudine Compared to Continued Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed HIV Infection: A Randomized Open-label Superiority Trial: AVERTAS-1 [NCT04904406]Phase 495 participants (Anticipated)Interventional2020-10-22Recruiting
A Randomized Phase II Study of the Safety, Immunologic, and Virologic Effects of Cyclosporine A in Conjunction With Trizivir(R) and Kaletra(R) Versus Trizivir(R) and Kaletra(R) Alone During Primary HIV-1 Infection [NCT00084149]Phase 254 participants (Actual)Interventional2004-02-29Completed
CCTG584: Viral Dynamics and Pharmacokinetics of Tenofovir and Abacavir Monotherapy Versus the Combination Therapy of TDF-ABC in HIV-Infected Treatment Naive Patients [NCT00214890]Phase 221 participants (Actual)Interventional2004-12-07Completed
IGHID 11417 - The Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection: Impact on the Latent HIV Reservoir and Long-Term Immunologic Effect [NCT02384395]40 participants (Actual)Interventional2015-09-30Completed
Early Intensive Antiretroviral Combination Therapy in HIV-1 Infected Infants and Children [NCT00000872]Phase 255 participants (Anticipated)InterventionalCompleted
A Comparison of a Four-Drug Regimen Comprised of 141W94, 1592U89, and Combivir With a Three-Drug Regimen Comprised of Nelfinavir and Combivir in Antiretroviral-Naive HIV-Infected Patients. [NCT00002216]0 participants InterventionalCompleted
A Phase I Safety and Pharmacokinetic Study of 1592U89 Alone and In Combination With Other Antiretroviral Agents in Infants and Children With HIV Infection [NCT00000865]Phase 132 participants InterventionalCompleted
A Randomized, Double-Blind, Parallel-Group, Multicenter Trial to Evaluate the Safety and Efficacy of 1592U89 in Combination With Lamivudine (3TC) and Zidovudine (ZDV) Versus 3TC/ZDV in HIV-1-Infected, Antiretroviral Therapy-Naive Subjects With CD4+ Counts [NCT00002389]Phase 3210 participants InterventionalCompleted
A Phase II, 24-Week, Open-Label Study Designed to Evaluate the Safety, Tolerability, and Efficacy of Novel Quadruple-Combination Therapy With Preveon (Adefovir Dipivoxil; Bis-POM PMEA), Abacavir (1592U89), Sustiva (Efavirenz; DMP-266), and Amprenavir (141 [NCT00002419]Phase 225 participants InterventionalCompleted
1592U89 Open-Label Protocol for Pediatric Patients With HIV Infection. [NCT00002197]250 participants InterventionalCompleted
A Phase II, 48-Week, Uncontrolled, Open-Label Study Designed to Evaluate the Safety and Efficacy of Quadruple Antiretroviral Therapy (EPIVIR, Abacavir, Amprenavir, and Indinavir) in Subjects Acutely Infected With HIV-1 [NCT00002233]Phase 230 participants InterventionalCompleted
A Controlled Phase 2 Trial Assessing Three Doses of T-20 in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz in HIV-1 Infected Adults [NCT00002239]Phase 268 participants Interventional1999-05-31Completed
Effect of Amprenavir on Carbohydrate and Lipid Metabolism in Patients With HIV Infection [NCT00002245]Phase 30 participants Interventional1999-04-30Completed
A Phase IV 48-Week, Randomized, Open-Label, Multicenter Trial of Abacavir (300mg BID)/Efavirenz (600mg QD)/Didanosine (400mg QD) +/- Hydroxyurea (500mg BID) in HIV-1 Infected Subjects Failing Initial Therapy With 3TC/ZDV (or d4T) +/- Protease Inhibitor(s) [NCT00005018]Phase 4150 participants Interventional1999-07-31Completed
A Randomized, Open-Label, Pilot Treatment Trial Evaluating Cellular Dynamics and Immune Restoration in Treatment-Naive HIV-Infected Subjects Receiving Either the Protease Inhibitor LPV/r or the Nucleoside Analogue Reverse Transcriptase Inhibitors d4T/3TC/ [NCT00004855]55 participants InterventionalCompleted
A Phase IIIB Randomized, Multicenter Study of the Efficacy and Safety of Combivir 1 Tablet Po Bid Plus Ziagen 300mg Po Bid Versus an Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg Combination Tablet Po Bid, Administered for 24 Weeks in Subjects With HIV [NCT00004981]Phase 3230 participants InterventionalActive, not recruiting
A Phase IV, Open-Label, Randomized Study to Compare the Efficacy and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) for 96 Weeks in the Treatment of HIV-1 Infe [NCT00005017]Phase 4300 participants InterventionalActive, not recruiting
A Phase IV, Open-Label, Multicenter Study of the Efficacy and Safety of Quadruple Combination Antiretroviral Therapy With Combivir (Lamivudine 150mg/Zidovudine 300mg) BID, Ziagen (Abacavir) 300mg BID, and Sustiva (Efavirenz) 600mg QD for 24 Weeks, Followe [NCT00004585]Phase 440 participants Interventional1999-10-31Completed
A Phase II, Open-Label Trial for Treatment of HIV Infection in Subjects Who Have Failed Initial Combination Therapy With Regimens Containing Indinavir or Nelfinavir: Combination Therapy With 3TC (150 Mg BID), Abacavir (300 Mg BID) and Amprenavir (1200 Mg [NCT00002423]Phase 2100 participants Interventional1999-03-31Completed
A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients With HIV Infection [NCT00002183]Phase 160 participants InterventionalCompleted
A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy With 1592U89, 141W94 and DMP 266 in HIV-1 Infected Subjects With Detectable HIV-1 Plasma RNA Despite Treatment With a Protease Inhibitor Containing Regimen [NCT00002213]Phase 280 participants InterventionalCompleted
PENTA15: Plasma Pharmacokinetic Study of Once Versus Twice Daily Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV-1 Infection Aged 3 Months to <36 Months [NCT01973439]Phase 123 participants (Actual)Interventional2006-07-31Completed
Investigating Influence of Pregnancy-induced Changes in Antiretroviral Pharmacokinetics, Together With Polymorphisms in Drug Disposition Genes, on Viral Decay Dynamics in HIV Positive Women Starting Therapy Late in Pregnancy and Postpartum [NCT03284645]194 participants (Actual)Observational2017-12-22Completed
Randomised Double-Blind Placebo-Controlled Phase 3 Trial of Triumeq in Amyotrophic Lateral Sclerosis [NCT05193994]Phase 3390 participants (Anticipated)Interventional2022-02-24Recruiting
Effect of Substituting Truvada for Combivir or Trizivir vs Continuing Combivir or Trizivir on Physiologic Correlates of Mitochondrial Function in Subjects Infected With Human Immunodeficiency Virus on Highly Active Antiretroviral Therapy [NCT00960622]Phase 417 participants (Actual)Interventional2006-08-31Completed
A 96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of EPZICOM Versus TRUVADA Administered in Combination With KALETRA in Antiretroviral-Naive HIV-1 Infected Subjects [NCT00244712]Phase 4688 participants (Actual)Interventional2005-07-31Completed
Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive. Randomized Clinical, Not Masked, Trial Comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 Weeks [NCT02470650]Phase 4150 participants (Anticipated)Interventional2015-06-30Recruiting
Prospective Non-Interventional Observational Study of Use of Triumeq® and Corresponding Monitoring Measures in Clinical Practice in Germany [NCT02342769]403 participants (Actual)Observational2015-02-19Completed
An Open Label Study to Investigate the Safety and Efficacy of Abacavir/Lamivudine/Dolutegravir and the Pharmacokinetic Profile of Dolutegravir in HIV-infected Patients of 60 Years of Age and Older [NCT02509195]Phase 440 participants (Anticipated)Interventional2015-08-04Completed
A Randomised Trial of Monitoring Practice and Induction Maintenance Drug Regimens in the Management of Antiretroviral Therapy in Children With HIV Infection in Africa [NCT02028676]Phase 41,206 participants (Actual)Interventional2007-03-31Completed
A Phase IIb, Dose Ranging Study of Oral GSK1265744 in Combination With Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus -1 (HIV-1) Virologic Suppression Followed by an Evaluation of Maintenance of Virologic Suppres [NCT01641809]Phase 2244 participants (Actual)Interventional2012-08-06Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
NCT00042289 (26) [back to overview]PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
NCT00042289 (26) [back to overview]Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms
NCT00042289 (26) [back to overview]Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms
NCT00042289 (26) [back to overview]Plasma Concentration for Contraceptives
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in mg/L 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]Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs
NCT00042289 (26) [back to overview]Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in mg/L 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: Trough Concentration (C12) 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: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (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: 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
NCT00084149 (7) [back to overview]Adverse Events Related to Study Medication
NCT00084149 (7) [back to overview]CD4 T Cell Levels
NCT00084149 (7) [back to overview]HIV-1 Viral Load Levels
NCT00084149 (7) [back to overview]Number of Patients With Viral Load Less Than 50 Copies/ml
NCT00084149 (7) [back to overview]Proviral DNA Levels (log10)
NCT00084149 (7) [back to overview]Proviral DNA (log10)
NCT00084149 (7) [back to overview]Levels of Proviral DNA in Peripheral Blood Mononuclear Cells (PBMC) (log10)
NCT00102960 (13) [back to overview]Time to Death Alone or Death Plus Life Threatening Stage C Events or HIV Events Associated With Permanent End-organ Damage.
NCT00102960 (13) [back to overview]Time to Failure of First Line Therapy or Death
NCT00102960 (13) [back to overview]Time to First Hospitalization
NCT00102960 (13) [back to overview]Total Occurrence of Grade 3 or 4 Clinical Events
NCT00102960 (13) [back to overview]Total Occurrence of Grade 3 or 4 Laboratory Events
NCT00102960 (13) [back to overview]Number of Participants Who Experienced Virological Failure Defined as Confirmed HIV-1 RNA Value of at Least 10,000 Copies Per/ml Recorded on Two Consecutive Separate Occasions After 24 Weeks of Treatment (Initial Therapy or Restart)
NCT00102960 (13) [back to overview]Time From Randomization to Starting or Needing to Start Continuous Therapy
NCT00102960 (13) [back to overview]Duration of Hospitalisation
NCT00102960 (13) [back to overview]Hospitalization Rates
NCT00102960 (13) [back to overview]Number of Children Experiencing Severe CDC Stage B or Stage C Disease or Death (Cumulative After 3.5 Years)
NCT00102960 (13) [back to overview]Number of Participants Who Experienced Clinical Failure (Defined as Development of Severe CDC Stage B or Stage C Disease.) on Therapy.
NCT00102960 (13) [back to overview]Number of Participants Who Experienced Regimen-limiting ART Drug Toxicity
NCT00102960 (13) [back to overview]Number of Participants Who Experienced Immunological Failure Defined as Failure of CD4% to Reach 20% or CD4% Falls Below 20% on Two Occasions, Within 4 Weeks, at Any Time After the First 24 Weeks of Therapy (Initial Therapy or Restart)
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
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 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]Amount of Study Follow-up
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 a Grade 3/4 Safety Event
NCT00118898 (22) [back to overview]Number of Participants With Regimen Failure
NCT00118898 (22) [back to overview]Number of Participants With Treatment Modification
NCT00118898 (22) [back to overview]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
NCT00214890 (6) [back to overview]Compare the Intracellular Pharmacokinetic (PK) Data of the Two Monotherapy Regimens to the Dual NRTI Regimen
NCT00214890 (6) [back to overview]Change in Short-term Virologic Response
NCT00214890 (6) [back to overview]Compare the Plasma Data of the Two Monotherapy Regimens to the Dual NRTI Regimen
NCT00214890 (6) [back to overview]Evaluate Change in Cellular Regulatory Enzymes Involved With Nucleoside Analogue Transport Across Cell Membranes as Assessed by RT-PCR of Specific mRNA Transcripts
NCT00214890 (6) [back to overview]Determine Total Number of NRTI-associated Mutations After 7 Days of ABC or TDF Monotherapy or After 7 Days of Dual NRTI Therapy With ABC + TDF
NCT00214890 (6) [back to overview]Compare the Relative Viral Potency of TDF Monotherapy Versus ABC Monotherapy
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
NCT00244712 (14) [back to overview]Median Change From Baseline in CD4+ Cells at Weeks 48 and 96
NCT00244712 (14) [back to overview]Median Change From Baseline in HIV-1 RNA at Week 48 and 96
NCT00244712 (14) [back to overview]Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
NCT00244712 (14) [back to overview]Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
NCT00244712 (14) [back to overview]Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
NCT00244712 (14) [back to overview]Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
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.
NCT00427297 (4) [back to overview]Incidence of Severe Adverse Events (Excluding Mortality)
NCT00427297 (4) [back to overview]Incidence of Mortality
NCT00427297 (4) [back to overview]Immunologic Failure
NCT00427297 (4) [back to overview]Viral Failure
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 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]Mean Percent Compliance at Week 144
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]Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit
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]Change From Baseline in HIV-1 RNA at Week 84
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 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 Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
NCT00440947 (26) [back to overview]Number of Participants Who Met the PDVF Criteria at Week 144
NCT00440947 (26) [back to overview]Mean Percent Compliance at Week 84
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]Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit
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]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]Change From Baseline in HIV-1 RNA at Week 144
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]Change From Baseline in HIV-1 RNA at Week 36
NCT00440947 (26) [back to overview]Mean Percent Compliance at Week 36
NCT00440947 (26) [back to overview]Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96
NCT00549198 (58) [back to overview]Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
NCT00549198 (58) [back to overview]Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
NCT00549198 (58) [back to overview]Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
NCT00549198 (58) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
NCT00549198 (58) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
NCT00549198 (58) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
NCT00549198 (58) [back to overview]"Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized"
NCT00549198 (58) [back to overview]Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96
NCT00549198 (58) [back to overview]Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24
NCT00549198 (58) [back to overview]Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48
NCT00549198 (58) [back to overview]Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96
NCT00549198 (58) [back to overview]Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24
NCT00549198 (58) [back to overview]Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48
NCT00549198 (58) [back to overview]Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96
NCT00549198 (58) [back to overview]Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24
NCT00549198 (58) [back to overview]Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48
NCT00549198 (58) [back to overview]Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96
NCT00549198 (58) [back to overview]Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24
NCT00549198 (58) [back to overview]Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48
NCT00549198 (58) [back to overview]Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96
NCT00549198 (58) [back to overview]Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24
NCT00549198 (58) [back to overview]Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48
NCT00549198 (58) [back to overview]Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96
NCT00549198 (58) [back to overview]Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24
NCT00549198 (58) [back to overview]Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96
NCT00549198 (58) [back to overview]Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48
NCT00549198 (58) [back to overview]Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24
NCT00549198 (58) [back to overview]Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48
NCT00549198 (58) [back to overview]Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96
NCT00724711 (14) [back to overview]Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Fasting Lipid Parameters at Week 48
NCT00724711 (14) [back to overview]Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48
NCT00724711 (14) [back to overview]Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48
NCT00724711 (14) [back to overview]Change From Baseline C-Reactive Protein at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Fibrinogen at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48
NCT00724711 (14) [back to overview]Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Fasting Glucose at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48
NCT00724711 (14) [back to overview]Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm
NCT00724711 (14) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
NCT00724711 (14) [back to overview]Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48
NCT00851630 (4) [back to overview]Number of Serious Adverse Events (SAEs)
NCT00851630 (4) [back to overview]Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml
NCT00851630 (4) [back to overview]Tuberculosis-immune Reconstitution Inflammatory Syndrome Events
NCT00851630 (4) [back to overview]HIV RNA Level < 50 Copies/ml
NCT00915655 (2) [back to overview]Virological Response[Viral Load <50 Copies/mL, TLOVR]
NCT00915655 (2) [back to overview]Virological Response [Viral Load <50 Copies/mL, FDA-SNAPSHOT]
NCT00928187 (13) [back to overview]Tolerance: Gastrointestinal Complains
NCT00928187 (13) [back to overview]Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)
NCT00928187 (13) [back to overview]Development of Metabolic Syndrome
NCT00928187 (13) [back to overview]Number of Patients With WHO Stage 3 and 4 HIV Related Events
NCT00928187 (13) [back to overview]Number of Patients With Resistance Mutations
NCT00928187 (13) [back to overview]Number of Patients With Plasma HIV RNA < 50 Copies/mL
NCT00928187 (13) [back to overview]Number of Patients With HIV Plasma Viral Load < 50 Copies/ml
NCT00928187 (13) [back to overview]Number of Patients With HIV Plasma Viral Load < 200 Copies/ml
NCT00928187 (13) [back to overview]Number of Patients Discontinuing Study Treatment
NCT00928187 (13) [back to overview]Gain in CD4 Cells Between Baseline and W48
NCT00928187 (13) [back to overview]Patients With Plasma HIV RNA < 200 Copies/ml
NCT00928187 (13) [back to overview]Adherence
NCT00928187 (13) [back to overview]Tolerance: Neuropathies (Grade 1 to 4)
NCT00960622 (1) [back to overview]Change in Peak Oxygen Uptake.
NCT01052701 (2) [back to overview]Plasma RBV Trough Concentrations
NCT01052701 (2) [back to overview]Ribavirin Triphosphate (RBV-TP) Intracellular Concentrations
NCT01146873 (5) [back to overview]Viral Failure
NCT01146873 (5) [back to overview]CD4 Cell Percentage at 48 Weeks After Randomization
NCT01146873 (5) [back to overview]Viral Rebound
NCT01146873 (5) [back to overview]Highest Grade ALT After Randomization
NCT01146873 (5) [back to overview]Percentage of Participants With Elevated Total Cholesterol, Elevated LDL, Abnormal HDL, or Abnormal Triglycerides at 40 Weeks After Randomization
NCT01263015 (11) [back to overview]Change From Baseline in CD4+ Cell Counts at Week 144
NCT01263015 (11) [back to overview]Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48
NCT01263015 (11) [back to overview]Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities at Week144
NCT01263015 (11) [back to overview]Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) Through 144
NCT01263015 (11) [back to overview]Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144
NCT01263015 (11) [back to overview]Time to Viral Suppression (<50 c/mL)
NCT01263015 (11) [back to overview]Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144
NCT01263015 (11) [back to overview]Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24
NCT01263015 (11) [back to overview]Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences at Week 144
NCT01263015 (11) [back to overview]Change From Baseline in Plasma HIV-1 RNA at Weeks 2, 4, 8, 12, 16, 24, 32, 40,48, 60, 72, 84, 96, 108, 120, 132 and 144
NCT01263015 (11) [back to overview]Change From Baseline in the Symptom Bother Score (SBS) at Week 4 Through Week 48
NCT01352715 (9) [back to overview]Cumulative Probability of Virologic Failure by Week 48
NCT01352715 (9) [back to overview]Number of Participants Discontinuing Randomized Treatment for Toxicity
NCT01352715 (9) [back to overview]Number of Participants With a New AIDS-defining Events or Death
NCT01352715 (9) [back to overview]Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death
NCT01352715 (9) [back to overview]Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline
NCT01352715 (9) [back to overview]Percentage of Time Spent in Hospital
NCT01352715 (9) [back to overview]Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure
NCT01352715 (9) [back to overview]Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline
NCT01352715 (9) [back to overview]Change in CD4+ Cell Count From Baseline to Week 48
NCT01641809 (57) [back to overview]Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Hemoglobin Level Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Hemoglobin Level Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in CD4+ Cell Count Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in ALT, AST and CK Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in ALT, AST and CK Over Time by Visit
NCT01641809 (57) [back to overview]Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
NCT01641809 (57) [back to overview]Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
NCT01641809 (57) [back to overview]Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm
NCT01641809 (57) [back to overview]Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase
NCT01641809 (57) [back to overview]Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase
NCT01641809 (57) [back to overview]Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events
NCT01641809 (57) [back to overview]Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
NCT01641809 (57) [back to overview]Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2
NCT01641809 (57) [back to overview]Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2
NCT01641809 (57) [back to overview]Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2
NCT01641809 (57) [back to overview]Change From Baseline in CD4+ Cell Count Over Time by Visit
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm
NCT01641809 (57) [back to overview]Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit
NCT01641809 (57) [back to overview]Number of Participants With Adherence to Study Treatment
NCT01641809 (57) [back to overview]Number of Participants With Adherence to Study Treatment
NCT01641809 (57) [back to overview]Number of Participants With Adherence to Study Treatment
NCT01641809 (57) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase
NCT01641809 (57) [back to overview]Number of Participants With AEs and SAEs Over Time
NCT01641809 (57) [back to overview]Number of Participants With AEs and SAEs-Induction Phase
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase
NCT01641809 (57) [back to overview]Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease
NCT01641809 (57) [back to overview]Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance
NCT01641809 (57) [back to overview]Number of Participants With Treatment Emergent Phenotypic Resistance
NCT01641809 (57) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase
NCT01641809 (57) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
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 Lipase at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in TC/HDL Ratio at Week 48
NCT01910402 (48) [back to overview]Change From Baseline in Triglycerides at Week 48
NCT01910402 (48) [back to overview]Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase
NCT01910402 (48) [back to overview]Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase
NCT01910402 (48) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48
NCT01910402 (48) [back to overview]Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase
NCT01910402 (48) [back to overview]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 Erythrocytes at Indicated Time Points
NCT01973439 (4) [back to overview]Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing
NCT01973439 (4) [back to overview]Cmax of Abacavir on Once Daily Dosing
NCT01973439 (4) [back to overview]Cmax of Abacavir on Twice Daily Dosing
NCT01973439 (4) [back to overview]AUC(0-24) of Abacavir on Once Daily Dosing
NCT02028676 (58) [back to overview]Cotrimoxazole: New Serious Adverse Events Not Solely Related to HIV
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Weight-for-age Z-score
NCT02028676 (58) [back to overview]CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 72 Weeks After Baseline
NCT02028676 (58) [back to overview]Cotrimoxazole: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)
NCT02028676 (58) [back to overview]Cotrimoxazole: All-cause Mortality
NCT02028676 (58) [back to overview]Cotrimoxazole: Body Mass Index-for-age Z-score
NCT02028676 (58) [back to overview]Cotrimoxazole: Change From Baseline in Absolute CD4 to Week 72
NCT02028676 (58) [back to overview]Cotrimoxazole: Change From Baseline in CD4% to Week 72
NCT02028676 (58) [back to overview]Cotrimoxazole: Height-for-age Z-score
NCT02028676 (58) [back to overview]Cotrimoxazole: New Clinical and Diagnostic Positive Malaria
NCT02028676 (58) [back to overview]Cotrimoxazole: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
NCT02028676 (58) [back to overview]Cotrimoxazole: New Hospitalisation or Death
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 144
NCT02028676 (58) [back to overview]Cotrimoxazole: New Severe Pneumonia
NCT02028676 (58) [back to overview]Cotrimoxazole: New WHO Stage 3 or 4 Event or Death
NCT02028676 (58) [back to overview]Cotrimoxazole: New WHO Stage 3 Severe Recurrent Pneumonia or Diarrhoea
NCT02028676 (58) [back to overview]Cotrimoxazole: New WHO Stage 4 Event or Death
NCT02028676 (58) [back to overview]Cotrimoxazole: Weight-for-age Z-score
NCT02028676 (58) [back to overview]Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation
NCT02028676 (58) [back to overview]Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation
NCT02028676 (58) [back to overview]Induction ART: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
NCT02028676 (58) [back to overview]Induction ART: New WHO Stage 4 Event or Death
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: All-cause Mortality
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Body Mass Index-for-age Z-score
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Cessation of First-line Regimen for Clinical/Immunological Failure
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 72
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Height-for-age Z-score
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New ART-modifying Adverse Event
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New Grade 3 or 4 Adverse Event Definitely/Probably or Uncertainly Related to ART
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New or Recurrent WHO Stage 3 or 4 Event or Death
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New Serious Adverse Events Not Solely Related to HIV
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New WHO Stage 3 or 4 Event or Death
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Weight-for-age Z-score
NCT02028676 (58) [back to overview]LCM vs CDM: Change From Baseline in CD4% to Week 144
NCT02028676 (58) [back to overview]LCM vs CDM: Change From Baseline in CD4% to Week 72
NCT02028676 (58) [back to overview]LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death
NCT02028676 (58) [back to overview]LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 48 Weeks
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 96 Weeks
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: All-cause Mortality
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Body Mass Index-for-age Z-score
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 48
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 96
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 48
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 72
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 96
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Height-for-age Z-score
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV, Judged Definitely/Probably or Uncertain Whether Related to Lamivudine or Abacavir
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New Serious Adverse Events Not Solely Related to HIV
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 3 or 4 Event or Death
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 4 Event or Death
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Suppression of HIV RNA Viral Load 96 Weeks After Randomisation
NCT02028676 (58) [back to overview]CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 144 Weeks After Baseline
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 72
NCT02384395 (4) [back to overview]Median Change HIV-1 RNA Level Among Participants Completing Week 24 Visit
NCT02384395 (4) [back to overview]Number of Participants With Grade 3 or Higher Adverse Event (AE)
NCT02384395 (4) [back to overview]Number of Participants With Viral Load Measurement <200 Copies/mL at Week 24
NCT02384395 (4) [back to overview]Proportion of Treated Participants With HIV-1 RNA to <50 Copies/mL at Week 48
NCT03760458 (52) [back to overview]Parent/Guardian-reported Percent Adherence to Study Drug
NCT03760458 (52) [back to overview]Parent/Guardian-reported Number of Missed Doses of Study Drug
NCT03760458 (52) [back to overview]Median (Q1,Q3) Change From Baseline in Total Cholesterol
NCT03760458 (52) [back to overview]Median (Q1,Q3) Change From Baseline in LDL
NCT03760458 (52) [back to overview]Median (Q1,Q3) Change From Baseline in HDL
NCT03760458 (52) [back to overview]Median (Q1, Q3) CD4+ Percentage
NCT03760458 (52) [back to overview]Median (Q1, Q3) CD4+ Cell Count
NCT03760458 (52) [back to overview]Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Antiretroviral (ARV) Resistance Mutations
NCT03760458 (52) [back to overview]Percentage of Participants With at Least One Adverse Event Through Week 48
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24
NCT03760458 (52) [back to overview]Percentage of Participants Who Experienced Virologic Failure Through Week 60
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Adverse Event Through Week 60
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Adverse Event Through Week 24
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60
NCT03760458 (52) [back to overview]Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60
NCT03760458 (52) [back to overview]Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60
NCT03760458 (52) [back to overview]Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48
NCT03760458 (52) [back to overview]Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24
NCT03760458 (52) [back to overview]Median (Q1,Q3) Change From Baseline in Triglycerides
NCT03760458 (52) [back to overview]Parent/Guardian-reported Reason for Missed Doses of Study Drug
NCT03760458 (52) [back to overview]Parent/Guardian-reported Ease of Giving Study Drug
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24
NCT03760458 (52) [back to overview]Parent/Guardian-reported Response of Child's Face When Taking Study Drug
NCT03760458 (52) [back to overview]Percentage of Participants Who Experienced Virologic Failure Through Week 48
NCT03760458 (52) [back to overview]Percentage of Participants Who Experienced Virologic Failure Through Week 48
NCT03760458 (52) [back to overview]Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to
NCT03760458 (52) [back to overview]Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm
NCT03760458 (52) [back to overview]Percentage of Participants Who Experienced Virologic Failure Through Week 60
NCT03760458 (52) [back to overview]Parent/Guardian-reported Response of Child's Face When Taking Favorite Food
NCT03760458 (52) [back to overview]Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60
NCT03760458 (52) [back to overview]Parent/Guardian-reported Time for Study Drug Tablets to Dissolve
NCT03760458 (52) [back to overview]Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve
NCT03760458 (52) [back to overview]Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48

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

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

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

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

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

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

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

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

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

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PK Parameter: Area Under the Curve From 0 to 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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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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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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Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs

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

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

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

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

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

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

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

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

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Plasma Concentration for Contraceptives

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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PK Parameter: 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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CD4 T Cell Levels

(NCT00084149)
Timeframe: At Week 48

Interventioncells/mm^3 (Median)
Cyclosporine301
No Cyclosporine287

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HIV-1 Viral Load Levels

(NCT00084149)
Timeframe: At Week 48

Interventionlog10(copies/mL) (Mean)
Cyclosporine1.70
No Cyclosporine1.70

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Number of Patients With Viral Load Less Than 50 Copies/ml

(NCT00084149)
Timeframe: Week 48

InterventionParticipants (Count of Participants)
Cyclosporine27
No Cyclosporine13

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Proviral DNA Levels (log10)

(NCT00084149)
Timeframe: At Week 24

Interventionlog10(copies/mL) (Median)
Cyclosporine2.12
No Cyclosporine1.96

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Proviral DNA (log10)

(NCT00084149)
Timeframe: At Week 12

Interventionlog10(copies/mL) (Median)
Cyclosporine2.22
No Cyclosporine2.13

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Levels of Proviral DNA in Peripheral Blood Mononuclear Cells (PBMC) (log10)

(NCT00084149)
Timeframe: At 48 weeks after the start of treatment

Interventionlog10(copies/mL) (Median)
Cyclosporine1.88
No Cyclosporine1.92

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Time to Death Alone or Death Plus Life Threatening Stage C Events or HIV Events Associated With Permanent End-organ Damage.

This was a composite endpoint in which the number of children experiencing the events is reported. The number of participants experiencing the events did not reach the 50% survival and thus median time-to-event is not be presented. Therefore, we report the number of participants experiencing the events per Arm. (NCT00102960)
Timeframe: 4.8 years

InterventionParticipants (Count of Participants)
Deferred Therapy34
Early Therapy 40 Weeks18
Early Therapy 96 Weeks13

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Time to Failure of First Line Therapy or Death

To compare time to failure of first line ART (due to clinical, virological or immunological disease progression, or regimen-limiting ART toxicities) or death among three randomized arms (infants who receive early ART in Arms 2 and 3 and infants in whom ART is deferred until clinical or immunological disease progression in Arm 1) during the study (up to 4.8 years). The number of participants experiencing the events did not reach the 50% survival and thus median time-to-event is not be presented. Therefore we report the number of participants experiencing the events per Arm. (NCT00102960)
Timeframe: From date of randomization up to failure of first-line therapy or death from any cause, whichever came first, assessed up to 4.8 years

InterventionParticipants (Count of Participants)
Deferred Therapy48
Early Therapy up to 40 Weeks32
Early Therapy up to 96 Weeks26

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Time to First Hospitalization

To compare time to first hospitalization in the three randomized arms (infants who received early ART in Arms 2 and 3 and those who received deferred ART in Arm 1). Not all participants were hospitalized and thus the upper limits could not be evaluated. (NCT00102960)
Timeframe: From randomization up to 4.8 years

InterventionWeeks (Median)
Deferred Therapy73.1
Early Therapy 40 WeeksNA
Early Therapy 96 WeeksNA

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Total Occurrence of Grade 3 or 4 Clinical Events

This was a secondary outcome measure that assessed the total count of Grade 3 or 4 (clinical or laboratory) adverse events. (NCT00102960)
Timeframe: 4.8 years

InterventionCount of events (Number)
Deferred Therapy170
Early Therapy 40 Weeks118
Early Therapy 96 Weeks88

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Total Occurrence of Grade 3 or 4 Laboratory Events

(NCT00102960)
Timeframe: From randomization up to 4.8 years

InterventionCount of events (Number)
Deferred Therapy35
Early Therapy 40 Weeks44
Early Therapy 96 Weeks33

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Number of Participants Who Experienced Virological Failure Defined as Confirmed HIV-1 RNA Value of at Least 10,000 Copies Per/ml Recorded on Two Consecutive Separate Occasions After 24 Weeks of Treatment (Initial Therapy or Restart)

This was part of the primary outcome measure that was a composite endpoint that included confirmed HIV-1 RNA value of at least 10,000 copies per/ml recorded on two consecutive separate occasions after 24 weeks of treatment (initial therapy or restart). (NCT00102960)
Timeframe: Virological failure was assessed from randomization through the entire study duration of 4.8 years.

InterventionParticipants (Count of Participants)
Deferred Therapy10
Early Therapy 40 Weeks1
Early Therapy 96 Weeks1

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Time From Randomization to Starting or Needing to Start Continuous Therapy

Time from randomization to starting (deferred therapy Arm) or needing to start continuous therapy (early therapy 40 or 96 weeks) (NCT00102960)
Timeframe: 4.8 years

InterventionWeeks (Median)
Deferred Therapy20
Early Therapy 40 Weeks33
Early Therapy 96 Weeks70

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Duration of Hospitalisation

This is the total number of days spent in hospital by the participants and is reported per arm (NCT00102960)
Timeframe: 4.8 years, the study duration

InterventionDays (Number)
Deferred Therapy1018
Early Therapy 40 Weeks533
Early Therapy 96 Weeks414

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Hospitalization Rates

Hospitalisation rates in the three arms enrolled in the CHER study (NCT00102960)
Timeframe: 4.8 years

InterventionEvents per 100 person years (Number)
Deferred Therapy27.6
Early Therapy 40 Weeks16.4
Early Therapy 96 Weeks14.2

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Number of Children Experiencing Severe CDC Stage B or Stage C Disease or Death (Cumulative After 3.5 Years)

The outcome measure is defined as a number because it represents the number of children that experienced severe CDC Stage B or Stage C disease or death as defined in the outcome measure title above (NCT00102960)
Timeframe: Occurrence of severe CDC Stage B or Stage C disease or death (cumulative after 3.5 years), whichever came first, was assessed from randomization up to at least 3.5 years.

InterventionParticipants (Count of Participants)
Deferred Therapy41
Early Therapy 40 Weeks28
Early Therapy 96 Weeks21

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Number of Participants Who Experienced Clinical Failure (Defined as Development of Severe CDC Stage B or Stage C Disease.) on Therapy.

This included development of severe CDC Stage B or Stage C disease.This was part of the primary outcome measure that was a composite endpoint (NCT00102960)
Timeframe: Clinical failure on therapy was assessed at each visit for the entire study duration of 4.8 years.

InterventionParticipants (Count of Participants)
Deferred Therapy8
Early Therapy 40 Weeks6
Early Therapy 96 Weeks5

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Number of Participants Who Experienced Regimen-limiting ART Drug Toxicity

Development of toxicity requiring more than one drug substitution within the same class or a switch to a new class of drugs (regimen-limiting toxicity failure) or requiring a permanent treatment discontinuation. This was part of the primary outcome measure that was a composite endpoint. (NCT00102960)
Timeframe: Regimen limiting drug toxicity was monitored from randomization up to the entire study duration of 4.8 years.

InterventionParticipants (Count of Participants)
Deferred Therapy0
Early Therapy 40 Weeks0
Early Therapy 96 Weeks0

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Number of Participants Who Experienced Immunological Failure Defined as Failure of CD4% to Reach 20% or CD4% Falls Below 20% on Two Occasions, Within 4 Weeks, at Any Time After the First 24 Weeks of Therapy (Initial Therapy or Restart)

This was part of the primary outcome measure above. The primary outcome was a composite endpoint. The primary outcome analysis only considered the initially enrolled children that were 377 in total (ART-Deferred n=125, Early therapy 40 weeks n=126 and Early therapy 96 weeks n=126). This was part of the primary outcome measure that was a composite endpoint. (NCT00102960)
Timeframe: This outcome was assessed from the date of randomization to immunological failure. Immunological failure was assessed in the entire study duration of 4.8 years.

InterventionParticipants (Count of Participants)
Deferred Therapy9
Early ART for 40 Weeks14
Early Therapy for 96 Weeks11

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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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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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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 Regimen Failure

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

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

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Number of Participants With Treatment Modification

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

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

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

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

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

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Change in Short-term Virologic Response

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

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

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

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

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

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

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

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

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

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

Interventionmutations (Number)
Tenofovir0
Abacavir0

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Compare the Relative Viral Potency of TDF Monotherapy Versus ABC Monotherapy

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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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Incidence of Severe Adverse Events (Excluding Mortality)

(NCT00427297)
Timeframe: 2 years

Interventionevent (Number)
NVP-containing21
NVP-sparing6

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Incidence of Mortality

Death during follow-up (NCT00427297)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
NVP-containing4
NVP-sparing5

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Immunologic Failure

Immunologic treatment failure was defined as CD4% dropping below 15%, after a previous result greater than or equal to 15% (following along WHO Guidelines). (NCT00427297)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
NVP-containing2
NVP-sparing1

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Viral Failure

Virologic treatment failure was defined as follow-up (at least 24 weeks after enrollment date) viral load > 400 copies. (NCT00427297)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
NVP-containing2
NVP-sparing2

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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 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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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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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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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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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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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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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 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 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 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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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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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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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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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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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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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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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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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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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 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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Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline B2M value by the urine creatinine value. B2M, beta 2 microglobulin (measured in mg/mmol). (NCT00549198)
Timeframe: Baseline, Week 96

Interventionratio (Geometric Mean)
ABC/3TC FDC0.542
TDF/FTC FDC0.984

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Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96

Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionug/L (Geometric Mean)
ABC/3TC FDC1.111
TDF/FTC FDC2.542

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Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline NAG value by the urine creatinine value. NAG, N-acetyl-B-glucosaminidase (measured in micromoles per hour per millimole [umol/h/mmol]). (NCT00549198)
Timeframe: Baseline, Week 96

Interventionratio (Geometric Mean)
ABC/3TC FDC0.868
TDF/FTC FDC0.939

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Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96

Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionug/L (Geometric Mean)
ABC/3TC FDC3.01
TDF/FTC FDC5.79

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Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96

P1NP is a bone biomarker that was analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionmicrograms per Liter (ug/L) (Geometric Mean)
ABC/3TC FDC1.2
TDF/FTC FDC1.4

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Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline RBP value by the urine creatinine value. RBP, retinol binding protein (measured in micrograms per millimole [ug/mmol]). (NCT00549198)
Timeframe: Baseline, Week 96

Interventionratio (Geometric Mean)
ABC/3TC FDC1.099
TDF/FTC FDC1.550

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Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96

Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionnanograms per Liter (ng/L) (Geometric Mean)
ABC/3TC FDC89.9
TDF/FTC FDC203.6

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Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24

Change from baseline was calculated as the Week 24 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram; CG, Cockcroft-Gault. (NCT00549198)
Timeframe: Baseline, Week 24

InterventionmL/min (Mean)
ABC/3TC FDC4.27
TDF/FTC FDC2.54

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Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48

Change from baseline was calculated as the Week 48 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram. (NCT00549198)
Timeframe: Baseline, Week 48

InterventionmL/min (Mean)
ABC/3TC FDC2.66
TDF/FTC FDC3.80

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Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96

Change from baseline was calculated as the Week 96 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram. (NCT00549198)
Timeframe: Baseline, Week 96

InterventionmL/min (Mean)
ABC/3TC FDC4.37
TDF/FTC FDC2.68

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Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24

Change from baseline was calculated as the Week 24 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. (NCT00549198)
Timeframe: Baseline, Week 24

InterventionmL/min/1.73m^2 (Mean)
ABC/3TC FDC2.78
TDF/FTC FDC0.43

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Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48

Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine; BMI, body mass index. (NCT00549198)
Timeframe: Baseline, Week 48

Interventionmilliliters per minute (mL/min)/1.73 m^2 (Mean)
ABC/3TC FDC0.22
TDF/FTC FDC1.18

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Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96

Change from baseline was calculated as the Week 96 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^s, meters squared; Scr, serum creatinine. (NCT00549198)
Timeframe: Baseline, Week 96

InterventionmL/min/1.73m^2 (Mean)
ABC/3TC FDC1.48
TDF/FTC FDC-1.15

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Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 24

Interventionpercent change (Mean)
ABC/3TC FDC-1.19
TDF/FTC FDC-2.73

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Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 48

Interventionpercent change (Mean)
ABC/3TC FDC-1.90
TDF/FTC FDC-3.56

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Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionpercent change (Mean)
ABC/3TC FDC-2.17
TDF/FTC FDC-3.55

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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24

BMD is a measure (grams [g] per centimeters cubed [cm^3]) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 24

Interventionpercent change (Mean)
ABC/3TC FDC-2.12
TDF/FTC FDC-3.30

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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 48

Interventionpercent change (Mean)
ABC/3TC FDC-1.59
TDF/FTC FDC-2.41

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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionpercent change (Mean)
ABC/3TC FDC-0.87
TDF/FTC FDC-1.70

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"Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized"

Participants were asked at each visit whether or not they utilized unplanned healthcare resources. (NCT00549198)
Timeframe: Baseline to Week 96

,
Interventionparticipants (Number)
Week 4, Yes, n=178, 183Week 4, No, n=178, 183Week 12, Yes, n=162, 177Week 12, No, n=162, 177Week 24, Yes, n=156, 173Week 24, No, n=156, 173Week 36, Yes, n=148, 169Week 36, No, n=148, 169Week 48, Yes, n=137, 161Week 48, No, n=137, 161Week 60, Yes, n=129, 148Week 60, No, n=129, 148Week 72, Yes, n=126, 139Week 72, No, n=126, 139Week 84, Yes, n=121, 136Week 84, No, n=121, 136Week 96, Yes, n=113, 135Week 96, No, n=113, 135
ABC/3TC FDC601185610670864810044934782487834873083
TDF/FTC FDC49134471305911450119361254410440992410817118

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Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96

Viral resistance was measured using blood samples collected from participants throughout the study. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor. Virological failure was defined as any one of: participant does not achieve a 1 log10 copies (cop)/mL decrease in plasma HIV-1 RNA by Week (Wk) 4, or has two consecutive plasma HIV-1 RNA measures >=400 cop/mL separated by at least 2-4 wk after being previously <=400 cop/mL on/after Wk 4, or has two consecutive plasma HIV-1 RNA measures >400 cop/mL separated by at least 2-4 wk on/after Wk 24. (NCT00549198)
Timeframe: Week 96

,
Interventionparticipants (Number)
Any treatment-emergent mutationNRTINNRTI
ABC/3TC FDC442
TDF/FTC FDC000

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Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24

An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 24

,
Interventionparticipants (Number)
Any eventDrug hypersensitivityRashDizzinessHypersensitivityDrug eruption
ABC/3TC FDC26112031
TDF/FTC FDC1413201

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Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48

An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 48

,
Interventionparticipants (Number)
Any eventDrug hypersensitivityBone density decreasedRashDizzinessHypersensitivityDrug eruption
ABC/3TC FDC291102131
TDF/FTC FDC21123301

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Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96

An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 96

,
Interventionparticipants (Number)
Any eventDrug hypersensitivityBone density decreasedRashDizzinessHypersensitivityAbnormal dreamsDrug eruptionDepression
ABC/3TC FDC33110213310
TDF/FTC FDC2818330012

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Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24

"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 24

,
Interventionparticipants (Number)
Osteopenia, spine, n=147, 173Osteporosis, spine, n=147, 173Osteopenia, hip, n=149, 170Osteoporosis, hip, n=149, 170
ABC/3TC FDC4116384
TDF/FTC FDC689541

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Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48

"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 48

,
Interventionparticipants (Number)
Osteopenia, spine, n=132, 147Osteporosis, spine, n=132, 147Osteopenia, hip, n=130, 147Osteoporosis, hip, n=130, 147
ABC/3TC FDC4115374
TDF/FTC FDC575500

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Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96

"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 96

,
Interventionparticipants (Number)
Osteopenia, spine, n=64, 82Osteporosis, spine, n=64, 82Osteopenia, hip, n=65, 80Osteoporosis, hip, n=65, 80
ABC/3TC FDC215200
TDF/FTC FDC343310

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Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24

BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
>=2%, spine, n=142, 165>=6%, spine, n=142, 165>=2%, hip, n=137, 160>=6%, hip, n=137, 160
ABC/3TC FDC7310381
TDF/FTC FDC11517936

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Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48

BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
>=2%, spine, n=125, 141>=6%, spine, n=125, 141>=2%, hip, n=119, 140>=6%, hip, n=119, 140
ABC/3TC FDC515543
TDF/FTC FDC841311117

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Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96

BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
>=2%, spine, n=59, 79>=6%, spine, n=59, 79>=2%, hip, n=58, 76>=6%, hip, n=58, 76
ABC/3TC FDC213331
TDF/FTC FDC3985213

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Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24

mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
>=10 mL/min, MDRD>=10 mL/min, Cockcroft-Gault>=20 mL/min, MDRD>=20 mL/min, Cockcroft-Gault>=10%, MDRD>=10%, Cockcroft-Gault>=20%, MDRD>=20%, Cockcroft-Gault
ABC/3TC FDC161643151022
TDF/FTC FDC262064241733

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Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48

mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
>=10 mL/min, MDRD>=10 mL/min, Cockcroft-Gault>=20 mL/min, MDRD>=20 mL/min, Cockcroft-Gault>=10%, MDRD>=10%, Cockcroft-Gault>=20%, MDRD>=20%, Cockcroft-Gault
ABC/3TC FDC231544211143
TDF/FTC FDC21143221920

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Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96

mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
>=10 mL/min, MDRD>=10 mL/min, Cockcroft-Gault>=20 mL/min, MDRD>=20 mL/min, Cockcroft-Gault>=10%, MDRD>=10%, Cockcroft-Gault>=20%, MDRD>=20%, Cockcroft-Gault
ABC/3TC FDC151144151233
TDF/FTC FDC381975271664

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Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24

HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 24

,
Interventionparticipants (Number)
<50 copies/mL<400 copies/mL
ABC/3TC FDC126147
TDF/FTC FDC144168

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Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48

HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 48

,
Interventionparticipants (Number)
<50 copies/mL<400 copies/mL
ABC/3TC FDC121130
TDF/FTC FDC145151

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Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96

HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 96

,
Interventionparticipants (Number)
<50 copies/mL<400 copies/mL
ABC/3TC FDC98110
TDF/FTC FDC113126

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Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24

Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
NormalStage 1Stage 2Stage 3Stage 4Stage 5
ABC/3TC FDC97115100
TDF/FTC FDC114155100

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Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96

Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
MissingNormalStage 1Stage 2Stage 3Stage 4Stage 5
ABC/3TC FDC117534000
TDF/FTC FDC188344000

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
Low to lowLow to normalLow to highNormal to lowNormal to normalNormal to highHigh to lowHigh to normalHigh to high
ABC/3TC FDC197210012260010
TDF/FTC FDC3666913012035

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
Low to lowLow to normalLow to highNormal to lowNormal to normalNormal to highHigh to lowHigh to normalHigh to high
ABC/3TC FDC176718011270010
TDF/FTC FDC28731002320035

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
Low to lowLow to normalLow to highNormal to lowNormal to normalNormal to highHigh to lowHigh to normalHigh to high
ABC/3TC FDC11662508300010
TDF/FTC FDC23751301727017

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
Desirable to desirableDesirable to borderline highDesirable to highBorderline high to desirableBorderline high to borderline highBorderline high to highHigh to desirableHigh to borderline highHigh to high
ABC/3TC FDC5447321210003
TDF/FTC FDC104299396002

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
Desirable to desirableDesirable to borderline highDesirable to highBorderline high to desirableBorderline high to borderline highBorderline high to highHigh to desirableHigh to borderline highHigh to high
ABC/3TC FDC4652361210003
TDF/FTC FDC96379198002

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
Desirable to desirableDesirable to borderline highDesirable to highBorderline high to desirableBorderline high to borderline highBorderline high to highHigh to desirableHigh to borderline highHigh to high
ABC/3TC FDC3949461210003
TDF/FTC FDC864710198002

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
Normal to normalNormal to borderline highNormal to highNormal to very highBorderline high to normalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to normalHigh to borderline highHigh to highHigh to very highVery high to normalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC63212305590251230001
TDF/FTC FDC781990710150631500010

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
Normal to normalNormal to borderline highNormal to highNormal to very highBorderline high to normalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to normalHigh to borderline highHigh to highHigh to very highVery high to normalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC552230045110241240001
TDF/FTC FDC702312167190531500010

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150->200 mg/dL, borderline high; 200-<500 mg/dL, high;>= 500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
Normal to normalNormal to borderline highNormal to highNormal to very highBorderline high to normalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to normalHigh to borderline highHigh to highHigh to very highVery high to normalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC472534144111241150001
TDF/FTC FDC553120158190521600010

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
Optimal to optimalOptimal to near or above optimalOptimal to borderline highOptimal to highOptimal to very highNear or above optimal to optimalNear or above optimal to near or above optimalNear or above optimal to borderline highNear or above optimal to highNear or above optimal to very highBorderline high to optimalBorderline high to near or above optimalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to optimalHigh to near or above optimalHigh to borderline highHigh to highHigh to very highVery high to optimalVery high to near or above optimalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC224122610617124012430001000101
TDF/FTC FDC464311105221151063320001000001

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
Optimal to optimalOptimal to near or above optimalOptimal to borderline highOptimal to highOptimal to very highNear or above optimal to optimalNear or above optimal to near or above optimalNear or above optimal to borderline highNear or above optimal to highNear or above optimal to very highBorderline high to optimalBorderline high to near or above optimalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to optimalHigh to near or above optimalHigh to borderline highHigh to highHigh to very highVery high to optimalVery high to near or above optimalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC203827810419124012340001000101
TDF/FTC FDC424612103211361035420001000001

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
Optimal to optimalOptimal to near or above optimalOptimal to borderline highOptimal to highOptimal to very highNear or above optimal to optimalNear or above optimal to near or above optimalNear or above optimal to borderline highNear or above optimal to highNear or above optimal to very highBorderline high to optimalBorderline high to near or above optimalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to optimalHigh to near or above optimalHigh to borderline highHigh to highHigh to very highVery high to optimalVery high to near or above optimalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC183529930417126012340001000101
TDF/FTC FDC374617101191672035330001000001

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Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24

The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment. (NCT00549198)
Timeframe: Week 24

,
Interventionparticipants (Number)
Cholesterol, Grade 3Cholesterol, Grade 4LDL cholesterol, Grade 3LDL cholesterol, Grade 4Non-HDL cholesterol, Grade 3Non-HDL cholesterol, Grade 4Triglycerides, Grade 3Triglycerides, Grade 4Alanine aminotransferase, Grade 3Alanine aminotransferase, Grade 4Aspartate aminotransferase, Grade 3Aspartate aminotransferase, Grade 4Alkaline phosphatase, Grade 3Alkaline phosphatase, Grade 4Creatinine kinase, Grade 3Creatinine kinase, Grade 4Phosphorus inorganic, Grade 3Phosphorus inorganic, Grade 4Lipase, Grade 3Lipase, Grade 4Hyperkalaemia, Grade 3Hyperkalaemia, Grade 4Glomerular filtration rate, MDRD, Grade 3Glomerular filtration rate, MDRD, Grade 4Total neutrophils, Grade 3Total neutrophils, Grade 4Thrombocytopenia, Grade 3Thrombocytopenia, Grade 4
ABC/3TC FDC60801902011110001103201101110
TDF/FTC FDC1030500031021011101001100200

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Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48

The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment. (NCT00549198)
Timeframe: Week 48

,
Interventionparticipants (Number)
Cholesterol, Grade 3Cholesterol, Grade 4LDL cholesterol, Grade 3LDL cholesterol, Grade 4Non-HDL cholesterol, Grade 3Non-HDL cholesterol, Grade 4Triglycerides, Grade 3Triglycerides, Grade 4Alanine aminotransferase, Grade 3Alanine aminotransferase, Grade 4Aspartate aminotransferase, Grade 3Aspartate aminotransferase, Grade 4Alkaline phosphatase, Grade 3Alkaline phosphatase, Grade 4Total bilirubin Grade 3Total bilirubin, Grade 4Creatinine kinase, Grade 3Creatinine kinase, Grade 4Phosphorus inorganic, Grade 3Phosphorus inorganic, Grade 4Lipase, Grade 3Lipase, Grade 4Hyperkalaemia, Grade 3Hyperkalaemia, Grade 4Glomerular filtration rate, MDRD, Grade 3Glomerular filtration rate, MDRD, Grade 4Total neutrophils, Grade 3Total neutrophils, Grade 4Thrombocytopenia, Grade 4
ABC/3TC FDC7090200302222001001305202102310
TDF/FTC FDC103060004102100021101002100200

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Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96

The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug therapy. (NCT00549198)
Timeframe: Week 96

,
Interventionparticipants (Number)
Cholesterol, Grade 3Cholesterol, Grade 4LDL cholesterol, Grade 3LDL cholesterol, Grade 4Non-HDL cholesterol, Grade 3Non-HDL cholesterol, Grade 4Triglycerides, Grade 3Triglycerides, Grade 4Alanine aminotransferase, Grade 3Alanine aminotransferase, Grade 4Aspartate aminotransferase, Grade 3Aspartate aminotransferase, Grade 4Alkaline phosphatase, Grade 3Alkaline phosphatase, Grade 4Total bilirubin, Grade 3Total bilirubin, Grade 4Creatinine kinase, Grade 3Creatinine kinase, Grade 4Phosphorus inorganic, Grade 3Phosphorus inorganic, Grade 4Lipase, Grade 3Lipase, Grade 4Hyperkalaemia, Grade 3Hyperkalaemia, Grade 4Glomerular filtration rate, MDRD, Grade 3Glomerular filtration rate, MDRD, Grade 4Total neutrophils, Grade 3Total neutrophils, Grade 4Thrombocytopenia, Grade 3Thrombocytopenia, Grade 4
ABC/3TC FDC90130220212222001001406402103510
TDF/FTC FDC105050004112100022302200101300

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Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48

Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
MissingNormalStage 1Stage 2Stage 3Stage 4Stage 5
ABC/3TC FDC129073000
TDF/FTC FDC1910653000

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Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24

CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 24

Interventioncells/millimeters cubed (mm^3) (Median)
ABC/3TC FDC110.0
TDF/FTC FDC100.0

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Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48

CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 48

Interventioncells/mm^3 (Median)
ABC/3TC FDC150.0
TDF/FTC FDC150.0

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Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96

CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 96

Interventioncells/mm^3 (Median)
ABC/3TC FDC235.0
TDF/FTC FDC220.0

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Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline albumin value by the urine creatinine value. Albumin is measured in milligrams per millimole (mg/mmol). (NCT00549198)
Timeframe: Baseline, Week 96

Interventionratio (Geometric Mean)
ABC/3TC FDC0.872
TDF/FTC FDC0.973

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Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

,
Interventionpg/mL (Mean)
IL-10IL-6TNF-alpha
ABC/3TC + PI/r-0.2-0.64.7
TVD + PI/r0.0-0.20.0

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Change From Baseline Fasting Lipid Parameters at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

,
Interventionmg/dL (Mean)
Total CholesterolLDL (low-density lipoprotein)HDL (high-density lipoprotein)Triglycerides
ABC/3TC + PI/r-420-23
TVD + PI/r-21-6-2-51

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Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48

The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 50 copies/mL or the last HIV-1 RNA value >= 50 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionpercentage of participants (Number)
TVD + PI/r93.0
ABC/3TC + PI/r91.1

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Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48

The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionpercentage of participants (Number)
TVD + PI/r99.2
ABC/3TC + PI/r97.2

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Change From Baseline C-Reactive Protein at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionmg/dL (Mean)
TVD + PI/r-0.026
ABC/3TC + PI/r0.225

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Change From Baseline Fibrinogen at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionmg/dL (Mean)
TVD + PI/r-4
ABC/3TC + PI/r14

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Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

InterventionmL/min (Mean)
TVD + PI/r-8.4
ABC/3TC + PI/r-4.1

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Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

InterventionmL/min/1.73m^2 (Mean)
TVD + PI/r-9.0
ABC/3TC + PI/r-3.7

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Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventioncells/microliter (Mean)
TVD + PI/r8
ABC/3TC + PI/r34

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Change From Baseline Fasting Glucose at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionmg/dL (Mean)
TVD + PI/r1
ABC/3TC + PI/r1

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Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

InterventionRatio (Mean)
TVD + PI/r-0.1
ABC/3TC + PI/r-0.1

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Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm

The percentage of participants with HIV-1 RNA < 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionpercentage of participants (Number)
TVD + PI/r86.4
ABC/3TC + PI/r83.3

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

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was summarized. (NCT00724711)
Timeframe: 48 weeks

,
Interventionpercentage of participants (Number)
TLOVR Responder AnalysisOn-Treatment Response Analysis (Missing = Failure)Snapshot Responder Analysis (Virologic Success)
ABC/3TC + PI/r76.377.677.6
TVD + PI/r77.979.979.9

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Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48

The percentage of participants with HIV-1 RNA < 200 copies/mL at Week 48 was summarized. (NCT00724711)
Timeframe: 48 weeks

,
Interventionpercentage of participants (Number)
On-Treatment Response Analysis (Missing = Failure)Snapshot Responder Analysis (Virologic Success)
ABC/3TC + PI/r82.182.1
TVD + PI/r84.484.4

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Number of Serious Adverse Events (SAEs)

Feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV-infected subjects with tuberculosis in a resource-limited setting as assessed by the number of serious adverse events. Serious adverse events included any untoward medical occurrence that resulted in death, was considered life-threatening, required inpatient hospitalization or prolongation of existing hospitalization beyond what was required in the study, or resulted in persistent or resulted in significant disability/incapacity. (NCT00851630)
Timeframe: 104 weeks

InterventionEvents (Number)
Early12
Delayed7

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Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml

The number of subjects with plasma HIV RNA level <400 copies/ml. (NCT00851630)
Timeframe: 104 Weeks

InterventionParticipants (Number)
Early26
Delayed31

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Tuberculosis-immune Reconstitution Inflammatory Syndrome Events

Tuberculosis-immune reconstitution inflammatory syndrome was defined by the protocol as: a) new persistent fevers (temperature >101.5 degrees Fahrenheit) developing after the initiation of antiretroviral therapy, and not believed to be associated with antiretroviral therapy and without an identifiable source, b) marked worsening or emergence of intrathoracic lymphadenopathy, pulmonary infiltrates or pleural effusions on radiologic examination, or c) worsening or emergence of lymphadenopathy on serial examinations or worsening of other tuberculous lesions. (NCT00851630)
Timeframe: 104 weeks

InterventionEvents (Number)
Early0
Delayed0

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HIV RNA Level < 50 Copies/ml

The number of subjects with plasma HIV RNA level <50 copies/ml. (NCT00851630)
Timeframe: 104 Weeks

InterventionParticipants (Number)
Early23
Delayed26

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Virological Response[Viral Load <50 Copies/mL, TLOVR]

The analysis is based on virologic response defined as percentage of patients with confirmed plasma viral load <50 HIV-1 RNA copies/mL at Week 24 calculated according to the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) algorithm. (NCT00915655)
Timeframe: Week 24

InterventionParticipants (Number)
YesNo
DRV/Rtv111

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Virological Response [Viral Load <50 Copies/mL, FDA-SNAPSHOT]

The analysis is based on the last observed viral load (VL) data within the Week 24 window. Virologic response is defined as a VL<50 copies/mL (observed case). Virologic Failure includes a) patients who had >=50 copies/mL in the Week-24 window, b) patients who discontinued prior to Week 24 for lack or loss of efficacy, c) patients who had a switch in their background regimen that was not permitted by the protocol, and d) patients who discontinued for reasons other than adverse events (AEs)/death, and lack or loss of efficacy (provided their last available viral load was detectable). (NCT00915655)
Timeframe: Week 24

InterventionParticipants (Number)
DRV/Rtv12

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Tolerance: Gastrointestinal Complains

Gastrointestinal complaints (grade 1 to 4) between baseline and W48. (NCT00928187)
Timeframe: between baseline and 48 weeks

Interventionparticipants (Number)
Arm A50
Arm B48
Arm C26

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Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)

evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value (NCT00928187)
Timeframe: between baseline and W48

Interventionparticipants (Number)
Arm A28
Arm B14
Arm C19

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Development of Metabolic Syndrome

number of patients developing metabolic syndrome over a period of 48 weeks (NCT00928187)
Timeframe: from baseline to week 48

InterventionParticipants (Count of Participants)
Arm A12
Arm B21
Arm C9

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Number of Patients With Resistance Mutations

number of patients with resistance mutations after second line treatment failure (HIV RNA> 1000 copies/ml) (NCT00928187)
Timeframe: between W12 and W48

Interventionparticipants (Number)
Arm A0
Arm B0
Arm C0

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Number of Patients With Plasma HIV RNA < 50 Copies/mL

(NCT00928187)
Timeframe: 48 weeks

Interventionparticipants (Number)
Arm A105
Arm B92
Arm C97

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Number of Patients With HIV Plasma Viral Load < 50 Copies/ml

Snapshot of patients with HIV viral load less then 50 copies/ml at week 24 (NCT00928187)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
Arm A90
Arm B81
Arm C97

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Number of Patients With HIV Plasma Viral Load < 200 Copies/ml

number of patients having a plasma viral load below 200 copies/ml at week 24 (NCT00928187)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
Arm A127
Arm B117
Arm C129

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Number of Patients Discontinuing Study Treatment

number of patients discounting treatment because of adverse events (NCT00928187)
Timeframe: between baseline and W48

Interventionparticipants (Number)
Arm A0
Arm B4
Arm C1

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Gain in CD4 Cells Between Baseline and W48

median gain in circulating CD4 cells between baseline and W48 (NCT00928187)
Timeframe: between baseline and 48 weeks

Interventioncell/mm3 (Median)
Arm A133
Arm B136
Arm C115

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Patients With Plasma HIV RNA < 200 Copies/ml

number of patients with plasma HIV RNA below 200 copies/ml (NCT00928187)
Timeframe: 48 weeks

Interventionparticipants (Number)
Arm A130
Arm B118
Arm C127

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Adherence

number of patients in different categories of adherence as measured by questionnaire (NCT00928187)
Timeframe: between baseline and W48

,,
Interventionparticipants (Number)
Always above 95%At least once 80-95%At least once < 80%
Arm A508911
Arm B547214
Arm C67784

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Tolerance: Neuropathies (Grade 1 to 4)

any symptom of peripheral neuropathy (NCT00928187)
Timeframe: between baseline and W48

Interventionparticipants (Number)
Arm A5
Arm B11
Arm C8

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Change in Peak Oxygen Uptake.

change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups. (NCT00960622)
Timeframe: baseline and 6 months

Interventionml/Kg/min (Mean)
Truvada 200/300 mg, Daily, by Mouth.2.2
Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.2.8

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Plasma RBV Trough Concentrations

Plasma RBV trough concentrations. (NCT01052701)
Timeframe: Day 56

Interventionmicrograms per milliliter (Mean)
Ribavirin Plus Abacavir2.54
Ribavirin Alone2.60

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Ribavirin Triphosphate (RBV-TP) Intracellular Concentrations

Ribavirin Triphosphate (RBV-TP) intracellular concentrations. (NCT01052701)
Timeframe: Day 56

Interventionpicomoles per 10^6 cells (Mean)
Ribavirin Plus Abacavir15.87
Ribavirin Alone15.93

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Viral Failure

Probability of viral failure defined as >= 2 HIV RNA measurements >1000 copies/ml using survival analysis by 48 weeks post-randomization. (NCT01146873)
Timeframe: 48 weeks

Interventionprobability of viral failure (Mean)
Group 1: Lopinavir/Ritonavir (LPV/r)0.020
Group 2: Efavirenz (EFV)0.027

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CD4 Cell Percentage at 48 Weeks After Randomization

CD4 Cell Percentage at 48 Weeks After Randomization (NCT01146873)
Timeframe: 48 weeks

Interventionpercentage of cells (Mean)
Group 1: Lopinavir/Ritonavir (LPV/r)34.7
Group 2: Efavirenz (EFV)37.5

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Viral Rebound

Probability of viral rebound defined as >=1 HIV RNA measurements >50 copies/ml using survival analysis by 48 weeks post-randomization. (NCT01146873)
Timeframe: 48 weeks

Interventionprobability of viral rebound (Mean)
Group 1: Lopinavir/Ritonavir (LPV/r)0.284
Group 2: Efavirenz (EFV)0.176

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Highest Grade ALT After Randomization

Highest grade ALT after randomization. Grading was determined based on the Division of AIDS (2004) Toxicity Tables to grade adverse reactions. Grading scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (potentially life-threatening). (NCT01146873)
Timeframe: through 48 weeks post randomization

,
Interventionnumber of participants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Group 1: Lopinavir/Ritonavir (LPV/r)1398010
Group 2: Efavirenz (EFV)120161031

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Percentage of Participants With Elevated Total Cholesterol, Elevated LDL, Abnormal HDL, or Abnormal Triglycerides at 40 Weeks After Randomization

Percentage of participants with elevated total cholesterol, elevated LDL, abnormal HDL, or abnormal triglycerides at 40 weeks after randomization (NCT01146873)
Timeframe: 40 weeks

,
Interventionpercentage of participants (Number)
Elevated total cholesterolElevated LDLAbnormal HDLAbnormal triglycerides
Group 1: Lopinavir/Ritonavir (LPV/r)24.818.64.822.8
Group 2: Efavirenz (EFV)13.39.84.210.5

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Change From Baseline in CD4+ Cell Counts at Week 144

Cluster of differentiation (CD4) lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the Week 144 value minus the Baseline value. The least squares mean is the estimated mean change from Baseline in CD4+ cell counts at Week 144 calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, treatment*visit interaction, Baseline HIV-1 RNA*visit interaction, and Baseline CD4+ cell count*visit interaction. No assumptions were made about the correlations between a participant's readings of CD4+, i.e., the correlation matrix for within-participant errors is unstructured. (NCT01263015)
Timeframe: Baseline and Week 144

Interventioncells per millimeters cubed (cells/mm^3) (Least Squares Mean)
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily378.48
EFV/TDF/FTC 600/200/300 mg Once Daily331.57

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Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48

The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 48 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window. (NCT01263015)
Timeframe: Week 48

InterventionPercentage of participants (Number)
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily88
EFV/TDF/FTC 600/200/300 mg Once Daily81

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Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities at Week144

All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. (NCT01263015)
Timeframe: From Baseline until Week 144

,
InterventionParticipants (Number)
Week 144, ALTWeek 144, AlbuminWeek 144, ALPWeek 144, ASTWeek 144, CO2 content/bicarbonateWeek 144, CholesterolWeek 144, CKWeek 144, CreatinineWeek 144, HyperglycaemiaWeek 144, HyperkalemiaWeek 144, HypernatremiaWeek 144, HypoglycaemiaWeek 144, HypokalemiaWeek 144, HyponatremiaWeek 144, LDL cholesterol calculationWeek 144, LipaseWeek 144, Phosphorus, inorganicWeek 144, Total bilirubinWeek 144, TriglyceridesWeek 144, HemoglobinWeek 144, Platelet countWeek 144, Total neutrophilsWeek 144, White Blood Cell count
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily620177713515691171214112438631241111092211720709
EFV/TDF/FTC 600/200/300 mg Once Daily811538513414079610512921218611111013441111198018

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Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) Through 144

Whole blood samples were collected from participants to provide plasma for storage samples for potential viral genotypic and phenotypic analyses. Participants with confirmed virological failure (confirmed HIV-1 RNA >=50 copies/mL throughout the study and/or confirmed HIV-1 RNA >=200 copies/mL at Week 144) had plasma samples tested for HIV-1 RT genotype and HIV-1 integrase genotype from Baseline samples and from samples collected at the time of virological failure. Genotype testing was conducted at Day 1 and at the time of suspected protocol-defined virological failure (PDVF). A genotyping assessment was made of change across all amino acids within the integrase (IN)-encoding region, with particular attention paid to specific amino acid changes associated with the development of resistance to RAL, ELV, or DTG. (NCT01263015)
Timeframe: Through Week 144

,
InterventionParticipants (Number)
Week 144, RT mutation K65K/RWeek 144, RT mutation K101EWeek 144, RT mutation K103K/NWeek 144, RT mutation K103NWeek 144, RT mutation G190G/A
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily00000
EFV/TDF/FTC 600/200/300 mg Once Daily11222

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Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144

CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the value at Indicated visit minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles). (NCT01263015)
Timeframe: Baseline and Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144

,
Interventioncells per millimeters cubed (cells/mm^3) (Mean)
Week 4, n=404,390Week 8, n=396,382Week 12, n=394,378Week 16, n=386,366Week 24, n=388,361Week 32, n=380,353Week 40, n=364,347Week 48, n=368,344Week 60, n=359,330Week 72, n=354,319Week 84, n=352,314Week 96, n=343,309Week 108, n=339,300Week 120, n=332,287Week 132, n=323,283Week 144, n=313,270
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily117.6164.6187.5214.7216.9250.5265.5267.5271.3306.1315.2322.6349.3347.0377.9379.5
EFV/TDF/FTC 600/200/300 mg Once Daily80.9124.4153.0174.1177.8208.1216.2209.5235.3269.6272.1286.0298.9311.0327.2333.3

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Time to Viral Suppression (<50 c/mL)

Viral suppression is defined as the first viral load value<50 c/mL. The Kaplan-Meier method was used to estimate time to viral suppression, defined as the time from the first dose of study treatment until the first viral load value <50 c/mL was reached. Participants who withdrew for any reason without having suppressed prior to the analysis were censored. (NCT01263015)
Timeframe: From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)

InterventionDays (Median)
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily28
EFV/TDF/FTC 600/200/300 mg Once Daily84

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Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144

The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 96 and Week 144 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window. (NCT01263015)
Timeframe: Week 96 and Week 144

,
InterventionPercentage of participants (Number)
Week 96Week 144
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily7771
EFV/TDF/FTC 600/200/300 mg Once Daily7063

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Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24

Data are presented as Kaplan Meier estimates of virologic failure (VF), defined as a confirmed plasma HIV-1 RNA level >=1000 c/mL at or after Week 16 and before Week 24, or a confirmed plasma HIV-1 RNA level >=200 c/mL at or after Week 24. A plasma HIV-1 RNA value was considered to be confirmed failure if a consecutive measurement satisfied the same failure criterion. The number of participants who experienced autoimmune deficiency syndrome (AIDS) Clinical Trials Group (ACTG) VFs was measured. For participants who withdrew from the study/were not documented to have reached confirmed VF at the cut off date of the Week 48 analysis, time to VF was to be censored at the planned visit week of the last measured plasma HIV-1 RNA sample. Data for participants who missed three consecutive scheduled plasma HIV-1 RNA measurements were to be censored at the planned visit week of the last assessment prior to the 3 consecutive missed visits. (NCT01263015)
Timeframe: From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)

,
InterventionParticipants (Number)
ACTG virologic failuresCensored participants
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily11403
EFV/TDF/FTC 600/200/300 mg Once Daily8411

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Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences at Week 144

Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death. (NCT01263015)
Timeframe: From Baseline until Week 144

,
InterventionParticipants (Number)
Week 144, Any category conditionWeek 144, Any Category B conditionWeek 144, Any Category C conditionWeek 144, Any deathWeek 144, Progression from CAT A to CAT CWeek 144, Progression from CAT C to new CAT CWeek 144, Progression from CAT A, B, or C to death
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily171250410
EFV/TDF/FTC 600/200/300 mg Once Daily241762422

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Change From Baseline in Plasma HIV-1 RNA at Weeks 2, 4, 8, 12, 16, 24, 32, 40,48, 60, 72, 84, 96, 108, 120, 132 and 144

Blood samples were collected for the measurement of HIV-1 RNA in plasma. Changes from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles). (NCT01263015)
Timeframe: Baseline and at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144

,
Interventionlog10 copies/mL (Mean)
Week 2, n=387, 376Week 4, n=404, 391Week 8, n=395, 386Week 12, n=394, 377Week 16, n=386, 366Week 24, n=389, 364Week 32, n=380, 355Week 40, n=370, 345Week 48, n=370, 343Week 60, n=360, 330Week 72, n=354, 320Week 84, n=353, 314Week 96, n=345, 310Week 108, n=340, 300Week 120, n=333, 289Week 132, n=323, 284Week 144, n=313,269
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily-2.46-2.88-2.99-3.01-3.03-3.05-3.04-3.05-3.03-3.03-3.03-3.02-2.99-3.01-3.00-3.03-3.02
EFV/TDF/FTC 600/200/300 mg Once Daily-1.96-2.25-2.60-2.85-2.98-3.01-3.05-3.04-3.04-3.05-3.06-3.07-3.06-3.08-3.07-3.06-3.04

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Change From Baseline in the Symptom Bother Score (SBS) at Week 4 Through Week 48

"The Symptom Distress Module (SDM) is a 20-item, self-reported questionnaire measuring the presence/perceived distress linked to symptoms associated with HIV/its treatments. Developed with support from the AIDS Clinical Trials Group of the U.S. National Institute of Allergy and Infectious Diseases, it has demonstrated construct validity and has shown strong associations with physical/mental health summary scores and with disease severity. The SDM consists of 2 main scores: symptom count and the SBS, ranging from 0 (best) to 80 (worst) and based on the degree of bother that each symptom present posed. The SBS was calculated by adding the 20 individual bother item scores, which were calculated as: 0, I do not have this symptom; 1, It doesn't bother me; 2, It bothers me a little; 3, It bothers me; 4, It bothers me a lot. Estimates are calculated from an analysis of covariance (ANCOVA) model adjusting for age, sex, race, Baseline (BL) viral load, BL CD4+ cell count, and BL SBS." (NCT01263015)
Timeframe: Baseline and Week 4 through 48

InterventionScores on a scale (Least Squares Mean)
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily-1.818
EFV/TDF/FTC 600/200/300 mg Once Daily-1.246

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Cumulative Probability of Virologic Failure by Week 48

The primary endpoint was time to virologic failure. Virologic failure was defined as confirmed viral load >400 copies/mL at or after week 24. The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 48 was used. (NCT01352715)
Timeframe: From study entry to week 48

Interventioncumulative probability per 100 persons (Number)
Arm A: LPV/r Plus RAL10.3
Arm B: LPV/r Plus Best Available NRTIs12.4

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Number of Participants Discontinuing Randomized Treatment for Toxicity

Discontinuation of randomized treatment for toxicity included participant decision to discontinue for low grade toxicity. Within class NRTI changes were not considered discontinuations. (NCT01352715)
Timeframe: From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks)

Interventionparticipants (Number)
Arm A: LPV/r Plus RAL3
Arm B: LPV/r Plus Best Available NRTIs3

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Number of Participants With a New AIDS-defining Events or Death

AIDS-defining events were those recognized by the Centers for Disease Control (CDC) and World Health Organization (WHO) (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)

Interventionparticipants (Number)
Arm A: LPV/r Plus RAL15
Arm B: LPV/r Plus Best Available NRTIs17

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Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death

Serious non-AIDS diagnoses were based on ACTG Appendix 60 Diagnosis Codes (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)

Interventionparticipants (Number)
Arm A: LPV/r Plus RAL7
Arm B: LPV/r Plus Best Available NRTIs7

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Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline

The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. (NCT01352715)
Timeframe: From start of randomized treatment to off randomized treatment (up to 96 weeks)

Interventionparticipants (Number)
Arm A: LPV/r Plus RAL62
Arm B: LPV/r Plus Best Available NRTIs81

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Percentage of Time Spent in Hospital

The percentage of total study time that participants were in hospital. (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)

Interventionpercentage of time spent in hospital (Number)
Arm A: LPV/r Plus RAL0.08
Arm B: LPV/r Plus Best Available NRTIs0.12

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Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure

Mutations were defined as major IAS mutations in the IAS-USA July 2014 list. New mutations were those detected at virologic failure but not at baseline. (NCT01352715)
Timeframe: From study entry through to week 96

,
Interventionparticipants (Number)
No new IAS mutations1-2 new IAS mutations3 new IAS mutations
Arm A: LPV/r Plus RAL2991
Arm B: LPV/r Plus Best Available NRTIs32130

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Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline

Fasting was for 8 hours and the metabolic panel was drawn locally. (NCT01352715)
Timeframe: Study entry and week 48

,
Interventionmg/dL (Mean)
total cholesterol changehigh-density lipoprotein (HDL) cholesterol changelow-density lipoprotein (LDL) cholesterol changetriglycerides changeglucose change
Arm A: LPV/r Plus RAL31417802
Arm B: LPV/r Plus Best Available NRTIs15210313

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Change in CD4+ Cell Count From Baseline to Week 48

Change in CD4+ cell count was calculated as CD4+ cell count at week 48 minus CD4+ cell count at study entry. (NCT01352715)
Timeframe: Study entry and week 48

Interventioncells/mm^3 (Mean)
Arm A: LPV/r Plus RAL199
Arm B: LPV/r Plus Best Available NRTIs190

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Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit

Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionLog10 copies per milliliter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40
Efavirenz 600 mg-1.875-2.092-2.344-2.533-2.602-2.666-2.694-2.733-2.714-2.672-2.679-2.679-2.676-2.615-2.738-2.739-2.731

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Change From Baseline in Hemoglobin Level Over Time by Visit

Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionGrams per liter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=57, 57, 59, 57Week 8; n=58, 56, 56, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 55, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=50, 52, 52, 45Week 32; n=51, 53, 55, 45Week 36; n=52, 53, 55, 44Week 40; n=51, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 52, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 51, 42Week 96; n=46, 46, 52, 41Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 46, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=35, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=32, 39, 44, 0Week 228; n=31, 39, 47, 0Week 240; n=32, 39, 47, 0Week 252; n=31, 36, 45, 0Week 264; n=32, 38, 46, 0Week 276; n=31, 38, 46, 0Week 288; n=30, 38, 44, 0Week 300; n=30, 37, 43, 0Week 312; n=31, 33, 42, 0Week 324; n=3, 4, 2, 0
GSK1265744 10 mg0.1-0.22.72.01.12.12.61.81.71.60.30.51.22.61.83.32.74.04.23.54.04.06.35.53.34.54.75.16.26.26.36.67.34.67.04.3
GSK1265744 30 mg0.00.54.83.93.53.84.83.44.03.12.92.22.74.74.54.03.33.44.73.02.65.16.04.03.54.74.14.85.86.46.05.56.85.16.110.0
GSK1265744 60 mg-0.70.62.02.62.33.13.62.51.53.52.72.1-0.52.22.43.03.63.02.12.52.32.74.82.73.03.23.43.12.15.85.55.46.95.58.020.5

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Change From Baseline in Hemoglobin Level Over Time by Visit

Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionGrams per liter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=57, 57, 59, 57Week 8; n=58, 56, 56, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 55, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=50, 52, 52, 45Week 32; n=51, 53, 55, 45Week 36; n=52, 53, 55, 44Week 40; n=51, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 52, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 51, 42Week 96; n=46, 46, 52, 41
Efavirenz 600 mg0.70.72.02.81.10.81.92.20.10.6-0.8-0.20.02.32.41.71.9

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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264

InterventionMilliliters per minute (Mean)
Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 20; n=2, 0, 0, 1Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40Week 180; n=1, 0, 0, 0
GSK1265744 10 mg-3.0-1.45.52.28.0-2.7-2.62.21.0

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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264

InterventionMilliliters per minute (Mean)
Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40Week 264; n=0, 0, 1, 0
GSK1265744 60 mg-4.97.0-2.7-5.8-4.5-9.0-143.0

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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264

InterventionMilliliters per minute (Mean)
Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 24; n=52, 53, 55, 46Week 26; n=0, 1, 0, 0Week 40; n=0, 1, 0, 0Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40Week 204; n=0, 1, 0, 0Week 252; n=0, 1, 0, 0
GSK1265744 30 mg-10.0-3.7-1.00.2-6.4-7.0-95.0-1.1-2.4-23.00.0

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Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit

Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionMicromoles per liter (Mean)
Creatinine; Week 2; n=58, 56, 58, 58Creatinine; Week 4; n=58, 57, 59, 57Creatinine; Week 8; n=58, 55, 57, 54Creatinine; Week 12; n=58, 53, 57, 51Creatinine; Week 16; n=57, 54, 57, 52Creatinine; Week 20; n=56, 54, 55, 49Creatinine; Week 24; n=56, 53, 56, 47Creatinine; Week 26; n=48, 50, 53, 45Creatinine; Week 28; n=51, 52, 52, 45Creatinine; Week 32; n=52, 53, 55, 45Creatinine; Week 36; n=52, 52, 55, 45Creatinine; Week 40; n=52, 53, 55, 44Creatinine; Week 48; n=51, 53, 54, 44Creatinine; Week 60; n=48, 47, 53, 44Creatinine; Week 72; n=47, 47, 52, 42Creatinine; Week 84; n=46, 48, 52, 42Creatinine; Week 96; n=45, 48, 52, 40Creatinine; Week 108; n=43, 46, 48, 0Creatinine; Week 120; n=40, 45, 48, 0Creatinine; Week 132; n=40, 46, 49, 0Creatinine; Week 144; n=37, 45, 47, 0Creatinine; Week 156; n=37, 42, 49, 0Creatinine; Week 168; n=35, 43, 47, 0Creatinine; Week 180; n=36, 41, 47, 0Creatinine; Week 192; n=36, 39, 47, 0Creatinine; Week 204; n=34, 39, 47, 0Creatinine; Week 216; n=33, 39, 46, 0Creatinine; Week 228; n=32, 39, 47, 0Creatinine; Week 240; n=30, 39, 46, 0Creatinine; Week 252; n=31, 38, 46, 0Creatinine; Week 264; n=32, 38, 47, 0Creatinine; Week 276; n=31, 38, 45, 0Creatinine; Week 288; n=31, 38, 45, 0Creatinine; Week 300; n=30, 37, 44, 0Creatinine; Week 312; n=31, 34, 43, 0Creatinine; Week 324; n=3, 4, 3, 0T. Bilirubin; Week 2; n=58, 56, 58, 58T. Bilirubin; Week 4; n=58, 57, 59, 57T. Bilirubin; Week 8; n=58, 55, 57, 54T. Bilirubin; Week 12; n=58, 53, 57, 51T. Bilirubin; Week 16; n=57, 54, 57, 52T. Bilirubin; Week 20; n=56, 54, 55, 49T. Bilirubin; Week 24; n=56, 53, 56, 47T. Bilirubin; Week 26; n=48, 50, 53, 45T. Bilirubin; Week 28; n=51, 52, 52, 45T. Bilirubin; Week 32; n=52, 53, 55, 45T. Bilirubin; Week 36; n=52, 52, 55, 45T. Bilirubin; Week 40; n=52, 53, 55, 44T. Bilirubin; Week 48; n=51, 53, 54, 44T. Bilirubin; Week 60; n=48, 47, 53, 44T. Bilirubin; Week 72; n=47, 47, 52, 42T. Bilirubin; Week 84; n=46, 48, 52, 42T. Bilirubin; Week 96; n=45, 48, 52, 40T. Bilirubin; Week 108; n=43, 46, 48, 0T. Bilirubin; Week 120; n=40, 45, 48, 0T. Bilirubin; Week 132; n=40, 46, 49, 0T. Bilirubin; Week 144; n=37, 45, 47, 0T. Bilirubin; Week 156; n=37, 42, 49, 0T. Bilirubin; Week 168; n=35, 43, 47, 0T. Bilirubin; Week 180; n=36, 41, 47, 0T. Bilirubin; Week 192; n=36, 39, 47, 0T. Bilirubin; Week 204; n=34, 39, 47, 0T. Bilirubin; Week 216; n=33, 39, 46, 0T. Bilirubin; Week 228; n=32, 39, 47, 0T. Bilirubin; Week 240; n=30, 39, 46, 0T. Bilirubin; Week 252; n=31, 38, 46, 0T. Bilirubin; Week 264; n=32, 38, 47, 0T. Bilirubin; Week 276; n=31, 38, 45, 0T. Bilirubin; Week 288; n=31, 38, 45, 0T. Bilirubin; Week 300; n=30, 37, 44, 0T. Bilirubin; Week 312; n=31, 34, 43, 0T. Bilirubin; Week 324; n=3, 4, 3, 0
GSK1265744 10 mg3.362.242.383.392.912.542.522.742.223.363.112.832.753.283.894.581.905.874.413.765.995.286.575.896.906.218.347.168.486.965.977.898.8110.497.9815.900.00.10.00.40.4-0.10.51.11.10.71.21.60.91.91.52.31.00.70.91.00.71.61.11.10.71.10.51.61.21.40.40.70.51.11.45.3
GSK1265744 30 mg2.582.502.061.591.100.852.441.802.801.693.412.362.182.304.713.805.345.184.154.025.806.365.625.087.916.469.317.197.337.527.105.847.849.167.869.75-0.3-0.3-0.5-0.9-1.2-0.70.20.50.70.20.61.70.10.00.10.10.01.41.12.01.11.00.80.00.30.70.80.50.92.02.92.81.91.71.15.5
GSK1265744 60 mg4.154.083.443.792.095.294.456.035.015.006.004.764.474.466.596.537.767.266.784.995.075.166.825.915.905.167.426.617.087.646.996.196.208.197.105.03-0.4-0.8-0.6-0.5-0.2-0.4-0.71.00.50.91.41.5-0.30.90.61.21.70.81.31.10.41.01.41.00.90.60.3-0.3-0.10.2-0.10.90.00.90.80.7

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Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit

Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionMicromoles per liter (Mean)
Creatinine; Week 2; n=58, 56, 58, 58Creatinine; Week 4; n=58, 57, 59, 57Creatinine; Week 8; n=58, 55, 57, 54Creatinine; Week 12; n=58, 53, 57, 51Creatinine; Week 16; n=57, 54, 57, 52Creatinine; Week 20; n=56, 54, 55, 49Creatinine; Week 24; n=56, 53, 56, 47Creatinine; Week 26; n=48, 50, 53, 45Creatinine; Week 28; n=51, 52, 52, 45Creatinine; Week 32; n=52, 53, 55, 45Creatinine; Week 36; n=52, 52, 55, 45Creatinine; Week 40; n=52, 53, 55, 44Creatinine; Week 48; n=51, 53, 54, 44Creatinine; Week 60; n=48, 47, 53, 44Creatinine; Week 72; n=47, 47, 52, 42Creatinine; Week 84; n=46, 48, 52, 42Creatinine; Week 96; n=45, 48, 52, 40T. Bilirubin; Week 2; n=58, 56, 58, 58T. Bilirubin; Week 4; n=58, 57, 59, 57T. Bilirubin; Week 8; n=58, 55, 57, 54T. Bilirubin; Week 12; n=58, 53, 57, 51T. Bilirubin; Week 16; n=57, 54, 57, 52T. Bilirubin; Week 20; n=56, 54, 55, 49T. Bilirubin; Week 24; n=56, 53, 56, 47T. Bilirubin; Week 26; n=48, 50, 53, 45T. Bilirubin; Week 28; n=51, 52, 52, 45T. Bilirubin; Week 32; n=52, 53, 55, 45T. Bilirubin; Week 36; n=52, 52, 55, 45T. Bilirubin; Week 40; n=52, 53, 55, 44T. Bilirubin; Week 48; n=51, 53, 54, 44T. Bilirubin; Week 60; n=48, 47, 53, 44T. Bilirubin; Week 72; n=47, 47, 52, 42T. Bilirubin; Week 84; n=46, 48, 52, 42T. Bilirubin; Week 96; n=45, 48, 52, 40
Efavirenz 600 mg0.65-0.32-0.92-1.42-2.92-3.26-2.03-2.67-3.42-3.50-3.26-2.83-2.73-3.87-4.48-2.48-2.28-3.0-3.4-3.4-2.4-2.4-2.6-2.9-2.7-2.8-2.6-2.7-2.9-2.6-2.2-2.7-2.6-2.5

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Change From Baseline in CD4+ Cell Count Over Time by Visit

CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionCells per cubic millimeter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=58, 56, 57, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=49, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=46, 46, 52, 41Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 46, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=35, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=33, 39, 47, 0Week 228; n=32, 39, 47, 0Week 240; n=32, 39, 47, 0Week 252; n=31, 38, 47, 0Week 264; n=32, 38, 47, 0Week 276; n=31, 38, 46, 0Week 288; n=30, 38, 45, 0Week 300; n=30, 37, 44, 0Week 312; n=30, 34, 43, 0Week 324; n=3, 4, 3, 0
GSK1265744 10 mg92.6136.4129.9140.5159.3165.2172.5186.4205.0191.4192.0203.6235.1217.7232.0261.5269.4296.2266.1297.1330.7334.5338.1338.0300.8369.5397.0331.8356.5400.3344.4398.3411.0437.7335.0402.0
GSK1265744 30 mg79.576.9117.8140.8142.2153.8180.9177.7188.1205.2213.0212.8241.6269.4201.4287.0267.5304.3279.3305.2308.9319.2332.4348.6351.0332.9373.4366.5395.9343.7365.0350.3383.5404.4433.0276.0
GSK1265744 60 mg91.788.290.5145.2148.3182.6204.0194.7193.3209.9265.0212.3259.0266.1254.0278.1286.2288.4307.2313.2322.4320.4361.3384.2342.3340.0357.8383.7408.4383.1391.8362.2337.1353.5407.0272.0

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Change From Baseline in ALT, AST and CK Over Time by Visit

Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionInternational Units per Liter (Mean)
ALT; Week 2; n=58, 56, 58, 58ALT; Week 4; n=58, 57, 59, 57ALT; Week 8; n=58, 55, 57, 54ALT; Week 12; n=58, 53, 57, 51ALT; Week 16; n=57, 54, 57, 52ALT; Week 20; n=56, 54, 55, 49ALT; Week 24; n=56, 53, 56, 47ALT; Week 26; n=48, 50, 53, 45ALT; Week 28; n=51, 52, 52, 45ALT; Week 32; n=52, 53, 55, 45ALT; Week 36; n=52, 52, 55, 45ALT; Week 40; n=52, 53, 55, 44ALT; Week 48; n=51, 53, 54, 44ALT; Week 60; n=48, 47, 53, 44ALT; Week 72; n=47, 47, 52, 42ALT; Week 84; n=46, 48, 52, 42ALT; Week 96; n=45, 48, 52, 40AST; Week 2; n=58, 56, 58, 58AST; Week 4; n=58, 57, 59, 57AST; Week 8; n=58, 55, 57, 54AST; Week 12; n=58, 53, 57, 50AST; Week 16; n=57, 54, 57, 52AST; Week 20; n=56, 54, 55, 49AST; Week 24; n=56, 53, 56, 47AST; Week 26; n=48, 50, 53, 45AST; Week 28; n=51, 52, 52, 45AST; Week 32; n=52, 53, 55, 45AST; Week 36; n=52, 52, 55, 45AST; Week 40; n=52, 53, 55, 44AST; Week 48; n=51, 53, 54, 44AST; Week 60; n=48, 47, 53, 44AST; Week 72; n=47, 47, 52, 42AST; Week 84; n=46, 48, 52, 42AST; Week 96; n=45, 48, 52, 40CK; Week 2; n=58, 56, 58, 58CK; Week 4; n=58, 57, 59, 57CK; Week 8; n=58, 55, 57, 54CK; Week 12; n=58, 53, 57, 51CK; Week 16; n=57, 54, 57, 52CK; Week 20; n=56, 54, 55, 49CK; Week 24; n=56, 53, 56, 47CK; Week 26; n=48, 50, 53, 45CK; Week 28; n=51, 52, 52, 45CK; Week 32; n=52, 53, 55, 45CK; Week 36; n=52, 52, 55, 45CK; Week 40; n=52, 53, 55, 44CK; Week 48; n=51, 53, 54, 44CK; Week 60; n=48, 47, 53, 44CK; Week 72; n=47, 47, 52, 42CK; Week 84; n=46, 48, 52, 42CK; Week 96; n=45, 48, 52, 40
Efavirenz 600 mg-1.30.1-6.3-6.3-1.6-4.8-6.0-3.7-8.1-8.6-8.2-8.0-8.6-6.3-8.5-4.0-7.60.9-2.9-7.3-7.94.4-3.6-2.1-2.6-5.1-2.8-1.9-5.1-4.4-3.2-4.62.3-0.3159.8-120.3-212.8-220.1269.7135.3103.921.24.1110.3158.73.82.824.5-14.3123.9143.9

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Change From Baseline in ALT, AST and CK Over Time by Visit

Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionInternational Units per Liter (Mean)
ALT; Week 2; n=58, 56, 58, 58ALT; Week 4; n=58, 57, 59, 57ALT; Week 8; n=58, 55, 57, 54ALT; Week 12; n=58, 53, 57, 51ALT; Week 16; n=57, 54, 57, 52ALT; Week 20; n=56, 54, 55, 49ALT; Week 24; n=56, 53, 56, 47ALT; Week 26; n=48, 50, 53, 45ALT; Week 28; n=51, 52, 52, 45ALT; Week 32; n=52, 53, 55, 45ALT; Week 36; n=52, 52, 55, 45ALT; Week 40; n=52, 53, 55, 44ALT; Week 48; n=51, 53, 54, 44ALT; Week 60; n=48, 47, 53, 44ALT; Week 72; n=47, 47, 52, 42ALT; Week 84; n=46, 48, 52, 42ALT; Week 96; n=45, 48, 52, 40ALT; Week 108; n=43, 46, 48, 0ALT; Week 120; n=40, 45, 48, 0ALT; Week 132; n=40, 46, 49, 0ALT; Week 144; n=37, 45, 47, 0ALT; Week 156; n=37, 42, 49, 0ALT; Week 168; n=35, 43, 47, 0ALT; Week 180; n=36, 41, 47, 0ALT; Week 192; n=36, 39, 47, 0ALT; Week 204; n=34, 39, 47, 0ALT; Week 216; n=33, 39, 46, 0ALT; Week 228; n=32, 39, 47, 0ALT; Week 240; n=30, 39, 46, 0ALT; Week 252; n=31, 38, 46, 0ALT; Week 264; n=32, 38, 47, 0ALT; Week 276; n=31, 38, 45, 0ALT; Week 288; n=31, 38, 45, 0ALT; Week 300; n=30, 37, 44, 0ALT; Week 312; n=31, 34, 43, 0ALT; Week 324; n=3, 4, 3, 0AST; Week 2; n=58, 56, 58, 58AST; Week 4; n=58, 57, 59, 57AST; Week 8; n=58, 55, 57, 54AST; Week 12; n=58, 53, 57, 50AST; Week 16; n=57, 54, 57, 52AST; Week 20; n=56, 54, 55, 49AST; Week 24; n=56, 53, 56, 47AST; Week 26; n=48, 50, 53, 45AST; Week 28; n=51, 52, 52, 45AST; Week 32; n=52, 53, 55, 45AST; Week 36; n=52, 52, 55, 45AST; Week 40; n=52, 53, 55, 44AST; Week 48; n=51, 53, 54, 44AST; Week 60; n=48, 47, 53, 44AST; Week 72; n=47, 47, 52, 42AST; Week 84; n=46, 48, 52, 42AST; Week 96; n=45, 48, 52, 40AST; Week 108; n=43, 46, 48, 0AST; Week 120; n=40, 45, 48, 0AST; Week 132; n=40, 46, 49, 0AST; Week 144; n=37, 45, 47, 0AST; Week 156; n=37, 42, 49, 0AST; Week 168; n=35, 43, 47, 0AST; Week 180; n=36, 41, 47, 0AST; Week 192; n=36, 39, 47, 0AST; Week 204; n=34, 39, 47, 0AST; Week 216; n=33, 39, 46, 0AST; Week 228; n=32, 39, 47, 0AST; Week 240; n=30, 39, 46, 0AST; Week 252; n=31, 38, 46, 0AST; Week 264; n=32, 38, 47, 0AST; Week 276; n=31, 38, 45, 0AST; Week 288; n=31, 38, 45, 0AST; Week 300; n=30, 37, 44, 0AST; Week 312; n=31, 34, 43, 0AST; Week 324; n=3, 4, 3, 0CK; Week 2; n=58, 56, 58, 58CK; Week 4; n=58, 57, 59, 57CK; Week 8; n=58, 55, 57, 54CK; Week 12; n=58, 53, 57, 51CK; Week 16; n=57, 54, 57, 52CK; Week 20; n=56, 54, 55, 49CK; Week 24; n=56, 53, 56, 47CK; Week 26; n=48, 50, 53, 45CK; Week 28; n=51, 52, 52, 45CK; Week 32; n=52, 53, 55, 45CK; Week 36; n=52, 52, 55, 45CK; Week 40; n=52, 53, 55, 44CK; Week 48; n=51, 53, 54, 44CK; Week 60; n=48, 47, 53, 44CK; Week 72; n=47, 47, 52, 42CK; Week 84; n=46, 48, 52, 42CK; Week 96; n=45, 48, 52, 40CK; Week 108; n=43, 46, 48, 0CK; Week 120; n=40, 45, 48, 0CK; Week 132; n=40, 46, 49, 0CK; Week 144; n=37, 45, 47, 0CK; Week 156; n=37, 42, 49, 0CK; Week 168; n=35, 43, 47, 0CK; Week 180; n=36, 41, 47, 0CK; Week 192; n=36, 39, 47, 0CK; Week 204; n=34, 39, 47, 0CK; Week 216; n=33, 39, 46, 0CK; Week 228; n=32, 39, 47, 0CK; Week 240; n=30, 39, 46, 0CK; Week 252; n=31, 38, 46, 0CK; Week 264; n=32, 38, 47, 0CK; Week 276; n=31, 38, 45, 0CK; Week 288; n=31, 38, 45, 0CK; Week 300; n=30, 37, 44, 0CK; Week 312; n=31, 34, 43, 0CK; Week 324; n=3, 4, 3, 0
GSK1265744 10 mg0.1-0.72.21.22.1-0.7-2.11.1-2.3-3.10.80.1-4.1-1.0-2.8-2.4-0.40.54.44.30.1-0.52.31.74.91.91.736.85.32.03.33.36.64.85.517.70.7-1.04.21.3-0.71.3-1.43.3-2.0-2.74.60.1-3.3-0.9-2.7-2.2-0.8-1.00.1-0.2-3.4-3.0-0.8-1.9-1.5-1.7-2.713.5-1.0-2.2-1.6-1.5-1.4-2.011.72.740.0-2.3216.9120.6-2.0144.227.5133.79.83.1325.957.1-1.3115.4-19.8-0.7335.464.211.530.610.6-5.327.722.45.279.143.264.01.224.61.939.921.625.3727.5-1.3
GSK1265744 30 mg-2.1-2.60.52.70.1-3.6-1.2-2.6-2.3-1.7-4.2-4.1-3.8-2.62.71.920.6-2.7-2.6-3.0-3.4-1.8-1.1-2.8-3.3-1.7-3.0-1.1-0.12.80.72.91.2-1.47.61.3-1.3-2.81.51.61.9-3.1-0.3-0.9-0.2-1.0-2.1-2.9-3.2-2.03.72.020.5-4.0-2.5-3.9-4.3-3.2-3.4-4.2-5.3-4.8-4.9-5.9-5.3-2.1-4.3-3.3-3.6-5.3-2.3-5.3-32.2-82.0115.839.8156.3-68.932.4-16.374.1-25.1-33.6-48.6-54.7-80.153.833.6-22.8-88.5-48.9-41.3-72.4-87.9-60.7-16.4-98.5-101.8-74.4-129.0-108.1-110.1-31.3-126.5-98.5-100.7-141.3-195.0
GSK1265744 60 mg-1.51.78.0-0.6-0.33.01.4-1.7-2.9-4.0-3.0-1.4-2.40.5-0.9-2.0-1.7-0.7-3.7-3.8-1.8-2.2-3.6-1.21.3-3.4-2.70.5-0.7-1.62.01.11.9-1.80.01.0-1.60.15.3-1.7-0.64.61.5-1.7-1.9-1.4-0.6-0.5-3.03.0-0.5-1.8-1.00.6-2.40.7-3.9-4.1-3.8-2.90.1-4.5-4.3-2.8-3.4-3.9-2.9-1.4-2.2-4.1-0.3-6.70.4-2.9266.727.128.6298.955.954.496.8122.166.1103.528.6206.267.614.919.6100.361.4649.668.773.374.462.898.648.341.940.492.062.538.9146.443.456.0209.4102.7

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Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionGiga cells per liter (Mean)
T. neutrophils; Baseline; n=60, 60, 61, 62T. neutrophils; Week 2; n=57, 56, 59, 59T. neutrophils; Week 4; n=57, 57, 59, 57T. neutrophils; Week 8; n=58, 56, 56, 55T. neutrophils; Week 12; n=58, 53, 57, 51T. neutrophils; Week 16; n=57, 54, 57, 52T. neutrophils; Week 20; n=56, 54, 55, 49T. neutrophils; Week 24; n=56, 53, 56, 47T. neutrophils; Week 26; n=48, 50, 53, 45T. neutrophils; Week 28; n=50, 52, 52, 45T. neutrophils; Week 32; n=51, 53, 55, 45T. neutrophils; Week 36; n=52, 53, 55, 44T. neutrophils; Week 40; n=51, 53, 55, 45T. neutrophils; Week 48; n=51, 53, 54, 44T. neutrophils; Week 60; n=48, 47, 52, 44T. neutrophils; Week 72; n=47, 48, 52, 42T. neutrophils; Week 84; n=46, 48, 51, 42T. neutrophils; Week 96; n=46, 46, 52, 41Platelet count; Baseline; n=60, 60, 61, 62Platelet count; Week 2; n=57, 56, 59, 59Platelet count; Week 4; n=57, 57, 59, 57Platelet count; Week 8; n=58, 56, 56, 55Platelet count; Week 12; n=58, 53, 57, 51Platelet count; Week 16; n=57, 54, 57, 52Platelet count; Week 20; n=56, 54, 55, 49Platelet count; Week 24; n=56, 53, 56, 47Platelet count; Week 26; n=48, 50, 53, 45Platelet count; Week 28; n=50, 52, 52, 45Platelet count; Week 32; n=51, 52, 55, 45Platelet count; Week 36; n=52, 53, 55, 44Platelet count; Week 40; n=51, 53, 54, 45Platelet count; Week 48; n=51, 52, 53, 44Platelet count; Week 60; n=48, 47, 51, 44Platelet count; Week 72; n=47, 48, 52, 42Platelet count; Week 84; n=46, 48, 51, 42Platelet count; Week 96; n=46, 45, 51, 41WBC count; Baseline; n=60, 60, 61, 62WBC count; Week 2; n=57, 56, 59, 59WBC count; Week 4; n=57, 57, 59, 57WBC count; Week 8; n=58, 56, 56, 55WBC count; Week 12; n=58, 53, 57, 51WBC count; Week 16; n=57, 54, 57, 52WBC count; Week 20; n=56, 54, 55, 49WBC count; Week 24; n=56, 53, 56, 47WBC count; Week 26; n=48, 50, 53, 45WBC count; Week 28; n=50, 52, 52, 45WBC count; Week 32; n=51, 53, 55, 45WBC count; Week 36; n=52, 53, 55, 44WBC count; Week 40; n=51, 53, 55, 45WBC count; Week 48; n=51, 53, 54, 44WBC count; Week 60; n=48, 47, 52, 44WBC count; Week 72; n=47, 48, 52, 42WBC count; Week 84; n=46, 48, 51, 42WBC count; Week 96; n=46, 46, 52, 41
Efavirenz 600 mg2.4413.2072.8482.7462.9792.8583.1873.1422.8862.9163.1742.9143.1873.1343.2693.3613.2593.297200.1216.2216.0209.8213.7211.4214.9220.9214.4215.4212.6209.8217.7220.3230.5225.9216.5214.04.705.455.025.025.275.135.505.345.085.145.485.175.515.535.755.845.785.75
GSK1265744 10 mg2.6432.7232.6852.8992.8123.0782.9583.1512.8853.1832.7973.1623.1553.1383.1643.1973.2453.466212.5225.0225.2224.5227.2230.0231.3226.1224.9223.3220.5220.0224.9225.6232.5234.0224.8237.15.065.325.245.445.415.565.465.575.305.715.305.645.635.515.735.805.916.14
GSK1265744 30 mg2.8912.7762.7712.8022.9332.7162.9042.9962.9583.0053.0362.9163.0653.1323.3333.1313.3853.540202.3222.0222.4228.4216.4212.4215.5219.7215.5217.0214.0212.1210.1221.2219.8224.4218.8221.85.195.305.175.305.505.205.415.535.505.535.635.485.615.725.935.716.116.15
GSK1265744 60 mg2.4872.5982.6492.7382.8222.6652.9892.8842.8302.9893.1673.0103.0503.0043.2003.1633.5123.494190.0204.8204.6211.5209.2209.5205.4210.9199.4209.8207.8204.2199.3209.9212.2212.2210.1210.64.725.025.025.045.344.975.395.285.295.385.575.565.455.415.635.736.056.01

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Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit

Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionLog10 copies per milliliter (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 47, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=36, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=33, 39, 47, 0Week 228; n=32, 39, 47, 0Week 240; n=31, 39, 45, 0Week 252; n=31, 38, 47, 0Week 264; n=32, 38, 47, 0Week 276; n=31, 38, 45, 0Week 288; n=30, 38, 45, 0Week 300; n=31, 37, 44, 0Week 312; n=31, 33, 43, 0Week 324; n=3, 4, 3, 0
GSK1265744 10 mg4.4241.8831.7061.6951.6431.6191.6231.6151.5951.5911.6091.6041.6121.6861.6481.6251.6451.6811.6341.6381.6461.6821.6341.6651.6131.6891.6281.5911.5911.5961.5911.5911.5911.5911.6011.5971.591
GSK1265744 30 mg4.2701.9841.7311.6661.6181.6021.5961.5971.6021.6071.6201.6101.6181.6541.5981.6971.6431.6031.6091.5911.6311.6981.6031.6421.5911.5911.5951.5921.5911.6011.5991.5911.5911.5921.5911.6001.591
GSK1265744 60 mg4.4281.9391.7251.6661.6411.6161.5991.6031.5941.5911.6181.6061.6081.5981.5941.5911.5921.5961.5911.6181.5911.6301.6191.6031.6001.6991.6341.6341.6251.5911.5931.6171.6181.5911.6251.5911.591

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Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit

Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionLog10 copies per milliliter (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40
Efavirenz 600 mg4.2902.4152.2011.9501.7581.6971.6491.6101.6101.6001.6141.6071.6071.5961.6571.5921.5911.598

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Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionGrams per liter (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=57, 57, 59, 57Week 8; n=58, 56, 56, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 55, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=50, 52, 52, 45Week 32; n=51, 53, 55, 45Week 36; n=52, 53, 55, 44Week 40; n=51, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 52, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 51, 42Week 96; n=46, 46, 52, 41
Efavirenz 600 mg145.4146.4146.6148.1149.2147.6147.2148.5148.2145.9145.9145.0145.1145.4147.6147.7147.0147.0
GSK1265744 10 mg141.9142.0141.9144.9144.3143.5144.3144.8144.4143.7144.6142.3142.2142.9144.5143.9145.6144.9
GSK1265744 30 mg143.2142.8143.5147.7147.4146.5146.9147.8145.8146.8146.1145.9145.2145.7148.3148.1147.7147.1
GSK1265744 60 mg146.6145.9147.3148.6149.1148.7149.8150.4149.8149.3150.5149.8149.2146.5149.8149.6150.3150.8

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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96

InterventionMilliliters per minute (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 20; n=2, 0, 0, 1Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40
GSK1265744 10 mg131.096.0129.3125.0132.4137.0127.9127.0130.8

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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96

InterventionMilliliters per minute (Mean)
Baseline; n=60, 60, 61, 62Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40
GSK1265744 60 mg128.3122.4143.0123.9120.7122.3116.6

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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96

InterventionMilliliters per minute (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 24; n=52, 53, 55, 46Week 26; n=0, 1, 0, 0Week 40; n=0, 1, 0, 0Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40
GSK1265744 30 mg135.2106.0132.5124.0139.4132.8147.0180.0139.2137.7

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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96

InterventionMilliliters per minute (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 20; n=2, 0, 0, 1Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 60; n=0, 0, 0, 1Week 96; n=45, 48, 52, 40
Efavirenz 600 mg125.699.0127.0101.0132.3122.0135.1131.0144.0134.8

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Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionMicromoles per liter (Mean)
Creatinine; Baseline; n=60, 60, 61, 62Creatinine; Week 2; n=58, 56, 58, 58Creatinine; Week 4; n=58, 57, 59, 57Creatinine; Week 8; n=58, 55, 57, 54Creatinine; Week 12; n=58, 53, 57, 51Creatinine; Week 16; n=57, 54, 57, 52Creatinine; Week 20; n=56, 54, 55, 49Creatinine; Week 24; n=56, 53, 56, 47Creatinine; Week 26; n=48, 50, 53, 45Creatinine; Week 28; n=51, 52, 52, 45Creatinine; Week 32; n=52, 53, 55, 45Creatinine; Week 36; n=52, 52, 55, 45Creatinine; Week 40; n=52, 53, 55, 44Creatinine; Week 48; n=51, 53, 54, 44Creatinine; Week 60; n=48, 47, 53, 44Creatinine; Week 72; n=47, 47, 52, 42Creatinine; Week 84; n=46, 48, 52, 42Creatinine; Week 96; n=45, 48, 52, 40T. Bilirubin; Baseline; n=60, 60, 61, 62T. Bilirubin; Week 2; n=58, 56, 58, 58T. Bilirubin; Week 4; n=58, 57, 59, 57T. Bilirubin; Week 8; n=58, 55, 57, 54T. Bilirubin; Week 12; n=58, 53, 57, 51T. Bilirubin; Week 16; n=57, 54, 57, 52T. Bilirubin; Week 20; n=56, 54, 55, 49T. Bilirubin; Week 24; n=56, 53, 56, 47T. Bilirubin; Week 26; n=48, 50, 53, 45T. Bilirubin; Week 28; n=51, 52, 52, 45T. Bilirubin; Week 32; n=52, 53, 55, 45T. Bilirubin; Week 36; n=52, 52, 55, 45T. Bilirubin; Week 40; n=52, 53, 55, 44T. Bilirubin; Week 48; n=51, 53, 54, 44T. Bilirubin; Week 60; n=48, 47, 53, 44T. Bilirubin; Week 72; n=47, 47, 52, 42T. Bilirubin; Week 84; n=46, 48, 52, 42T. Bilirubin; Week 96; n=45, 48, 52, 40
Efavirenz 600 mg83.183.883.182.481.179.679.580.078.678.578.178.479.279.077.977.779.781.09.76.86.46.37.07.06.86.66.86.46.66.56.36.67.06.56.66.8
GSK1265744 10 mg80.483.882.982.983.883.483.283.283.483.083.883.583.383.483.984.585.082.09.29.29.49.39.59.69.09.610.610.39.810.310.810.011.210.811.710.3
GSK1265744 30 mg80.583.383.082.282.782.382.083.382.683.882.684.683.283.183.086.184.886.49.49.19.39.08.98.59.09.89.910.29.810.111.29.69.810.09.99.9
GSK1265744 60 mg79.984.684.283.584.182.486.185.287.085.685.786.785.485.085.287.387.388.510.510.09.810.110.210.410.410.012.011.411.712.212.310.411.611.412.012.5

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Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96

CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionCells per cubic millimeter (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=58, 56, 57, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=49, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=46, 46, 52, 41
Efavirenz 600 mg456.5487.0509.9531.4564.3594.4607.7599.5625.7635.7663.8651.5687.9732.6733.9722.5744.7747.8
GSK1265744 10 mg445.5544.0580.5576.6588.4608.3607.3614.6632.8652.2638.1638.7650.2677.3668.1683.2718.3726.2
GSK1265744 30 mg444.9525.1522.0555.2599.0595.8607.4626.5629.5635.9650.8658.6658.5687.2720.9651.3736.9722.9
GSK1265744 60 mg459.0549.3545.8544.3596.6599.7636.6658.0645.8653.3665.2720.3667.6713.8719.8710.9735.0743.1

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Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionInternational Units per Liter (Mean)
ALT; Baseline; n=60, 60, 61, 62ALT; Week 2; n=58, 56, 58, 58ALT; Week 4; n=58, 57, 59, 57ALT; Week 8; n=58, 55, 57, 54ALT; Week 12; n=58, 53, 57, 51ALT; Week 16; n=57, 54, 57, 52ALT; Week 20; n=56, 54, 55, 49ALT; Week 24; n=56, 53, 56, 47ALT; Week 26; n=48, 50, 53, 45ALT; Week 28; n=51, 52, 52, 45ALT; Week 32; n=52, 53, 55, 45ALT; Week 36; n=52, 52, 55, 45ALT; Week 40; n=52, 53, 55, 44ALT; Week 48; n=51, 53, 54, 44ALT; Week 60; n=48, 47, 53, 44ALT; Week 72; n=47, 47, 52, 42ALT; Week 84; n=46, 48, 52, 42ALT; Week 96; n=45, 48, 52, 40AST; Baseline; n=60, 60, 61, 62AST; Week 2; n=58, 56, 58, 58AST; Week 4; n=58, 57, 59, 57AST; Week 8; n=58, 55, 57, 54AST; Week 12; n=58, 53, 57, 51AST; Week 16; n=57, 54, 57, 52AST; Week 20; n=56, 54, 55, 49AST; Week 24; n=56, 53, 56, 47AST; Week 26; n=48, 50, 53, 45AST; Week 28; n=51, 52, 52, 45AST; Week 32; n=52, 53, 55, 45AST; Week 36; n=52, 52, 55, 45AST; Week 40; n=52, 53, 55, 44AST; Week 48; n=51, 53, 54, 44AST; Week 60; n=48, 47, 53, 44AST; Week 72; n=47, 47, 52, 42AST; Week 84; n=46, 48, 52, 42AST; Week 96; n=45, 48, 52, 40CK; Baseline; n=60, 60, 61, 62CK; Week 2; n=58, 56, 58, 58CK; Week 4; n=58, 57, 59, 57CK; Week 8; n=58, 55, 57, 54CK; Week 12; n=58, 53, 57, 51CK; Week 16; n=57, 54, 57, 52CK; Week 20; n=56, 54, 55, 49CK; Week 24; n=56, 53, 56, 47CK; Week 26; n=48, 50, 53, 45CK; Week 28; n=51, 52, 52, 45CK; Week 32; n=52, 53, 55, 45CK; Week 36; n=52, 52, 55, 45CK; Week 40; n=52, 53, 55, 44CK; Week 48; n=51, 53, 54, 44CK; Week 60; n=48, 47, 53, 44CK; Week 72; n=47, 47, 52, 42CK; Week 84; n=46, 48, 52, 42CK; Week 96; n=45, 48, 52, 40
Efavirenz 600 mg30.530.031.425.025.730.427.025.728.324.223.123.523.422.624.922.727.124.331.532.829.024.424.436.728.726.125.823.725.426.323.023.724.922.929.927.7349.8512.1236.2152.9161.2646.5528.2247.4163.5154.7254.7303.1150.2146.3168.0120.5258.6281.1
GSK1265744 10 mg23.924.023.125.425.026.022.320.924.220.419.523.422.718.421.419.920.122.025.025.624.028.726.324.226.023.328.422.621.929.224.721.423.421.822.323.6197.3237.9196.7413.3316.1195.1342.7226.0344.1213.4205.6528.4259.5203.5315.7182.5204.3542.7
GSK1265744 30 mg28.126.325.629.331.428.524.927.526.626.526.924.724.624.825.930.729.948.727.526.625.029.529.029.224.227.226.926.726.525.424.524.325.331.029.247.7295.9276.1221.8427.2314.7427.3202.1306.3267.7276.8248.8242.9225.4219.3215.5354.0329.2272.8
GSK1265744 60 mg28.527.230.335.926.626.930.328.623.524.823.224.225.824.828.126.325.325.528.126.828.332.825.526.531.728.624.525.525.626.426.524.230.426.425.225.9181.2184.8180.5451.7211.8213.3485.3243.0242.5290.4311.3255.2292.6219.8399.6247.7195.0199.7

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Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product. (NCT01641809)
Timeframe: Week 48

InterventionPercentage of participants (Number)
GSK1265744 10 mg80
GSK1265744 30 mg80
GSK1265744 60 mg87
Efavirenz 600 mg71

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Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase

AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Week 24 to Week 96

InterventionPercentage of participants (Number)
GSK1265744 10 mg2
GSK1265744 30 mg4
GSK1265744 60 mg2
Efavirenz 600 mg2

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Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase

AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Up to Week 24

InterventionPercentage of participants (Number)
GSK1265744 10 mg0
GSK1265744 30 mg2
GSK1265744 60 mg5
Efavirenz 600 mg13

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Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events

AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Up to Week 324

InterventionPercentage of participants (Number)
GSK1265744 10 mg7
GSK1265744 30 mg7
GSK1265744 60 mg7
Efavirenz 600 mg15

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Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings

Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented. (NCT01641809)
Timeframe: Up to Week 324

InterventionParticipants (Count of Participants)
GSK1265744 10 mg25
GSK1265744 30 mg19
GSK1265744 60 mg15
Efavirenz 600 mg10

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Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2

Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2

InterventionMicrograms per milliliter (Geometric Mean)
GSK1265744 10 mg2.77
GSK1265744 30 mg7.49
GSK1265744 60 mg13.12

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Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2

Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post dose at Week 2

InterventionMicrograms per milliliter (Geometric Mean)
GSK1265744 10 mg1.45
GSK1265744 30 mg4.34
GSK1265744 60 mg5.83

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Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2

Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2

InterventionHours*micrograms per milliliter (Geometric Mean)
GSK1265744 10 mg45.69
GSK1265744 30 mg133.74
GSK1265744 60 mg227.58

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Change From Baseline in CD4+ Cell Count Over Time by Visit

CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionCells per cubic millimeter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=58, 56, 57, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=49, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=46, 46, 52, 41
Efavirenz 600 mg24.846.065.6103.4135.5149.0143.4166.4178.2197.4185.2221.5262.5263.8257.1279.4281.7

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312

,,,
InterventionPercentage of participants (Number)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 24Week 26Week 28Week 32Week 36Week 40Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312
Efavirenz 600 mg013244861747466696971687168686863000000000000000000
GSK1265744 10 mg048809088908778858385838078727268686562585857585755555350525352505252
GSK1265744 30 mg050788375838575788082828073737575727370676365676562636362626262626052
GSK1265744 60 mg051708782878785858785858785858584808080778075757475777574757570747070

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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264

InterventionMilliliters per minute (Mean)
Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 20; n=2, 0, 0, 1Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 60; n=0, 0, 0, 1Week 96; n=45, 48, 52, 40
Efavirenz 600 mg-0.7-0.10.03.44.04.80.416.05.1

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Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit

Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionLog10 copies per milliliter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 47, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=36, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=33, 39, 47, 0Week 228; n=32, 39, 47, 0Week 240; n=31, 39, 45, 0Week 252; n=31, 38, 47, 0Week 264; n=32, 38, 47, 0Week 276; n=31, 38, 45, 0Week 288; n=30, 38, 45, 0Week 300; n=31, 37, 44, 0Week 312; n=31, 33, 43, 0Week 324; n=3, 4, 3, 0
GSK1265744 10 mg-2.534-2.731-2.733-2.793-2.823-2.823-2.831-2.788-2.784-2.763-2.768-2.760-2.682-2.729-2.745-2.722-2.670-2.723-2.712-2.705-2.690-2.737-2.680-2.747-2.671-2.750-2.787-2.770-2.798-2.787-2.780-2.786-2.768-2.776-2.780-2.488
GSK1265744 30 mg-2.306-2.550-2.611-2.634-2.659-2.665-2.659-2.662-2.663-2.636-2.646-2.638-2.602-2.613-2.514-2.568-2.608-2.632-2.650-2.610-2.555-2.645-2.592-2.628-2.641-2.632-2.636-2.636-2.627-2.601-2.659-2.659-2.659-2.664-2.569-2.215
GSK1265744 60 mg-2.504-2.718-2.741-2.790-2.815-2.834-2.830-2.792-2.791-2.781-2.792-2.790-2.799-2.787-2.783-2.782-2.778-2.743-2.717-2.743-2.703-2.716-2.700-2.767-2.667-2.718-2.718-2.726-2.736-2.758-2.734-2.764-2.775-2.730-2.789-2.438

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Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit

Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionGiga cells per liter (Mean)
T. neutrophils; Week 2; n=57, 56, 59, 59T. neutrophils; Week 4; n=57, 57, 59, 57T. neutrophils; Week 8; n=58, 56, 56, 55T. neutrophils; Week 12; n=58, 53, 57, 51T. neutrophils; Week 16; n=57, 54, 57, 52T. neutrophils; Week 20; n=56, 54, 55, 49T. neutrophils; Week 24; n=56, 53, 56, 47T. neutrophils; Week 26; n=48, 50, 53, 45T. neutrophils; Week 28; n=50, 52, 52, 45T. neutrophils; Week 32; n=51, 53, 55, 45T. neutrophils; Week 36; n=52, 53, 55, 44T. neutrophils; Week 40; n=51, 53, 55, 45T. neutrophils; Week 48; n=51, 53, 54, 44T. neutrophils; Week 60; n=48, 47, 52, 44T. neutrophils; Week 72; n=47, 48, 52, 42T. neutrophils; Week 84; n=46, 48, 51, 42T. neutrophils; Week 96; n=46, 46, 52, 41T. neutrophils; Week 108; n=43, 46, 49, 0T. neutrophils; Week 120; n=41, 46, 49, 0T. neutrophils; Week 132; n=40, 46, 49, 0T. neutrophils; Week 144; n=37, 45, 46, 0T. neutrophils; Week 156; n=37, 42, 49, 0T. neutrophils; Week 168; n=35, 43, 47, 0T. neutrophils; Week 180; n=36, 41, 47, 0T. neutrophils; Week 192; n=35, 40, 47, 0T. neutrophils; Week 204; n=34, 39, 47, 0T. neutrophils; Week 216; n=32, 39, 43, 0T. neutrophils; Week 228; n=30, 39, 47, 0T. neutrophils; Week 240; n=32, 39, 47, 0T. neutrophils; Week 252; n=31, 36, 45, 0T. neutrophils; Week 264; n=32, 38, 46, 0T. neutrophils; Week 276; n=31, 38, 45, 0T. neutrophils; Week 288; n=30, 38, 44, 0T. neutrophils; Week 300; n=30, 37, 43, 0T. neutrophils; Week 312; n=31, 33, 41, 0T. neutrophils; Week 324; n=3, 4, 2, 0Platelet count; Week 2; n=57, 56, 59, 59Platelet count; Week 4; n=57, 57, 59, 57Platelet count; Week 8; n=58, 56, 56, 55Platelet count; Week 12; n=58, 53, 57, 51Platelet count; Week 16; n=57, 54, 57, 52Platelet count; Week 20; n=56, 54, 55, 49Platelet count; Week 24; n=56, 53, 56, 47Platelet count; Week 26; n=48, 50, 53, 45Platelet count; Week 28; n=50, 52, 52, 45Platelet count; Week 32; n=51, 52, 55, 45Platelet count; Week 36; n=52, 53, 55, 44Platelet count; Week 40; n=51, 53, 54, 45Platelet count; Week 48; n=51, 52, 53, 44Platelet count; Week 60; n=48, 47, 51, 44Platelet count; Week 72; n=47, 48, 52, 42Platelet count; Week 84; n=46, 48, 51, 42Platelet count; Week 96; n=46, 45, 51, 41Platelet count; Week 108; n=43, 46, 49, 0Platelet count; Week 120; n=41, 46, 49, 0Platelet count; Week 132; n=40, 46, 48, 0Platelet count; Week 144; n=37, 45, 44, 0Platelet count; Week 156; n=37, 42, 47, 0Platelet count; Week 168; n=35, 43, 46, 0Platelet count; Week 180; n=36, 41, 46, 0Platelet count; Week 192; n=35, 40, 46, 0Platelet count; Week 204; n=34, 39, 45, 0Platelet count; Week 216; n=32, 39, 44, 0Platelet count; Week 228; n=31, 39, 46, 0Platelet count; Week 240; n=32, 39, 47, 0Platelet count; Week 252; n=31, 36, 44, 0Platelet count; Week 264; n=32, 38, 45, 0Platelet count; Week 276; n=31, 38, 45, 0Platelet count; Week 288; n=30, 38, 43, 0Platelet count; Week 300; n=30, 37, 40, 0Platelet count; Week 312; n=31, 33, 41, 0Platelet count; Week 324; n=3, 4, 2, 0WBC count; Week 2; n=57, 56, 59, 59WBC count; Week 4; n=57, 57, 59, 57WBC count; Week 8; n=58, 56, 56, 55WBC; Week 12; n=58, 53, 57, 51WBC count; Week 16; n=57, 54, 57, 52WBC count; Week 20; n=56, 54, 55, 49WBC count; Week 24; n=56, 53, 56, 47WBC count; Week 26; n=48, 50, 53, 45WBC count; Week 28; n=50, 52, 52, 45WBC count; Week 32; n=51, 53, 55, 45WBC count; Week 36; n=52, 53, 55, 44WBC count; Week 40; n=51, 53, 55, 45WBC count; Week 48; n=51, 53, 54, 44WBC count; Week 60; n=48, 47, 52, 44WBC count; Week 72; n=47, 48, 52, 42WBC count; Week 84; n=46, 48, 51, 42WBC count; Week 96; n=46, 46, 52, 41WBC count; Week 108; n=43, 46, 49, 0WBC count; Week 120; n=41, 46, 49, 0WBC count; Week 132; n=40, 46, 49, 0WBC count; Week 144; n=37, 45, 46, 0WBC count; Week 156; n=37, 42, 49, 0WBC count; Week 168; n=35, 43, 47, 0WBC count; Week 180; n=36, 41, 47, 0WBC count; Week 192; n=35, 40, 47, 0WBC count; Week 204; n=34, 39, 47, 0WBC count; Week 216; n=32, 39, 43, 0WBC count; Week 228; n=31, 39, 47, 0WBC count; Week 240; n=32, 39, 47, 0WBC count; Week 252; n=31, 36, 45, 0WBC count; Week 264; n=32, 38, 46, 0WBC count; Week 276; n=31, 38, 45, 0WBC count; Week 288; n=30, 38, 44, 0WBC count; Week 300; n=30, 37, 43, 0WBC count; Week 312; n=31, 33, 41, 0WBC count; Week 324; n=3, 4, 2, 0
GSK1265744 10 mg0.0420.0380.2510.1380.3880.2700.4620.1200.4960.0710.4200.4300.3860.3740.3830.4100.6310.6230.3720.7770.6720.7620.5880.7690.4900.6180.5430.7800.5080.2680.4750.4000.4560.1390.2430.86011.09.910.313.716.517.212.08.36.67.75.211.112.520.923.713.625.924.523.816.827.126.634.928.434.733.928.128.727.215.927.948.444.128.527.331.70.190.160.370.320.450.360.470.190.670.250.560.570.430.600.630.710.950.890.590.920.911.050.971.070.610.980.880.980.790.660.620.920.920.580.571.97
GSK1265744 30 mg-0.084-0.083-0.0660.040-0.1560.0320.1090.0520.2130.1490.0290.1780.2450.4580.2740.5280.6980.5700.6500.4050.4680.4180.5340.4050.5940.6480.5880.7890.8130.7610.7610.6270.6730.4550.4170.31516.620.125.914.611.314.518.411.215.811.610.88.920.018.722.817.220.824.626.921.023.230.636.427.624.626.425.227.126.215.423.234.535.526.830.98.30.130.020.150.280.020.230.340.260.420.450.300.420.530.760.560.961.010.901.010.710.820.750.970.690.890.951.011.131.151.101.211.041.130.770.700.53
GSK1265744 60 mg0.1040.1550.3410.3590.2030.5250.4060.3750.5020.6920.5350.5750.5340.7110.6661.0060.9971.0060.7690.6710.8311.0951.0110.8400.7220.8210.9140.8191.0830.8121.1761.1060.9130.6990.5640.96014.314.118.417.717.913.719.310.317.815.411.87.817.626.622.721.121.733.120.432.233.541.240.045.427.937.633.529.127.430.832.845.846.745.435.32.00.310.300.480.730.360.770.640.660.690.930.920.810.781.041.091.431.381.351.161.021.221.641.581.331.111.241.371.311.531.171.661.571.321.020.95-0.05

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Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit

Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionGiga cells per liter (Mean)
T. neutrophils; Week 2; n=57, 56, 59, 59T. neutrophils; Week 4; n=57, 57, 59, 57T. neutrophils; Week 8; n=58, 56, 56, 55T. neutrophils; Week 12; n=58, 53, 57, 51T. neutrophils; Week 16; n=57, 54, 57, 52T. neutrophils; Week 20; n=56, 54, 55, 49T. neutrophils; Week 24; n=56, 53, 56, 47T. neutrophils; Week 26; n=48, 50, 53, 45T. neutrophils; Week 28; n=50, 52, 52, 45T. neutrophils; Week 32; n=51, 53, 55, 45T. neutrophils; Week 36; n=52, 53, 55, 44T. neutrophils; Week 40; n=51, 53, 55, 45T. neutrophils; Week 48; n=51, 53, 54, 44T. neutrophils; Week 60; n=48, 47, 52, 44T. neutrophils; Week 72; n=47, 48, 52, 42T. neutrophils; Week 84; n=46, 48, 51, 42T. neutrophils; Week 96; n=46, 46, 52, 41Platelet count; Week 2; n=57, 56, 59, 59Platelet count; Week 4; n=57, 57, 59, 57Platelet count; Week 8; n=58, 56, 56, 55Platelet count; Week 12; n=58, 53, 57, 51Platelet count; Week 16; n=57, 54, 57, 52Platelet count; Week 20; n=56, 54, 55, 49Platelet count; Week 24; n=56, 53, 56, 47Platelet count; Week 26; n=48, 50, 53, 45Platelet count; Week 28; n=50, 52, 52, 45Platelet count; Week 32; n=51, 52, 55, 45Platelet count; Week 36; n=52, 53, 55, 44Platelet count; Week 40; n=51, 53, 54, 45Platelet count; Week 48; n=51, 52, 53, 44Platelet count; Week 60; n=48, 47, 51, 44Platelet count; Week 72; n=47, 48, 52, 42Platelet count; Week 84; n=46, 48, 51, 42Platelet count; Week 96; n=46, 45, 51, 41WBC count; Week 2; n=57, 56, 59, 59WBC count; Week 4; n=57, 57, 59, 57WBC count; Week 8; n=58, 56, 56, 55WBC; Week 12; n=58, 53, 57, 51WBC count; Week 16; n=57, 54, 57, 52WBC count; Week 20; n=56, 54, 55, 49WBC count; Week 24; n=56, 53, 56, 47WBC count; Week 26; n=48, 50, 53, 45WBC count; Week 28; n=50, 52, 52, 45WBC count; Week 32; n=51, 53, 55, 45WBC count; Week 36; n=52, 53, 55, 44WBC count; Week 40; n=51, 53, 55, 45WBC count; Week 48; n=51, 53, 54, 44WBC count; Week 60; n=48, 47, 52, 44WBC count; Week 72; n=47, 48, 52, 42WBC count; Week 84; n=46, 48, 51, 42WBC count; Week 96; n=46, 46, 52, 41
Efavirenz 600 mg0.7160.3750.2730.5250.3670.7400.6370.4490.4460.7170.4140.7300.6650.8000.8920.7900.83117.115.610.311.29.317.123.917.517.213.812.318.920.630.828.318.917.50.690.290.270.540.360.780.550.350.390.710.360.750.730.951.020.950.92

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Number of Participants With Adherence to Study Treatment

Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312

InterventionParticipants (Count of Participants)
Baseline; n=57, 55, 56, 52Week 4; n=54, 52, 53, 50Week 8; n=53, 50, 56, 48Week 12; n=55, 48, 53, 48Week 16; n=53, 51, 53, 44Week 20; n=51, 49, 55, 44Week 24; n=51, 46, 51, 43Week 28; n=49, 48, 53, 41Week 32; n=47, 48, 55, 41Week 36; n=46, 48, 50, 41Week 40; n=38, 35, 45, 39Week 48; n=33, 37, 45, 35Week 60; n=38, 38, 40, 37Week 72; n=35, 37, 44, 32Week 84; n=36, 39, 42, 33
Efavirenz 600 mg484447434241393537363433352729

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Number of Participants With Adherence to Study Treatment

Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312

InterventionParticipants (Count of Participants)
Baseline; n=57, 55, 56, 52Week 4; n=54, 52, 53, 50Week 8; n=53, 50, 56, 48Week 12; n=55, 48, 53, 48Week 16; n=53, 51, 53, 44Week 20; n=51, 49, 55, 44Week 24; n=51, 46, 51, 43Week 28; n=49, 48, 53, 41Week 32; n=47, 48, 55, 41Week 36; n=46, 48, 50, 41Week 40; n=38, 35, 45, 39Week 48; n=33, 37, 45, 35Week 60; n=38, 38, 40, 37Week 72; n=35, 37, 44, 32Week 84; n=36, 39, 42, 33Week 96; n=31, 36, 33, 0Week 108; n=23, 23, 29, 0Week 120; n=30, 38, 41, 0Week 132; n=29, 32, 40, 0Week 144; n=33, 34, 43, 0Week 156; n=31, 28, 39, 0Week 168; n=29, 33, 41, 0Week 180; n=26, 29, 39, 0Week 192; n=30, 30, 39, 0Week 204; n=29, 32, 38, 0Week 216; n=29, 30, 37, 0Week 228; n=27, 34, 40, 0Week 240; n=28, 26, 41, 0Week 252; n=23, 26, 33, 0Week 264; n=15, 18, 24, 0Week 276; n=14, 14, 21, 0Week 288; n=12, 14, 18, 0Week 300; n=12, 13, 20, 0
GSK1265744 60 mg555253465051484852484141374139302739354135353435333135352921181718

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Number of Participants With Adherence to Study Treatment

Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312

,
InterventionParticipants (Count of Participants)
Baseline; n=57, 55, 56, 52Week 4; n=54, 52, 53, 50Week 8; n=53, 50, 56, 48Week 12; n=55, 48, 53, 48Week 16; n=53, 51, 53, 44Week 20; n=51, 49, 55, 44Week 24; n=51, 46, 51, 43Week 28; n=49, 48, 53, 41Week 32; n=47, 48, 55, 41Week 36; n=46, 48, 50, 41Week 40; n=38, 35, 45, 39Week 48; n=33, 37, 45, 35Week 60; n=38, 38, 40, 37Week 72; n=35, 37, 44, 32Week 84; n=36, 39, 42, 33Week 96; n=31, 36, 33, 0Week 108; n=23, 23, 29, 0Week 120; n=30, 38, 41, 0Week 132; n=29, 32, 40, 0Week 144; n=33, 34, 43, 0Week 156; n=31, 28, 39, 0Week 168; n=29, 33, 41, 0Week 180; n=26, 29, 39, 0Week 192; n=30, 30, 39, 0Week 204; n=29, 32, 38, 0Week 216; n=29, 30, 37, 0Week 228; n=27, 34, 40, 0Week 240; n=28, 26, 41, 0Week 252; n=23, 26, 33, 0Week 264; n=15, 18, 24, 0Week 276; n=14, 14, 21, 0Week 288; n=12, 14, 18, 0Week 300; n=12, 13, 20, 0Week 312; n=1, 1, 0, 0
GSK1265744 10 mg5346494444454745464033323732342521282832302924282729252818121312111
GSK1265744 30 mg514945404540414642433033353536322036302925242427262728222116131071

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase

An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product. (NCT01641809)
Timeframe: Week 24 to Week 96

,,,
InterventionParticipants (Count of Participants)
Any AEAny SAE
Efavirenz 600 mg352
GSK1265744 10 mg405
GSK1265744 30 mg505
GSK1265744 60 mg505

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Number of Participants With AEs and SAEs Over Time

An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
Any AEAny SAE
Efavirenz 600 mg604
GSK1265744 10 mg5713
GSK1265744 30 mg5712
GSK1265744 60 mg6011

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Number of Participants With AEs and SAEs-Induction Phase

An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. (NCT01641809)
Timeframe: Up to Week 24

,,,
InterventionParticipants (Count of Participants)
Any AEAny SAE
Efavirenz 600 mg592
GSK1265744 10 mg542
GSK1265744 30 mg540
GSK1265744 60 mg552

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Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time

Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
ALT; Grade 1ALT; Grade 2ALT; Grade 3ALT; Grade 4Albumin; Grade 1Albumin; Grade 2Albumin; Grade 3Albumin; Grade 4ALP; Grade 1ALP; Grade 2ALP; Grade 3ALP; Grade 4AST; Grade 1AST; Grade 2AST; Grade 3AST; Grade 4CO2/bicarbonate; Grade 1CO2/bicarbonate; Grade 2CO2/bicarbonate; Grade 3CO2/bicarbonate; Grade 4Cholesterol; Grade 1Cholesterol; Grade 2Cholesterol; Grade 3Cholesterol; Grade 4CK; Grade 1CK; Grade 2CK; Grade 3CK; Grade 4Creatinine; Grade 1Creatinine; Grade 2Creatinine; Grade 3Creatinine; Grade 4Glucose; Grade 1Glucose; Grade 2Glucose; Grade 3Glucose; Grade 4LDL cholesterol; Grade 1LDL cholesterol; Grade 2LDL cholesterol; Grade 3LDL cholesterol; Grade 4Lipase; Grade 1Lipase; Grade 2Lipase; Grade 3Lipase; Grade 4Inorganic phosphorus; Grade 1Inorganic phosphorus; Grade 2Inorganic phosphorus; Grade 3Inorganic phosphorus; Grade 4Potassium; Grade 1Potassium; Grade 2Potassium; Grade 3Potassium; Grade 4Sodium; Grade 1Sodium; Grade 2Sodium; Grade 3Sodium; Grade 4Total bilirubin; Grade 1Total bilirubin; Grade 2Total bilirubin; Grade 3Total bilirubin; Grade 4Triglycerides; Grade 1Triglycerides; Grade 2Triglycerides; Grade 3Triglycerides; Grade 4
Efavirenz 600 mg84010000500072328100910605045110012601874010710892041001110000000111
GSK1265744 10 mg960100002000762261001773092371100191400147401195251120140001420072000110
GSK1265744 30 mg1261110001100138011400017120010426100018100017112098203111070001210013100400
GSK1265744 60 mg1950200004000155409000191530124452000211120131470911621065080001600084000331

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Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase

Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Week 24 to Week 96

,,,
InterventionParticipants (Count of Participants)
ALT; Grade 1ALT; Grade 2ALT; Grade 3ALT; Grade 4Albumin; Grade 1Albumin; Grade 2Albumin; Grade 3Albumin; Grade 4ALP; Grade 1ALP; Grade 2ALP; Grade 3ALP; Grade 4AST; Grade 1AST; Grade 2AST; Grade 3AST; Grade 4CO2/bicarbonate; Grade 1CO2/bicarbonate; Grade 2CO2/bicarbonate; Grade 3CO2/bicarbonate; Grade 4Cholesterol; Grade 1Cholesterol; Grade 2Cholesterol; Grade 3Cholesterol; Grade 4CK; Grade 1CK; Grade 2CK; Grade 3CK; Grade 4Creatinine; Grade 1Creatinine; Grade 2Creatinine; Grade 3Creatinine; Grade 4Glucose; Grade 1Glucose; Grade 2Glucose; Grade 3Glucose; Grade 4LDL cholesterol; Grade 1LDL cholesterol; Grade 2LDL cholesterol; Grade 3LDL cholesterol; Grade 4Lipase; Grade 1Lipase; Grade 2Lipase; Grade 3Lipase; Grade 4Inorganic phosphorus; Grade 1Inorganic phosphorus; Grade 2Inorganic phosphorus; Grade 3Inorganic phosphorus; Grade 4Potassium; Grade 1Potassium; Grade 2Potassium; Grade 3Potassium; Grade 4Sodium; Grade 1Sodium; Grade 2Sodium; Grade 3Sodium; Grade 4Total bilirubin; Grade 1Total bilirubin; Grade 2Total bilirubin; Grade 3Total bilirubin; Grade 4Triglycerides; Grade 1Triglycerides; Grade 2Triglycerides; Grade 3Triglycerides; Grade 4
Efavirenz 600 mg630100004000523281009104050351000115008640970079204100710000000110
GSK1265744 10 mg96010000200055226100176308236110017140014640995251020120001420072000110
GSK1265744 30 mg126111000110013801140001712009426100017100016112098103111070001210013100400
GSK1265744 60 mg175000000400013520900019153011445200020112013147081162955080001600084000331

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Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase

Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 24

,,,
InterventionParticipants (Count of Participants)
ALT; Grade 1ALT; Grade 2ALT; Grade 3ALT; Grade 4Albumin; Grade 1Albumin; Grade 2Albumin; Grade 3Albumin; Grade 4ALP; Grade 1ALP; Grade 2ALP; Grade 3ALP; Grade 4AST; Grade 1AST; Grade 2AST; Grade 3AST; Grade 4CO2/bicarbonate; Grade 1CO2/bicarbonate; Grade 2CO2/bicarbonate; Grade 3CO2/bicarbonate; Grade 4Chloride; Grade 1Chloride; Grade 2Chloride; Grade 3Chloride; Grade 4Cholesterol; Grade 1Cholesterol; Grade 2Cholesterol; Grade 3Cholesterol; Grade 4CK; Grade 1CK; Grade 2CK; Grade 3CK; Grade 4Creatinine; Grade 1Creatinine; Grade 2Creatinine; Grade 3Creatinine; Grade 4Glucose; Grade 1Glucose; Grade 2Glucose; Grade 3Glucose; Grade 4HDL cholesterol; Grade 1HDL cholesterol; Grade 2HDL cholesterol; Grade 3HDL cholesterol; Grade 4LDL cholesterol; Grade 1LDL cholesterol; Grade 2LDL cholesterol; Grade 3LDL cholesterol; Grade 4Lipase; Grade 1Lipase; Grade 2Lipase; Grade 3Lipase; Grade 4Inorganic phosphorus; Grade 1Inorganic phosphorus; Grade 2Inorganic phosphorus; Grade 3Inorganic phosphorus; Grade 4Potassium; Grade 1Potassium; Grade 2Potassium; Grade 3Potassium; Grade 4Sodium; Grade 1Sodium; Grade 2Sodium; Grade 3Sodium; Grade 4Total bilirubin; Grade 1Total bilirubin; Grade 2Total bilirubin; Grade 3Total bilirubin; Grade 4Triglycerides; Grade 1Triglycerides; Grade 2Triglycerides; Grade 3Triglycerides; Grade 4Urea/BUN; Grade 1Urea/BUN; Grade 2Urea/BUN; Grade 3Urea/BUN; Grade 4
Efavirenz 600 mg8400000030006120600000004960412411006501000048206510682021008100000002010000
GSK1265744 10 mg31000000000062101000000073007232010010500000054009620561070007000020000000000
GSK1265744 30 mg4500000011008500500000008200521400008300000091003110221010004000110001000000
GSK1265744 60 mg1300200004000713010000000123206312000013120000085305741722020007000410003100000

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Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time

Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
APTT; Grade 1APTT; Grade 2APTT; Grade 3APTT; Grade 4Hemoglobin; Grade 1Hemoglobin; Grade 2Hemoglobin; Grade 3Hemoglobin; Grade 4INR; Grade 1INR; Grade 2INR; Grade 3INR; Grade 4Platelet count; Grade 1Platelet count; Grade 2Platelet count; Grade 3Platelet count; Grade 4PT; Grade 1PT; Grade 2PT; Grade 3PT; Grade 4Total neutrophils; Grade 1Total neutrophils; Grade 2Total neutrophils; Grade 3Total neutrophils; Grade 4WBC count; Grade 1WBC count; Grade 2WBC count; Grade 3WBC count; Grade 4
Efavirenz 600 mg5001000031001000310023113000
GSK1265744 10 mg5001010020104000100075112100
GSK1265744 30 mg5101000041010000301192015100
GSK1265744 60 mg50010000010041110010103132110

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Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase

Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 24

,,,
InterventionParticipants (Count of Participants)
APTT; Grade 1APTT; Grade 2APTT; Grade 3APTT; Grade 4Basophils; Grade 1Basophils; Grade 2Basophils; Grade 3Basophils; Grade 4Eosinophils; Grade 1Eosinophils; Grade 2Eosinophils; Grade 3Eosinophils; Grade 4Hematocrit; Grade 1Hematocrit; Grade 2Hematocrit; Grade 3Hematocrit; Grade 4Hemoglobin; Grade 1Hemoglobin; Grade 2Hemoglobin; Grade 3Hemoglobin; Grade 4INR; Grade 1INR; Grade 2INR; Grade 3INR; Grade 4Lymphocytes; Grade 1Lymphocytes; Grade 2Lymphocytes; Grade 3Lymphocytes; Grade 4MCV; Grade 1MCV; Grade 2MCV; Grade 3MCV; Grade 4Monocytes; Grade 1Monocytes; Grade 2Monocytes; Grade 3Monocytes; Grade 4Platelet count; Grade 1Platelet count; Grade 2Platelet count; Grade 3Platelet count; Grade 4PT; Grade 1PT; Grade 2PT; Grade 3PT; Grade 4RBC; Grade 1RBC; Grade 2RBC; Grade 3RBC; Grade 4Total neutrophils; Grade 1Total neutrophils; Grade 2Total neutrophils; Grade 3Total neutrophils; Grade 4WBC count; Grade 1WBC count; Grade 2WBC count; Grade 3WBC count; Grade 4
Efavirenz 600 mg30000000000000000000100000000000000010001000000022111000
GSK1265744 10 mg10000000000000000100000000000000000020000000000083000000
GSK1265744 30 mg00010000000000000000200100000000000000001001000062002100
GSK1265744 60 mg10010000000000000000000000000000000020000000000083012000

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Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase

Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Week 24 to Week 96

,,,
InterventionParticipants (Count of Participants)
APTT; Grade 1APTT; Grade 2APTT; Grade 3APTT; Grade 4Hemoglobin; Grade 1Hemoglobin; Grade 2Hemoglobin; Grade 3Hemoglobin; Grade 4INR; Grade 1INR; Grade 2INR; Grade 3INR; Grade 4Platelet count; Grade 1Platelet count; Grade 2Platelet count; Grade 3Platelet count; Grade 4PT; Grade 1PT; Grade 2PT; Grade 3PT; Grade 4Total neutrophils; Grade 1Total neutrophils; Grade 2Total neutrophils; Grade 3Total neutrophils; Grade 4WBC count; Grade 1WBC count; Grade 2WBC count; Grade 3WBC count; Grade 4
Efavirenz 600 mg5001000031001000310023113000
GSK1265744 10 mg5001010020104000100075112100
GSK1265744 30 mg5101000041010000301192015100
GSK1265744 60 mg50010000010041110010103132110

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Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease

HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
CDC Class A to CDC Class CCDC Class B to CDC Class CCDC Class C to new CDC Class CCDC Class A, B or C to Death
Efavirenz 600 mg0000
GSK1265744 10 mg1000
GSK1265744 30 mg1001
GSK1265744 60 mg0001

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Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance

Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
Any INI mutationAny mutation to other classes
Efavirenz 600 mg00
GSK1265744 10 mg34
GSK1265744 30 mg00
GSK1265744 60 mg11

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Number of Participants With Treatment Emergent Phenotypic Resistance

Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/ritonavir [ATV/r], Darunavir (DRV)/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
INI, GSK1265744; Resistant; n=5, 1, 2, 2INI, GSK1265744; Sensitive; n=5, 1, 2, 2INI, RAL; Resistant; n=5, 1, 2, 2INI, RAL; Sensitive; n=5, 1, 2, 2NNRTI, DLV; Resistant; n=6, 2, 2, 5NNRTI, DLV; Sensitive; n=6, 2, 2, 5NNRTI, EFV; Resistant; n=6, 2, 2, 5NNRTI, EFV; Sensitive; n=6, 2, 2, 5NNRTI, ETR; Resistant; n=6, 2, 2, 5NNRTI, ETR; Partially sensitive; n=6, 2, 2, 5NNRTI, ETR; Sensitive; n=6, 2, 2, 5NNRTI, NVP; Resistant; n=6, 2, 2, 5NNRTI, NVP; Sensitive; n=6, 2, 2, 5NNRTI, RPV; Resistant; n=6, 2, 2, 5NNRTI, RPV; Sensitive; n=6, 2, 2, 5NRTI, 3TC; Resistant; n=6, 2, 2, 5NRTI, 3TC; Sensitive; n=6, 2, 2, 5NRTI, ABC; Resistant; n=6, 2, 2, 5NRTI, ABC; Partially sensitive; n=6, 2, 2, 5NRTI, ABC; Sensitive; n=6, 2, 2, 5NRTI, FTC; Resistant; n=6, 2, 2, 5NRTI, FTC; Sensitive; n=6, 2, 2, 5NRTI, TDF; Resistant; n=6, 2, 2, 5NRTI, TDF; Partially sensitive; n=6, 2, 2, 5NRTI, TDF; Sensitive; n=6, 2, 2, 5NRTI, ZDV; Resistant; n=6, 2, 2, 5NRTI, ZDV; Sensitive; n=6, 2, 2, 5NRTI, d4T; Resistant; n=6, 2, 2, 5NRTI, d4T; Sensitive; n=6, 2, 2, 5NRTI, ddI; Resistant; n=6, 2, 2, 5NRTI, ddI; Partially sensitive; n=6, 2, 2, 5NRTI, ddI; Sensitive; n=6, 2, 2, 5PI, ATV/r; Resistant; n=6, 2, 2, 5PI, ATV/r; Sensitive; n=6, 2, 2, 5PI, DRV/r; Resistant; n=6, 2, 2, 5PI, DRV/r; Partially sensitive; n=6, 2, 2, 5PI, DRV/r; Sensitive; n=6, 2, 2, 5PI, FPV/r; Resistant; n=6, 2, 2, 5PI, FPV/r; Partially sensitive; n=6, 2, 2, 5PI, FPV/r; Sensitive; n=6, 2, 2, 5PI, IDV/r; Resistant; n=6, 2, 2, 5PI, IDV/r; Sensitive; n=6, 2, 2, 5PI, LPV/r; Resistant; n=6, 2, 2, 5PI, LPV/r; Partially sensitive; n=6, 2, 2, 5PI, LPV/r; Sensitive; n=6, 2, 2, 5PI, NFV; Resistant; n=6, 2, 2, 5PI, NFV; Sensitive; n=6, 2, 2, 5PI, RTV; Resistant; n=6, 2, 2, 5PI, RTV; Sensitive; n=6, 2, 2, 5PI, SQV/r; Resistant; n=6, 2, 2, 5PI, SQV/r; Partially sensitive; n=6, 2, 2, 5PI, SQV/r; Sensitive; n=6, 2, 2, 5PI, TPV/r; Resistant; n=6, 2, 2, 5PI, TPV/r; Partially sensitive; n=6, 2, 2, 5PI, TPV/r; Sensitive; n=6, 2, 2, 5
Efavirenz 600 mg0202050500505050500505005050500505005005050050505005005
GSK1265744 10 mg2332333330333330600606015240600606006006060060606006006
GSK1265744 30 mg0101020200202020200202002020200202002002020020202002002
GSK1265744 60 mg1111020200202020200202002020200202002002020020202002002

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Week 16 and Week 24

,,,
InterventionPercentage of participants (Number)
Week 16Week 24
Efavirenz 600 mg7474
GSK1265744 10 mg9087
GSK1265744 30 mg8385
GSK1265744 60 mg8787

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Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase

Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study. (NCT01641809)
Timeframe: Weeks 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionPercentage of participants (Number)
Week 24Week 26Week 28Week 32Week 36Week 40Week 48Week 60Week 72Week 84Week 96
Efavirenz 600 mg9687919194899489898983
GSK1265744 10 mg9690989698969290838379
GSK1265744 30 mg9485899192929183838585
GSK1265744 60 mg9695959695959695959593

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Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm

Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionPercentage of participants (Number)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 24Week 26Week 28Week 32Week 36Week 40Week 48Week 60Week 72Week 84Week 96
Efavirenz 600 mg068687973817971737373737371686865
GSK1265744 10 mg087939390939380858787878380777775
GSK1265744 30 mg080939285878780838585858577757777
GSK1265744 60 mg084939289939287858990908987858585

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Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionPercentage of participants (Number)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40
Efavirenz 600 mg0717491929610010010010010010010010098100100100
GSK1265744 10 mg0919795979810010010010010010010098969810096
GSK1265744 30 mg0869898100100100100100100100100100981009698100
GSK1265744 60 mg08697989810010010010010098100100100100100100100

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionPercentage of participants (Number)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40
Efavirenz 600 mg0142655768791969396969893989510010098

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionPercentage of participants (Number)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 47, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=36, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=33, 39, 47, 0Week 228; n=32, 39, 47, 0Week 240; n=31, 39, 45, 0Week 252; n=31, 38, 47, 0Week 264; n=32, 38, 47, 0Week 276; n=31, 38, 45, 0Week 288; n=30, 38, 45, 0Week 300; n=31, 37, 44, 0Week 312; n=31, 33, 43, 0Week 324; n=3, 4, 3, 0
GSK1265744 10 mg0518392959591939810096989692949191899595959295949794971001009710010010010097100100
GSK1265744 30 mg05482898894989894949496969296929498961009693959510010097100100979710010010010097100
GSK1265744 60 mg0537393919398959810096959598981001009810098100989898989698989810098989610095100100

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Change From Baseline in 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 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 TC/HDL Ratio at Week 48

Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48

InterventionRatio (Least Squares Mean)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-0.264
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-0.158

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Change From Baseline in Triglycerides at Week 48

Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48

InterventionMillimoles per liter (Least Squares Mean)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.045
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.070

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Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase4

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Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. (NCT01910402)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase10
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase17

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

Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells per millimeter cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48

InterventionPercentage of participants (Number)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase82
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase71

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Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase

Absolute values in CD4+ cell count were assessed at indicated time points. (NCT01910402)
Timeframe: Week 96 and Week 432

InterventionCells per cubic millimeter (Mean)
Week 96, n=99Week 432, n=3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase635.3553.0

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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 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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Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing

Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication. (NCT01973439)
Timeframe: Week 0

Interventionh*mg/L (Geometric Mean)
Single Arm10.85

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Cmax of Abacavir on Once Daily Dosing

Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication. (NCT01973439)
Timeframe: Week 4

Interventionmg/L (Geometric Mean)
Single Arm4.68

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Cmax of Abacavir on Twice Daily Dosing

Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication. (NCT01973439)
Timeframe: Week 0

Interventionmg/L (Geometric Mean)
Single Arm2.29

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AUC(0-24) of Abacavir on Once Daily Dosing

Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication (NCT01973439)
Timeframe: Week 4

Interventionh*mg/L (Geometric Mean)
Single Arm11.57

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Once Versus Twice Daily Abacavir+Lamivudine: Weight-for-age Z-score

Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)

Interventionage-adjusted z-score (Mean)
Once-daily ABC+3TC0.01
Twice-daily ABC+3TC-0.00

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CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 72 Weeks After Baseline

Number of participants with HIV RNA viral load <80 copies/ml 72 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes. (NCT02028676)
Timeframe: 72 weeks

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)76
Laboratory Plus Clinical Monitoring (LCM)78
Arm A: ABC+3TC+NNRTI56
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance72
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance26

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Cotrimoxazole: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)

Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks. (NCT02028676)
Timeframe: Mean over median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Intervention% of visits reporting missed pills (Mean)
Continued Cotrimoxazole Prophylaxis9
Stopped Cotrimoxazole Prophylaxis8

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Cotrimoxazole: All-cause Mortality

Number of participants who died, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis3
Stopped Cotrimoxazole Prophylaxis2

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Cotrimoxazole: Body Mass Index-for-age Z-score

Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionage-adjusted z-score (Mean)
Continued Cotrimoxazole Prophylaxis-0.24
Stopped Cotrimoxazole Prophylaxis-0.28

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Cotrimoxazole: Change From Baseline in Absolute CD4 to Week 72

Estimated in those >5 years at randomization to stop vs continue, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.) (NCT02028676)
Timeframe: Baseline, week 72

Interventioncells per mm3 (Mean)
Continued Cotrimoxazole Prophylaxis7
Stopped Cotrimoxazole Prophylaxis-2

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Cotrimoxazole: Change From Baseline in CD4% to Week 72

(NCT02028676)
Timeframe: Baseline, week 72

Interventionpercentage of total lymphocytes (Mean)
Continued Cotrimoxazole Prophylaxis1.7
Stopped Cotrimoxazole Prophylaxis1.1

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Cotrimoxazole: Height-for-age Z-score

Age-adjusted change in height-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionage-adjusted z-score (Mean)
Continued Cotrimoxazole Prophylaxis0.22
Stopped Cotrimoxazole Prophylaxis0.19

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Cotrimoxazole: New Clinical and Diagnostic Positive Malaria

Number of participants with a new clinical and diagnostic positive malaria, to be analysed using time-to-event methods. Diagnostic positive by either microscopy (thick film) or rapid diagnostic test (RDT) (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis39
Stopped Cotrimoxazole Prophylaxis77

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Cotrimoxazole: New Hospitalisation or Death

Number of participants with a new hospitalisation or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis48
Stopped Cotrimoxazole Prophylaxis72

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LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 144

Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.) (NCT02028676)
Timeframe: Baseline, week 144

Interventionabsolute cells per mm3 (Mean)
Clinically Driven Monitoring (CDM)418
Laboratory Plus Clinical Monitoring (LCM)420
Arm A: ABC+3TC+NNRTI446
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance450
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance360

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Cotrimoxazole: New Severe Pneumonia

Number of participants with a new severe pneumonia, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis7
Stopped Cotrimoxazole Prophylaxis10

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Cotrimoxazole: New WHO Stage 3 or 4 Event or Death

Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis8
Stopped Cotrimoxazole Prophylaxis19

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Cotrimoxazole: New WHO Stage 3 Severe Recurrent Pneumonia or Diarrhoea

Number of participants with a new WHO stage 3 severe recurrent pneumonia or diarrhoea, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis1
Stopped Cotrimoxazole Prophylaxis4

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Cotrimoxazole: New WHO Stage 4 Event or Death

Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis4
Stopped Cotrimoxazole Prophylaxis7

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Cotrimoxazole: Weight-for-age Z-score

Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionage-adjusted z-score (Mean)
Continued Cotrimoxazole Prophylaxis-0.01
Stopped Cotrimoxazole Prophylaxis-0.05

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Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation

(NCT02028676)
Timeframe: Baseline, 72 weeks

Interventionpercentage of total lymphocytes (Mean)
Arm A: ABC+3TC+NNRTI16.4
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance17.1
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance17.3

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Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation

(NCT02028676)
Timeframe: Baseline, 144 weeks

Interventionpercentage of total lymphocytes (Mean)
Arm A: ABC+3TC+NNRTI19.8
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance19.6
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance19.2

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Induction ART: New WHO Stage 4 Event or Death

Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Arm A: ABC+3TC+NNRTI30
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance28
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance28

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LCM vs CDM, Induction ART: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)

Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks. (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Intervention% of visits reporting missed pills (Mean)
Clinically Driven Monitoring (CDM)8.5
Laboratory Plus Clinical Monitoring (LCM)9.4
Arm A: ABC+3TC+NNRTI8.3
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance9.5
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance9.1

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LCM vs CDM, Induction ART: All-cause Mortality

Number of participants who died from any cause, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)25
Laboratory Plus Clinical Monitoring (LCM)29
Arm A: ABC+3TC+NNRTI20
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance14
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance20

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LCM vs CDM, Induction ART: Body Mass Index-for-age Z-score

Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 4 years (maximum 5 years)

Interventionage-adjusted z-score (Mean)
Clinically Driven Monitoring (CDM)0.65
Laboratory Plus Clinical Monitoring (LCM)0.61
Arm A: ABC+3TC+NNRTI0.56
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance0.64
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance0.69

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LCM vs CDM, Induction ART: Cessation of First-line Regimen for Clinical/Immunological Failure

Number of participants stopping their first-line regimen for clinical/immunological failure, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)28
Laboratory Plus Clinical Monitoring (LCM)35

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LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 72

Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.) (NCT02028676)
Timeframe: Baseline, week 72

Interventionabsolute cells per mm3 (Mean)
Clinically Driven Monitoring (CDM)408
Laboratory Plus Clinical Monitoring (LCM)385
Arm A: ABC+3TC+NNRTI402
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance447
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance336

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LCM vs CDM, Induction ART: Height-for-age Z-score

Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 4 years (maximum 5 years)

Interventionage-adjusted z-score (Mean)
Clinically Driven Monitoring (CDM)0.36
Laboratory Plus Clinical Monitoring (LCM)0.43
Arm A: ABC+3TC+NNRTI0.40
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance0.40
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance0.38

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LCM vs CDM, Induction ART: New ART-modifying Adverse Event

Number of participants with a new ART-modifying adverse event, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)31
Laboratory Plus Clinical Monitoring (LCM)32
Arm A: ABC+3TC+NNRTI8
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance30
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance25

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LCM vs CDM, Induction ART: New or Recurrent WHO Stage 3 or 4 Event or Death

Number of participants with a new or recurrent WHO stage 3 or 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)91
Laboratory Plus Clinical Monitoring (LCM)79
Arm A: ABC+3TC+NNRTI64
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance53
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance53

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LCM vs CDM, Induction ART: New WHO Stage 3 or 4 Event or Death

Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)77
Laboratory Plus Clinical Monitoring (LCM)73
Arm A: ABC+3TC+NNRTI73
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance61
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance54

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LCM vs CDM, Induction ART: Weight-for-age Z-score

Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 4 years (maximum 5 years)

Interventionage-adjusted z-score (Mean)
Clinically Driven Monitoring (CDM)0.76
Laboratory Plus Clinical Monitoring (LCM)0.78
Arm A: ABC+3TC+NNRTI0.72
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance0.79
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance0.80

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LCM vs CDM: Change From Baseline in CD4% to Week 144

(NCT02028676)
Timeframe: Baseline, week 144

Interventionpercentage of total lymphocytes (Mean)
Clinically Driven Monitoring (CDM)19.7
Laboratory Plus Clinical Monitoring (LCM)19.4

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LCM vs CDM: Change From Baseline in CD4% to Week 72

(NCT02028676)
Timeframe: Baseline, week 72

Interventionpercentage of total lymphocytes (Mean)
Clinically Driven Monitoring (CDM)17.2
Laboratory Plus Clinical Monitoring (LCM)16.7

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LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death

Number of participants with disease progression to a new WHO stage 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)47
Laboratory Plus Clinical Monitoring (LCM)39

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Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)

Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks. (NCT02028676)
Timeframe: Mean over median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)

Intervention% of visits reporting missed pills (Mean)
Once-daily ABC+3TC8
Twice-daily ABC+3TC8

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Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 48 Weeks

Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 48 weeks. (NCT02028676)
Timeframe: 48 weeks after randomization to once- versus twice-daily

Interventionparticipants (Number)
Once-daily ABC+3TC32
Twice-daily ABC+3TC29

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Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 96 Weeks

Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 96 weeks. (NCT02028676)
Timeframe: 96 weeks after randomization to once- versus twice-daily

Interventionparticipants (Number)
Once-daily ABC+3TC26
Twice-daily ABC+3TC25

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Once Versus Twice Daily Abacavir+Lamivudine: All-cause Mortality

Number of participants who died, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)

Interventionparticipants (Number)
Once-daily ABC+3TC1
Twice-daily ABC+3TC4

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Once Versus Twice Daily Abacavir+Lamivudine: Body Mass Index-for-age Z-score

Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)

Interventionage-adjusted z-score (Mean)
Once-daily ABC+3TC-0.29
Twice-daily ABC+3TC-0.35

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Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 48

Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.) (NCT02028676)
Timeframe: Randomisation to once vs twice daily, week 48

Interventioncells per mm3 (Mean)
Once-daily ABC+3TC3
Twice-daily ABC+3TC-3

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Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 96

All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured (NCT02028676)
Timeframe: Randomisation to once vs twice daily, week 96

Interventioncells per mm3 (Mean)
Once-daily ABC+3TC-26
Twice-daily ABC+3TC60

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Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 48

(NCT02028676)
Timeframe: Randomisation to once vs twice daily, week 48

Interventionpercentage of total lymphocytes (Mean)
Once-daily ABC+3TC0.9
Twice-daily ABC+3TC1.3

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Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 72

(NCT02028676)
Timeframe: Baseline, week 72

Interventionpercentage of total lymphocytes (Mean)
Once-daily ABC+3TC1.9
Twice-daily ABC+3TC1.9

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Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 96

(NCT02028676)
Timeframe: Randomisation to once vs twice daily, week 96

Interventionpercentage of lymphocytes (Mean)
Once-daily ABC+3TC1.6
Twice-daily ABC+3TC2.5

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Once Versus Twice Daily Abacavir+Lamivudine: Height-for-age Z-score

Age-adjusted change in height-for-age Z-score over all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)

Interventionage-adjusted z-score (Mean)
Once-daily ABC+3TC0.28
Twice-daily ABC+3TC0.32

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Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 3 or 4 Event or Death

Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)

Interventionparticipants (Number)
Once-daily ABC+3TC9
Twice-daily ABC+3TC12

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Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 4 Event or Death

Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)

Interventionparticipants (Number)
Once-daily ABC+3TC3
Twice-daily ABC+3TC7

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Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation

Number of participants with HIV RNA viral load <80 copies/ml at 48 weeks. Measured retrospectively on stored plasma specimens: due to low stored volumes from some children, samples had to be diluted and therefore a threshold of <80 copies/ml was used to indicate suppression. (NCT02028676)
Timeframe: 48 weeks

Interventionparticipants (Number)
Once-daily ABC+3TC236
Twice-daily ABC+3TC242

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Once Versus Twice Daily Abacavir+Lamivudine: Suppression of HIV RNA Viral Load 96 Weeks After Randomisation

Number of participants with HIV RNA viral load <80 copies/ml at 96 weeks. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes. (NCT02028676)
Timeframe: 96 weeks

Interventionparticipants (Number)
Once-daily ABC+3TC230
Twice-daily ABC+3TC234

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CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 144 Weeks After Baseline

Number of participants with HIV RNA viral load <80 copies/ml 144 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes. (NCT02028676)
Timeframe: 144 weeks

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)192
Laboratory Plus Clinical Monitoring (LCM)193
Arm A: ABC+3TC+NNRTI127
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance135
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance124

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Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 72

All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured (NCT02028676)
Timeframe: Baseline, week 72

Interventioncells per mm3 (Mean)
Once-daily ABC+3TC-6
Twice-daily ABC+3TC27

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Median Change HIV-1 RNA Level Among Participants Completing Week 24 Visit

(NCT02384395)
Timeframe: Baseline, Week 24

Interventioncopies/mL (Median)
DTG/3TC/ABC FDC-590211

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Number of Participants With Grade 3 or Higher Adverse Event (AE)

Sign/symptom, lab toxicity, or clinical events, or Grade 3 or higher AE that is definitely, probably, or possibly related to study treatment (NCT02384395)
Timeframe: Baseline through Week 96

InterventionParticipants (Count of Participants)
DTG/3TC/ABC FDC1

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Number of Participants With Viral Load Measurement <200 Copies/mL at Week 24

Total number of participants on study at Week 24 with an HIV-1 RNA level less than 200 copies/mL (NCT02384395)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
DTG/3TC/ABC FDC34

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Proportion of Treated Participants With HIV-1 RNA to <50 Copies/mL at Week 48

Proportion of participants completing Week 48 with an HIV-1 RNA level less than 50 copies/mL (NCT02384395)
Timeframe: Week 48

Interventionproportion of participants (Number)
DTG/3TC/ABC FDC0.88

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Parent/Guardian-reported Percent Adherence to Study Drug

Parent/guardian-reported percent adherence to study drug in the 30 days prior to the study visit according to adherence questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

,,,,
Interventionpercentage of study drug taken (Median)
Week 4Week 24Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)100.0100.0100.0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)100.0100.0100.0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)100.0100.0100.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)100.0100.0100.0
Weight Band #5 (25 kg or Greater at Study Entry)100.0100.0100.0

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Parent/Guardian-reported Number of Missed Doses of Study Drug

Parent/guardian-reported number of missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

,,,,
Interventionmissed doses (Median)
Week 4Week 24Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)000
Weight Band #2 (10 to Less Than 14 kg at Study Entry)000
Weight Band #3 (14 to Less Than 20 kg at Study Entry)000
Weight Band #4 (20 to Less Than 25 kg at Study Entry)000
Weight Band #5 (25 kg or Greater at Study Entry)000

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Median (Q1,Q3) Change From Baseline in Total Cholesterol

Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation. (NCT03760458)
Timeframe: Baseline, Weeks 24 and 48

,,,,
Interventionmmol/L (Median)
Baseline to Week 24Baseline to Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)-0.310.00
Weight Band #2 (10 to Less Than 14 kg at Study Entry)-0.70-0.50
Weight Band #3 (14 to Less Than 20 kg at Study Entry)-0.67-0.68
Weight Band #4 (20 to Less Than 25 kg at Study Entry)-0.32-0.25
Weight Band #5 (25 kg or Greater at Study Entry)-0.18-0.09

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Median (Q1,Q3) Change From Baseline in LDL

Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation. (NCT03760458)
Timeframe: Baseline, Weeks 24 and 48

,,,,
Interventionmmol/L (Median)
Baseline to Week 24Baseline to Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0.180.05
Weight Band #2 (10 to Less Than 14 kg at Study Entry)-0.20-0.13
Weight Band #3 (14 to Less Than 20 kg at Study Entry)-0.26-0.30
Weight Band #4 (20 to Less Than 25 kg at Study Entry)-0.220.00
Weight Band #5 (25 kg or Greater at Study Entry)-0.210.03

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Median (Q1,Q3) Change From Baseline in HDL

Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation. (NCT03760458)
Timeframe: Baseline, Weeks 24 and 48

,,,,
Interventionmmol/L (Median)
Baseline to Week 24Baseline to Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)-0.01-0.10
Weight Band #2 (10 to Less Than 14 kg at Study Entry)-0.06-0.20
Weight Band #3 (14 to Less Than 20 kg at Study Entry)-0.19-0.24
Weight Band #4 (20 to Less Than 25 kg at Study Entry)-0.15-0.19
Weight Band #5 (25 kg or Greater at Study Entry)-0.060.05

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Median (Q1, Q3) CD4+ Percentage

Per protocol, CD4+ cell count percentages were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

,,,,
Interventionpercentage of CD4+ in total lymphocytes (Median)
Week 4Week 24Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)41.636.634.8
Weight Band #2 (10 to Less Than 14 kg at Study Entry)33.935.234.1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)32.433.530.5
Weight Band #4 (20 to Less Than 25 kg at Study Entry)34.437.733.5
Weight Band #5 (25 kg or Greater at Study Entry)39.538.637.6

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Median (Q1, Q3) CD4+ Cell Count

Per protocol, CD4 + cell counts were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

,,,,
Interventioncells/mm^3 (Median)
Week 4Week 24Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)352822081853
Weight Band #2 (10 to Less Than 14 kg at Study Entry)138511841235
Weight Band #3 (14 to Less Than 20 kg at Study Entry)812894930
Weight Band #4 (20 to Less Than 25 kg at Study Entry)992944942
Weight Band #5 (25 kg or Greater at Study Entry)841920777

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Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC

Based on analysis of intensive PK samples. Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens. (NCT03760458)
Timeframe: Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.

,,,,
Interventionug/mL (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)7.307.402.29
Weight Band #2 (10 to Less Than 14 kg at Study Entry)8.368.853.55
Weight Band #3 (14 to Less Than 20 kg at Study Entry)6.267.042.92
Weight Band #4 (20 to Less Than 25 kg at Study Entry)6.657.292.99
Weight Band #5 (25 kg or Greater at Study Entry)9.046.254.15

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Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC

Based on analysis of intensive PK samples. The geometric mean C24h for each Weight Band was compared to the lower and upper reference values (in ug/mL) for DTG (0.67, 2.97). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens. (NCT03760458)
Timeframe: Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.

,,,,
Interventionug/mL (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0.0030.910.055
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0.0051.220.046
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0.0030.790.058
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0.0041.350.060
Weight Band #5 (25 kg or Greater at Study Entry)0.0110.980.084

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Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC

Based on analysis of intensive pharmacokinetic (PK) samples. The geometric mean AUC0-24h for each Weight Band was compared to the lower and upper reference values (in ug*h/mL) for DTG (35.1, 134), ABC (6.3, 50.4), and 3TC (6.3, 26.5). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens. (NCT03760458)
Timeframe: Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.

,,,,
Interventionh*ug/mL (Geometric Mean)
Abacavir (ABC)Dolutegravir (DTG)Lamivudine (3TC)
Weight Band #1 (6 to Less Than 10 kg at Study Entry)17.775.910.7
Weight Band #2 (10 to Less Than 14 kg at Study Entry)19.891.014.2
Weight Band #3 (14 to Less Than 20 kg at Study Entry)15.171.413.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)17.484.414.5
Weight Band #5 (25 kg or Greater at Study Entry)25.771.821.7

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Antiretroviral (ARV) Resistance Mutations

ARV resistance mutations at time of virologic failure and at entry for children with virologic failure. (NCT03760458)
Timeframe: Entry and confirmation of virologic failure

InterventionParticipants (Count of Participants)
Entry Visit: Integrase K14REntry Visit: Integrase A21TEntry Visit: Integrase V31IEntry Visit: Integrase V72IEntry Visit: Integrase L74IEntry Visit: Integrase T112VEntry Visit: Integrase V113IEntry Visit: Integrase T125AEntry Visit: Integrase V126LEntry Visit: Integrase G134NEntry Visit: Integrase I135VEntry Visit: Integrase K136REntry Visit: Integrase V165IEntry Visit: Integrase A196PEntry Visit: Integrase V236IEntry Visit: Integrase V281MEntry Visit: Integrase S283GEntry Visit: Protease L10VEntry Visit: Protease I13VEntry Visit: Protease G16EEntry Visit: Protease E35DEntry Visit: Protease M36IEntry Visit: Protease R41KEntry Visit: Protease K43REntry Visit: Protease H69KEntry Visit: Protease I72VEntry Visit: Protease L89MEntry Visit: Reverse Transcriptase E6DEntry Visit: Reverse Transcriptase K11TEntry Visit: Reverse Transcriptase K20REntry Visit: Reverse Transcriptase V35TEntry Visit: Reverse Transcriptase T39KEntry Visit: Reverse Transcriptase K43EEntry Visit: Reverse Transcriptase Q102KEntry Visit: Reverse Transcriptase K122EEntry Visit: Reverse Transcriptase D123SEntry Visit: Reverse Transcriptase C162SEntry Visit: Reverse Transcriptase T165IEntry Visit: Reverse Transcriptase K173AEntry Visit: Reverse Transcriptase Q174KEntry Visit: Reverse Transcriptase D177EEntry Visit: Reverse Transcriptase T200AEntry Visit: Reverse Transcriptase I202VEntry Visit: Reverse Transcriptase Q207AEntry Visit: Reverse Transcriptase L210MEntry Visit: Reverse Transcriptase R211SEntry Visit: Reverse Transcriptase V245EEntry Visit: Reverse Transcriptase A272PEntry Visit: Reverse Transcriptase R277KEntry Visit: Reverse Transcriptase T286AEntry Visit: Reverse Transcriptase L295L/IEntry Visit: Reverse Transcriptase E312NEntry Visit: Reverse Transcriptase I326VEntry Visit: Reverse Transcriptase I329VEntry Visit: Reverse Transcriptase G335DEntry Visit: Reverse Transcriptase M357KEntry Visit: Reverse Transcriptase K358REntry Visit: Reverse Transcriptase G359SEntry Visit: Reverse Transcriptase K366REntry Visit: Reverse Transcriptase A371VEntry Visit: Reverse Transcriptase T377SEntry Visit: Reverse Transcriptase K390REntry Visit: Reverse Transcriptase K395REntry Visit: Reverse Transcriptase A400T
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1111111111111111111111111111111111111111111111111111111111111111

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Percentage of Participants With at Least One Adverse Event Through Week 48

AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. (NCT03760458)
Timeframe: Measured from treatment initiation through Week 48

Interventionpercentage of participants (Number)
Weight Band #1 (6 to Less Than 10 kg at Study Entry)100.0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)90.9
Weight Band #3 (14 to Less Than 20 kg at Study Entry)100.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)100.0
Weight Band #5 (25 kg or Greater at Study Entry)90.0

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Percentage of Participants Who Experienced Virologic Failure Through Week 60

Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall. (NCT03760458)
Timeframe: Measured from treatment initiation through Week 60

Interventionpercentage of participants (Number)
OverallART-experiencedART-naive
Weight Band #1 (6 to Less Than 10 kg at Study Entry)12.50.033.3

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Percentage of Participants Who Had at Least One Adverse Event Through Week 60

AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. (NCT03760458)
Timeframe: Measured from treatment initiation through Week 60

Interventionpercentage of participants (Number)
Weight Band #1 (6 to Less Than 10 kg at Study Entry)100.0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)90.9
Weight Band #3 (14 to Less Than 20 kg at Study Entry)100.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)100.0
Weight Band #5 (25 kg or Greater at Study Entry)90.0

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Percentage of Participants Who Had at Least One Adverse Event Through Week 24

Adverse event (AE) grading was based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. AEs of any grade were reported. (NCT03760458)
Timeframe: Measured from treatment initiation through Week 24

Interventionpercentage of participants (Number)
Weight Band #1 (6 to Less Than 10 kg at Study Entry)100.0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)90.9
Weight Band #3 (14 to Less Than 20 kg at Study Entry)100.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)80.0
Weight Band #5 (25 kg or Greater at Study Entry)80.0

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

Viral loads less than the lower limit of quantification were imputed as one less than the lower limit. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

,,,,
Interventionpercentage of participants (Number)
Week 4Week 24Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)75.087.5100.0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)100.0100.0100.0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)100.0100.0100.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)100.0100.0100.0
Weight Band #5 (25 kg or Greater at Study Entry)100.0100.0100.0

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Median (Q1,Q3) Change From Baseline in Triglycerides

Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation. (NCT03760458)
Timeframe: Baseline, Weeks 24 and 48

,,,,
Interventionmmol/L (Median)
Baseline to Week 24Baseline to Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)-0.51-0.43
Weight Band #2 (10 to Less Than 14 kg at Study Entry)-0.51-0.32
Weight Band #3 (14 to Less Than 20 kg at Study Entry)-0.17-0.21
Weight Band #4 (20 to Less Than 25 kg at Study Entry)-0.200.00
Weight Band #5 (25 kg or Greater at Study Entry)-0.24-0.27

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Parent/Guardian-reported Reason for Missed Doses of Study Drug

Parent/guardian-reported reason for missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570429Week 472570430Week 472570431Week 472570427Week 472570428Week 2472570428Week 2472570430Week 2472570427Week 2472570429Week 2472570431Week 4872570429Week 4872570431Week 4872570428Week 4872570430Week 4872570427
Tried to spit it out because of taste (away from cNo missed dosesBoth parents were admitted in the hospitalCaregiver too sickCaregiver was too busy to give the medicationChange in daily routineForgot to administer medicationMom was in a hurry and forgot to give child medica
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0
Weight Band #5 (25 kg or Greater at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)8
Weight Band #2 (10 to Less Than 14 kg at Study Entry)10
Weight Band #3 (14 to Less Than 20 kg at Study Entry)14
Weight Band #4 (20 to Less Than 25 kg at Study Entry)10
Weight Band #5 (25 kg or Greater at Study Entry)0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)7
Weight Band #2 (10 to Less Than 14 kg at Study Entry)8
Weight Band #3 (14 to Less Than 20 kg at Study Entry)13
Weight Band #5 (25 kg or Greater at Study Entry)10
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)5
Weight Band #2 (10 to Less Than 14 kg at Study Entry)9
Weight Band #4 (20 to Less Than 25 kg at Study Entry)9

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Parent/Guardian-reported Ease of Giving Study Drug

Parent/guardian-reported ease of giving study drug according to palatability questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 12, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570431Week 472570427Week 472570428Week 472570429Week 472570430Week 1272570427Week 1272570428Week 1272570429Week 1272570430Week 1272570431Week 2472570427Week 2472570428Week 2472570429Week 2472570430Week 2472570431Week 4872570429Week 4872570427Week 4872570428Week 4872570430Week 4872570431
The child takes by themselves easilyThe child takes easily with helpThe child takes with help but you need to threatenYou need to hold and force the child
Weight Band #2 (10 to Less Than 14 kg at Study Entry)2
Weight Band #3 (14 to Less Than 20 kg at Study Entry)11
Weight Band #4 (20 to Less Than 25 kg at Study Entry)9
Weight Band #5 (25 kg or Greater at Study Entry)9
Weight Band #1 (6 to Less Than 10 kg at Study Entry)6
Weight Band #2 (10 to Less Than 14 kg at Study Entry)8
Weight Band #5 (25 kg or Greater at Study Entry)2
Weight Band #1 (6 to Less Than 10 kg at Study Entry)2
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)10
Weight Band #4 (20 to Less Than 25 kg at Study Entry)7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)5
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)3
Weight Band #3 (14 to Less Than 20 kg at Study Entry)12
Weight Band #4 (20 to Less Than 25 kg at Study Entry)8
Weight Band #5 (25 kg or Greater at Study Entry)8
Weight Band #2 (10 to Less Than 14 kg at Study Entry)6
Weight Band #3 (14 to Less Than 20 kg at Study Entry)3
Weight Band #5 (25 kg or Greater at Study Entry)3
Weight Band #2 (10 to Less Than 14 kg at Study Entry)4
Weight Band #4 (20 to Less Than 25 kg at Study Entry)6
Weight Band #5 (25 kg or Greater at Study Entry)10
Weight Band #1 (6 to Less Than 10 kg at Study Entry)8
Weight Band #2 (10 to Less Than 14 kg at Study Entry)5
Weight Band #3 (14 to Less Than 20 kg at Study Entry)4
Weight Band #4 (20 to Less Than 25 kg at Study Entry)2
Weight Band #5 (25 kg or Greater at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0
Weight Band #5 (25 kg or Greater at Study Entry)0

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Parent/Guardian-reported Response of Child's Face When Taking Study Drug

Parent/guardian-reported response of child's face when taking study drug according to palatability questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 12, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570427Week 472570428Week 472570429Week 472570430Week 472570431Week 1272570427Week 1272570428Week 1272570429Week 1272570431Week 1272570430Week 2472570427Week 2472570428Week 2472570429Week 2472570430Week 2472570431Week 4872570428Week 4872570429Week 4872570430Week 4872570431Week 4872570427
Very badVery goodGoodAverageBad
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0
Weight Band #5 (25 kg or Greater at Study Entry)5
Weight Band #3 (14 to Less Than 20 kg at Study Entry)10
Weight Band #2 (10 to Less Than 14 kg at Study Entry)2
Weight Band #1 (6 to Less Than 10 kg at Study Entry)2
Weight Band #2 (10 to Less Than 14 kg at Study Entry)3
Weight Band #3 (14 to Less Than 20 kg at Study Entry)4
Weight Band #5 (25 kg or Greater at Study Entry)6
Weight Band #3 (14 to Less Than 20 kg at Study Entry)5
Weight Band #5 (25 kg or Greater at Study Entry)2
Weight Band #1 (6 to Less Than 10 kg at Study Entry)4
Weight Band #2 (10 to Less Than 14 kg at Study Entry)4
Weight Band #3 (14 to Less Than 20 kg at Study Entry)3
Weight Band #5 (25 kg or Greater at Study Entry)3
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)2
Weight Band #5 (25 kg or Greater at Study Entry)0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)5
Weight Band #4 (20 to Less Than 25 kg at Study Entry)3
Weight Band #1 (6 to Less Than 10 kg at Study Entry)3
Weight Band #4 (20 to Less Than 25 kg at Study Entry)2
Weight Band #5 (25 kg or Greater at Study Entry)4
Weight Band #5 (25 kg or Greater at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)6
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0

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Percentage of Participants Who Experienced Virologic Failure Through Week 48

Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall. (NCT03760458)
Timeframe: Measured from treatment initiation through Week 48

Interventionpercentage of participants (Number)
OverallART-experiencedART-naive
Weight Band #1 (6 to Less Than 10 kg at Study Entry)12.50.033.3

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Percentage of Participants Who Experienced Virologic Failure Through Week 48

Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall. (NCT03760458)
Timeframe: Measured from treatment initiation through Week 48

,,,
Interventionpercentage of participants (Number)
OverallART-experienced
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0.00.0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0.00.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0.00.0
Weight Band #5 (25 kg or Greater at Study Entry)0.00.0

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Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to

Parent/guardian-reported response of how often the child received the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570431Week 472570428Week 472570430Week 472570427Week 472570429Week 2472570431Week 2472570427Week 2472570428Week 2472570429Week 2472570430Week 4872570430Week 4872570431Week 4872570427Week 4872570428Week 4872570429
AlwaysAlmost alwaysUsuallySometimesNever
Weight Band #1 (6 to Less Than 10 kg at Study Entry)8
Weight Band #2 (10 to Less Than 14 kg at Study Entry)9
Weight Band #3 (14 to Less Than 20 kg at Study Entry)14
Weight Band #4 (20 to Less Than 25 kg at Study Entry)10
Weight Band #5 (25 kg or Greater at Study Entry)10
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0
Weight Band #5 (25 kg or Greater at Study Entry)1
Weight Band #5 (25 kg or Greater at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)12
Weight Band #4 (20 to Less Than 25 kg at Study Entry)6
Weight Band #5 (25 kg or Greater at Study Entry)9
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)2
Weight Band #3 (14 to Less Than 20 kg at Study Entry)3
Weight Band #4 (20 to Less Than 25 kg at Study Entry)2
Weight Band #5 (25 kg or Greater at Study Entry)2
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)6
Weight Band #2 (10 to Less Than 14 kg at Study Entry)7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)13
Weight Band #4 (20 to Less Than 25 kg at Study Entry)9
Weight Band #5 (25 kg or Greater at Study Entry)11
Weight Band #2 (10 to Less Than 14 kg at Study Entry)3
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0

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Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm

Percentage of participants with virologic success of HIV-1 RNA less than 200 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

,,,,
Interventionpercentage of participants (Number)
Week 4Week 24Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)66.777.888.9
Weight Band #2 (10 to Less Than 14 kg at Study Entry)100.091.791.7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)100.0100.0100.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)100.0100.090.0
Weight Band #5 (25 kg or Greater at Study Entry)100.0100.0100.0

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Percentage of Participants Who Experienced Virologic Failure Through Week 60

Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall. (NCT03760458)
Timeframe: Measured from treatment initiation through Week 60

,,,
Interventionpercentage of participants (Number)
OverallART-experienced
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0.00.0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0.00.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0.00.0
Weight Band #5 (25 kg or Greater at Study Entry)0.00.0

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Parent/Guardian-reported Response of Child's Face When Taking Favorite Food

Parent/guardian-reported response of child's face when taking favorite food according to palatability questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 12, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570427Week 472570431Week 472570430Week 472570428Week 472570429Week 1272570427Week 1272570428Week 1272570430Week 1272570431Week 1272570429Week 2472570427Week 2472570428Week 2472570430Week 2472570431Week 2472570429Week 4872570427Week 4872570428Week 4872570429Week 4872570430Week 4872570431
AverageVery goodGoodBadVery bad
Weight Band #1 (6 to Less Than 10 kg at Study Entry)3
Weight Band #2 (10 to Less Than 14 kg at Study Entry)7
Weight Band #4 (20 to Less Than 25 kg at Study Entry)4
Weight Band #5 (25 kg or Greater at Study Entry)8
Weight Band #3 (14 to Less Than 20 kg at Study Entry)9
Weight Band #5 (25 kg or Greater at Study Entry)2
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)4
Weight Band #2 (10 to Less Than 14 kg at Study Entry)6
Weight Band #3 (14 to Less Than 20 kg at Study Entry)7
Weight Band #4 (20 to Less Than 25 kg at Study Entry)6
Weight Band #5 (25 kg or Greater at Study Entry)10
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)2
Weight Band #3 (14 to Less Than 20 kg at Study Entry)4
Weight Band #4 (20 to Less Than 25 kg at Study Entry)3
Weight Band #5 (25 kg or Greater at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)3
Weight Band #3 (14 to Less Than 20 kg at Study Entry)3
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0
Weight Band #5 (25 kg or Greater at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)6
Weight Band #3 (14 to Less Than 20 kg at Study Entry)8
Weight Band #2 (10 to Less Than 14 kg at Study Entry)4
Weight Band #3 (14 to Less Than 20 kg at Study Entry)5
Weight Band #4 (20 to Less Than 25 kg at Study Entry)2
Weight Band #3 (14 to Less Than 20 kg at Study Entry)2
Weight Band #1 (6 to Less Than 10 kg at Study Entry)8
Weight Band #4 (20 to Less Than 25 kg at Study Entry)7
Weight Band #5 (25 kg or Greater at Study Entry)11
Weight Band #3 (14 to Less Than 20 kg at Study Entry)6

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Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC

Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. (NCT03760458)
Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

,,,,
Interventionhours (Median)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1.002.002.00
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1.002.002.00
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1.002.002.00
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1.002.502.00
Weight Band #5 (25 kg or Greater at Study Entry)1.003.002.00

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Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC

Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. (NCT03760458)
Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

,,,,
Interventionug/mL (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)6.046.792.29
Weight Band #2 (10 to Less Than 14 kg at Study Entry)7.426.632.64
Weight Band #3 (14 to Less Than 20 kg at Study Entry)7.076.362.98
Weight Band #4 (20 to Less Than 25 kg at Study Entry)8.046.592.65
Weight Band #5 (25 kg or Greater at Study Entry)9.605.433.59

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Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC

Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. (NCT03760458)
Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

,,,,
Interventionhours (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)3.218.343.38
Weight Band #2 (10 to Less Than 14 kg at Study Entry)3.439.423.23
Weight Band #3 (14 to Less Than 20 kg at Study Entry)3.726.752.97
Weight Band #4 (20 to Less Than 25 kg at Study Entry)3.328.343.46
Weight Band #5 (25 kg or Greater at Study Entry)3.308.143.51

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Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC

Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. (NCT03760458)
Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

,,,,
Interventionug/mL (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0.011.080.01
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0.021.350.03
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0.010.710.02
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0.011.090.01
Weight Band #5 (25 kg or Greater at Study Entry)0.021.010.02

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Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC

Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. (NCT03760458)
Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

,,,,
Interventionug/mL (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0.011.080.01
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0.021.350.02
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0.010.710.01
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0.011.090.02
Weight Band #5 (25 kg or Greater at Study Entry)0.021.010.03

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Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC

Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. (NCT03760458)
Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

,,,,
Interventionug*h/mL (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)17.3082.209.97
Weight Band #2 (10 to Less Than 14 kg at Study Entry)18.9086.9014.90
Weight Band #3 (14 to Less Than 20 kg at Study Entry)17.2071.5013.60
Weight Band #4 (20 to Less Than 25 kg at Study Entry)19.5081.6013.10
Weight Band #5 (25 kg or Greater at Study Entry)26.1072.6020.30

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Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC

Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. (NCT03760458)
Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

,,,,
InterventionL/hour (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)10.400.189.03
Weight Band #2 (10 to Less Than 14 kg at Study Entry)12.700.238.04
Weight Band #3 (14 to Less Than 20 kg at Study Entry)17.400.3511.00
Weight Band #4 (20 to Less Than 25 kg at Study Entry)18.400.3713.80
Weight Band #5 (25 kg or Greater at Study Entry)23.000.6914.80

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Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm

Percentage of participants with virologic success of HIV-1 RNA less than 50 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

,,,,
Interventionpercentage of participants (Number)
Week 4Week 24Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)44.477.877.8
Weight Band #2 (10 to Less Than 14 kg at Study Entry)91.783.366.7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)86.793.386.7
Weight Band #4 (20 to Less Than 25 kg at Study Entry)80.0100.070.0
Weight Band #5 (25 kg or Greater at Study Entry)100.0100.090.9

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Parent/Guardian-reported Time for Study Drug Tablets to Dissolve

Parent/guardian-reported time for study drug tablets to dissolve according to acceptability questionnaire responses (NCT03760458)
Timeframe: Weeks 4, 12, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570429Week 472570428Week 472570427Week 472570430Week 1272570429Week 1272570427Week 1272570428Week 1272570430Week 2472570427Week 2472570428Week 2472570429Week 2472570430Week 4872570427Week 4872570428Week 4872570429Week 4872570430
Less than 1 minute1 to less than 3 minutes3 to 5 minutes
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)5
Weight Band #4 (20 to Less Than 25 kg at Study Entry)7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)4
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)5
Weight Band #2 (10 to Less Than 14 kg at Study Entry)7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)8
Weight Band #4 (20 to Less Than 25 kg at Study Entry)6
Weight Band #2 (10 to Less Than 14 kg at Study Entry)2
Weight Band #3 (14 to Less Than 20 kg at Study Entry)3
Weight Band #4 (20 to Less Than 25 kg at Study Entry)3
Weight Band #3 (14 to Less Than 20 kg at Study Entry)10
Weight Band #4 (20 to Less Than 25 kg at Study Entry)5
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)3
Weight Band #2 (10 to Less Than 14 kg at Study Entry)4
Weight Band #2 (10 to Less Than 14 kg at Study Entry)6
Weight Band #3 (14 to Less Than 20 kg at Study Entry)11
Weight Band #4 (20 to Less Than 25 kg at Study Entry)2
Weight Band #1 (6 to Less Than 10 kg at Study Entry)2
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)2
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0

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Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve

Parent/guardian-reported satisfaction with the number of study drug tablets to dissolve according to acceptability questionnaire responses (NCT03760458)
Timeframe: Weeks 4, 12, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570429Week 472570427Week 472570428Week 472570430Week 1272570427Week 1272570428Week 1272570429Week 1272570430Week 2472570429Week 2472570430Week 2472570427Week 2472570428Week 4872570429Week 4872570427Week 4872570430Week 4872570428
It is too fewIt is acceptableIt is too many
Weight Band #2 (10 to Less Than 14 kg at Study Entry)10
Weight Band #4 (20 to Less Than 25 kg at Study Entry)8
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #4 (20 to Less Than 25 kg at Study Entry)2
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)8
Weight Band #4 (20 to Less Than 25 kg at Study Entry)9
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)14
Weight Band #4 (20 to Less Than 25 kg at Study Entry)10
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)7
Weight Band #2 (10 to Less Than 14 kg at Study Entry)11
Weight Band #3 (14 to Less Than 20 kg at Study Entry)15
Weight Band #4 (20 to Less Than 25 kg at Study Entry)4
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0

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Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to

Parent/guardian-reported response of how well the person usually responsible administered the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570427Week 472570428Week 472570429Week 472570430Week 472570431Week 2472570427Week 2472570428Week 2472570429Week 2472570430Week 2472570431Week 4872570427Week 4872570428Week 4872570430Week 4872570431Week 4872570429
ExcellentVery goodGoodFairPoor
Weight Band #1 (6 to Less Than 10 kg at Study Entry)4
Weight Band #3 (14 to Less Than 20 kg at Study Entry)12
Weight Band #4 (20 to Less Than 25 kg at Study Entry)7
Weight Band #5 (25 kg or Greater at Study Entry)9
Weight Band #1 (6 to Less Than 10 kg at Study Entry)3
Weight Band #2 (10 to Less Than 14 kg at Study Entry)4
Weight Band #3 (14 to Less Than 20 kg at Study Entry)2
Weight Band #4 (20 to Less Than 25 kg at Study Entry)2
Weight Band #1 (6 to Less Than 10 kg at Study Entry)2
Weight Band #2 (10 to Less Than 14 kg at Study Entry)7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)10
Weight Band #4 (20 to Less Than 25 kg at Study Entry)5
Weight Band #1 (6 to Less Than 10 kg at Study Entry)5
Weight Band #2 (10 to Less Than 14 kg at Study Entry)3
Weight Band #3 (14 to Less Than 20 kg at Study Entry)4
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #5 (25 kg or Greater at Study Entry)2
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #4 (20 to Less Than 25 kg at Study Entry)3
Weight Band #5 (25 kg or Greater at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0
Weight Band #5 (25 kg or Greater at Study Entry)11
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0

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